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., Canon USA, Inc. and Siemens Medical Solutions USA, Inc..

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 Jan 02, 2002
CANON X-RAY DIGITAL CAMERA, MODEL CXDI-31
K003689
Canon USA, Inc.
Radiology · 398d
Cleared Dec 23, 1994
FUJI FCR IMAGE PROCESSING UNIT IP-U515
K942561
Fujifilm Medical System U.S.A., Inc.
Radiology · 206d
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

About Product Code IXK - Regulatory Context