Saige-Dx
K251873DeepHealth, Inc. · cleared 2025-08-11 · product code QDQ · Radiology
Premarket evidence — what FDA accepted
source quote (p.6)
“Saige-Dx is a software device that processes screening mammograms using artificial intelligence to aid interpreting radiologists.”
source quote (p.6)
“Saige-Dx is a software device that processes screening mammograms using artificial intelligence to aid interpreting radiologists.”
Validation studies (2)
Retrospective clinical
n=2,002 cases · 12 site(s)
endpoints: to demonstrate that the performance of the subject device was non-inferior to the performance of the predicate device
standards: ISO 14971:2019 – Medical Devices – Application of Risk Management to Medical Devices (#5-125), IEC 62304:2015 – Medical Device Software – Software Life Cycles Processes (#13-79), NEMA PS3 – Digital Imaging and Communications in Medicine (DICOM) Set (#12-300), Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May, 2005), Guidance for Industry and FDA Staff: Software as a Medical Devices (SAMD): Clinical Evaluation (December 2017)
Reader study (MRMC)
sample size not stated
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).