ITY · Class I · 21 CFR 892.1760

FDA Product Code ITY: Assembly, Tube Housing, X-ray, Diagnostic

Leading manufacturers include Inmark Corp., Shimadzu Medical Systems and Comet Ltd. C/O Radiology Resources, Inc..

40
Total
40
Cleared
76d
Avg days
1976
Since

FDA 510(k) Cleared Assembly, Tube Housing, X-ray, Diagnostic Devices (Product Code ITY)

40 devices
1–24 of 40
Cleared Feb 10, 2000
X-RAY MONOBLOCK, MONOBLOCK XRS-60-330
K000052
Dynarad Corp.
Radiology · 34d
Cleared Oct 07, 1993
MRX-750
K933162
Mrx Corp.
Radiology · 100d
Cleared Mar 04, 1993
MOLYBDENUM
K923094
Southeastern Medical Diagnostics, Inc.
Radiology · 252d
Cleared Jan 21, 1993
PHILIPS PRE-FILTER OPTION
K923141
Philips Medical Systems, Inc.
Radiology · 206d
Cleared Oct 05, 1992
MRX-700
K921129
Mrx-Ray Tube Corp.
Radiology · 209d
Cleared Sep 10, 1992
MRX-865
K921130
Mrx-Ray Tube Corp.
Radiology · 184d
Cleared Jun 22, 1992
MG-1001 TUBE HOUSING ASSEMBLY
K921316
Magma Corp.
Radiology · 97d
Cleared May 29, 1992
X-RAY TUBE ASSEMBLY CIRCLEX1.2UG
K920731
Shimadzu Medical Systems
Radiology · 101d
Cleared Apr 27, 1992
HIGH SPEED ROTATION STARTER SA-40
K920723
Shimadzu Medical Systems
Radiology · 69d
Cleared Apr 27, 1992
HIGH SPEED ROTATION STARTER SA-50
K920724
Shimadzu Medical Systems
Radiology · 69d
Cleared Apr 14, 1992
CIRCLEXO.3T X-RAY TUBE ASSEMBLY
K920387
Shimadzu Medical Systems
Radiology · 75d
Cleared Apr 13, 1992
OR340 INTRAOPERATIVE ULTRASOUND BIOPSY NEEDLE GUID
K913987
Codman & Shurtleff, Inc.
Radiology · 221d
Cleared Aug 28, 1991
MCS 50MO X-RAY TUBE INSERT/MXS 50MO TUBE HOU ASSEM
K913301
Comet North America, Inc.
Radiology · 34d
Cleared Aug 07, 1991
TUBE HOUSING ASSEMBLIES
K912338
Comet Ltd. C/O Radiology Resources, Inc.
Radiology · 75d
Cleared Jun 19, 1991
VARIOUS X-RAY TUBES
K911695
Comet Ltd. C/O Radiology Resources, Inc.
Radiology · 64d
Cleared Mar 27, 1991
X-RAY TUBE HOUSING ASSEMBLY POLARIX II GEN/XO 110
K910308
Inmark Corp.
Radiology · 62d
Cleared Mar 06, 1991
X-RAY TUBE HOUSING ASSEMBLY SOREDEX DC/CIR 51
K910276
Inmark Corp.
Radiology · 42d
Cleared Mar 06, 1991
DI2000/HS-45-150 X-RAY TUBE INSERT
K910842
Comet Ltd. C/O Radiology Resources, Inc.
Radiology · 7d
Cleared Nov 13, 1990
R-800-SF
K904182
Advantech
Radiology · 63d
Cleared Feb 26, 1990
HOFMANN-NAGEL (HOFNA) X-RAY TUBES
K900367
Hofmann
Radiology · 31d
Cleared Oct 27, 1989
RELOADING OF X-RAY TUBE HOUSING ASSEM., VARIOUS
K894742
Inmark Corp.
Radiology · 102d
Cleared Sep 22, 1989
X-RAY TUBE HOUSING ASSEMBLY, VARIOUS MODELS
K894413
Inmark Corp.
Radiology · 67d
Cleared Nov 04, 1988
NIOBI-X RADIATION REDUCTION FILTER
K882939
American Canadian Products, Inc.
Radiology · 114d
Cleared Jun 30, 1988
MEICOR X-RAY TUBE, MODELS MC1000, MC1500, MC2000
K882323
Meicor, Inc.
Radiology · 24d

About Product Code ITY - Regulatory Context