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Philips Xd-S Direct Radiography Workstation/Package

by Philips Medical Systems North America Co.

510(k) K063781

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 · Traditional NumberK063781 Date5 Jan 2007ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2194-2010 FDA Unclassified (pre-2012) initiated 9 Jul 2008 on shared 510(k) K063781

    Potential for bright artifacts to appear on the patient image from a previous exposure.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
LLZ
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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