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by Imaging Sciences Intl., Inc.

510(k) K051980

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 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 · Traditional NumberK051980 Date19 Aug 2005ClearedStatusActive

Recalls

3 recalls · FDA

    • Terminated Z-3018-2011 FDA Unclassified (pre-2012) initiated 15 Dec 2010

    Recalling firm received a customer complaint regarding a defective X-ray tube head and power supply

    • Terminated Z-0543-2010 FDA Unclassified (pre-2012) initiated 30 Oct 2009

    overhead carriage drops quickly

    • Terminated Z-1645-2008 FDA Unclassified (pre-2012) initiated 19 Mar 2008

    incorrect scatter labeling

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  • Withdrawn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
JAK
Device Class
Class II
Regulation
21 CFR Part 892.1750
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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