510(k) K254230
- Device
- CapsoView (CVV); CapsoCloud (CLD)
- Applicant
- CapsoVision, Inc.
- 510(k) number
- K254230
- Product code
- QZF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-09-25
- Date received
- 2025-12-29
- Regulation
- 876.1540
- Classification name
- Gastrointestinal Capsule Endoscopy Analysis Software Device
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Azimun Jamal
- Address
- 18805 Cox Ave. Suite 250 Saratoga CA US 95070 95070
FDA Registration Numbers#
- 3016544248