# DeepHealth, Inc.

- Location (FDA's records): Somerville, MA
- FDA decisions: 10 (2021–2026): 10 510(k) clearances
- Product codes: QDQ (5), QIH (3), QFM (1), LLZ (1)
- 510(k) review time since 2016: median 139 days, against 153 for FDA's reviews in the same codes and years (5 of 10 faster)
- Predicates its devices cite: 10 (5 its own); citations of its devices by later devices: 6 (5 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Curemetrix, Inc.: 2 (https://510kreport.com/company/curemetrix)
- Siemens Healthcare GmbH: 1 (https://510kreport.com/company/siemens-healthcare)
- Screenpoint Medical B.V.: 1 (https://510kreport.com/company/screenpoint-medical)
- Densitas, Inc.: 1 (https://510kreport.com/company/densitas)

## Firms that cite its devices most
- Neurocareai, Inc. (Dba Savelife.Ai): 1 (https://510kreport.com/company/neurocareai-dba-savelife-ai)

## Its most-cited devices
- K251873: Saige-Dx (2025), cited by 1
- K203517: Saige-Q (2021), cited by 1
- K241747: Saige-Dx (2024), cited by 1
- K220105: Saige-Dx (2022), cited by 1
- K243688: Saige-Dx (3.1.0) (2024), cited by 1
- K222275: Saige-Density (2022), cited by 1

## Recent decisions
- K253825: Saige-Dx (Jun 15, 2026)
- K254131: BAC (May 21, 2026)
- K251873: Saige-Dx (Aug 11, 2025)
- K243703: TechLive (Jun 5, 2025)
- K243705: Saige-Density (2.5.0) (Dec 19, 2024)
- K243688: Saige-Dx (3.1.0) (Dec 19, 2024)
- K241747: Saige-Dx (Nov 18, 2024)
- K222275: Saige-Density (Dec 16, 2022)

Source page: https://510kreport.com/company/deephealth