510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K250655Substantially Equivalent

Deep Capsule® (Deep Capsule US)

Digestaid - Artificial Intelligence Development SA, Gondomar, PT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K250655 is the FDA 510(k) clearance record for Deep Capsule® (Deep Capsule US), a class II device, cleared for Digestaid - Artificial Intelligence Development SA on under FDA product code QZF (Gastrointestinal Capsule Endoscopy Analysis Software Device). FDA's definition for product code QZF reads: "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...". FDA records list one 510(k) clearance for Digestaid - Artificial Intelligence Development SA. As of , FDA records show no recalls naming K250655.

Clearance record

Decision date
Received
(372 days to decision)
Product code
QZF Gastrointestinal Capsule Endoscopy Analysis Software Device
Regulation
21 CFR 876.1540
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Digestaid - Artificial Intelligence Development SA Rua Particular Carlos Fontes, 117, São Cosme, Gondomar, PT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QZF

Trailing 12 months
2 clearances under product code QZF in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QZF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260