Samsung Raypax Long Term Archive

No FDA recalls found in the data synced 10 Oct 2026.

510(k) Number

K992131 ↗

FDA Product Code

LMB

Device Class

Class I

Regulation

21 CFR Part 892.2010

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Samsung Raypax Film Digitizer

  Class II

  FDA 510(k) K992112 Active Cleared 9 Sep 1999

• Samsung 10DR Implant System

  Class II

  FDA 510(k) K002062 Active Cleared 9 Nov 2000

• Samsung Raypax System

  Class I

  FDA 510(k) K991537 Active Cleared 6 Jul 1999

• Raypax Web Clinical System

  Class I

  FDA 510(k) K992426 Active Cleared 13 Oct 1999

• Samsung Raypax Display Workstation

  Class II

  FDA 510(k) K992306 Active Cleared 22 Sep 1999