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Practix Convenio

by Philips Medical Systems North America Co.

510(k) K042368

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

4 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 · Abbreviated NumberK042368 Date4 Oct 2004ClearedStatusActive

Recalls

4 recalls · FDA

    • Terminated Z-1689-2012 FDA Not yet classified initiated 2 May 2012

    Unexpected Low-level X-ray pulse

  • 3 recalls, same reason

    • Terminated Z-0764-2007 FDA Unclassified (pre-2012) initiated 23 Mar 2007
    • Terminated Z-0763-2007 FDA Unclassified (pre-2012) initiated 23 Mar 2007
    • Terminated Z-0762-2007 FDA Unclassified (pre-2012) initiated 23 Mar 2007

    X-ray systems lack product report certification demonstrating compliance, and were illegally introduced into the United States commerce.

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  • Withdrawn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
IZL
Device Class
Class II
Regulation
21 CFR Part 892.1720
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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