Home / 510(k) Clearances / K973219

510(k) K973219

AMBER DU by Oldelft Corp. of America — Product Code KPR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 1997
Date Received
August 27, 1997
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 Oldelft Corp. of America

  • K980296 — OLDELFT DIGIDELCA (April 17, 1998)
  • K946128 — SIMULIX-HP (May 12, 1995)
  • K950037 — N 800 HF (February 15, 1995)
  • K932848 — SIMULIX-MC CT EXTENSION (March 22, 1994)
  • K923584 — THERAPAX DXT 300 SERIES 3 (January 15, 1993)
  • K914784 — PAPILLION PROCTOSCOPE (June 5, 1992)
  • K912466 — OLDELFT SIMULIX-MC (June 28, 1991)
  • K892659 — ELECTRODELCA (November 21, 1989)

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)