Saige-Density

K222275

DeepHealth, Inc. · cleared 2022-12-16 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.5)

“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.”

Algorithmdeep learning techniques

source quote (p.5)

“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.”

Adaptive (vs locked)No

source quote (p.6)

“The data used in the validation testing was obtained from different clinical sites than those used to develop the Saige-Density algorithm. DeepHealth ensured that there was no overlap between the data used to train and test the Saige-Density algorithm.”

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (1)

Retrospective clinical

n=796 cases · 5 site(s)

endpoints: Accuracy of density category outputs

Reported performance (3 observations)

sensitivity0.952

source quote (p.7)

“dense (95.2%)”

specificity0.878

source quote (p.7)

“nondense (87.8%)”

accuracyas written: “Four-class categorization accuracy”0.8128CI 78.42, 83.84

source quote (p.6)

“Saige-Density's accuracy on four-class categorization (density categories A, B, C, or D) was 81.28% (95% CI: 78.42, 83.84).”

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

recalls in product code, 24mo

MAUDE reports in code, 12mo

—

vs code's own 3-yr baseline

drift signals on this device

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
re_clearance
The FDA AI/ML device list shows a newer 510(k) K243705 (decision 2024-12-19) from DeepHealth, Inc for a matching device line ("Saige-Density (2.5.0)") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K243705
re_clearance
The FDA AI/ML device list shows a newer 510(k) K243688 (decision 2024-12-19) from DeepHealth, Inc. for a matching device line ("Saige-Dx (3.1.0)") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K243688
re_clearance
The FDA AI/ML device list shows a newer 510(k) K241747 (decision 2024-11-18) 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:K241747

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).