SubtleMR

K191688

Subtle Medical, Inc. · cleared 2019-09-16 · product code LLZ · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“SubtleMR is Software as a Medical Device (SaMD) consisting of a software algorithm that enhances images taken by MRI scanners.”
Algorithmimage enhancement algorithm using convolutional neural network based filtering. Original images are enhanced by running through a cascade of filter banks, where thresholding and scaling operations are applied. Separate neural network based filters are obtained for noise reduction and sharpness increase. The parameters of the filters were obtained through an image-guided optimization process.
source quote (p.6)
“SubtleMR software implements an image enhancement algorithm using convolutional neural network based filtering. Original images are enhanced by running through a cascade of filter banks, where thresholding and scaling operations are applied. Separate neural network based filters are obtained for noise reduction and sharpness increase. The parameters of the filters were obtained through an image-guided optimization process.”
Adaptive (vs locked)No
source quote (p.5)
“For each choice, there is a fixed set of parameters and the algorithm is working as a fixed nonlinear filter.”
PCCPNo
Cybersecurity addressedNo

Validation studies (3)

Bench

sample size not stated

Retrospective clinical

sample size not stated

endpoints: signal-to-noise ratio (SNR) improvement

Retrospective clinical

sample size not stated

endpoints: improvement in thickness of anatomic structure; improvement in sharpness of structure boundaries; visibility of small structures

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

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

48
recalls in product code, 24mo
295
MAUDE reports in code, 12mo
+683%
vs code's own 3-yr baseline
28
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K223623 (decision 2023-05-11) from Subtle Medical Inc. for a matching device line ("SubtleMR (2.3.x)") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K223623

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K203182 (decision 2021-02-26) from Subtle Medical, Inc. for a matching device line ("SubtleMR") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K203182

  • adverse_event_inflection

    MAUDE adverse-event reports for product code LLZ: 295 in the 12 months ending 2026-06, vs a 37.7/12mo average over the prior 3 windows (+683%). Code-level count — reports are not attributed to this specific device.

    first seen 2026-07-08 · openFDA /device/event.json count=date_received product_code=LLZ

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (GE Medical Systems SCS, initiated 2026-05-08): "GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When a user selects a patient or exam in the AW Server Web Client worklist and launches" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:99042

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands, initiated 2026-03-05): "Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display out of sequence." Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:98520

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (GE Medical Systems, LLC, initiated 2026-01-30): "There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, w" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:98428

  • …and 22 more.

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/K191688