meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
33
Latest Decision
1991-11-29

Clearances · page 124 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K913352 C-150 ULTRAFAST CT SCANNER Imatron, Inc. JAK Class II 1991-11-29
K913463 MAG RES IMAG SYST/BRUKER MODEL R28 WHOLE BODY SCAN Bruker Medical Imaging, Inc. LNH Class II 1991-11-29
K914535 MODEL 311GE-64: WHOLE VOLUME NECK COIL Medical Advances, Inc. LNH Class II 1991-11-27
K914012 MRT-150A Toshiba America Mri, Inc. LNH Class II 1991-11-27
K914313 HICOR Siemens Gammasonics, Inc. IZI Class II 1991-11-27
K914296 CEQUAL(TM) QUANITATIVE ANALYSIS CARDIOLITE(R) SPEC Nuccardiac Software, Inc. KPS Class II 1991-11-27
K913637 ECAT SCANNER (MODEL 921) Cti Pet Systems, Inc. KPS Class II 1991-11-27
K914184 P2020-8-0 BEAM-LIMITING DEVICE Precise Optics KPW Class II 1991-11-27
K914536 MODELS 190GE-64/191GE-64/192GE-64/193GE-64 Medical Advances, Inc. LNH Class II 1991-11-27
K914266 MICRO-X 30 HF Fischer Imaging Corp. IZO Class I 1991-11-27
K914236 MICRO-X 50 HF Fischer Imaging Corp. IZO Class I 1991-11-27
K905694 FVP-1000 FAMILY AND FVP-1000D FAMILY Fischer Imaging Corp. JAA Class II 1991-11-27
K913869 RF-OPAQUE BLANKET FOR MAGNETOM SYSTEM Siemens Medical Solutions USA, Inc. LNH Class II 1991-11-25
K914263 MRP-5000 & MRP-7000 HS/MR QUADRATURE KNEE COILS Hitachi Medical Systems America, Inc. LNH Class II 1991-11-22
K913674 RECORD AND VERIFY MEVATRON ADAPTER Computerized Medical Systems, Inc. IYE Class II 1991-11-22
K914281 I-125 SEEDS, CODE: 6711 Medi-Physics Inc. Dba Nycomed Amersham Imaging KXK Class II 1991-11-22
K911872 PHILIPS RIGID VOLUME COILS Philips Medical Systems, Inc. LNH Class II 1991-11-22
K914527 CEQUAL(TM) General Electric Co. KPS Class II 1991-11-22
K914268 I-125 SEEDS IN CARRIER, CODE: 6720 Medi-Physics Inc. Dba Nycomed Amersham Imaging KXK Class II 1991-11-22
K914350 ICON COMPUTER SYSTEM Siemens Gammasonics, Inc. JWM Class II 1991-11-22
K913996 COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM OPTION Siemens Medical Solutions USA, Inc. JAK Class II 1991-11-22
K911993 MRH-500 Hitachi Medical Systems America, Inc. LNH Class II 1991-11-22
K913755 STATVIEW Image Systems, Inc. LLZ Class II 1991-11-19
K911114 INTERSON ENDOCAVITY PROBE/ALOKA ULTRASOUND SYSTEM Interson Corp. ITX Class II 1991-11-19
K912600 INTERPRET(TM) INTRAVASCULAR IMAGING CATHETER Intertherapy, Inc. ITX Class II 1991-11-19
K912516 CLASSIC-II 4-WAY HORIZONTAL TABLE CAT.# T-9111 Continental X-Ray Corp. IZZ Class II 1991-11-19
K914525 FLUROSPOT H VERSION 2 Siemens Medical Solutions USA, Inc. JAA Class II 1991-11-19
K913685 UNICATH EP. Xre Corp. IZI Class II 1991-11-07
K913119 VARIAN C-SERIES CLINACS (CLINAC 2300C/D) Varian Assoc., Inc. IYE Class II 1991-11-07
K914165 X-RAY TABLE Siemens Medical Solutions USA, Inc. IXR Class II 1991-11-05
K913577 MILESTONE MS 325 RADIOGRAPHIC X-RAY GENERATOR Control-X, Inc. IZO Class I 1991-11-05
K912250 ISORAD(TM) INTEGRAL BUILDUP PHOTON DIODES Theta Systems, Inc. IWB Class II 1991-11-05
K913174 VARIAN CLINAC 600SR Varian Assoc., Inc. IYE Class II 1991-11-05
K912630 XKNIFE RADIOSURGERY SYSTEM Rsa, Inc. IYE Class II 1991-11-04
K913321 HOLOGIC QDR-2000 X-RAY BONE DENSITOMETER Hologic, Inc. KGI Class II 1991-11-01
K913264 HYDRAVIEW 1000 DIGITAL IMAGE PROCESS/STOR DEVICE Mallinckrodt Group, Inc. LLZ Class II 1991-11-01
K913578 MILESTONE MS 525 RADIOGRAPHIC X-RAY GENERATOR Control-X, Inc. IZO Class I 1991-11-01
K914348 ER-1000 CATHERIZATION C-ARM SYSTEMS Shimadzu Medical Systems IYB Class I 1991-11-01
K914019 MRP-5000 HS/MR QUADRATURE BODY COIL(P/N MR-QBC-31) Hitachi Medical Systems America, Inc. LNH Class II 1991-11-01
K913325 40-140 SPIN ECHO FLOW COMPENSATED PULSE SEQUENCE Resonex, Inc. LNH Class II 1991-11-01
K911767 ACUSON V510 TRANSDUCER Acuson Corp. ITX Class II 1991-10-31
K913475 MAGNETIC RESONANCE DIAGNOSTIC DEVICE GE Medical Systems LNH Class II 1991-10-30
K914301 GEN-X 800/800 Swissray Finatech, Inc. IZO Class I 1991-10-30
K914179 CARDIOFOCAL COLLIMATOR Siemens Gammasonics, Inc. KPS Class II 1991-10-30
K914302 GEN-X 800/650 Swissray Finatech, Inc. IZO Class I 1991-10-30
K913757 HOLOGIC CER 20/20, COMPUTED EQUAL RADIO DIAG CHEST Hologic, Inc. KPR Class II 1991-10-30
K911975 SMT-100X Shimadzu Medical Systems LNH Class II 1991-10-30
K913416 TETLEY PATIENT ADMINISTRATION SET Tetley Medical , Ltd. IYT Class II 1991-10-28
K912573 VISION (NUCLEAR MEDICINE COMPUTER) Summit Nuclear KPS Class II 1991-10-28
K911562 EDITOR MP 800/HF-850 X-RAY CONTROL AND GENERATOR Continental X-Ray Corp. IZO Class I 1991-10-24
K911584 DIAGNOSTIC ULTRASOUND SYSTEM MODEL SC480 Pie Medical Equipment B.V. IYO Class II 1991-10-24
K913630 MULTISPECT 2 DUAL DETECTOR CAMERA SYSTEM Siemens Gammasonics, Inc. KPS Class II 1991-10-23
K911739 SWEMAC REISON BIPLANAR 300 Seemac Reison AB Co. OXO Class II 1991-10-23
K913471 CIRRUS GAMMA CAMERA Adac Laboratories KPS Class II 1991-10-23
K913525 MOBILE X-RAY SYSTEM Siemens Medical Solutions USA, Inc. OXO Class II 1991-10-23
K911563 INVENTOR RT/EXPLORER TRAUMA UNIT Continental X-Ray Corp. IYB Class I 1991-10-23
K912180 MODEL MGB-301 DIAPHRAGM FILM 24 X 30 CM Instrumentarium Imaging, Inc. IZX Class II 1991-10-21
K913754 CARDIO 500 Kontron Elektronik GmbH LLZ Class II 1991-10-21
K913441 MODEL #SCT-32 AUTO QUADRATURE SPINE COIL TRANSPORT Mri Devices Corp. LNH Class II 1991-10-21
K913017 MODULEX RTP SYSTEM Computerized Medical Systems, Inc. KPQ Class II 1991-10-17
K911750 COMPUTER ASSIST STEREOTACTIC SURG SYST, MODIFIED Medical Instrumentation & Diagnostics Corp.(Midco) IYE Class II 1991-10-15
K913478 RADIOGRAPHIC FILM MARKING SYSTEM Lorad Medical Systems, Inc. JAC Class I 1991-10-15
K911888 PHILIPS ANGIOPRO Philips Medical Systems North America, Inc. IZP Class II 1991-10-15
K913029 GYROVIEW-HR Philips Medical Systems, Inc. JAK Class II 1991-10-15
K912033 ULTRASOUND STETHOSCOPE(R) INTRADOP(R) Medadonics, Inc. JAF Class II 1991-10-15
K912382 MILITARY RADIOGRAPHIC FLAT TABLE, CAT # T-9130 Continental X-Ray Corp. IXQ Class II 1991-10-10
K911043 HEMISPHERE MULTIPLANE ENDORECTAL PROBE Pie Medical Equipment B.V. ITX Class II 1991-10-09
K903313 RAHD 3100 Esm , Ltd. KPQ Class II 1991-10-07
K910503 DISCOGRAPHY KIT B. Braun of America, Inc. IZG Class II 1991-10-07
K911044 7.5 MHZ APAS TRANSDUCER (ART.NOL: 50.04918.1) Pie Medical Equipment B.V. ITX Class II 1991-10-07
K912741 ELITE R 90/15 Fischer Imaging Corp. IXR Class II 1991-10-04
K912963 INSTRUMENTARIUM MEGA4 Instrumentarium Imaging, Inc. LNH Class II 1991-09-30
K912539 SIGNA ADVANTAGE 0.5T MAGNETIC RESONANCE SYSTEM GE Medical Systems LNH Class II 1991-09-27
K911464 INTERSON DISPOSABLE BIOPSY NEEDLE Interson Corp. IYO Class II 1991-09-27
K913621 RINN PROTECTIVE X-RAY APRON AND PROTECTIVE COLLAR Rinn Dental Products EAJ Class I 1991-09-27
K912454 KODAK EKTASCAN XLP PRELIMINARY DV2000 INTERFACE Eastman Kodak Company JAK Class II 1991-09-27
K913241 JAMIESON JT-CRP CINE FILM PROCESSOR Jamieson Film Co. IXX Class II 1991-09-24
K913078 LATERAL SPINE OPT. XR-SERIES X-RAY BONE DENSITOMET Norland Corp. KGI Class II 1991-09-24
K912829 CARDIOTRACE CARDIAC EVALUATION SYSTEMS Cine Graphics, Inc. LLZ Class II 1991-09-24
K910111 VARIOUS MODELS OF DAYLIGHT CASSETTE HOLDERS Instrumentarium Imaging, Inc. IZH Class II 1991-09-23
K913234 VPW2906A1: 480V, 3 PHASE, X-RAY POWER SUPPLY Varian Canada, Inc. IZO Class I 1991-09-23
K913012 DIGITAL FLUORO STORE(DFS) W/NUMERICAL SUFFIXES Eigen JAA Class II 1991-09-23
K911764 IMAC2000 Medical Imaging Technologies, Inc. JAK Class II 1991-09-23
K912517 FLOOR MOUNT TUBESTAND PERFORMER, 6610.101/S-9109 Continental X-Ray Corp. KPR Class II 1991-09-19
K913534 VISTA HPQ SYSTEM Philips Medical Systems (Cleveland), Inc. LNH Class II 1991-09-19
K912515 FLOOR MOUNT TUBESTAND-PERFORMER-N 6610.102/S-9110 Continental X-Ray Corp. KPR Class II 1991-09-19
K911127 COLLIMASTER-90 Varian Assoc., Inc. IZW Class II 1991-09-19
K910647 XIMATRON/CT OPTION Fischer Imaging Corp. KPQ Class II 1991-09-19
K912974 MAM-3RM-A MAMMOGRAPHIC X-RAY SYSTEM Elscint, Inc. IZH Class II 1991-09-19
K913243 BENNETT X-RAY HORIZ RADIO FLOAT/HI-LO ELEV TABLE Bennett X-Ray Corp. IXG Class I 1991-09-19
K913147 SHIMADZU MULTI-DIRECTIONAL DIAGNOSTIC TABLE VS-100 Shimadzu Medical Systems IXR Class II 1991-09-19
K912696 TRAUMA VIEW RAD SYST MODEL #B-TRV/STRET MOBIL TABL Bennett X-Ray Corp. IYB Class I 1991-09-16
K913063 SHIMADZU X-RAY HIGH VOLTAGE GENERATOR XUD150B-10 Shimadzu Medical Systems IZO Class I 1991-09-16
K913062 SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150B-10 Shimadzu Medical Systems IZO Class I 1991-09-16
K911732 ADVANCE DISPOSABLE CONTROL SYRINGE Advance Medical Designs, Inc. IZI Class II 1991-09-16
K910757 THE BULLION Octostop, Inc. KPR Class II 1991-09-16
K913065 SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150L Shimadzu Medical Systems IZO Class I 1991-09-16
K913064 SHIMADZU X-RAY HIGH VOLTAGE GENERATOR XUD 150L Shimadzu Medical Systems IZO Class I 1991-09-16
K912474 CLASSIC 4-WAY ELEVATING TABLE Continental X-Ray Corp. IZZ Class II 1991-09-16
K913563 MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIY Siemens Medical Solutions USA, Inc. LNH Class II 1991-09-11

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