MRCAT Head & Neck
K214081Philips Oy · cleared 2022-04-05 · product code MUJ · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“MRCAT Head & Neck is a software application to Ingenia, Ingenia Ambition, and Ingenia Elition MR systems. MRCAT Head and Neck functionality is implemented as a software plug-in for the MR main software”
source quote (p.5)
“MRCAT algorithm enables automatic tissue characterization: Bones are segmented from mDixon in-phase and water images using machine learning based segmentation. The intensity normalized images are then used as input in a convolutional neural network (CNN).”
source quote (p.6)
“The training of the CNN is locked and is not adapted during use. Both algorithms are locked; they do not change after installation based on new data during the use.”
Validation studies (2)
Retrospective clinical
sample size not stated
endpoints: The simulated dose based on MRCAT Head & Neck images shall not differ in 95% of the indicated patients (gamma analysis criterion 2%/2mm realized in 98% of voxels within the PTV or exceeding 75% of the maximum dose) when compared with CT-based plan.; The average simulated dose based on MRCAT Head & Neck shall not deviate more than 5% or 1 Gy, which ever is greater, in 99% of the indicated patients in the volume of sensitive organs when compared with CT based plan.
standards: ANSI/AAMI ES60601-1: 2012, IEC 60601-1-6:2010, IEC 60601-2-33:2015, IEC 62304:2016, IEC 62366-1:2020, ISO 14971:2019
Bench
sample size not stated
endpoints: MRCAT accuracy: ± 1 mm accuracy: 200 mm diameter sphere; MRCAT accuracy: ± 2 mm accuracy: 400 mm diameter sphere (limited in the bore direction by +/- 160 mm from the z=0 mm plane); MRCAT accuracy: ± 5 mm accuracy: 500 mm diameter sphere (limited in the bore direction by +/- 160 mm from the z=0 mm plane)
standards: ANSI/AAMI ES60601-1: 2012, IEC 60601-1-6:2010, IEC 60601-2-33:2015, IEC 62304:2016, IEC 62366-1:2020, ISO 14971:2019
Reported performance (3 observations)
source quote (p.12)
“MRCAT accuracy: ± 1 mm accuracy: 200 mm diameter sphere”
source quote (p.12)
“MRCAT accuracy: ± 2 mm accuracy: 400 mm diameter sphere (limited in the bore direction by +/- 160 mm from the z=0 mm plane)”
source quote (p.12)
“MRCAT accuracy: ± 5 mm accuracy: 500 mm diameter sphere (limited in the bore direction by +/- 160 mm from the z=0 mm plane)”
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).