Data / Medical devices / United States / Deephealth
Deephealth: FDA-registered device maker in Somerville, MA, United States, 24 510(k) clearances
Deephealth is registered with the FDA (registration 3018733944) in Somerville, MA, United States. It lists 5 device types. The FDA files 24 510(k) clearances under its listings, the newest dated June 15, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3018733944
- Address
- 212 Elm St., Somerville, MA, United States, 02144
- Owner or operator
- DeepHealth (10081546)
- Roles
- Manufacturer
- First device listed
- April 22, 2021
- Registered through
- 2026
- Brand names listed
- Brain Age, Brain WMH, Breast Arterial Calcification (BAC), DeepHealth Prostate AI, DeepHealth Viewer, Mammo Density, PracticeBuilder 1-2-3, ProFound Pro and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Manufacturer | accessdata.fda.gov |
| Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer | QDQ | 2 | Manufacturer | accessdata.fda.gov |
| Radiological Computer-Assisted Prioritization Software For Lesions | QFM | 2 | Manufacturer | accessdata.fda.gov |
| System, Digital Image Communications, Radiological | LMD | 1 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 15, 2026 | K253825 | Saige-Dx | QDQ | Substantially Equivalent | DeepHealth, Inc. | accessdata.fda.gov |
| May 21, 2026 | K254131 | BAC | QIH | Substantially Equivalent | DeepHealth, Inc. | accessdata.fda.gov |
| April 29, 2026 | K253682 | DeepHealth ProstateAI | QDQ | Substantially Equivalent | Quantib B.V. | accessdata.fda.gov |
| September 25, 2025 | K251527 | Brain WMH | QIH | Substantially Equivalent | Quantib B.V. | accessdata.fda.gov |
| August 11, 2025 | K251873 | Saige-Dx | QDQ | Substantially Equivalent | DeepHealth, Inc. | accessdata.fda.gov |
| June 5, 2025 | K243703 | TechLive | LLZ | Substantially Equivalent | DeepHealth, Inc. | accessdata.fda.gov |
| December 19, 2024 | K243705 | Saige-Density (2.5.0) | QIH | Substantially Equivalent | DeepHealth, Inc. | accessdata.fda.gov |
| December 19, 2024 | K243688 | Saige-Dx (3.1.0) | QDQ | Substantially Equivalent | DeepHealth, Inc. | accessdata.fda.gov |
| November 18, 2024 | K241747 | Saige-Dx | QDQ | Substantially Equivalent | DeepHealth, Inc. | accessdata.fda.gov |
| October 31, 2024 | K241223 | eRAD PACS | LLZ | Substantially Equivalent | Erad, Inc. | accessdata.fda.gov |
| April 17, 2023 | K230772 | Quantib Prostate | LLZ | Substantially Equivalent | Quantib B.V. | accessdata.fda.gov |
| December 16, 2022 | K222275 | Saige-Density | QIH | Substantially Equivalent | DeepHealth, Inc. | accessdata.fda.gov |
| May 13, 2022 | K221106 | Quantib Prostate | LLZ | Substantially Equivalent | Quantib B.V. | accessdata.fda.gov |
| May 12, 2022 | K220105 | Saige-Dx | QDQ | Substantially Equivalent | DeepHealth, Inc. | accessdata.fda.gov |
| January 14, 2022 | K213737 | Quantib ND | LLZ | Substantially Equivalent | Quantib B.V. | accessdata.fda.gov |
| April 16, 2021 | K203517 | Saige-Q | QFM | Substantially Equivalent | DeepHealth, Inc. | accessdata.fda.gov |
| October 11, 2020 | K202501 | Quantib Prostate | LLZ | Substantially Equivalent | Quantib B.V. | accessdata.fda.gov |
| September 30, 2020 | K192051 | THINQ | LLZ | Substantially Equivalent | Corticometrics, LLC | accessdata.fda.gov |
| June 15, 2020 | K200899 | Quantib AI Node | LLZ | Substantially Equivalent | Quantib B.V. | accessdata.fda.gov |
| December 27, 2018 | K182564 | Quantib ND | LLZ | Substantially Equivalent | Quantib B.V. | accessdata.fda.gov |
| March 9, 2018 | K173939 | Quantib Brain | LLZ | Substantially Equivalent | Quantib B.V. | accessdata.fda.gov |
| January 6, 2017 | K163013 | Quantib Brain 1.2 | LLZ | Substantially Equivalent | Quantib B.V. | accessdata.fda.gov |
| June 17, 2016 | K153351 | Quantib Brain 1 | LLZ | Substantially Equivalent | Quantib B.V. | accessdata.fda.gov |
| December 3, 2012 | K120995 | ERAD PACS/ERAD RIS/PACS/ERAD EPVLITE VIEWER SOFTWARE PRODUCT | LLZ | Substantially Equivalent | Erad, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Image Processing, Radiological
- All makers of System, Digital Image Communications, Radiological
- All makers of Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
- All makers of Automated Radiological Image Processing Software
- All makers of Radiological Computer-Assisted Prioritization Software For Lesions
Updated June 15, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.