Home / 510(k) Clearances / K933512

510(k) K933512

UPSCAN by Merlin Engineering Works, Inc. — Product Code KPR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 1995
Date Received
July 20, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Stationary
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type

Other clearances by Merlin Engineering Works, Inc.

  • K974882 — DOWNSCAN LT (May 22, 1998)
  • K971153 — SPLITSCREEN (ME-975) (June 25, 1997)
  • K971154 — MULTIPICS(ME-977) (June 25, 1997)
  • K970451 — DOWNSCAN 120 (April 7, 1997)
  • K970450 — UPSCAN 120 (April 1, 1997)
  • K954211 — CRISPICS (December 5, 1995)
  • K953398 — UNISCAN (October 6, 1995)

Other clearances for product code KPR

  • K250954 — DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 dete (January 20, 2026)
  • K252000 — uDR Arria & uDR Aris (November 26, 2025)
  • K251167 — uDR Aurora CX (September 19, 2025)
  • K250788 — Definium Tempo Select (August 28, 2025)
  • K250790 — INNOVISION-DXII (August 1, 2025)
  • K250738 — YSIO X.pree (July 31, 2025)
  • K242019 — GXR-Series Diagnostic X-Ray System (January 7, 2025)
  • K242499 — Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E)) (January 6, 2025)
  • K242119 — INNOVISION-EXII (January 3, 2025)
  • K241068 — uDR 780i (November 1, 2024)