meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
33
Latest Decision
1993-12-13

Clearances · page 117 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K933778 WHITMORE ANKLE X-RAY EXTENSION (AXE) Whitmore Ent., Inc. KPR Class II 1993-12-13
K926315 PRACTICE PARTNER Rs Imaging LMD Class I 1993-12-13
K932644 PHILIPS GYROSCAN TN5 & TN5 LITE Philips Medical Systems, Inc. LNH Class II 1993-12-13
K934311 INTRASCAN(R) MINI-PACS Markcare Medical Systems, Inc. IYO Class II 1993-12-13
K932410 HEARTVIEW(R) CORONARY ANGIOGRAPH DIAGRAM/REPORT SY Heartware Intl. Corp. IZI Class II 1993-12-13
K935004 MODEL ALPHA TS-2 Dpa Consulting, Inc. IYB Class I 1993-12-13
K935209 INSTA-FLO Medtec, Inc. JAD Class II 1993-12-13
K934519 RADIATION EXIT VERIFICATION SYSTEM/BACK POINTER SYSTEM Medtec, Inc. IWE Class I 1993-12-13
K933632 MEDSCAN 12 Vidar Systems Corp. LMA Class II 1993-12-13
K932645 PHILIPS GYROSCAN TN 15 Philips Medical Systems, Inc. LNH Class II 1993-12-13
K933777 CONCEPT ONE Innerscan, Inc. IZO Class I 1993-12-13
K935068 RADIOGRAPHIC GENERATOR HFQ-WHIS Bennett X-Ray Corp. IZO Class I 1993-12-13
K924184 CVI-Q(TM) OPTION FOR P700 Philips Medical Systems, Inc. IYO Class II 1993-12-10
K925858 OE 1.5 SI Otsuka Electronics LNH Class II 1993-12-02
K933471 SHIMADZU X-RAY HIGH VOLTAGE GENERATOR AUD150G Shimadzu Corp. IZO Class I 1993-11-24
K933473 CATHETERIZATION C-ARM SUPPORT MH-51BM/MH-51CM Shimadzu Corp. JAA Class II 1993-11-24
K934005 SHIMADZU CEILING TUBE SUPPORT CH-30GX Shimadzu Corp. KPR Class II 1993-11-24
K934396 QUADRATURE LOWER EXTREMITY COIL Medical Advances, Inc. LNH Class II 1993-11-24
K933513 R &D BATTERIES, INC. PART # 5015, 5192, 5482 R & D Batteries, Inc. IYX Class I 1993-11-24
K924432 MEDISON 1500 Medison Co., Ltd. IYO Class II 1993-11-24
K932372 CEMAX VIPSTATION(TM) AND/OR SOFTWARE Cemax, Inc. LLZ Class II 1993-11-22
K934850 NUCLEAR ASSOCIATES PERSONNEL PROTECTIVE SHIELDS Victoreen, Inc. KPX Class II 1993-11-22
K933791 PHILIPS ANGIOPRO RELEASE 2.1 Philips Medical Systems North America, Inc. JAA Class II 1993-11-22
K933659 MODEL #100GE1500 LOWER EXTREM QUAD DETECT ARRAY COIL Medic, Inc. LNH Class II 1993-11-22
K933835 0.5T ASSET SYSTEM Philips Medical Systems (Cleveland), Inc. LNH Class II 1993-11-22
K931186 PHOTOPHONE MULTIVIEW Image Data Corp. LMD Class I 1993-11-22
K931544 1.5T EDGE AND 1.0T VISTA SYSTEMS Philips Medical Systems (Cleveland), Inc. LNH Class II 1993-11-22
K934755 FAST FIND GRIND Webb Research Ii, Inc. KPR Class II 1993-11-19
K930752 CT/MRI TOPOGRAPHIC MARKER I.Z.I. Corp. JAC Class I 1993-11-19
K925956 MICROSELECTRON - HDR FOR MOBILE ENVIRONMENT Nucletron-Oldelft Corp. JAQ Class II 1993-11-19
K933658 MODEL 300GE1500 SHOULDER COIL Medic, Inc. LNH Class II 1993-11-19
K926348 SC1000 SCAN CONVERTER Perkins Mfg. Co. LMB Class I 1993-11-19
K931795 TELERAD STAT Magnetic Research, Inc. LMD Class I 1993-11-19
K934626 GOODALL LASER TARGETING DEVICE Protectair, Inc. JAA Class II 1993-11-19
K931927 VICTOREEN MODEL 530 Victoreen, Inc. IYE Class II 1993-11-15
K933645 ECG GATING HARDWARE FOR MRP-5000 AND MRP-7000 Hitachi Medical Systems America, Inc. LNH Class II 1993-11-12
K934362 NUCLEAR ASSOCIATES GLASSERS Victoreen, Inc. IWS Class I 1993-11-12
K934548 ALL-VUE & GAMMA-VUE VIAL SHIELDS Victoreen, Inc. IWW Class I 1993-11-12
K923211 DIGITAL OPHTHALMIC ULTRASOUND BIOMICROSCOPE Zeiss Humphrey System IYO Class II 1993-11-08
K933100 ARC-600 B C Medical , Ltd. JAA Class II 1993-11-08
K930709 PHILIPS GYROSCAN ACS-II RELEASE 3 Philips Medical Systems, Inc. LNH Class II 1993-11-08
K933299 QL MULTIPULSE 2048 Infimed, Inc. JAA Class II 1993-11-03
K934566 RADASSIST Diacor, Inc. IYE Class II 1993-11-03
K930579 MEDISON 88P DIAGNOSTIC ULTRASOUND IMAGING SYTEM Medison America, Inc. IYO Class II 1993-11-03
K931279 ACU-RAY Sterne Equipment Co., Ltd. IZL Class II 1993-11-03
K933409 IMPAX 1000 Heraeus Kulzer, Inc. LMD Class I 1993-11-03
K933493 RAM-PACS Medical Knowledge Systems, Inc. IYE Class II 1993-11-03
K934481 EP-X Fischer Imaging Corp. JAA Class II 1993-11-03
K933321 DELTAMANAGER Medimage, Inc. KPS Class II 1993-11-03
K931392 ECG GATING UNIT Resonex, Inc. LNH Class II 1993-11-02
K933297 MODEL #510GE1500 LIVER ARRAY COIL Medic, Inc. LNH Class II 1993-11-02
K931184 MULTI-VIEW PROCESSOR (MVP) Adac Laboratories IZI Class II 1993-11-02
K930960 ACCESS MAGNETIC RESONANCE DEVICE ACCESSORY Toshiba America Mri, Inc. LNH Class II 1993-11-01
K933372 VISIONLINK INTERFILE CONVERSION SOFTWARE Evergreen Technologies, Inc. KPS Class II 1993-11-01
K933446 PICTURE ARCHIVING & COMMUNICATIONS SYSTEMS(PACS) Sudbury Systems, Inc. KPS Class II 1993-11-01
K933256 FAN BEAM COLLIMATOR Siemens Gammasonics, Inc. IYX Class I 1993-10-29
K926275 PHILIPS MRI BREAST COIL Philips Medical Systems, Inc. LNH Class II 1993-10-28
K932344 MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIES Siemens Medical Solutions USA, Inc. LNH Class II 1993-10-25
K926252 CATHSCANNER II INTRAVASCULAR ULTRASONIC IMAGING SY Endosonics Corp. IYO Class II 1993-10-25
K925627 ADDITIONAL FEATURES ESI-3000 ULTRASOUND UNIT Elscint, Inc. IYO Class II 1993-10-08
K926001 MRT-50A, MRT-150A Toshiba America Mri, Inc. LNH Class II 1993-10-08
K933035 BCM-600TX B C Medical , Ltd. KPX Class II 1993-10-08
K931974 AZ 92 A2j, Inc. IWE Class I 1993-10-08
K933161 ULTRA-VISION SUPER RAPID INTENSIFYING SCREEN Dupont Medical Products EAM Class I 1993-10-07
K932693 EDGE SYSTEM Philips Medical Systems (Cleveland), Inc. LNH Class II 1993-10-07
K933650 PHILIPS XRG 90 X-RAY GENERATOR SYSTEM Philips Medical Systems North America, Inc. IZO Class I 1993-10-07
K925985 GYREX V-DIX & 2T-DIX SOFTWARE VERSION 3.0 Elscint, Inc. LNH Class II 1993-10-07
K933162 MRX-750 Mrx Corp. ITY Class I 1993-10-07
K934206 MAVIG ANGIO SHIELD MODELS 6290 & 6272 F. Walter Hanel GmbH KPY Class I 1993-10-07
K933129 LUMISCAN 50 Lumisys, Inc. LMA Class II 1993-10-07
K930779 MRINNERVU DISPOSABLE ENDORECTAL CERVIX COIL#BCR-15 Medrad, Inc. LNH Class II 1993-10-07
K925597 SNR-3000 UPGRADE RECEIVER COILS Magnetic Resonance Plus, Inc. LNH Class II 1993-10-07
K933134 SPECTRUM DG-P7000 PEDIATRIC CRADLE Spectrum X-Ray Corp. KXH Class I 1993-10-07
K933613 3-WAY HEAD IMMOBILIZER; 3WAY DELUXE REUSABLE FRAME HEAD IMMOBILIZER Bionix Development Corp. IYE Class II 1993-10-07
K925286 MRT-150A MRI SYSTEM W/SUPER PERFORMANCE PACKAGE Toshiba America Mri, Inc. LNH Class II 1993-10-07
K933614 PITUITARY BOARD Bionix Development Corp. IYE Class II 1993-10-07
K933073 HEARTTRACE LEFT VENTRICULAR ANALYSIS SOFTWARE Heartware Intl. Corp. IZI Class II 1993-10-07
K931022 ARTOSCAN Biosound, Inc. LNH Class II 1993-10-07
K932777 SMARTNEEDLE(R) OVER-THE-NEEDLE CATHETER Peripheral Systems Group ITX Class II 1993-10-07
K933431 ORTHOTRAC COAXIAL LASER Trac Medical, Inc. OXO Class II 1993-10-05
K933103 DIGITAL IMAGE COMMUNICATIONS SYSTEM Analogic Corp. LMD Class I 1993-10-05
K925434 SECTOR & TRANSVAGINAL MODEL #'S SW4/5B/A,EW5/7K/A Kretz Technik ITX Class II 1993-09-30
K930544 MRINNERVU DISPOSABLE ENDORECTAL COLON COIL,#PCC-15 Medrad, Inc. LNH Class II 1993-09-29
K933209 VISIONTOOL Evergreen Technologies, Inc. LLZ Class II 1993-09-29
K930755 ULTRA COMPACT VIDEO IMAGER International Imaging Electronics LMC Class II 1993-09-28
K932536 CARDIOMETRICS FLOWIRE & FLOMAP Cardio Metrics, Inc. ITX Class II 1993-09-28
K925081 SURFAS D.O. Weaver and Co. ITX Class II 1993-09-28
K933001 KODAK XML 300 DARKROOM FILM FEEDER Eastman Kodak Company IXW Class II 1993-09-28
K933058 HEARTTRACK QUANTITATIVE CORONARY ANGIOGRAPHY SOFTW Heartware Intl. Corp. IZI Class II 1993-09-28
K924079 CFM-800 COLOR FLOW MAPPING SYSTEM Diasonics, Inc. IYO Class II 1993-09-28
K926108 VINGMED SOUND COLOR FLOW MAPPING SYSTEM, CFM-800 Vingmed Sound, Inc. ITX Class II 1993-09-24
K933754 CHENOWETH-FRANK RADIOPATHOLOGICAL GRID Cook, Inc. IZH Class II 1993-09-20
K925864 COURIER PC Shoreline Business Consulting LMD Class I 1993-09-20
K933098 MEDICAL IMAGE MANAGEMENT SYSTEM/X-RAY TERMINAL Siemens Medical Solutions Health Services Corporat LMD Class I 1993-09-20
K933023 CERVICAL TRACTION STRAP Cook (Canada), Inc. KPR Class II 1993-09-20
K930674 MODEL 640GE-64: QUADRATURE PELVIC COIL Medical Advances, Inc. LNH Class II 1993-09-16
K926351 COLORMARK(TM) VISUALIZATION SYSTEM Echocath, Inc. IYN Class II 1993-09-16
K926251 B-SCAN OPTHALMIC ULTRASOUND IMAGING SYSTEM Biovision, Inc. IYO Class II 1993-09-14
K925650 IMAGEVIEW 5000 Nuclear Data Systems LMC Class II 1993-09-14
K930765 ULTRA COMPACT VIDEO IMAGER International Imaging Electronics JAK Class II 1993-09-13

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