SubtleMR

K191688

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

FDA 510(k) summary for SubtleMR (K191688)

Constat organizes this clearance into predicate context, validation evidence, reported performance, postmarket signals, and reimbursement links. Each extracted claim stays tied to the public FDA source; missing fields remain explicitly unstated.

Validation studies
3
Cited predicates
1
Performance observations
0
Product code
LLZ
Official FDA 510(k) database record ↗FDA 510(k) source PDF ↗

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

25
recalls in product code, 24mo
397
MAUDE reports in code, 12mo
+963%
vs code's own 3-yr baseline
32
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

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (Merge Healthcare, Inc., initiated 2026-07-22): "Software issue may cause measurements to be displayed inaccurately." Recalling firm is another firm in the same product code.

    first seen 2026-09-02 · recall res_event_number:99520

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (FUJIFILM Healthcare Americas Corporation, initiated 2026-07-22): "Software issue may cause the ruler measurement to be inaccurate." Recalling firm is another firm in the same product code.

    first seen 2026-09-02 · recall res_event_number:99529

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (Merge Healthcare, Inc., initiated 2026-06-30): "Merge Healthcare has identified a potential issue that may cause thumbnails from a previously opened patient study to be displayed in the Thumbnail Bar while a different patient st" Recalling firm is another firm in the same product code.

    first seen 2026-09-02 · recall res_event_number:99391

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (Boston Scientific Corporation, initiated 2026-06-19): "Software anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the Activity Calculator to modify one or more input. When a user modifies an inpu" Recalling firm is another firm in the same product code.

    first seen 2026-09-02 · recall res_event_number:99236

  • …and 26 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 2026-09-02.

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.

Related FDA clearances

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These are recent clearances in the same FDA product-code category. Shared classification does not by itself make a device an appropriate predicate.

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Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K191688