IXK · Class II · 21 CFR 892.1630

FDA Product Code IXK: System, Imaging, X-ray, Electrostatic

Leading manufacturers include Fujifilm Medical System U.S.A., Inc., Agfa Corp. and Xeroradiography.

14
Total
14
Cleared
135d
Avg days
1976
Since

FDA 510(k) Cleared System, Imaging, X-ray, Electrostatic Devices (Product Code IXK)

14 devices
1–14 of 14
Cleared Apr 29, 2011
DIGITAL X-RAY DETECTORS FAMILY KRC AND DIRA
K093640
Electron Jsco.
Radiology · 521d
Cleared Dec 11, 2007
PVMED DDR 2520 DIGITAL IMAGING SYSTEM
K072766
Portavision Medical
Radiology · 74d
Cleared Oct 21, 2004
RADIOTHERAPY SOLUTION BASED ON CR
K042779
Agfa Corp.
Radiology · 15d
Cleared Oct 09, 2003
PORT CASSETTE
K032654
Orex Computed Radiography, Ltd.
Radiology · 42d
Cleared Jan 02, 2002
CANON X-RAY DIGITAL CAMERA, MODEL CXDI-31
K003689
Canon USA, Inc.
Radiology · 398d
Cleared Feb 16, 2000
AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLO
K000159
Agfa Corp.
Radiology · 28d
Cleared Dec 23, 1994
FUJI FCR IMAGE PROCESSING UNIT IP-U515
K942561
Fujifilm Medical System U.S.A., Inc.
Radiology · 206d
Cleared Feb 10, 1994
DIGORA
K934949
Orion Corporation Soredex
Radiology · 115d
Cleared Jun 08, 1993
FUJI COMPUTED RADIOGRAP HI-C654 DMS CRT IMAGE CONS
K931002
Fujifilm Medical System U.S.A., Inc.
Radiology · 102d
Cleared Dec 17, 1992
FUJI COMPUTED RADIOGRAPHY HI-C652B DMS CRT IMAGE
K923990
Fujifilm Medical System U.S.A., Inc.
Radiology · 129d
Cleared Dec 17, 1992
DIGISCAN 2
K924459
Siemens Medical Solutions USA, Inc.
Radiology · 106d
Cleared Oct 16, 1992
FUJI COMPUTED RADIOGRAPHY HI-C653 DMS CRT IMAGE
K924012
Fujifilm Medical System U.S.A., Inc.
Radiology · 67d
Cleared Oct 30, 1985
XERORADIOGRAPHY LIQUID TONER IMAGING SYSTEM
K853459
Xerox Medical Systems
Radiology · 75d
Cleared Nov 24, 1976
XERORADIOGRAPHY 125 SYSTEM - MODIFIED
K761022
Xeroradiography
Radiology · 13d

About Product Code IXK - Regulatory Context