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Endocapsule Software 10; Endocapsule Software 10 Light

by Olympus Medical Systems Corp.

510(k) K142680

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 6 Oct 2026.

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK142680 Date8 Feb 2015ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
NEZ
Models / Variants
Device class
Class II
Regulation
21 CFR Part 876.1300
Advisory committee
Gastroenterology, Urology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Endocapsule Software 10 is a wireless gastrointestinal imaging system designed for capsule endoscopy. It captures high-resolution images of the small intestine using a swallowable capsule equipped with an imaging device, transmitting data wirelessly for diagnostic review. This system is classified as a gastrointestinal wireless capsule imaging system and is intended for visualizing the mucosal surface of the small bowel.

The Endocapsule Software 10 is supplied as a software platform for use with compatible wireless capsule endoscopes, enabling real-time imaging and data processing. It operates in a clinical setting, with the capsule ingested by the patient and the software installed on a dedicated workstation for analysis. The system is classified under FDA 510(k) clearance (K142680) and is intended for single-use capsules, though the software itself may be reusable across multiple procedures. No specific sterility or MRI safety information is provided for the software platform.

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