meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
33
Latest Decision
1992-10-16

Clearances · page 121 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K923736 GAMMA 600T Strichman Medical Equipment, Inc. KPS Class II 1992-10-16
K923099 X-RAY DRAPES Hydro-Med Products, Inc. IWQ Class I 1992-10-15
K914748 COMET C-125 Fischer Imaging Corp. OXO Class II 1992-10-15
K921875 X-RAY CONTROL AND HI-VOLTAGE GENERATOR Continental X-Ray Corp. IZO Class I 1992-10-15
K911973 LINEAR ACCELERATOR COLLIMATOR Medical Equipment Development Co., Inc. IYE Class II 1992-10-15
K920196 OX-600 Stardard X-Ray Sales Co. KPX Class II 1992-10-14
K922117 C-TRAK BIOPSY SYSTEM Care Wise Medical Products Corp. IZD Class I 1992-10-14
K913659 LITTLE PRISM Octostop, Inc. KPR Class II 1992-10-14
K920506 CONTOURING DEVICE X-Icon Medical Systems KPQ Class II 1992-10-14
K913711 GENTLE SLOPE Octostop, Inc. KPR Class II 1992-10-14
K923582 SIENET CAMERA SERVER Siemens Gammasonics, Inc. LMD Class I 1992-10-14
K913293 QUICK SEEDER Mick Radio-Nuclear Instruments, Inc. IWJ Class I 1992-10-13
K923615 VISTA HPQ SYSTEM Philips Medical Systems (Cleveland), Inc. LNH Class II 1992-10-09
K922274 MEDRAD PATHFINDER-E ROADMAPPING SYSTEM Medrad, Inc. JAA Class II 1992-10-09
K904070 COMBISON(R) 330, MODEL # IR17.5AG/A & VRW177AK/A Kretztechnik AG IYO Class II 1992-10-09
K923352 INSTRUMENTARIUM MEGA4 HT Instrumentarium Imaging, Inc. LNH Class II 1992-10-06
K923454 SHIMADZU IMAGE AMPLIFIER IA-9LS SERIES Shimadzu Medical Systems JAA Class II 1992-10-05
K923453 SHIMADZU IMAGE AMPLIFIER IA-9LM SERIES Shimadzu Medical Systems JAA Class II 1992-10-05
K921886 NEEDLE TECHNOLOGIES SEED IMPLANT NEEDLE Needle Technologies, Inc. IWJ Class I 1992-10-05
K921426 ULTRA PCI Advanced Medical Products, Inc. IYO Class II 1992-10-05
K921116 PX-100 PORTABLE X-RAY GENERATOR Acoma Medical Imaging, Inc. IZL Class II 1992-10-05
K921129 MRX-700 Mrx-Ray Tube Corp. ITY Class I 1992-10-05
K920862 BCM-400C B C Medical , Ltd. IZI Class II 1992-09-30
K923264 GENERAL PURPOSE FLEX COIL General Electric Co. LNH Class II 1992-09-30
K923222 3M COLOR LASER IMAGER, MODEL 979 3M Medical Products Group LMC Class II 1992-09-30
K922427 SUMMIT NUCLEAR VISION 1024RZ GAMMA CAMERA SYSTEM Summit Nuclear KPS Class II 1992-09-29
K923309 ARGUS PET SYSTEM GE Medical Systems KPS Class II 1992-09-29
K922426 SUMMIT NUCLEAR VISION T-22 GAMMA CAMERA SYSTEM Summit Nuclear KPS Class II 1992-09-28
K922848 ULTRALITE X-RAY FILM ILLUMINATOR A & S Trading Co. IXC Class I 1992-09-28
K915622 PLATO BRACHYTHERAPHY TREATMENT PLANNING SYSTEM Nucletron-Oldelft Corp. JAQ Class II 1992-09-25
K923075 3M LASER IMAGER MODEL 969 3M Medical Products Group LMC Class II 1992-09-23
K923110 SCAN BAND Cook, Inc. JAK Class II 1992-09-23
K923114 HEAD RESTRAINT FOR CT TABLES Cook, Inc. JAK Class II 1992-09-23
K923112 ANGIO-BAND Cook, Inc. IZI Class II 1992-09-23
K923137 CSL X-RAY IMAGESCOPE Csi Opto-Electronics Corp. JAA Class II 1992-09-23
K923109 ADULT CHIN STRAP FOR CT TABLES Cook, Inc. JAK Class II 1992-09-23
K923108 WRIST RESTRAINT FOR GE9800 C.T. TABLES Cook, Inc. JAK Class II 1992-09-23
K923111 ARM EXTENDER FOR CT TABLES Cook, Inc. JAK Class II 1992-09-23
K923022 INSTRUMENTARIUM MEGA4 HT Instrumentarium Imaging, Inc. LNH Class II 1992-09-22
K923130 IR-192 IMPLANT -- MODIFICATION Omnitron Intl., Inc. KXK Class II 1992-09-21
K922549 UST-665P-5, UST-664-5/7.5, ASU-35WL-10, SCU-35 Aloka Co., Ltd. ITX Class II 1992-09-21
K923356 MEDX ROTATIONAL GANTRY SYSTEM Bfi- Medical Waste Systems IYX Class I 1992-09-21
K923049 UROSKOP D1, UROSKOP D2, AND UROSKOP D3 Siemens Medical Solutions USA, Inc. OWB Class II 1992-09-15
K922798 QD WHOLE BODY COIL, MRT-150A Toshiba America Mri, Inc. LNH Class II 1992-09-14
K922814 TEC1410 ANATOMICAL PROGRAMMING GENERATOR-MODIFICAT Bay Shore Medical Equipment Corp. IZO Class I 1992-09-11
K922483 DU PONT COMPACT DAYLIGHT SYSTEM 2000 E.I. Dupont DE Nemours & Co., Inc. KPX Class II 1992-09-11
K923106 SCAN BAND Cook, Inc. JAK Class II 1992-09-11
K911435 CPA/3.5 MHZ PROBE Diasonics, Inc. ITX Class II 1992-09-11
K922454 MOBILE ATHENA HF Fischer Imaging Corp. IZH Class II 1992-09-11
K921878 SCANMATE III Circadian, Inc. IYP Class I 1992-09-11
K923270 KODAK EKTASCAN IMAGELINK QUALITY CONTROL WORKSTATI Eastman Kodak Company LLZ Class II 1992-09-11
K921130 MRX-865 Mrx-Ray Tube Corp. ITY Class I 1992-09-10
K923345 BIAD NEW DETECTOR OPTION Trionix Research Laboratory, Inc. KPS Class II 1992-09-10
K923151 CARDIAC TRIAD NEW DETECTOR OPTION Trionix Research Laboratory, Inc. KPS Class II 1992-09-10
K923061 MAMMOSCAN Fischer Imaging Corp. IZH Class II 1992-09-10
K922364 DUA-900A IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYST Toshiba America Medical Systems, In.C IXR Class II 1992-09-04
K902515 ACUSON S228 TRANSDUCER FOR TRANSCRANIAL COLOR DOPP Acuson Corp. ITX Class II 1992-09-04
K922677 MAGNETIZATION TRANSFER CONTRAST Resonex, Inc. LNH Class II 1992-09-04
K922804 AWOS ANGIOGRAPHIC WORKSTATION Siemens Medical Solutions USA, Inc. IZI Class II 1992-08-28
K915365 AP-6CR CINERADIOGRAPHIC FILM PROCESSOR The Allen Products Co. IXX Class II 1992-08-27
K923044 MONAD NUCLEAR IMAGING SYSTEM Trionix Research Laboratory, Inc. KPS Class II 1992-08-27
K921425 SCD-105 AND SCD-125 CAPACITOR DISCHARGE MOBILE X-R Acoma Medical Imaging, Inc. IZL Class II 1992-08-27
K920470 MEYER FOREIGN BODY LOCATOR Seymour W. Meyer IZH Class II 1992-08-26
K912364 ELECTRONIC ULTRASOUND SCANNER EUB-315, MODIFIED Hitachi Medical Corp. of America ITX Class II 1992-08-26
K921826 KODAK INSIGHT PORTABLE IMAGING SYSTEM Eastman Kodak Company IXA Class II 1992-08-26
K923010 MAGNETIC RESONANCE DIAGNOSTIC DEVICE Hitachi Medical Systems America, Inc. LNH Class II 1992-08-25
K922411 KODAK EKTASCAN, XLT7720, XLT7700, PCD 2000 Eastman Kodak Company LMC Class II 1992-08-24
K920227 QUADRATURE SHOULDER CONTOUR COIL Magnetic Research, Inc. LNH Class II 1992-08-24
K922554 STANDARD IMAGING HDR 1000 ION CHAMBER Standard Imaging, Inc. JAQ Class II 1992-08-24
K920714 VISTA HPQ SYSTEM Philips Medical Systems (Cleveland), Inc. LNH Class II 1992-08-20
K922372 MULTISPECT(TM) 3 TRIPLE DETECTOR CAMERA SYSTEM Siemens Gammasonics, Inc. KPS Class II 1992-08-17
K922373 MULTISPECT(TM) 2 DUAL DETECTOR CAMERA SYSTEM Siemens Gammasonics, Inc. KPS Class II 1992-08-17
K921413 MRT-50 Toshiba America Mri, Inc. LNH Class II 1992-08-14
K921777 CARDIAC FIRST PASS ANALYSIS GE Medical Systems KPS Class II 1992-08-12
K922622 PHILIPS CARDIAC WORKSTATION Philips Medical Systems, Inc. IZI Class II 1992-08-11
K922813 GEN-X 800-400 -- MODIFICATION Swiss Ray Medical Systems KPR Class II 1992-08-11
K922647 COLOR DISKSTORE Camtronics, Ltd. IYO Class II 1992-08-11
K921539 GEN-X 800/6/50 Swiss Ray Medical Systems KPR Class II 1992-08-11
K922671 CEDARS SINAI QUANTITATIVE THALLIUM 201 ANALYSIS Nuccardiac Software, Inc. KPS Class II 1992-08-11
K921484 MEDVISION Evergreen Technologies, Inc. LLZ Class II 1992-08-07
K920958 SUMMIT NUCLEAR VISION NEUROSPECT Summit Nuclear KPS Class II 1992-08-07
K922240 ELECTRONIC PHOTOSPOT 20 Toshiba America Medical Systems, In.C JAA Class II 1992-08-07
K920204 INSTASCAN Advanced Nmr Systems, Inc. LNH Class II 1992-08-05
K921896 TILTING MAG Continental X-Ray Corp. IZH Class II 1992-08-03
K922310 VORTECH'S PERSONAL DISPLAY SYSTEM Vortech Data, Inc. LLZ Class II 1992-07-30
K922184 HP SONOS 100 CF ULTRASOUND IMAGING SYSTEM Hewlett-Packard Co. ITX Class II 1992-07-30
K920441 3D TOF ANGIOGRAPHY MEASURING FUNCTION Hitachi Medical Systems America, Inc. LNH Class II 1992-07-30
K922006 QQUADRATURE LUMBAR CONTOUR COIL Magnetic Research, Inc. LNH Class II 1992-07-29
K915201 CYTOGUIDE STEREOTACTIC BIOPSY SYSTEM MODEL MF-CYTO Bennett X-Ray Corp. IZH Class II 1992-07-28
K922000 MODEL #QSC-200, 20CM. QUADRATURE SHOULDER COIL Mri Devices Corp. LNH Class II 1992-07-28
K922098 CAG-02A Toshiba America Medical Systems, In.C KXJ Class II 1992-07-27
K922165 ATC725, ATC525, AND AP300 Gendex Corp. IZO Class I 1992-07-27
K921951 MPG 65-80-100 X-RAY GENERATOR AND CONTROL General Electric Co. IZO Class I 1992-07-21
K915738 EXCEL CT TWIN Elscint, Inc. JAK Class II 1992-07-21
K921881 VISTA HPQ SYSTEM Philips Medical Systems (Cleveland), Inc. LNH Class II 1992-07-17
K922080 GENESYS II Adac Laboratories KPS Class II 1992-07-17
K920793 PHILIPS DSI SYSTEM RELEASE 3.2 Philips Medical Systems, Inc. IZJ Class II 1992-07-17
K914267 GE 4096 PLUS & GE 2048 GE Medical Systems KPS Class II 1992-07-16
K921720 MRT-50A QD SPINE COIL Toshiba America Mri, Inc. LNH Class II 1992-07-16
K921750 CVIS INSIGHT III SYSTEM Cardiovascular Imaging Systems, Inc. ITX Class II 1992-07-13

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