meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
36
Latest Decision
1993-09-07

Clearances · page 118 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K932153 THYROID UPTAKE SYSTEM & ATOMLAB 950 MED. SPECTROME Biodan Medical Systems, Ltd. IZD Class I 1993-09-07
K932445 SIRESKOP CX Siemens Medical Solutions USA, Inc. JAA Class II 1993-09-07
K931930 POYDOROS LX Siemens Medical Solutions USA, Inc. IZO Class I 1993-09-07
K932374 MAG RESON DIAG DEVI ACCESS CIR POLAR(CP) HEAD COIL Siemens Medical Solutions USA, Inc. LNH Class II 1993-09-07
K931312 KONICA SRX-101 AUTOMATIC X-RAY FILM PROCESSOR Konica Medical Corp. IXW Class II 1993-09-07
K930213 MODEL ASYM-100 Nucletron Mfg. Corp. KPQ Class II 1993-09-07
K931313 KONICA QX-130APLUS AUTOMATIC X-RAY FILM PROCESSOR Konica Medical Corp. IXW Class II 1993-09-07
K932375 MAG RES DIAG DEV ACCESS CIR POL(CP) BODY/SPINE COI Siemens Medical Solutions USA, Inc. LNH Class II 1993-09-07
K933240 POLYDOROS IS Siemens Medical Solutions USA, Inc. IZO Class I 1993-09-07
K930635 MULTISTAR D ANGIOGRAPHIC X-RAY SYSTEM Siemens Medical Solutions USA, Inc. IZI Class II 1993-09-07
K930811 MODIFIED BODY HELMHOLTZ COIL Siemens Medical Solutions USA, Inc. LNH Class II 1993-09-07
K931314 KONICA QX-70 AUTOMATIC X-RAY FILM PROCESSOR Konica Medical Corp. IXW Class II 1993-09-07
K932338 MAGNETOM P8 Siemens Medical Solutions USA, Inc. LNH Class II 1993-08-30
K922208 FUKUDA DENSHI MODEL UF-4500 Fukuda Denshi USA, Inc. IYO Class II 1993-08-30
K932292 AUTOTUNE DEVICE (ATD II) FOR PICKER MRI SYSTEMS Medrad, Inc. LNH Class II 1993-08-26
K931883 AX-390SE AUTOMATIC X-RAY FILM PROCESSOR 9586.033 Alphatek Corp. IXW Class II 1993-08-23
K931882 MAMMO-300 AUTOMATIC X-RAY FILM PROCESSOR Alphatek Corp. IXW Class II 1993-08-23
K931815 2000 X-RAY - TOMOGRAPHIC Imaging Sciences Intl., Inc. IZF Class II 1993-08-23
K931563 SPECTRUM MARK I SPECIAL PROCEDURES TABLE Spectrum X-Ray Corp. IXR Class II 1993-08-23
K930282 AVIVA F22/MAM-CH22 W/OPTIONAL CYTOGUIDE BIOPSY SYS Elscint, Inc. IZH Class II 1993-08-23
K933447 STENOSCOP MOBILE FLUOROSCOPIC XRAY SYSTEM GE Medical Systems OXO Class II 1993-08-23
K923522 LINAC-BASED STEROTACTIC RADIOSURGERY Radionics Software Applications, Inc. IYE Class II 1993-08-18
K933408 FUJI DAYLIGHT CASSETTE MULTI-LOADER Fujifilm Medical System U.S.A., Inc. IXW Class II 1993-08-16
K933253 SUPERSTAND 3000 Wuestec Medical, Inc. IYB Class I 1993-08-16
K930699 M6-M X-Cel X-Ray Corp. IZL Class II 1993-08-09
K932957 QUANTEM (TM) GE Medical Systems IYX Class I 1993-08-05
K932745 C-EQUAL(CEDERS-EMORY QUANTITIVE ANALYSIS) Adac Laboratories KPS Class II 1993-08-05
K932355 9150A, 1100F Dynarad Corp. IZL Class II 1993-08-03
K931292 MULTIVIEW FOR WINDOWS Image Data Corp. LMD Class I 1993-07-29
K931376 GAMMACON IMAGE TRANSLATION SYSTEM Numa Corp. LLZ Class II 1993-07-28
K931998 LCR GENERATOR Philips Medical Systems (Cleveland), Inc. IZO Class I 1993-07-27
K931657 NUCLEAR ASSOCIATES MODEL 34-070 BRACHYTHERAPY CAL. Victoreen, Inc. KPT Class II 1993-07-27
K931297 GCA-7200A Toshiba America Medical Systems, In.C KPS Class II 1993-07-27
K930279 REFIX(TM) SYSTEM Nomos Corp. IYE Class II 1993-07-27
K932242 RADIOACTIVE SAMARIUM 145 SEEDS/SOURCES #2341-2345 Best Industries KXK Class II 1993-07-27
K932565 FUJIFILM EC-B SERIES CASETTE Fujifilm Medical System U.S.A., Inc. IXA Class II 1993-07-26
K930045 MODEL #QSC-200-21 20 CM. QUADRATURE SHOULDER COIL Mri Devices Corp. LNH Class II 1993-07-26
K932134 RINN UNIVERSAL COLLIMATOR Rinn Corp. IZX Class II 1993-07-26
K923180 SPECTURN, MODEL TTK-128 Harpell Assoc., Inc. IYX Class I 1993-07-26
K930246 MAMMORX Diacor, Inc. IYE Class II 1993-07-26
K930122 MODEL 600GE-64: BILATERAL BREAST COIL Medical Advances, Inc. LNH Class II 1993-07-26
K932357 FUJI EC ID CAMERA Fujifilm Medical System U.S.A., Inc. JAC Class I 1993-07-26
K926300 DTX-100 Hologic, Inc. KGI Class II 1993-07-23
K932354 9170, 1170 Dynarad Corp. IZL Class II 1993-07-23
K931604 3M MEDICAL DIAGNOSTIC VIDEOCASSETTE 3M Health Care, Ltd. IWZ Class I 1993-07-21
K926571 MRINNERVU(R) ENDORECTAL PROSTATE COIL BPX-15 Medrad, Inc. LNH Class II 1993-07-20
K926009 MATRIX CCM 600 Heraeus Kulzer, Inc. IYO Class II 1993-07-20
K931605 3M MEDICAL DIAGNOSTIC SUPER VHS VIDEOCASSETTE 3M Health Care, Ltd. IWZ Class I 1993-07-20
K930051 FATHOM CMP-1000 Fathom Ent., Inc. IYO Class II 1993-07-20
K931941 SUNSCOPE 100 Sunning Corp. JAA Class II 1993-07-20
K931268 URETERAL COMPRESSION DEVICE Bt Medical Co., Inc. JAA Class II 1993-07-19
K930273 ALPHA Raymax Medical Corp. IZZ Class II 1993-07-13
K930357 ACCESSORY TO UNIVERSAL OCTOPAQUE Octostop, Inc. KXH Class I 1993-07-13
K930885 PNEUMATIC COMPRESSION DEVICE Bt Medical Co., Inc. JAA Class II 1993-07-13
K931200 BATTERY PACKS (VARIOUS MODELS) Access / God Loves You IZL Class II 1993-07-13
K925354 COMBISON(R) 311 Kretztechnik AG IYO Class II 1993-07-08
K926206 POSICAM-HZ & POSICAM-HZL Positron KPS Class II 1993-07-08
K931551 KODAK EKTASCAN IMAGELINK SYSTEM (KEIS) Eastman Kodak Company LMD Class I 1993-06-29
K926098 DIGIRAY Telescan Corp. LMD Class I 1993-06-25
K925664 SERIES V-SCAN RADIOGRAPHIC FILM SCANNER Vision Ten, Inc. LLZ Class II 1993-06-22
K930049 INFRARED EXPOSURE HAND SWITCH Mid X-Ray, Inc. IZL Class II 1993-06-22
K930283 THYRUS Adac Laboratories IYX Class I 1993-06-21
K930527 DENTAL LINK Escan, Inc. LLZ Class II 1993-06-21
K931193 SIM-400 SYSTEM Scinticor, Inc. KPS Class II 1993-06-21
K931008 MODEL #QWH-63, QUADRATURE WRIST AND HAND COIL Mri Devices Corp. LNH Class II 1993-06-18
K930991 BILATERAL TEMPORAL MANDIBULAR JOINT COIL Magnetic Research, Inc. LNH Class II 1993-06-18
K925965 PICTURE ARCHIVING AND COMMUNICATION SYSTEMS Advanced Light Imaging Technologies , Ltd. IYO Class II 1993-06-14
K931170 SONY CARDIAC ANALYSIS AND REVIEW STATION (CARS) Sony Medical Systems IZI Class II 1993-06-14
K924231 INTERSPEC APOGEE CLA Interspec, Inc. IYO Class II 1993-06-14
K931724 ELECTROPHYSIOLOGY (EP) TABLE EP 2000 SERIES Continental X-Ray Corp. KXJ Class II 1993-06-14
K930324 EZ MOVER Prime Ideas, Inc. IYO Class II 1993-06-11
K925885 AFP 17 X 4 AUTOMATIC FILM PROCESSOR Afp Imaging Corp. IXW Class II 1993-06-09
K925265 IMAGEVIEW 46000 Canberra Industries, Inc. LMC Class II 1993-06-09
K931074 DU PONT MV DARKROOM CASSETTE E.I. Dupont DE Nemours & Co., Inc. IXA Class II 1993-06-08
K930428 PENN-PET SCANNER Ugm Medical Systems, Inc. KPS Class II 1993-06-08
K931002 FUJI COMPUTED RADIOGRAP HI-C654 DMS CRT IMAGE CONS Fujifilm Medical System U.S.A., Inc. IXK Class II 1993-06-08
K925714 BREAST SIMULATION SYSTEM Severn Research, Inc. IYE Class II 1993-06-08
K922846 MRH-1500 Hitachi Medical Systems America, Inc. LNH Class II 1993-06-08
K931283 MICROVISION FAST DETAIL INTENSIFYING SCREEN E.I. Dupont DE Nemours & Co., Inc. EAM Class I 1993-06-08
K924495 PHILIPS RTNET RADIOTHERAPY NETWORKING SYSTEM Philips Medical Systems, Inc. IYE Class II 1993-06-08
K926133 CORT-EX General Electric Co. KPS Class II 1993-06-08
K924204 NEW ULTRASOUND IMAGING SYSTEM & TRANSDUCERS Tetra Corp. IYN Class II 1993-06-07
K930570 RADIOACTIVE PALLADIUM 103 SEEDS/SOURCES Best Industries KXK Class II 1993-06-04
K924290 BEST INDUSTRIES CARTRIDGE & GUN Best Industries IWJ Class I 1993-06-04
K924261 RADIOACTIVE CESIUM-131 SEEDS/SOURCES Best Industries KXK Class II 1993-06-04
K930294 PATPOS GREEN Cp Bio-Medical Corp. IWE Class I 1993-06-04
K931269 LEAD APRON Bt Medical Co., Inc. EAJ Class I 1993-06-02
K924605 MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY General Electric Co. LNH Class II 1993-05-21
K930295 PATPOS COMPACT Cp Bio-Medical Corp. IWE Class I 1993-05-21
K930296 PATPOS RED Cp Bio-Medical Corp. IWE Class I 1993-05-21
K925220 PMI100 VIDEO IMAGER Heraeus Kulzer, Inc. LMC Class II 1993-05-20
K931060 STATVIEW Image Data Corp. LMD Class I 1993-05-20
K923246 SONACE 2000 Medison Co., Ltd. IYO Class II 1993-05-20
K925029 MRINNERVU ENDORECTAL PROSTATE COIL Medrad, Inc. LNH Class II 1993-05-19
K930792 RSX 30HF Fischer Imaging Corp. IZO Class I 1993-05-19
K925987 INSTRUMENTARIUM MEGA4 HT Instrumentarium Imaging, Inc. LNH Class II 1993-05-19
K931049 ADVANTX SYSTEM GE Medical Systems IZO Class I 1993-05-19
K926416 SAT PAD(TM) Alliance Pharmaceutical Corp. LNH Class II 1993-05-19
K930962 CAPTUS 2000 WEL COUNTER Capintec Instruments, Inc. IZD Class I 1993-05-18
K925892 SOLSTICE XRAY RING MARKER PAD Solstice Corp. JAC Class I 1993-05-18

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