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510(k) K934949

DIGORA by Orion Corporation Soredex — Product Code IXK

K934949 is an FDA 510(k) premarket notification submitted by Orion Corporation Soredex for the device "DIGORA". The FDA issued a decision of Substantially Equivalent on February 10, 1994. The device falls under product code IXK (System, Imaging, X-Ray, Electrostatic), a Class II device regulated under 21 CFR 892.1630. Orion Corporation Soredex has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 1994
Date Received
October 18, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, X-Ray, Electrostatic
Device Class
Class II
Regulation Number
892.1630
Review Panel
RA
Submission Type

Other clearances by Orion Corporation Soredex

  • K983267 — DIGORA FOR WINDOWS 2.0 (December 30, 1998)
  • K974877 — CRANEX TOME CEPH, OR CRANEX TOME (March 27, 1998)
  • K880982 — ORALIX PAN DC III CEPH OR PANORAMIC MODE ONLY (June 6, 1988)

Other clearances for product code IXK

  • K093640 — DIGITAL X-RAY DETECTORS FAMILY KRC AND DIRA (April 29, 2011)
  • K072766 — PVMED DDR 2520 DIGITAL IMAGING SYSTEM (December 11, 2007)
  • K042779 — RADIOTHERAPY SOLUTION BASED ON CR (October 21, 2004)
  • K032654 — PORT CASSETTE (October 9, 2003)
  • K003689 — CANON X-RAY DIGITAL CAMERA, MODEL CXDI-31 (January 2, 2002)
  • K000159 — AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLO (February 16, 2000)
  • K942561 — FUJI FCR IMAGE PROCESSING UNIT IP-U515 (December 23, 1994)
  • K931002 — FUJI COMPUTED RADIOGRAP HI-C654 DMS CRT IMAGE CONS (June 8, 1993)
  • K924459 — DIGISCAN 2 (December 17, 1992)
  • K923990 — FUJI COMPUTED RADIOGRAPHY HI-C652B DMS CRT IMAGE (December 17, 1992)

FDA data resources