MRCAT brain

K193109

Philips Medical Systems MR Finland · cleared 2020-01-24 · product code MUJ · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.3)

“MRCAT Brain is a software add-on for Ingenia, Ingenia Ambition, and Ingenia Elition MR systems.”

Algorithmconvolutional neural network (CNN)

source quote (p.6)

“The intensity normalized images are then used as input in a convolutional neural network (CNN).”

Adaptive (vs locked)No

source quote (p.6)

“The training of the CNN is locked and is not adapted during use.”

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (1)

Retrospective clinical

sample size not stated

endpoints: gamma analysis criterion 2%/2mm realized in 98% of voxels within the PTV or exceeding 75% of the maximum dose; average simulated dose based on MRCAT Brain shall not deviate more than 5% or 1 Gy, whichever is greater, in 99% of the indicated patients in the volume of sensitive organs

standards: ANSI/AAMI ES60601-1: 2012, IEC 60601-1-6:2010, IEC 60601-2-33:2015, IEC 62304:2016, IEC 62366-1:2015, ISO 14971:2007

Reported performance (2 observations)

accuracyas written: “geometric accuracy (1mm)”1CI ± 1 mm

source quote (p.14)

“MRCAT accuracy: ± 1 mm accuracy: 200 mm diameter sphere”

accuracyas written: “geometric accuracy (5mm)”5CI ± 5 mm

source quote (p.14)

“± 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

recalls in product code, 24mo

MAUDE reports in code, 12mo

-50%

vs code's own 3-yr baseline

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).