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Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
32
Latest Decision
1979-03-28

Clearances · page 146 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K790536 CLEARVIEW Hipoint Research, Inc. KXJ Class II 1979-03-28
K790451 X-RAY UNITS, GX-101, UCIS-510 AND GX-111 General X-Ray, Inc. IZL Class II 1979-03-28
K790499 MULTIPLE PINHOLE TOMOGRAPHIC COLLIMOTER Engineering Dynamics Corp. IYX Class I 1979-03-26
K790443 PORTABLE X-RAY UNIT General X-Ray, Inc. IZL Class II 1979-03-26
K790392 510 CARBINETTE X-RAY UNIT General X-Ray, Inc. IZL Class II 1979-03-26
K790463 MODU-SET COLLIMOTOR Medtronic Vascular IYX Class I 1979-03-26
K790393 PORTABLE X-RAY UNIT, MATRIX S GX-101 General X-Ray, Inc. IZL Class II 1979-03-26
K790388 MEVATRON 60 Siemens Medical Laboratories, Inc. IYE Class II 1979-03-26
K790512 PORTABLE X-RAY UNIT General X-Ray, Inc. IZL Class II 1979-03-26
K790511 MOBILE X-RAY UNIT General X-Ray, Inc. IZL Class II 1979-03-26
K790213 GENERATOR, R-WAVE Amr Co. IYY Class I 1979-03-22
K790342 SOMATOM SD Siemens Corp. JAK Class II 1979-03-22
K790396 ULTRASONIC DIAGNOSTIC SYSTEM Hoffrel Instruments, Inc. IYO Class II 1979-03-21
K790273 MAMMOGRAPHY SYSTEM AND CASSETTE Agfa-Gevaert, Inc. IZH Class II 1979-03-21
K790285 IMAGER, PHO/SONIC SERIES 2000 G.D. Searle and Co. IYO Class II 1979-03-08
K790121 FILM-X 90 Automatic Film Processor Corp. IXW Class II 1979-02-21
K790134 RADIOTHERAPY TREATMENT General Electric Co. JAK Class II 1979-02-21
K790132 TECNOTOMO Teknomed, Inc. IZF Class II 1979-02-21
K790169 TOMOGRAPHIC PROGRAMS Cmsi KPS Class II 1979-02-15
K790168 COLLIMATOR, BILATERIAL Cmsi KQA Class II 1979-02-15
K790023 OCCULAR COMPU-SCAN Storz Instrument Co. IYO Class II 1979-02-12
K790081 CAMERA, CLEON 720 LARGE FIELD GAMMA Union Carbide Corp. IYX Class I 1979-01-26
K790070 SIREGRAPH B-150 Siemens Corp. KPR Class II 1979-01-26
K790069 BUCKYMAT Siemens Corp. KPR Class II 1979-01-26
K790080 APRON, LEADED VINYL Pinnacle Distributors, Inc. KPY Class I 1979-01-26
K790037 SONO TRAK T.M. Narco Air-Shields IYO Class II 1979-01-26
K782158 SCANNER-SV Hrl, Inc. IYO Class II 1979-01-25
K782155 GENERAL EQUIPMENT COVER Contour Fabricators, Inc. IZL Class II 1979-01-17
K781177 ULTRASOUND BREAST SCANNING DEVICE Life Instrument Corp. IYO Class II 1979-01-03
K782029 MAXI CAMERA 400T General Electric Co. IYX Class I 1978-12-22
K782005 RADIATION ONCOLOGY SYSTEM Adac Laboratories KPQ Class II 1978-12-20
K782060 MULTIFORMAT FILM CASSETTE TRANSPORT Mediscan, Inc. IYO Class II 1978-12-20
K782047 PROCESSING SYSTEM, A2 IMAGE Medtronic Vascular IYX Class I 1978-12-20
K781649 ULTRASONIC TRANSDUCERS Echo Laboratories, Inc. ITX Class II 1978-12-07
K781992 KOORDINAT ANGIO Siemens Corp. KXJ Class II 1978-12-07
K781991 ANGIOSKIP Siemens Corp. IZI Class II 1978-12-07
K781936 SCANNER-EMI 7020 AND 7020R Emi Medical, Inc. JAK Class II 1978-12-04
K781933 DISPENSOR, XENON GAS Diagnostic Isotapes, Inc. IYT Class II 1978-12-04
K781742 INHAMATIC 33 Medimatic IZD Class I 1978-12-04
K781975 MOBILE CARRIER General X-Ray, Inc. IZL Class II 1978-12-04
K781984 COLLIMATOR, HEART CONTOUR Siemens Corp. KPW Class II 1978-12-04
K781983 EXPLORAMAT, COSMIC 2 Siemens Corp. KPR Class II 1978-12-04
K781982 INCLINOMETER, VERMONT Associates IN Radiology, Inc. IZL Class II 1978-12-04
K781976 MOBILE X-RAY UNIT General X-Ray, Inc. IZL Class II 1978-12-04
K781934 PROCESSOR, MODEL M8 Eastman Kodak Company IXW Class II 1978-12-04
K781872 CLINAC 2500 Varian Assoc., Inc. IYE Class II 1978-11-27
K781739 CAMERA, GCA-10A, LOW ENERGY Toshiba Medical Systems IYX Class I 1978-11-27
K781571 L/U ARM-VASCULAR General Electric Co. IYB Class I 1978-11-27
K781852 GLOVE, SUPERFLEX MOLDED Pinnacle Distributors, Inc. KPY Class I 1978-11-15
K781752 SCANNER, CT 0450 Pfizer Medical Systems, Inc. JAK Class II 1978-11-03
K781753 TOMOGSCANNER 2 Tomogscanner OK , Ltd. KPS Class II 1978-11-03
K781705 MOBIL XR Siemens Corp. IZL Class II 1978-10-24
K781709 SCANNER, LINEAR Philips Medical Systems (Cleveland), Inc. IYO Class II 1978-10-24
K781711 EVALUSKOP Siemens Corp. JAA Class II 1978-10-24
K781676 X-RAY STAND, PORTABLE General X-Ray, Inc. IZL Class II 1978-10-17
K781673 MAXI-CAMERA 535 General Electric Co. IYX Class I 1978-10-17
K781681 PHIPIOLOGICAL SYNCHRONIZER PART#205 Brattle Instrument Corp. IXQ Class II 1978-10-17
K781524 MAXIRAY 125 TUBE UNIT General Electric Co. ITY Class I 1978-10-17
K781642 RA-I Diasonics, Inc. IYN Class II 1978-10-10
K781613 SIREMAT Siemens Corp. KPR Class II 1978-10-03
K781590 PORTABLE X-RAY UNIT General X-Ray, Inc. IZL Class II 1978-10-03
K781508 WATERPATH SCANNING OPTION G.D. Searle and Co. IYO Class II 1978-09-26
K781532 UROSKOP A AND B Siemens Corp. IXR Class II 1978-09-14
K781531 OPTIPLANIMAT Siemens Corp. IZF Class II 1978-09-14
K781540 OPTI 110/12/50 HSG Siemens Corp. ITY Class I 1978-09-14
K781496 XIMATRON IV Siemens Elema AB KPQ Class II 1978-09-14
K781174 CLINAC 12/10 Varian Assoc., Inc. IYE Class II 1978-09-14
K781519 EMI SIMULATOR REMOTE CONTROL CONSOLE Emi Medical, Inc. KPQ Class II 1978-09-14
K781425 CAP-MOBILE Philips Medical Systems (Cleveland), Inc. IZL Class II 1978-09-11
K781473 BUCKY WALL STAND Philips Medical Systems (Cleveland), Inc. KPR Class II 1978-09-11
K781431 ELECTRIC CT/T OPERATOR DISPLAY CONSOLE General Electric Co. JAK Class II 1978-09-07
K781344 OPTION PHO/SONIC B-MODE SCANNER G.D. Searle and Co. IYO Class II 1978-08-21
K781274 GAMMA MED II Mick Radio-Nuclear Instruments, Inc. JAQ Class II 1978-08-10
K781276 X-RAY, PORTABLE Air-Shields, Inc. IZL Class II 1978-08-10
K780742 INTRAORAL DENTAL X-RAY GENERATOR Siemens Corp. IZO Class I 1978-07-27
K781040 CT SCANNER ND 8000 Cgr Medical Corp. JAK Class II 1978-07-18
K781084 THERAPAX 150A Emi Therapy Systems, Inc. JAD Class II 1978-07-18
K781065 PLURIMAT;RADIOGRAPHIC TUBE MOUNT Tecnomed, Inc. IYB Class I 1978-07-17
K781051 EMISONIC 4201 Emi Medical, Inc. IYO Class II 1978-07-17
K781066 PLURIX C; RADIOGRAPHIC TABLE Tecnomed, Inc. IXQ Class II 1978-07-17
K781068 AUTOMATIC FILM PROCESSORIO M. R80 Tecnomed, Inc. IWX Class I 1978-07-17
K781067 PLURIX B; RADIOGRAPHIC TABLE Tecnomed, Inc. IXQ Class II 1978-07-17
K781079 SONOGRAF ULTRASOUND B-SCANNING SYSTEM Ohio Nuclear, Inc. IYO Class II 1978-07-17
K781057 CLINAC 20 (OPTIONAL 18 MV VERSION) Varian Assoc., Inc. IYE Class II 1978-07-17
K781030 X-RAY UNIT, PORTABLE GX-101 AEC General X-Ray, Inc. IZL Class II 1978-07-17
K781107 DISPENSER, GAS XENON Mallinckrodt Critical Care IYT Class II 1978-07-17
K780999 X-RAY FRAME HOLDER Great Eastern Lumber Co., Inc. IZL Class II 1978-06-27
K780963 X-RAY SYSTEM General X-Ray, Inc. KPQ Class II 1978-06-27
K780969 GAMMA CAMERA Machlett Laboratories, Inc. IYX Class I 1978-06-27
K780995 COMPUTERIZED AXIAL TOMOGRAPHY Emi Medical, Inc. IZF Class II 1978-06-22
K780947 510 BEDSIDE X-RAY SYSTEM Union Carbide Corp. IZL Class II 1978-06-22
K780971 CLINICAL ACQUISITION MODULE Analytical Development Assoc. Corp. IYX Class I 1978-06-22
K780948 SYSTEM, PLANNING, TREATMENT Emi Therapy Systems, Inc. IWB Class II 1978-06-22
K780930 5543 INDEPENDENT VIEWING SYSTEM Emi Medical, Inc. JAK Class II 1978-06-14
K780928 CT5137 HIGH RESOLUTION OPTION Emi Medical, Inc. JAK Class II 1978-06-14
K780737 CT BLANKETS (BOLUS MATERIAL) Emi Medical, Inc. JAK Class II 1978-06-02
K780736 CT 5221 DOSE REDUCING COLLIMATORS Emi Medical, Inc. IZX Class II 1978-06-02
K780769 S-100 CT SCANNER Syntex Corp. JAK Class II 1978-06-02
K780855 GAMMA CAMERA G.D. Searle and Co. IYX Class I 1978-06-02
K780578 SONOGRAF EDP REAL-TIME ADAPTER Foley, Lardner, Hollabaugh & Jacobs IYO Class II 1978-05-25

14,721 clearances in the Radiology panel. Data: openFDA.