SubtleSYNTH (1.x)

K241329

Subtle Medical, Inc. · cleared 2024-07-11 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.3)
“SubtleSYNTH is a software as a medical device consisting of a software machine learning algorithm that synthesizes a SynthSTIR contrast image of a case from T1-weighted and T2-weighted spine MR images.”
Algorithmconvolutional neural network-based algorithm
source quote (p.5)
“SubtleSYNTH uses a convolutional neural network-based algorithm to synthesize an image with desired contrast weighting from other, previously obtained sequences such as T1- and T2-weighted images.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedYes
source quote (p.5)
“Users are provided cybersecurity recommendations in labeling.”

Validation studies (4)

Retrospective clinical

n=80 cases

endpoints: interchangeability of the SynthSTIR against the acquired STIR using Root Mean Square Error (RMSE); pairwise tissue contrast heatmap among the tissues; full Bland-Altman analysis

Bench

n=80 cases

endpoints: Root Mean Square Error (RMSE) between the reference STIR and the SynthSTIR; pairwise tissue contrast heatmap among the tissues; Bland-Altman analysis for each tissue

Reader study (MRMC)

n=104 cases

endpoints: interchangeability between acquired STIR and SynthSTIR images is not significantly greater than 10%

Reader study (MRMC)

n=104 cases

endpoints: interchangeability between acquired STIR and SynthSTIR images is not significantly greater than 10%

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

0
recalls in product code, 24mo
3
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device

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/K241329