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)FDA source did not state this
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 (3 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, demonstrating strong performance relative to the unaided reader performance in the reader study.”
aurocas written: “Reader Study AUC (aided)”0.925CI 0.041, 0.079
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).”
aurocas written: “Reader Study AUC (unaided)”0.865
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

0
recalls in product code, 24mo
0
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
5
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); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K220105