SubtleMR

K203182

Subtle Medical, Inc. · cleared 2021-02-26 · 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.”

Algorithmconvolutional neural network-based algorithm

source quote (p.5)

“The software uses a convolutional neural network-based algorithm to improve image quality by reducing noise or enhancing the image sharpness.”

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.”

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (1)

Retrospective clinical

sample size not stated

endpoints: signal-to-noise ratio (SNR) of a selected region of interest (ROI) in each test dataset is on average improved by greater than or equal to 5% after SubtleMR enhancement compared to the original images; the visibility of small structures in the test datasets before and after SubtleMR is on average less than or equal to 0.5 Likert scale points; the thickness of anatomic structure and the sharpness of structure boundaries are improved after SubtleMR enhancement in at least 90% of the test datasets

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

recalls in product code, 24mo

295

MAUDE reports in code, 12mo

+683%

vs code's own 3-yr baseline

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
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
recall_reason_pattern
Software/algorithm-related recall in product code LLZ (Focalyx Technologies, LLC., initiated 2025-12-23): "Software device that is an accessory for image-guided interventional and diagnostic procedures involving prostate has accessories that may not function properly with Windows 10, wh" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98137
…and 21 more.

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).