MOZI TPS
K223724Manteia Technologies Co., Ltd. · cleared 2023-07-10 · product code MUJ · Radiology
Premarket evidence — what FDA accepted
Device typesamd
source quote (p.4)
“The proposed device, MOZI Treatment Planning System (MOZI TPS), is a standalone software which is used to plan radiotherapy treatments (RT) for patients with malignant or benign diseases.”
AlgorithmMonte Carlo based algorithm for dose calculation; deep learning method for automatic contouring of structure delineation.
source quote (p.5)
“For dose calculation, the subject device incorporates a Monte Carlo based algorithm while the predicate device an AAA/AXB based algorithm. And it also uses deep learning method for automatic contouring of structure delineation.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.13)
“The cybersecurity of the subject device has been comprehensively risk assessed and tested, and has traceability. Corresponding supporting documents are provided in this submission.”
Validation studies (6)
Bench
sample size not stated
endpoints: verify the IMRT/VMAT performance; accuracy in clinically relevant settings according to specification
standards: AAPM TG-119 Report
Bench
sample size not stated
endpoints: evaluate the performance in formulating external irradiation photon therapy plan; equivalent performance in dose calculation
Bench
sample size not stated
endpoints: evaluate the deformable registration accuracy; NMI and HD values of the proposed device was non-inferiority compares with that of the predicate device
Bench
sample size not stated
endpoints: met the requirements for the safety of radiotherapy treatment planning systems
standards: IEC 62083-2009 Standard
Retrospective clinical
n=18 patients
endpoints: test results are all passed that the entire workflow for the treatment planning have been adequately validated prior to the treatment of patients
Bench
n=38 images
endpoints: equivalent performance in segmentation; Mean Dice Similarity Coefficient (DSC) values
Reported performance (61 observations)
diceas written: “Mean DSC values (Brain)”0.98
source quote (p.11)
“The DSC values of the subject device's auto segmentation on the testing image set with 38 sample size are as follows: ... Brain 0.98 0.01”
diceas written: “Mean DSC values (Brainstem)”0.88
source quote (p.11)
“The DSC values of the subject device's auto segmentation on the testing image set with 38 sample size are as follows: ... Brainstem 0.88 0.03”
diceas written: “Mean DSC values (BrachialPlexus L)”0.61
source quote (p.11)
“The DSC values of the subject device's auto segmentation on the testing image set with 38 sample size are as follows: ... BrachialPlexus L 0.61 0.05”
diceas written: “Mean DSC values (BrachialPlexus R)”0.64
source quote (p.11)
“The DSC values of the subject device's auto segmentation on the testing image set with 38 sample size are as follows: ... BrachialPlexus R 0.64 0.05”
diceas written: “Mean DSC values (Esophagus - Head&Neck)”0.84
source quote (p.11)
“The DSC values of the subject device's auto segmentation on the testing image set with 38 sample size are as follows: ... Esophagus 0.84 0.02”
diceas written: “Mean DSC values (Eye-L)”0.93
source quote (p.11)
“The DSC values of the subject device's auto segmentation on the testing image set with 38 sample size are as follows: ... Eye-L 0.93 0.02”
diceas written: “Mean DSC values (Eye-R)”0.93
source quote (p.12)
“The DSC values of the subject device's auto segmentation on the testing image set with 38 sample size are as follows: ... Eye-R 0.93 0.02”
diceas written: “Mean DSC values (InnerEar-L)”0.78
source quote (p.12)
“The DSC values of the subject device's auto segmentation on the testing image set with 38 sample size are as follows: ... InnerEar-L 0.78 0.06”
diceas written: “Mean DSC values (InnerEar-R)”0.82
source quote (p.12)
“The DSC values of the subject device's auto segmentation on the testing image set with 38 sample size are as follows: ... InnerEar-R 0.82 0.04”
diceas written: “Mean DSC values (Larynx)”0.87
source quote (p.12)
“The DSC values of the subject device's auto segmentation on the testing image set with 38 sample size are as follows: ... Larynx 0.87 0.02”
diceas written: “Mean DSC values (Lens-L)”0.77
source quote (p.12)
“The DSC values of the subject device's auto segmentation on the testing image set with 38 sample size are as follows: ... Lens-L 0.77 0.07”
diceas written: “Mean DSC values (Lens-R)”0.72
source quote (p.12)
“The DSC values of the subject device's auto segmentation on the testing image set with 38 sample size are as follows: ... Lens-R 0.72 0.08”
diceas written: “Mean DSC values (Mandible)”0.9
source quote (p.12)
“The DSC values of the subject device's auto segmentation on the testing image set with 38 sample size are as follows: ... Mandible 0.90 0.02”
diceas written: “Mean DSC values (MiddleEar L)”0.73
source quote (p.12)
“The DSC values of the subject device's auto segmentation on the testing image set with 38 sample size are as follows: ... MiddleEar L 0.73 0.04”
diceas written: “Mean DSC values (MiddleEar R)”0.74
source quote (p.12)
“The DSC values of the subject device's auto segmentation on the testing image set with 38 sample size are as follows: ... MiddleEar R 0.74 0.04”
diceas written: “Mean DSC values (OpticNerve_L)”0.61
source quote (p.12)
“The DSC values of the subject device's auto segmentation on the testing image set with 38 sample size are as follows: ... OpticNerve_L 0.61 0.07”
diceas written: “Mean DSC values (OpticNerve_R)”0.62
source quote (p.12)
“The DSC values of the subject device's auto segmentation on the testing image set with 38 sample size are as follows: ... OpticNerve_R 0.62 0.08”
diceas written: “Mean DSC values (OralCavity)”0.9
source quote (p.12)
“The DSC values of the subject device's auto segmentation on the testing image set with 38 sample size are as follows: ... OralCavity 0.90 0.03”
diceas written: “Mean DSC values (OpticChiasm)”0.64
source quote (p.12)
“The DSC values of the subject device's auto segmentation on the testing image set with 38 sample size are as follows: ... OpticChiasm 0.64 0.10”
diceas written: “Mean DSC values (Parotid-L)”0.83
source quote (p.12)
“The DSC values of the subject device's auto segmentation on the testing image set with 38 sample size are as follows: ... Parotid-L 0.83 0.03”
diceas written: “Mean DSC values (Parotid-R)”0.83
source quote (p.12)
“The DSC values of the subject device's auto segmentation on the testing image set with 38 sample size are as follows: ... Parotid-R 0.83 0.04”
diceas written: “Mean DSC values (PharyngealConstrictors_U)”0.87
source quote (p.12)
“The DSC values of the subject device's auto segmentation on the testing image set with 38 sample size are as follows: ... PharyngealConstrictors_U 0.87 0.03”
diceas written: “Mean DSC values (PharyngealConstrictors_M)”0.88
source quote (p.12)
“The DSC values of the subject device's auto segmentation on the testing image set with 38 sample size are as follows: ... PharyngealConstrictors_M 0.88 0.02”
diceas written: “Mean DSC values (PharyngealConstrictors_L)”0.87
source quote (p.12)
“The DSC values of the subject device's auto segmentation on the testing image set with 38 sample size are as follows: ... PharyngealConstrictors_L 0.87 0.03”
diceas written: “Mean DSC values (Pituitary)”0.74
source quote (p.12)
“The DSC values of the subject device's auto segmentation on the testing image set with 38 sample size are as follows: ... Pituitary 0.74 0.14”
diceas written: “Mean DSC values (SpinalCord - Head&Neck)”0.85
source quote (p.12)
“The DSC values of the subject device's auto segmentation on the testing image set with 38 sample size are as follows: ... SpinalCord 0.85 0.04”
diceas written: “Mean DSC values (Submandibular L)”0.86
source quote (p.12)
“The DSC values of the subject device's auto segmentation on the testing image set with 38 sample size are as follows: ... Submandibular L 0.86 0.04”
diceas written: “Mean DSC values (Submandibular R)”0.87
source quote (p.12)
“The DSC values of the subject device's auto segmentation on the testing image set with 38 sample size are as follows: ... Submandibular R 0.87 0.03”
diceas written: “Mean DSC values (TemporalLobe_L)”0.89
source quote (p.12)
“The DSC values of the subject device's auto segmentation on the testing image set with 38 sample size are as follows: ... TemporalLobe_L 0.89 0.03”
diceas written: “Mean DSC values (TemporalLobe_R)”0.89
source quote (p.12)
“The DSC values of the subject device's auto segmentation on the testing image set with 38 sample size are as follows: ... TemporalLobe_R 0.89 0.03”
diceas written: “Mean DSC values (Thyroid)”0.86
source quote (p.12)
“The DSC values of the subject device's auto segmentation on the testing image set with 38 sample size are as follows: ... Thyroid 0.86 0.03”
diceas written: “Mean DSC values (TMJ L)”0.79
source quote (p.12)
“The DSC values of the subject device's auto segmentation on the testing image set with 38 sample size are as follows: ... TMJ L 0.79 0.06”
diceas written: “Mean DSC values (TMJ R)”0.74
source quote (p.12)
“The DSC values of the subject device's auto segmentation on the testing image set with 38 sample size are as follows: ... TMJ R 0.74 0.06”
diceas written: “Mean DSC values (Trachea - Head&Neck)”0.9
source quote (p.12)
“The DSC values of the subject device's auto segmentation on the testing image set with 38 sample size are as follows: ... Trachea 0.90 0.02”
diceas written: “Mean DSC values (Esophagus - Thorax)”0.8
source quote (p.12)
“The DSC values of the subject device's auto segmentation on the testing image set with 38 sample size are as follows: ... Esophagus 0.80 0.05”
diceas written: “Mean DSC values (Heart)”0.98
source quote (p.12)
“The DSC values of the subject device's auto segmentation on the testing image set with 38 sample size are as follows: ... Heart 0.98 0.01”
diceas written: “Mean DSC values (Lung_L)”0.99
source quote (p.12)
“The DSC values of the subject device's auto segmentation on the testing image set with 38 sample size are as follows: ... Lung_L 0.99 0.00”
diceas written: “Mean DSC values (Lung_R)”0.99
source quote (p.12)
“The DSC values of the subject device's auto segmentation on the testing image set with 38 sample size are as follows: ... Lung_R 0.99 0.00”
diceas written: “Mean DSC values (Spinal Cord - Thorax)”0.97
source quote (p.12)
“The DSC values of the subject device's auto segmentation on the testing image set with 38 sample size are as follows: ... Spinal Cord 0.97 0.02”
diceas written: “Mean DSC values (Trachea - Thorax)”0.95
source quote (p.12)
“The DSC values of the subject device's auto segmentation on the testing image set with 38 sample size are as follows: ... Trachea 0.95 0.02”
diceas written: “Mean DSC values (Duodenum)”0.64
source quote (p.12)
“The DSC values of the subject device's auto segmentation on the testing image set with 38 sample size are as follows: ... Duodenum 0.64 0.05”
diceas written: “Mean DSC values (Kidney_L)”0.96
source quote (p.12)
“The DSC values of the subject device's auto segmentation on the testing image set with 38 sample size are as follows: ... Kidney_L 0.96 0.02”
diceas written: “Mean DSC values (Kidney_R)”0.97
source quote (p.12)
“The DSC values of the subject device's auto segmentation on the testing image set with 38 sample size are as follows: ... Kidney_R 0.97 0.01”
diceas written: “Mean DSC values (Liver)”0.95
source quote (p.12)
“The DSC values of the subject device's auto segmentation on the testing image set with 38 sample size are as follows: ... Liver 0.95 0.02”
diceas written: “Mean DSC values (Pancreas)”0.79
source quote (p.12)
“The DSC values of the subject device's auto segmentation on the testing image set with 38 sample size are as follows: ... Pancreas 0.79 0.04”
diceas written: “Mean DSC values (SpinalCord - Abdomen)”0.82
source quote (p.12)
“The DSC values of the subject device's auto segmentation on the testing image set with 38 sample size are as follows: ... SpinalCord 0.82 0.02”
diceas written: “Mean DSC values (Stomach)”0.89
source quote (p.12)
“The DSC values of the subject device's auto segmentation on the testing image set with 38 sample size are as follows: ... Stomach 0.89 0.02”
diceas written: “Mean DSC values (Bladder - Pelvic-Man)”0.92
source quote (p.12)
“The DSC values of the subject device's auto segmentation on the testing image set with 38 sample size are as follows: ... Bladder 0.92 0.03”
diceas written: “Mean DSC values (BowelBag - Pelvic-Man)”0.89
source quote (p.12)
“The DSC values of the subject device's auto segmentation on the testing image set with 38 sample size are as follows: ... BowelBag 0.89 0.04”
diceas written: “Mean DSC values (FemurHead L - Pelvic-Female)”0.96
source quote (p.13)
“The DSC values of the subject device's auto segmentation on the testing image set with 38 sample size are as follows: ... FemurHead L 0.96 0.02”
diceas written: “Mean DSC values (FemurHead R - Pelvic-Female)”0.95
source quote (p.13)
“The DSC values of the subject device's auto segmentation on the testing image set with 38 sample size are as follows: ... FemurHead R 0.95 0.02”
diceas written: “Mean DSC values (Marrow - Pelvic-Female)”0.89
source quote (p.13)
“The DSC values of the subject device's auto segmentation on the testing image set with 38 sample size are as follows: ... Marrow 0.89 0.02”
diceas written: “Mean DSC values (Rectum - Pelvic-Female)”0.77
source quote (p.13)
“The DSC values of the subject device's auto segmentation on the testing image set with 38 sample size are as follows: ... Rectum 0.77 0.04”
diceas written: “Mean DSC values (FemurHead L - Pelvic-Man)”0.96
source quote (p.13)
“The DSC values of the subject device's auto segmentation on the testing image set with 38 sample size are as follows: ... FemurHead L 0.96 0.02”
diceas written: “Mean DSC values (FemurHead R - Pelvic-Man)”0.95
source quote (p.13)
“The DSC values of the subject device's auto segmentation on the testing image set with 38 sample size are as follows: ... FemurHead R 0.95 0.02”
diceas written: “Mean DSC values (Marrow - Pelvic-Man)”0.9
source quote (p.13)
“The DSC values of the subject device's auto segmentation on the testing image set with 38 sample size are as follows: ... Marrow 0.90 0.02”
diceas written: “Mean DSC values (Prostate)”0.85
source quote (p.13)
“The DSC values of the subject device's auto segmentation on the testing image set with 38 sample size are as follows: ... Prostate 0.85 0.04”
diceas written: “Mean DSC values (Rectum - Pelvic-Man)”0.88
source quote (p.13)
“The DSC values of the subject device's auto segmentation on the testing image set with 38 sample size are as follows: ... Rectum 0.88 0.03”
diceas written: “Mean DSC values (SeminalVesicle)”0.72
source quote (p.13)
“The DSC values of the subject device's auto segmentation on the testing image set with 38 sample size are as follows: ... SeminalVesicle 0.72 0.07”
diceas written: “Mean DSC values (Bladder - Pelvic-Man)”0.88
source quote (p.13)
“The DSC values of the subject device's auto segmentation on the testing image set with 38 sample size are as follows: ... Bladder 0.88 0.02”
diceas written: “Mean DSC values (BowelBag - Pelvic-Man)”0.87
source quote (p.13)
“The DSC values of the subject device's auto segmentation on the testing image set with 38 sample size are as follows: ... BowelBag 0.87 0.02”
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
35
recalls in product code, 24mo
17
MAUDE reports in code, 12mo
-50%
vs code's own 3-yr baseline
2
drift signals on this device
- recall_reason_pattern
Software/algorithm-related recall in product code MUJ (Philips Medical Systems (Cleveland) Inc, initiated 2025-08-05): "Due to a software issue, there is a potential image error of the Region of Interest for expansion/contraction for HFP (Head First Prone), FFS (Feet First Supine) and FFP (Feet Firs" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:97049
- recall_reason_pattern
Software/algorithm-related recall in product code MUJ (Philips Medical Systems (Cleveland) Inc, initiated 2025-07-17): "Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the "Stopping Power Ratio" (SPR) ," Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:97309
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).