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
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)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=796 cases · 5 site(s)

endpoints: accuracy of density category outputs

Reported performance (3 observations)

sensitivity0.952
source quote (p.7)
“(95.2%)”
specificity0.878
source quote (p.7)
“(87.8%)”
accuracyas written: “accuracy on four-class categorization”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

0
recalls in product code, 24mo
3
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
4
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); 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/K222275