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.”
Algorithmmachine learning based segmentation, convolutional neural network (CNN)
source quote (p.6)
“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). The CNN is trained using matched pairs of CT and MRCAT source images.”
Adaptive (vs locked)No
source quote (p.6)
“The training of the CNN is locked and is not adapted during use.”
PCCPNo
Cybersecurity addressedNo

Validation studies (2)

Retrospective clinical

sample size not stated

endpoints: The simulated dose based on MRCAT Brain 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 Brain 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.

Bench

sample size not stated

endpoints: ± 1 mm accuracy: 200 mm diameter sphere; ± 5 mm accuracy: 500 mm diameter sphere (limited in the bore direction by +/- 160 mm from the z=0 mm plane)

Reported performance (2 observations)

accuracyas written: “Geometric accuracy (1mm)”1
source quote (p.14)
“± 1 mm accuracy: 200 mm diameter sphere”
accuracyas written: “Geometric accuracy (5mm)”5
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

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); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K193109