SubtleSYNTH (1.x)
K241329Subtle Medical, Inc. · cleared 2024-07-11 · product code QIH · Radiology
Premarket evidence — what FDA accepted
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.”
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. 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.”
source quote (p.5)
“The SubtleSYNTH device itself is not networked and therefore does not increase the cybersecurity risk of its users. Users are provided cybersecurity recommendations in labeling.”
Validation studies (3)
Bench
n=80 cases
endpoints: assess the interchangeability of the SynthSTIR against the acquired STIR using Root Mean Square Error (RMSE), pairwise tissue contrast heatmap among the tissues, and a full Bland-Altman analysis
Reader study (MRMC)
n=104 cases
endpoints: interchangeability between acquired STIR and SynthSTIR images is not significantly greater than 10%; radiologists classify them into primary categories as well as secondary categories
Reader study (MRMC)
n=104 cases
endpoints: interchangeability between acquired STIR and SynthSTIR images is not significantly greater than 10%; radiologists classify them into primary categories as well as secondary categories
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
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).