510(k) Report

FDA applicant

DeepHealth, Inc.

Somerville, MA10 decisions2021–20260 recalls

FDA records 10 decisions for DeepHealth, Inc. (Somerville, MA) from 2021 to 2026: 10 510(k) clearances. Most are in product codes QDQ (Radiological Computer Assisted…) and QIH (Automated Radiological Image Processing Software). Since 2016 its 510(k)s took a median of 139 days from receipt to decision, against 153 for FDA’s reviews in the same codes and years. Its devices cite 10 predicates, 5 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided DeepHealth, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2021: 12022: 22024: 32025: 22026 (partial year): 2
2021high 3 (2024) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — DeepHealth, Inc. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like DeepHealth, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • QDQRadiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For…5decisions
  • QIHAutomated Radiological Image Processing Software3decisions
  • QFMRadiological Computer-Assisted Prioritization Software For Lesions1decision
  • LLZSystem, Image Processing, Radiological1decision

How long do its 510(k) reviews take?

Since 2016, its 10 510(k)s took a median of 139 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 153 days; 5 of its 10 were faster than that.

Whose devices does it build on?

Its devices cite 10 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 5 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K251873Saige-DxDeepHealth, Inc. · 20251cites it
  • K203517Saige-QDeepHealth, Inc. · 20211cites it
  • K241747Saige-DxDeepHealth, Inc. · 20241cites it
  • K220105Saige-DxDeepHealth, Inc. · 20221cites it
  • K243688Saige-Dx (3.1.0)DeepHealth, Inc. · 20241cites it
  • K222275Saige-DensityDeepHealth, Inc. · 20221cites it

What has FDA decided for it lately?

  • K253825Saige-DxDeepHealth, Inc. · 2026
  • K254131BACDeepHealth, Inc. · 2026
  • K251873Saige-DxDeepHealth, Inc. · 2025
  • K243703TechLiveDeepHealth, Inc. · 2025
  • K243705Saige-Density (2.5.0)DeepHealth, Inc. · 2024
  • K243688Saige-Dx (3.1.0)DeepHealth, Inc. · 2024
  • K241747Saige-DxDeepHealth, Inc. · 2024
  • K222275Saige-DensityDeepHealth, Inc. · 2022

All 10 as DeepHealth, Inc. →