DeviceClearance

Product code QZF— Gastroenterology, Urology

Deep Capsule® (Deep Capsule US)

Classification name
Gastrointestinal Capsule Endoscopy Analysis Software Device
Device class
Class 2
Regulation
21 CFR 876.1540
Advisory panel
Gastroenterology, Urology
Total cleared
2
First cleared
Most recent

FDA classification definition

“A gastrointestinal capsule endoscopy analysis software device is used to analyze pre-recorded capsule endoscopy videos of the gastrointestinal tract that are suspected of containing lesions. This device uses software algorithms to identify images and areas of interest as outputs to aid the clinician in analyzing suspected lesions, for clinician review of device outputs. The device may contain hardware to support interfacing with a capsule imaging system.”

— U.S. Food and Drug Administration, device classification record for product code QZF under 21 CFR 876.1540, via openFDA

Market context for product code QZF

FDA has cleared 2 devices under product code QZF between 2023 and 2026, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QZF

Recent clearances under product code QZF

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