RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; (Elements) Spine SRS; (Elements) Cranial SRS w/ Cones; (Elements) RT Planning Platform; (Elements) Dose Review; (Elements) Retreatment Review; Elements Segmentation [Cranial , Basal Ganglia, Head & Neck, Pelvic, Spine, Thoracic & Spine, Extracranial] RT; Elements AI Tumor Segmentation RT; Elements SmartBrush [Angio, Spine] RT; Elements Object Management RT
K250440Brainlab AG · cleared 2025-06-17 · product code MUJ · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“RT Elements are computed-based software applications for radiation therapy treatment planning and dose optimization for linac-based conformal radiation treatments, i.e. stereotactic radiosurgery (SRS), fractionated stereotactic radiotherapy (SRT) or stereotactic ablative radiotherapy (SBRT), also known as stereotactic body radiation therapy (SBRT) for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions.The device is composed by software only and can be controlled via mouse and keyboard. The software is displayed on a computer screen.”
source quote (p.6)
“The Cranial Tumor Segmentation feature uses AI/ML. The algorithm was trained on MRI image data with contrast-enhancing tumors from multiple clinical sites, including a wide variety of scanner models and patient characteristics.”
Validation studies (2)
Retrospective clinical
n=412 patients
endpoints: Dice coefficient; Recall; Precision
Bench
sample size not stated
Reported performance (15 observations)
source quote (p.15)
“All 0.75 [0.74; 0.76]”
source quote (p.15)
“All 0.86 [0.85; 0.88]”
source quote (p.15)
“All 0.85 [0.83; 0.87]”
source quote (p.15)
“Metastases to the CNS 0.74 [0.73; 0.75]”
source quote (p.15)
“Metastases to the CNS 0.85 [0.83; 0.87]”
source quote (p.15)
“Metastases to the CNS 0.84 [0.82; 0.86]”
source quote (p.16)
“Meningiomas 0.76 [0.73; 0.79]”
source quote (p.16)
“Meningiomas 0.89 [0.84; 0.94]”
source quote (p.16)
“Meningiomas 0.90 [0.85; 0.94]”
source quote (p.16)
“Cranial and paraspinal nerve tumors 0.89 [0.88; 0.90]”
source quote (p.16)
“Cranial and paraspinal nerve tumors 0.97 [0.93; 1.0]”
source quote (p.16)
“Cranial and paraspinal nerve tumors 0.97 [0.93; 1.0]”
source quote (p.16)
“Gliomas and glio-/neuronal tumors 0.81 [0.76; 0.86]”
source quote (p.16)
“Gliomas and glio-/neuronal tumors 0.95 [0.88; 1.0]”
source quote (p.16)
“Gliomas and glio-/neuronal tumors 0.85 [0.74; 0.94]”
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
- 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).