Saige-Dx

K220105

DeepHealth, Inc. · cleared 2022-05-12 · product code QDQ · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.5)

“Saige-Dx is a software device that processes screening mammograms using artificial intelligence to aid interpreting radiologists.”

Algorithmartificial intelligence

source quote (p.5)

“Saige-Dx is a software device that processes screening mammograms using artificial intelligence to aid interpreting radiologists.”

Adaptive (vs locked)No

source quote (p.6)

“DeepHealth ensured that there was no overlap between the data used to train and test the Saige-Dx AI algorithm.”

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (2)

Reader study (MRMC)

n=240 cases

endpoints: compare breast cancer detection performance of radiologists reading with the aid of Saige-Dx versus without Saige-Dx

Retrospective clinical

n=1,304 cases · 9 site(s)

Reported performance (2 observations)

aurocas written: “auc”0.93CI 0.902, 0.958

source quote (p.7)

“Saige-Dx exhibited an AUC of 0.930 (95% CI: 0.902, 0.958) on the dataset”

aurocas written: “Aided Reader Study AUC”0.925

source quote (p.7)

“The reader performance increased with the aid of Saige-Dx from an average AUC of 0.865 when unaided to 0.925 when aided (difference of 0.06; 95% CI: 0.041, 0.079, p < 0.00001).”

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
re_clearance
The FDA AI/ML device list shows a newer 510(k) K222275 (decision 2022-12-16) from DeepHealth, Inc. for a matching device line ("Saige-Density") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K222275

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).