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560 High Definition Camera System

by Smith & Nephew, Inc.

510(k) K070266

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK070266 Date22 Feb 2007ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1479-2012 FDA Not yet classified initiated 29 Mar 2012

    May experience intermittent loss of video due to a defective board component

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  • Withdrawn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
GCJ
Device class
Class II
Regulation
21 CFR Part 876.1500
Advisory committee
Gastroenterology, Urology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The 560 High Definition Camera System is a high-definition endoscopic imaging device designed for use in gastroenterology and urology procedures. It features a 3-CCD (charge-coupled device) configuration to deliver broadcast-quality HD 1080i imaging, enabling clear and detailed visualization of internal anatomical structures during endoscopic examinations. This system is classified under product code GCJ and is intended for specialized medical imaging applications requiring superior resolution and color fidelity.

The device is supplied as a reusable medical instrument and is intended for use in controlled clinical settings such as operating rooms or endoscopy suites. It is not sterile upon delivery and must be cleaned, disinfected, and maintained according to manufacturer guidelines. The system includes high-definition outputs (HD-SDI) for compatibility with both analog and digital displays, ensuring flexibility in integration with existing medical imaging infrastructure. Regulatory clearance under FDA 510K (K070266) confirms its compliance with U.S. medical device standards for endoscopic imaging systems.

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