Saige-Density (2.5.0)
K243705DeepHealth, Inc · cleared 2024-12-19 · product code QIH · Radiology
Premarket evidence — what FDA accepted
source quote (p.6)
“Saige-Density is Software as a Medical Device that processes screening and diagnostic digital mammograms using deep learning techniques and generates outputs that serve as an aid for interpreting radiologists in assessing breast density.”
source quote (p.6)
“Saige-Density is Software as a Medical Device that processes screening and diagnostic digital mammograms using deep learning techniques and generates outputs that serve as an aid for interpreting radiologists in assessing breast density.”
Validation studies (2)
Bench
sample size not stated
endpoints: software unit testing; software integration testing; system testing
Retrospective clinical
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
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K251873 (decision 2025-08-11) from DeepHealth, Inc. for a matching device line ("Saige-Dx") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K251873
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).