FDA 510(k) Applications for Medical Device Product Code "ITY"
(Assembly, Tube Housing, X-Ray, Diagnostic)

FDA 510(k) Number Applicant Device Name Decision Date
K864042 ABSOLUTE X-RAY CORP. MAMMOGRAPHIC MODEL CXR 51 MO-6'/0.6 SH 10/27/1986
K904182 ADVANTECH R-800-SF 11/13/1990
K882939 AMERICAN CANADIAN PRODUCTS, INC. NIOBI-X RADIATION REDUCTION FILTER 11/04/1988
K834306 CGR MEDICAL CORP. PHASIX-HIGH FREQUENCY GENERATOR 12/29/1983
K913987 CODMAN & SHURTLEFF, INC. OR340 INTRAOPERATIVE ULTRASOUND BIOPSY NEEDLE GUID 04/13/1992
K910842 COMET LTD. C/O RADIOLOGY RESOURCES, INC. DI2000/HS-45-150 X-RAY TUBE INSERT 03/06/1991
K912338 COMET LTD. C/O RADIOLOGY RESOURCES, INC. TUBE HOUSING ASSEMBLIES 08/07/1991
K911695 COMET LTD. C/O RADIOLOGY RESOURCES, INC. VARIOUS X-RAY TUBES 06/19/1991
K913301 COMET NORTH AMERICA, INC. MCS 50MO X-RAY TUBE INSERT/MXS 50MO TUBE HOU ASSEM 08/28/1991
K000052 DYNARAD CORP. X-RAY MONOBLOCK, MONOBLOCK XRS-60-330 02/10/2000
K760604 EUREKA X-RAY TUBE CORP. EUREKA X-SCAN 150 X-RAY TUBE HOUSING AS. 09/13/1976
K781524 GENERAL ELECTRIC CO. MAXIRAY 125 TUBE UNIT 10/17/1978
K812915 GENERAL ELECTRIC CO. MX 125 11/24/1981
K900367 HOFMANN HOFMANN-NAGEL (HOFNA) X-RAY TUBES 02/26/1990
K873314 INLAND TUBE CORP. TOSHIBA, SMIT ROENTGEN 11/02/1987
K894742 INMARK CORP. RELOADING OF X-RAY TUBE HOUSING ASSEM., VARIOUS 10/27/1989
K910308 INMARK CORP. X-RAY TUBE HOUSING ASSEMBLY POLARIX II GEN/XO 110 03/27/1991
K910276 INMARK CORP. X-RAY TUBE HOUSING ASSEMBLY SOREDEX DC/CIR 51 03/06/1991
K894413 INMARK CORP. X-RAY TUBE HOUSING ASSEMBLY, VARIOUS MODELS 09/22/1989
K770336 LITTON MEDICAL SYSTEMS X-RAY TUBE, ROTATING ANODE 03/01/1977
K871227 M. D. PRODUCTS LES RAD FILTER 06/29/1987
K921316 MAGMA CORP. MG-1001 TUBE HOUSING ASSEMBLY 06/22/1992
K882323 MEICOR, INC. MEICOR X-RAY TUBE, MODELS MC1000, MC1500, MC2000 06/30/1988
K933162 MRX CORP. MRX-750 10/07/1993
K921129 MRX-RAY TUBE CORP. MRX-700 10/05/1992
K921130 MRX-RAY TUBE CORP. MRX-865 09/10/1992
K870071 NORTH AMERICAN IMAGING, INC. TOSHIBA, SMIT ROENTGEN 01/21/1987
K923141 PHILIPS MEDICAL SYSTEMS, INC. PHILIPS PRE-FILTER OPTION 01/21/1993
K860760 REACTOR EXPERIMENTS, INC. ERBIUM X-RAY FILTER 06/10/1986
K920387 SHIMADZU MEDICAL SYSTEMS CIRCLEXO.3T X-RAY TUBE ASSEMBLY 04/14/1992
K920723 SHIMADZU MEDICAL SYSTEMS HIGH SPEED ROTATION STARTER SA-40 04/27/1992
K920724 SHIMADZU MEDICAL SYSTEMS HIGH SPEED ROTATION STARTER SA-50 04/27/1992
K920731 SHIMADZU MEDICAL SYSTEMS X-RAY TUBE ASSEMBLY CIRCLEX1.2UG 05/29/1992
K781540 SIEMENS CORP. OPTI 110/12/50 HSG 09/14/1978
K810190 SIEMENS CORP. OPTI 110/12/50HSG 03/02/1981
K923094 SOUTHEASTERN MEDICAL DIAGNOSTICS, INC. MOLYBDENUM 03/04/1993
K860504 VICTOREEN, INC. 36-101 XDS111 XENON DELIVERY/TRAP SYSTEM 04/04/1986
K833238 X-RAY TUBE CORP. CRISA 10/28/1983
K833847 X-RAY TUBE CORP. CRISA 12/12/1983
K840135 X-RAY TUBE CORP. CRISA 03/23/1984


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