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by Imaging Sciences Intl., Inc.

510(k) K061284

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 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 NumberK061284 Date3 Jul 2006ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-1265-2009 FDA Unclassified (pre-2012) initiated 8 Jan 2009

    faulty calibration

    • Terminated Z-1646-2008 FDA Unclassified (pre-2012) initiated 19 Mar 2008

    Incorrect scatter information in the manual.

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  • Withdrawn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
MUH
Device Class
Class II
Regulation
21 CFR Part 872.1800
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

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