Ceevra Reveal 4— 510(k) K261595
Substantially EquivalentCeevra, Inc.
FDA 510(k) clearance K261595 for Ceevra Reveal 4, Substantially Equivalent on 2026-08-25. Applicant: Ceevra, Inc.. Device class: 2.
Summary
Ceevra's Reveal 4 is filed under product code QIH, automated radiological image processing software. The record has no description beyond the name and that code name.
Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel. The submission was a Traditional 510(k).
Ceevra filed from San Francisco, California. The decision came 103 calendar days after FDA received it (May 14 to August 25, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Ceevra, Inc.
- Product code
- Product code QIH
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Francisco, CA, US
Recent devices under product code QIH
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