Saige-Dx

K241747

DeepHealth, Inc · cleared 2024-11-18 · product code QDQ · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.6)

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

Algorithmartificial intelligence (AI)/machine learning algorithms

source quote (p.7)

“Both the subject and predicate devices are software systems that use artificial intelligence (AI)/machine learning algorithms that analyze mammography images to detect and characterize findings and provide information regarding the presence and location of the findings to the user.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (1)

Retrospective clinical

n=1,804 patients · 12 site(s)

endpoints: demonstrate substantial equivalence of the subject device on compatible exams as compared to the performance of the predicate device on previously compatible exams, as defined as the lower bound of the 95% CI around the delta AUC between Hologic and GE cases as compared to Hologic only exams greater than the non-inferiority margin

standards: ISO 14971:2019, IEC 62304:2015, NEMA PS3, Guidance for Industry and FDA Staff Content of Premarket Submission for Device Software Functions (June 2023), Guidance for Industry and FDA Staff: Software as a Medical Devices (SAMD): Clinical Evaluation (December 2017)

Reported performance (1 observation)

aurocas written: “auc”0.91CI 0.886, 0.933

source quote (p.8)

“The case-level AUC on the compatible exams was 0.910 (0.886, 0.933).”

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

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).