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510(k) K032654

PORT CASSETTE by Orex Computed Radiography, Ltd. — Product Code IXK

K032654 is an FDA 510(k) premarket notification submitted by Orex Computed Radiography, Ltd. for the device "PORT CASSETTE". The FDA issued a decision of Substantially Equivalent on October 9, 2003. The device falls under product code IXK (System, Imaging, X-Ray, Electrostatic), a Class II device regulated under 21 CFR 892.1630. Orex Computed Radiography, Ltd. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 2003
Date Received
August 28, 2003
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 Orex Computed Radiography, Ltd.

  • K073670 — KODAK POINT OF CARE CR 120, KODAK POINT OF CARE CR 140, KODAK POINT OF CARE CR (January 25, 2008)
  • K003256 — PCCR DIGITAL IMAGING DEVICE (November 8, 2000)

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)
  • 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)
  • K934949 — DIGORA (February 10, 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