meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
33
Latest Decision
1990-09-27

Clearances · page 128 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K903527 MAGNETIC RESONANCE DIAGNOSTIC DEVICE-OR 41 MAGNET Siemens Medical Solutions USA, Inc. LNH Class II 1990-09-27
K902606 RADIOPAQUE RULER Professional Medical Services KPR Class II 1990-09-27
K902965 FDI 2000 ULTRASONIC SKIN SCANNER Fulmer Dyson Intl. IYO Class II 1990-09-26
K900881 OR-340 INTRAOPERATIVE ULTRASOUND SYSTEM Codman & Shurtleff, Inc. IYO Class II 1990-09-25
K903901 SCANNING COT Med-Tron Products, Inc. IYZ Class I 1990-09-21
K902217 TEMPOROMANDIBULAR JOINT (TMJ) COIL Siemens Medical Solutions USA, Inc. LNH Class II 1990-09-21
K903377 COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM OPTION Siemens Medical Solutions USA, Inc. JAD Class II 1990-09-21
K902005 MODEL B-200 C-ARM & MODEL C-300 CARDIAC TABLE Omega Medical Imaging, Inc. JAA Class II 1990-09-20
K902663 GE QUADRATURE T/L SPINE SURF COIL, M1085AP/M1285AP General Electric Co. LNH Class II 1990-09-20
K903203 MRP-20: HS/MR HEAD COIL 3-D FT RECONSTRUCTION Summit World Trade Corp. LNH Class II 1990-09-17
K897042 EUB-515 DIAGNOSTIC ULTRASOUND DEVICE Hitachi Medical Corp. of America IYO Class II 1990-09-13
K903028 GYREX 2T VERSION 2.1U. Elscint, Inc. LNH Class II 1990-09-10
K903204 MRP-20: SUPPL R/F COIL HS/MR QUADRATURE HEAD COIL Summit World Trade Corp. LNH Class II 1990-09-07
K903767 ECT (EMMISSION COMPUTED TOMOGRAPHY) CARBON FIB PAL Siemens Gammasonics, Inc. IYZ Class I 1990-09-07
K901467 VISION DIAGNOSTIC ULTRASONIC SCANNER The Probe Corp. IYO Class II 1990-09-05
K903576 PUCK 90M Elema-Schonander, Inc. KPX Class II 1990-09-04
K903422 MT-15 RADIOGRAPHIC/FLUOROSCOPIC TILT TABLE Imt America, Inc. IXR Class II 1990-09-04
K900683 SEVEN ADD'L TRANSDUCERS FOR THE EUB-450 ULTRASOUND Hitachi Medical Corp. of America ITX Class II 1990-08-31
K896707 PERLINK SCREEN, KIRAN SCREEN Perlink USA, Inc. EAM Class I 1990-08-30
K894795 HOLOGIC QDR-1000/W X-RAY BONE DENSITOMETER Hologic, Inc. KGI Class II 1990-08-30
K903395 UROMAT 2000 Pausch Corp. IXR Class II 1990-08-30
K903048 VISTA MR 2055 HP SYSTEM Philips Medical Systems (Cleveland), Inc. LNH Class II 1990-08-30
K902460 CARDIOSCINT (LEFT VENTRICULAR FUNCTION MONITOR) Oakfield Instruments, Ltd. IZD Class I 1990-08-28
K902070 RADIUS AND SONOCHROME General Electric Co. ITX Class II 1990-08-28
K900805 ALOKA 500 DIAGNOSTIC ULTRASOUND SCANNING SYSTEM Ge Medical Systems Information Technologies IYO Class II 1990-08-23
K902933 TESLACON (MAGNETIC RESONANCE DIAGNOSTIC DEVICE) General Electric Co. LNH Class II 1990-08-23
K902339 THERAVIEW DIGITAL PORTAL IMAGING COMPUTER S & S Inficon, Inc. IYE Class II 1990-08-23
K902044 MEGA 4 MAGNETIC RESONANCE IMAGING SYSTEM Instrumentarium Imaging, Inc. LNH Class II 1990-08-23
K901033 MER MULTIPLANE RECTAL PROBE (MRP) Medical Equipment Resources IYO Class II 1990-08-22
K900882 MULTI DOPPLEX, MD-1 Huntleigh Technology, Inc. JAF Class II 1990-08-22
K897073 ADDITIONAL TRANSDUCERS FOR USE W/SDL 300 Shimadzu Corp. ITX Class II 1990-08-21
K896644 ADDITIONAL TRANSDUCERS FOR USE WITH SDU 500 Shimadzu Corp. ITX Class II 1990-08-21
K901422 SCIVIEW SYSTEM, MODEL SC1250 AND PIXIE IMAGING SOF Image Systems, Inc. LLZ Class II 1990-08-21
K896356 AU530 DIAGNOSTIC ULTRASONIC PULSED ECHO SYSTEM Esaote Biomedica Spa IYO Class II 1990-08-21
K902732 KODAK X-OMAT 460 RA PROCESSOR Eastman Kodak Company IXW Class II 1990-08-17
K903319 MAGNETIC RESONANCE DIAGNOSTIC DEVICE GE Medical Systems LNH Class II 1990-08-17
K902542 PHILIPS INTEGRIS C2000 SYSTEM Philips Medical Systems North America, Inc. IZI Class II 1990-08-17
K901589 RTS TECHNOLOGY IRIDIUM 192 SOURCES Rts Technology, Inc. JAQ Class II 1990-08-17
K902648 PINNACLE IMAGE PROCESSING SYSTEM Medasys, Inc. LLZ Class II 1990-08-17
K902557 XPEED COMPUTED TOMOGRAPHY X-RAY SYSTEM Toshiba America Medical Systems, In.C JAK Class II 1990-08-17
K901952 MAG RESON DIAG DEV ACCESS SPEC PURP REC ONLY COIL Siemens Medical Solutions USA, Inc. LNH Class II 1990-08-17
K901725 ADD'L TRANSDUCER FOR USE W/THE COMBISON 310A Kretztechnik AG ITX Class II 1990-08-15
K902582 ALLERGAN HUMPHREY A/B SCAN , MODEL 835 Allergan Humphrey IYO Class II 1990-08-14
K903196 IMAGE INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM General Electric Co. LLZ Class II 1990-08-10
K902106 VPW 2877D5, X-RAY POWER SUPPLY Varian Assoc., Inc. IZO Class I 1990-08-10
K901888 PROSTATE PROBE SURFACE COIL, CATALOG #BPX-15 Medrad, Inc. LNH Class II 1990-08-10
K902622 MANAN PROSTATE SEEDING NEEDLE Manan Medical Products, Inc. KXK Class II 1990-08-10
K896999 SDL 310 DIAGNOSTIC ULTRASOUND INSTRUMENT Shimadzu Corp. IYO Class II 1990-08-09
K901671 HAFCON (FLOURO FOOTSWITCH) B & H Research Instruments JAA Class II 1990-08-08
K903160 LIEBEL-FLARSHEIM SERIES 8000 BUCKY,W/NON SIZE SENS Continental X-Ray Corp. IXQ Class II 1990-08-08
K902637 FUTURUS 2001 X-RAY GENERATOR Acoma Medical Imaging, Inc. IZO Class I 1990-08-03
K902849 PHILIPS VERIFLEX Philips Medical Systems, Inc. IYE Class II 1990-08-03
K902927 DIGITAL PHOTOSPOT Eigen JAA Class II 1990-08-03
K902314 LARGE FLEXIBLE BODY COIL Toshiba America Mri, Inc. LNH Class II 1990-08-03
K902316 KNEE QD COIL MRT 50A Toshiba America Mri, Inc. LNH Class II 1990-08-01
K902310 SOFTWARE RELEASE 4.2P, ACCESS(TM) Toshiba America Mri, Inc. LNH Class II 1990-08-01
K902315 CERVICAL COIL MRT 50A Toshiba America Mri, Inc. LNH Class II 1990-08-01
K902403 ELITE R/F SPOT FILM DRIVE Rms Div. IXL Class II 1990-08-01
K902848 FASTRECON 88 PERIFERAL Scientific Technology , Ltd. JAK Class II 1990-08-01
K902039 RAREX & OPTEX X-RAY SCREENS Mci Optonix, Inc. EAM Class I 1990-07-27
K901772 KODAK M35A-M X-OMAT PROCESSOR Eastman Kodak Company IXW Class II 1990-07-25
K900170 MODIFIED EXEL 2400 ELITE/U & EXEL 2400E/U Elscint, Inc. JAK Class II 1990-07-25
K902007 I3SYSTEM-ABD Innovative Imaging, Inc. IYO Class II 1990-07-20
K901655 1 TRANSDUCER FOR COMBISON 310A Kretztechnik AG ITX Class II 1990-07-20
K902630 BILATERAL TMJ COIL Resonex, Inc. LNH Class II 1990-07-19
K902531 EXAPHASE, SINGLE PHASE IMPRESSION MATERIAL G-C Intl. Corp. EGW Class II 1990-07-13
K896480 SIEMENS SONOLINE AC Siemens Medical Solutions USA, Inc. IYO Class II 1990-07-13
K896197 COLAB COCATH(TM) IMPLANTED CATHETER AND DEPOT Colab Intl., Inc. KXK Class II 1990-07-11
K901951 MODEL# MPC Amerisys IZO Class I 1990-07-11
K901842 PLASTIC-GUIDES M & K Co. IWJ Class I 1990-07-11
K901848 GADOLINIUM-153 BONE DENSITOMETER SOURCES Amersham Corp. KGI Class II 1990-07-09
K902643 FALCON DISK DRIVE SUBSYSTEM Sokar, Inc. JAK Class II 1990-07-09
K901857 GADOLINIUM-153 BONE DENSITOMETER (GDC.10413) Amersham Corp. KGI Class II 1990-07-09
K901854 GADOLINIUM-153 BONE DENSITOMETER (GDC.10411/10412) Amersham Corp. KGI Class II 1990-07-09
K901832 GADOLINIUM-153 BONE DENSITOMETER SOURCES GDC.10415 Amersham Corp. KGI Class II 1990-07-09
K900469 ULTRASOUND SCANNER MODEL #1150 Pie Medical USA BV IYO Class II 1990-07-09
K901730 GE SIGNA ADVANTAGE GE Medical Systems LNH Class II 1990-07-06
K901558 GIOTTO MAMMOGRAPHY HF Medical Device Marketing Network, Inc. IZH Class II 1990-07-03
K902610 GENERAL ELECTRIC AMX 3 Pro-Tronics, Inc. IZL Class II 1990-07-02
K901956 DIGITAL 8 W/OTHER NUMERICAL SUFFIXES (1-9, ETC.) Eigen LMB Class I 1990-07-02
K902535 SONY WBS-700H VIDEOCASSETTE RECORDER SYSTEM Sony Medical Electronics Co. JAA Class II 1990-06-29
K901980 MOBILE MRP-20 MAGNETIC RESONANCE DIAGNOSTIC DEVICE Summit World Trade Corp. LNH Class II 1990-06-28
K901545 GCA-9300 NUCLEAR TOMOGRAPHY SYSTEM Toshiba America Medical Systems, In.C JWM Class II 1990-06-26
K902378 CARDIOTHORACIC RULER Devcom, Inc. KPR Class II 1990-06-14
K896714 AUSONICS 5000 Ausonics Pty , Ltd. IYO Class II 1990-06-11
K901997 X-RAY TUBE HOUSING ASSEMBLY, VARIOUS MODELS Comet Ltd. C/O Radiology Resources, Inc. IZH Class II 1990-06-06
K901567 THE HUESTIS COMPU-PLOTTER Huestis Machine Corp. IXI Class II 1990-05-31
K901864 MODEL 4050-21; 5.25 LOOP SHOULDER COIL Medical Advances, Inc. LNH Class II 1990-05-31
K902146 SFD-035 SPOT FILM DEVICE Rms Div. IXL Class II 1990-05-31
K901679 RESUBMITTED ISG 3DMV WORKSTATION I.S.G. Technologies, Inc. LLZ Class II 1990-05-29
K901818 ADD'L SOFTWARE VERSION D2 FOR MAGNETOM 42 AND 63 Siemens Medical Solutions USA, Inc. LNH Class II 1990-05-23
K893863 ACUSON L538 TRANSDUCER Acuson Computed Sonography ITX Class II 1990-05-23
K900773 NUCLEAR MAX Scientific Imaging, Inc. IYX Class I 1990-05-23
K894763 FUJINON EDU SYSTEM Fujinon, Inc. ITX Class II 1990-05-22
K900935 DU PONT LINX LASER IMAGER W/THE LINX NETWORKING E.I. Dupont DE Nemours & Co., Inc. LMD Class I 1990-05-15
K900919 MODIFIED HITACHI MRP-20 MAGNETIC RESONANCE DIAGNOS Summit World Trade Corp. LNH Class II 1990-05-14
K900156 AP201 DENTAL X-RAY FILM PROCESSOR Allied Photo Products Co., Inc. EGY Class II 1990-05-14
K901639 MODEL 4050-64; 5.25 & 4065-64; 6.50 LOOP COIL Medical Advances, Inc. LNH Class II 1990-05-14
K900851 DIGITAL IMAGE ENHANCEMENT SYSTEM Atomic Products Corp. LLZ Class II 1990-05-11
K900697 CEDARS-SINAI QUANTITATIVE THALLIUM-201 ANALYSIS Nuccardiac Software, Inc. LLZ Class II 1990-05-11

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