meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
37
Latest Decision
1992-07-10

Clearances · page 122 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K920096 MRT-150 QD KNEE COIL Toshiba America Mri, Inc. LNH Class II 1992-07-10
K921992 MP3000 SERIES III VIDEO IMAGER International Imaging Electronics LMC Class II 1992-07-10
K920543 MRI OE 1.5 SI Otsuka Electronics LNH Class II 1992-07-10
K922313 P-LINK Virtual Imaging KPS Class II 1992-07-10
K915860 LINEAR PERIPHERALVASCULAR ULTRSOUND PROBE Biosound, Inc. ITX Class II 1992-07-02
K921631 CVIS INSIGHT IMAGING CATHETER FOR INTRALUMINAL Cardiovascular Imaging Systems, Inc. ITX Class II 1992-07-02
K915715 CINE RECALL FUNCTION/OPUS 1 REAL TIME SCANNER Ausonics Pty , Ltd. IYO Class II 1992-07-02
K921961 SDMO APPLICATOR CODE: ASN.8236 Medi-Physics Inc. Dba Nycomed Amersham Imaging IWJ Class I 1992-07-01
K921563 CARDIOMETRICS FLOWIRE/FLOMAP SYSTEM Cardio Metrics, Inc. ITX Class II 1992-07-01
K922619 DIGITIZER, MODEL # 3-000A-1518 Lorad Medical Systems, Inc. IZH Class II 1992-07-01
K921743 KODAK EKTASCAN 2180 LASER PRINTER Eastman Kodak Company LMC Class II 1992-07-01
K921877 AD/V SPOOLER Adaptive Video, Inc. LMD Class I 1992-07-01
K920746 VFC UNIT Tilane Corp. JAA Class II 1992-06-30
K920539 ORWO X-RAY FILM Burkhart Roentgen Intl., Inc. IWZ Class I 1992-06-30
K914945 DIAGNOSTIC ULTRASOUND SYSTEM TYPE 3535, MODIFIED Bruel & Kjaer Industri A/S IYO Class II 1992-06-26
K920789 B3000/B3000M MAGNETIC RESONANCE IMAGING SCANNER Fonar Corp. LNH Class II 1992-06-25
K921670 ACUSON IMAGE MANAGEMENT SYSTEM Acuson Corp. IYO Class II 1992-06-25
K921876 MKS BEAM OUTLINE PROJECTOR Medical Knowledge Systems, Inc. KPQ Class II 1992-06-25
K921527 STATVIEW Image Data Corp. LMD Class I 1992-06-24
K920373 MAESTRO DIGITAL VIDEO SYSTEM International Imaging Electronics IYO Class II 1992-06-24
K920254 COILS FOR RX4000 & RX5000 MRI SYSTEMS Resonex, Inc. LNH Class II 1992-06-22
K921316 MG-1001 TUBE HOUSING ASSEMBLY Magma Corp. ITY Class I 1992-06-22
K912925 ULTRA PVD Advanced Medical Products, Inc. JAF Class II 1992-06-18
K911916 ACUSON C366 TRANSDUCER Acuson Corp. ITX Class II 1992-06-18
K920938 VJW2919 PNEUMATIC COMPRESSION UPGRADE Varian Canada, Inc. IZH Class II 1992-06-17
K922079 ROTOLUX, SELECTOLUX, SHUTTERVUE American Medical Sales, Inc. IXC Class I 1992-06-16
K921147 CVIS INSIGHT IMAGING CATHETER FOR INTRALUMINAL USE Cardiovascular Imaging Systems, Inc. ITX Class II 1992-06-16
K921148 CVIS INSIGHT CATHETERS FOR INTRACARDIAC USE Cardiovascular Imaging Systems, Inc. ITX Class II 1992-06-16
K922012 SHIMADZU IMAGE AMPLIFIER IA-12VSA SERIES Shimadzu Medical Systems JAA Class II 1992-06-16
K921609 VISTA HP/HPQ SYSTEM Philips Medical Systems (Cleveland), Inc. LNH Class II 1992-06-15
K915342 UD 2000 VIDEO OPTION Diagnostic Ultrasound Corp. LLZ Class II 1992-06-10
K922011 SHIMADZU IMAGE AMPLIFIER IA-12VDA SERIES Shimadzu Medical Systems JAA Class II 1992-06-10
K921275 SONY LASER VIDEODISC RECORDING SYSTEM Sony Medical Systems LMB Class I 1992-06-10
K922013 SHIMADZU IMAGE AMPLIFIER IA-12VMA SERIES Shimadzu Medical Systems JAA Class II 1992-06-10
K915279 NEOPROBE PORTABLE RADIOSCOPE DETECTOR Neoprobe Corp. IZD Class I 1992-06-10
K920098 ACCESS QD HEAD COIL Toshiba America Mri, Inc. LNH Class II 1992-06-09
K914698 SETUP COMPUTER WITH SOFTWARE V-1261,62 AND 63 K.S., Inc. IYE Class II 1992-06-05
K914784 PAPILLION PROCTOSCOPE Oldelft Corp. of America KQA Class II 1992-06-05
K920431 OMNITRON NEEDLE APPLICATORS 18 AND 21 GAUGE Omnitron Intl., Inc. JAQ Class II 1992-05-29
K921036 SONOS 100 ULTRASOUND IMAGING SYSTEM Hewlett-Packard Co. ITX Class II 1992-05-29
K920726 UROLOGICAL X-RAY TABLE HS-10A Shimadzu Medical Systems IXR Class II 1992-05-29
K920538 PROTECTIVE RADIOGRAFIC GLOVE Burkhart Roentgen Intl., Inc. IWP Class I 1992-05-29
K920731 X-RAY TUBE ASSEMBLY CIRCLEX1.2UG Shimadzu Medical Systems ITY Class I 1992-05-29
K921516 P2900 X-RAY GENERATOR Precise Optics Photo Medic Equipment, Inc. IZO Class I 1992-05-28
K921046 BO POWER SUPPLY Resonex, Inc. LNH Class II 1992-05-28
K920190 ULTRA-VISION RAPID INTENSIFYING SCREEN E.I. Dupont DE Nemours & Co., Inc. EAM Class I 1992-05-28
K920200 ULTRA-VISION DETAIL INTENSIFYING SCREEN E.I. Dupont DE Nemours & Co., Inc. EAM Class I 1992-05-28
K921428 CAPTUS 500 Capintec Instruments, Inc. IZD Class I 1992-05-28
K920540 RADIOLOGICAL PROTECTIVE EYE SHIELD Burkhart Roentgen Intl., Inc. IWS Class I 1992-05-28
K921432 SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-4500TF Shimadzu Medical Systems JAK Class II 1992-05-28
K914926 SCANDIPLAN - VERSION 338 Scanditronix, Inc. KPQ Class II 1992-05-28
K921296 ADAC S315 Adac Laboratories IYX Class I 1992-05-28
K920728 X-RAY DIAGNOSTIC TABLE YSF-100 Shimadzu Medical Systems IXR Class II 1992-05-28
K920268 3M DIGITAL DISK INTERFACE UNIT 3M Company LMD Class I 1992-05-27
K920194 ULTRA-VISION FAST DETAIL INTENSIFYING SCREEN E.I. Dupont DE Nemours & Co., Inc. EAM Class I 1992-05-27
K920835 PRESATURATION Resonex, Inc. LNH Class II 1992-05-22
K920307 AUSONICS OPUS 1 SYSTEM, ANNULAR ARRAY OPTION Ausonics Pty , Ltd. ITX Class II 1992-05-19
K921255 PHILIPS BV26 MOBILE C-ARM STAND Philips Medical Systems, Inc. OXO Class II 1992-05-18
K921278 M-2000 DIAGNOSTIC AND TELERADIOLOGY WORKSTATION Metecon, Inc. LMD Class I 1992-05-18
K920094 MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIES Siemens Medical Solutions USA, Inc. LNH Class II 1992-05-15
K915567 MAGNETIC RESONANCE DIAGNOSTIC DEVICE(ACCESORY) Fonar Corp. LNH Class II 1992-05-15
K921101 PHILIPS INTEGRIS V3000 FILM Philips Medical Systems, Inc. IZI Class II 1992-05-15
K921098 MAGNETOM 63SP Siemens Medical Solutions USA, Inc. LNH Class II 1992-05-15
K921501 DELUXE C ARM RADIOLOGICAL TABLE, MODEL #056-004 Biodan Medical Systems, Ltd. IZZ Class II 1992-05-15
K920769 KONICA LI 10 AND 10A LASER IMAGER Konica Corp. LMC Class II 1992-05-06
K921269 KODAK X-OMAT MODEL 180 LP PROCESSOR Eastman Kodak Company IXW Class II 1992-05-01
K920095 MRT-50 MULTIVIEW COIL Toshiba America Mri, Inc. LNH Class II 1992-04-28
K920723 HIGH SPEED ROTATION STARTER SA-40 Shimadzu Medical Systems ITY Class I 1992-04-27
K920624 ECAT EXACT HR MODEL 961 Cti Pet Systems, Inc. KPS Class II 1992-04-27
K920715 KODAK X-OMAT FIXER MANAGER Eastman Kodak Company IXW Class II 1992-04-27
K920724 HIGH SPEED ROTATION STARTER SA-50 Shimadzu Medical Systems ITY Class I 1992-04-27
K920730 X-RAY HIGH VOLTAGE GENERATOR ED 125L Shimadzu Medical Systems IZO Class I 1992-04-27
K920776 CARDIAC TRIAD NUCLEAR IMAGING SYSTEM Trionix Research Laboratory, Inc. KPS Class II 1992-04-27
K920729 BUCKY TABLE BK-12 Shimadzu Medical Systems IXQ Class II 1992-04-27
K920950 PHILIPS EASYVISION Philips Medical Systems, Inc. LLZ Class II 1992-04-27
K921008 VECTOR SERIES Sopha Medical Systems, Inc. KPS Class II 1992-04-27
K920742 HYDRAJUST IV UROLOGICAL TABLE Mallinckrodt Group, Inc. IXR Class II 1992-04-27
K920705 POLYTRON DIGITAL IMAGING SYSTEM Siemens Medical Solutions USA, Inc. IZI Class II 1992-04-27
K920720 DIGITAL RADIOGRAPHY SYSTEM IDR-1000 Shimadzu Medical Systems JAA Class II 1992-04-20
K920962 MULTIPLE ACCESSORY TO GAMMA CAMERAS Nu Age Products IYZ Class I 1992-04-17
K910966 SECTOR TRANSDUCER MODEL NO. AWP3.5/A Kretztechnik AG ITX Class II 1992-04-17
K915470 OPTIMA NUCLEAR TOMOGRAPHY STYSTEM General Electric Co. KPS Class II 1992-04-16
K920727 CEILING TUBE SUPPORT CH-30X Shimadzu Medical Systems IYB Class I 1992-04-16
K920732 CATHERIZATION KS-50 Shimadzu Medical Systems IZZ Class II 1992-04-16
K920725 COLLIMATOR F-20 Shimadzu Medical Systems IZW Class II 1992-04-16
K920733 STEREO COLLIMATOR RF-T SERIES Shimadzu Medical Systems IZW Class II 1992-04-16
K920721 DIGITAL RADIOGRAPHY SYSTEM IDR-2000 Shimadzu Medical Systems JAA Class II 1992-04-15
K920215 INSTRUMENTARIUM MEGA4 HT Instrumentarium Imaging, Inc. LNH Class II 1992-04-14
K920387 CIRCLEXO.3T X-RAY TUBE ASSEMBLY Shimadzu Medical Systems ITY Class I 1992-04-14
K920722 X-RAY DIAGNOSTIC TABLE YSF-200-30-90 Shimadzu Medical Systems IXR Class II 1992-04-13
K920550 DISPLAY PROCESSOR - MODEL IDP5100 Perkins Mfg. Co. JAA Class II 1992-04-13
K920434 ATLAS 2000 VASCULAR ROAD MAPPING SYSTEM Squires & Assoc., Inc. IZI Class II 1992-04-13
K913987 OR340 INTRAOPERATIVE ULTRASOUND BIOPSY NEEDLE GUID Codman & Shurtleff, Inc. ITY Class I 1992-04-13
K920126 MRT-50 FLEXIBLE BODY COIL Toshiba America Mri, Inc. LNH Class II 1992-04-06
K920393 MU125M MOBILE X-RAY SYSTEM Shimadzu Medical Systems IZG Class II 1992-04-06
K915367 HDRS-1 SYSTEM Precision Radiation Measurement, Inc. JAQ Class II 1992-04-06
K915362 VORTECH'S FILM DIGITIZER, FD-1 Vortech Data, Inc. KPR Class II 1992-04-06
K905200 SACA, 3.5 MHZ PROBE Diasonics, Inc. ITX Class II 1992-04-02
K914006 BIPLANE TRANSRECTAL PROBE Biosound, Inc. ITX Class II 1992-04-02
K920374 ALOKA 650CL DIAGNOSTIC ULTRASOUND SYSTEM Ge Medical Systems Information Technologies IYO Class II 1992-04-02

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