Laser Alignment Tool

No FDA recalls on record, checked 10 Oct 2026.

510(k) Number

K943381 ↗

FDA Product Code

IWE

Device Class

Class I

Regulation

21 CFR Part 892.5780

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Tomoscan Stereotaxis Simulation Software

  Class II

  FDA 510(k) K900660 Active Cleared 13 Mar 1990

• Integris 3D-Ra, Release 4.2

  Class II

  FDA 510(k) K040254 Active Cleared 19 Feb 2004

• Ep Navigator R3

  Class II

  FDA 510(k) K101311 Active Cleared 30 Sep 2010

• Orthoralix Sd/Orthoralix Sd Ceph

  Class II

  FDA 510(k) K890351 Active Cleared 15 Jun 1989

• Doppler Option for Platinum

  Class II

  FDA 510(k) K900002 Active Cleared 2 Apr 1990

• Philips Bucky Diagnost Family

  Class II

  FDA 510(k) K945278 Active Cleared 14 Dec 1994

See all devices from Philips Medical Systems North America, Inc. →