DeviceClearance

CapsoView (CVV); CapsoCloud (CLD)— 510(k) K254230

Substantially Equivalent

CapsoVision, Inc.

FDA 510(k) clearance K254230 for CapsoView (CVV); CapsoCloud (CLD), Substantially Equivalent on 2026-09-25. Applicant: CapsoVision, Inc.. Device class: 2.

Summary

CapsoVision, Inc. cleared two software products together: CapsoView (CVV) and CapsoCloud (CLD). They're filed under QZF, gastrointestinal capsule endoscopy analysis software. That code covers software used to review and analyze capsule endoscopy images. The record doesn't break down what each product does.

Class II, 21 CFR 876.1540. The Gastroenterology and Urology panel reviewed it as a Traditional 510(k).

CapsoVision filed from Saratoga, California. Review took 270 days (December 29, 2025 to September 25, 2026).

Clearance details

Applicant
CapsoVision, Inc.
Product code
Product code QZF
Device class
Class 2
Regulation
21 CFR 876.1540
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Saratoga, CA, US
Download summary PDFView on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.