IXW · Class II · 21 CFR 892.1900

FDA Product Code IXW: Processor, Radiographic-film, Automatic

Leading manufacturers include Eastman Kodak Company, Konica Medical Corp. and Alphatek Corp..

83
Total
83
Cleared
89d
Avg days
1976
Since

FDA 510(k) Cleared Processor, Radiographic-film, Automatic Devices (Product Code IXW)

83 devices
1–24 of 83
Cleared Aug 18, 2011
XTENDER FILM PROCESSOR, SPRINT FILM PROCESSOR MODEL XTENDER MODEL SPRINT
K111167
Velopex International, Inc.
Radiology · 114d
Cleared Jan 06, 2010
INTRAX FILM PROCESSOR
K093503
Velopex International, Inc.
Radiology · 55d
Cleared Aug 21, 2009
OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAX
K091628
Protec GmbH & Co. KG
Radiology · 78d
Cleared Apr 23, 2003
RADIOGRAPHIC FILM PROCESSOR, MODELS XP400 AND XP1000
K024342
Daito Co., Ltd.
Radiology · 117d
Cleared Feb 12, 2003
FILM PROCESSOR, MODEL LIFE RAY PRO 1000
K023801
S.A.I.E.P. S.R.L.
Radiology · 90d
Cleared Feb 12, 2003
FILM PROCESSOR, MODEL LIFE RAY PRO 2500
K023825
S.A.I.E.P. S.R.L.
Radiology · 90d
Cleared Jan 23, 2003
AX200 AUTOMATIC X-RAY FILM PROCESSOR, MODEL 6586.036
K023613
Alphatek Corp.
Radiology · 87d
Cleared Sep 30, 2002
LEVEL 356 X-RAY FILM PROCESSOR, MODELS MD & MD-D
K022154
Fischer Industries, Inc.
Radiology · 90d
Cleared Nov 08, 2000
FREEDOM AUTOMATIC FILM PROCESSOR
K002640
J. Morita USA, Inc.
Radiology · 76d
Cleared Aug 30, 2000
MICRO-MAX, MODEL 319
K002404
Tek Marketing, Inc.
Radiology · 23d
Cleared May 16, 2000
ALL-PRO 2010
K001321
All-Pro Imaging Corp.
Radiology · 20d
Cleared Sep 01, 1999
OPTIMAX/ COMPACT 2
K992818
Protec GmbH & Co. KG
Radiology · 12d
Cleared Jun 18, 1999
KONICA SRX- 701 AUTOMATIC X-RAY FILM PROCESSOR
K990969
Konica Medical Corp.
Radiology · 87d
Cleared May 20, 1999
AII-PRO 100 PLUS AND ALL-PRO 200
K991435
All-Pro Imaging Corp.
Radiology · 24d
Cleared Apr 30, 1998
CP 1000, CURIX HT 330, CLASSIC E.O.S., CURIX HT 530, MAMORAY HT 300, MAMORAY CMPACT PLUS, CURIX COMPACT PLUS, CURIX COMS
K981280
Bayer Corp., Agfa Div.
Radiology · 22d
Cleared Oct 08, 1997
MAMMOLOADER BY C.M.A. SRL
K973125
C.M.A.
Radiology · 49d
Cleared Jan 27, 1997
KODAK MINILOADER(2000)
K970059
Eastman Kodak Company
Radiology · 20d
Cleared Aug 21, 1996
3M TRIMATIC MODULAR ADVANCED PROCESSING SYSTEM AND 3M APS AUTOMATIC FILM PROCESSOR
K962750
Imation Corp.
Radiology · 37d
Cleared Feb 12, 1996
JPI AUTOMATIC X-RAY FILM PROCESSOR
K955706
Jpi Healthcare Co, Ltd.
Radiology · 59d
Cleared Oct 27, 1995
FUJI COMPUTED RADIOGRAPHY SYSTEM FCR9000HQ, FCR9501HQ
K951373
Fujifilm Medical System U.S.A., Inc.
Radiology · 214d
Cleared Oct 18, 1995
DOOSAN DSP 3800 AUTOMATIC X-RAY FILM PROCESSOR
K954345
Doosan Corp.
Radiology · 30d
Cleared Oct 18, 1995
KODAK AUTOMIXER II PLUS
K954484
Eastman Kodak Company
Radiology · 21d
Cleared May 15, 1995
KODAK X-OMAT 3000 RA PROCESSOR
K951396
Eastman Kodak Company
Radiology · 49d
Cleared May 15, 1995
KODAK X-OMAT 5000 RA PROCESSOR
K951397
Eastman Kodak Company
Radiology · 49d

About Product Code IXW - Regulatory Context