Saige-Dx (3.1.0)

K243688

DeepHealth, Inc. · cleared 2024-12-19 · 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 (2)

Reader study (MRMC)

sample size not stated

standards: ISO 14971:2019, IEC 62304:2015, NEMA PS3, Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May, 2005), Guidance for Industry and FDA Staff: Software as a Medical Devices (SAMD): Clinical Evaluation (December 2017)

Standalone

sample size not stated

standards: ISO 14971:2019, IEC 62304:2015, NEMA PS3, Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May, 2005), Guidance for Industry and FDA Staff: Software as a Medical Devices (SAMD): Clinical Evaluation (December 2017)

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

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
1
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

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/K243688