Cemax Sparcstation Imaging Software and Workstatio

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K905801 ↗

FDA Product Code

LLZ

Device Class

Class II

Regulation

21 CFR Part 892.2050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Cemax Vipstation(Tm) and/or Software

  Class II

  FDA 510(k) K932372 Active Cleared 22 Nov 1993

• Cemax Clinicalview Station And/Or Software

  Class II

  FDA 510(k) K932371 Active Cleared 18 Feb 1994

• Cemax Vipstation and/or Software

  Class II

  FDA 510(k) K945188 Active Cleared 2 Aug 1995

• Cemax 5000 Multidimensional Imaging Workstation

  Class II

  FDA 510(k) K880169 Active Cleared 9 Mar 1988

• Archivemanager

  Class I

  FDA 510(k) K950513 Active Cleared 13 Nov 1995

• Cemax Scanlink V

  Class II

  FDA 510(k) K943357 Active Cleared 22 Nov 1994