510(k) clearance
CapsoView (CVV); CapsoCloud (CLD)
- 510(k) number
- K254230
- Applicant
- CapsoVision, Inc.
- Decision date
- Sep 25, 2026
- Date received
- Dec 29, 2025
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- QZF
- Device type
- Gastrointestinal Capsule Endoscopy Analysis Software Device
- Device class
- Class II
- Regulation
- 21 CFR 876.1540
- Advisory committee
- Gastroenterology, Urology
- Statement or summary
- Summary
- Third party
- N
- Location
- Saratoga, CA, US