Data / Medical devices / United States / Precision Medical Ventures, Inc. Dba Revealdx
Precision Medical Ventures, Inc. Dba Revealdx: FDA-registered device maker in Seattle, WA, United States, 2 510(k) clearances
Precision Medical Ventures, Inc. Dba Revealdx is registered with the FDA (registration 3044622018) in Seattle, WA, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 30, 2026. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3044622018
- Address
- 1800 Westlake Ave N Ste 104, Seattle, WA, United States, 98109
- Owner or operator
- Precision Medical Ventures, Inc. dba RevealDx (10095483)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- March 18, 2026
- Registered through
- 2027
- Brand names listed
- ReViewer, RevealAI-Lung
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer | POK | 2 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| January 30, 2026 | K251769 | RevealAI-Lung | POK | Substantially Equivalent | Precision Medical Ventures, Inc. Dba Revealdx | accessdata.fda.gov |
| December 6, 2022 | K222320 | MedDream | LLZ | Substantially Equivalent | Softneta Uab | accessdata.fda.gov |
Compare with other makers
- All makers of Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
- All makers of System, Image Processing, Radiological
Updated January 30, 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.