meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
35
Latest Decision
1991-09-11

Clearances · page 125 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K911414 CVIS INSIGHT IMAGING CATHETERS Cardiovascular Imaging Systems, Inc. ITX Class II 1991-09-11
K911959 SIGNA ADVANTAGE MAGNETIC RESONANCE SYSTEM M1090GF GE Medical Systems LNH Class II 1991-09-10
K910902 VMX MOBILE X-RAY SYSTEM GE Medical Systems IZL Class II 1991-09-09
K912176 ACQUPRO Trionix Research Laboratory, Inc. KPS Class II 1991-09-06
K912881 GE MR MAX GE Medical Systems LNH Class II 1991-09-06
K912323 THE REMOTE Remote Technologies, Inc. IZL Class II 1991-09-06
K913055 THYROID UPTAKE SYST/AUTOMLAB 900 MEDI SPEC 187-900 Atomic Products Corp. IZD Class I 1991-09-06
K913491 VORTECH'S PERSONAL DISPLAY SYSTEM Vortech Data, Inc. JAK Class II 1991-09-06
K912752 PHILIPS TOMOSCAN SR Philips Medical Systems North America, Inc. JAK Class II 1991-09-06
K912177 VISIONPRO Trionix Research Laboratory, Inc. KPS Class II 1991-09-06
K913354 KODAK EKTASCAN STORAGE PHOSPHOR READER MODEL 1A Eastman Kodak Company IXW Class II 1991-09-04
K910956 COMPUSCAN LT BIOMETRIC RULER AND IOL CALCULATOR Storz Instrument Co. IYO Class II 1991-09-04
K912249 PATIENT DOSE MONITOR Theta Systems, Inc. KPZ Class II 1991-08-30
K913301 MCS 50MO X-RAY TUBE INSERT/MXS 50MO TUBE HOU ASSEM Comet North America, Inc. ITY Class I 1991-08-28
K912449 MICRO-X 15 HF Fischer Imaging Corp. IZO Class I 1991-08-28
K912416 ANGIOGRAPHIC OR FLUOROSCOPIC X-RAY SYSTEM Xre Corp. IZI Class II 1991-08-28
K912448 CSP Fischer Imaging Corp. OWB Class II 1991-08-28
K912073 POLAROID HELIOS LASER IMAGER Polaroid Medical Corp. LMC Class II 1991-08-28
K905198 DIAGNOSTIC ULTRASOUND SYSTEM TYPE 3535 Bruel & Kjaer IYN Class II 1991-08-28
K912363 ELECTRONIC ULTRASOUND SCAN MODELS EUP-U12/012T/TC3 Hitachi Medical Corp. of America ITX Class II 1991-08-27
K912896 DIGISTORE 2100 Enhanced Imaging Technologies, Inc. JAA Class II 1991-08-26
K911841 MINXRAY P300 X-RAY SYSTEM Minxray, Inc. IZL Class II 1991-08-26
K913252 LITEBOX Siemens Gammasonics, Inc. JAK Class II 1991-08-26
K911340 AUTOCOMP Victoreen, Inc. KPQ Class II 1991-08-26
K912341 MULTICAM I 8X10 Camtronics, Ltd. JAA Class II 1991-08-26
K911749 L-LINEX-RAY FLUORESCENCE Montifore Medical Center JAO Class II 1991-08-20
K910342 SONOACE 4500 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM Medison Co., Ltd. IYO Class II 1991-08-19
K911290 EAGLE NUCLEAR IMAGING SYSTEM Trionix Research Laboratory, Inc. KPS Class II 1991-08-19
K913121 OMNIFLEX OVERHEAD TUBECRANE CAT.#S-9108/#6713.400 Continental X-Ray Corp. KXJ Class II 1991-08-16
K913120 POLYSTAR ANGIOGRAPHIC X-RAY SYSTEM Siemens Medical Solutions USA, Inc. IZI Class II 1991-08-16
K911746 H.I.STANDARD CALIBRE UPGRADE Health Images, Inc. LNH Class II 1991-08-16
K912410 COXEL FLINGER 2500/5000 3-D IMAGING SYSTEM Reality Imaging Corp. LNH Class II 1991-08-13
K905291 LATERAL SPINE DETERMAINATIONS DPX/DPX-L/DPX-ALPHA Lunar KGI Class II 1991-08-09
K912400 MOBILE X-RAY FLOOR STAND Dntl Corp. IZL Class II 1991-08-09
K912095 MAGNETIC RESONANCE DIAGNOSTIC DEVICE Siemens Medical Solutions USA, Inc. LNH Class II 1991-08-09
K911691 XYZ CRANK IMAGING TABLE Med-Tron Products, Inc. IYZ Class I 1991-08-09
K912170 RADIOACTIVE IODINE-125 SOURCES Best Industries IWI Class II 1991-08-09
K912338 TUBE HOUSING ASSEMBLIES Comet Ltd. C/O Radiology Resources, Inc. ITY Class I 1991-08-07
K910838 TREATMENT TABLE Tri W-G, Inc. IXR Class II 1991-08-07
K912470 PHILIPS DIAGNOST 96 Philips Medical Systems, Inc. JAA Class II 1991-08-07
K912626 BOLUS XENON CIRCUIT Vital Signs, Inc. IYT Class II 1991-08-02
K912586 TANGENT IV Fischer Imaging Corp. IXR Class II 1991-08-02
K912286 CARDIAC SPECT PALLET Siemens Gammasonics, Inc. IYZ Class I 1991-08-02
K912555 GAMMAMED 12IT HIGH DOSE RATE REMOTE AFTERLOADER Rts Technology, Inc. JAQ Class II 1991-08-02
K912481 ECT CARBON FIBER PALLET, MODIFICATION Siemens Gammasonics, Inc. IYZ Class I 1991-08-02
K911752 ICON TELERADIOLOGY SYSTEM Icon Medical Systems, Inc. LLZ Class II 1991-07-31
K910839 ULTIMATE 3000 Fonar Corp. LNH Class II 1991-07-26
K910648 THERAPY CHAIR SYSTEM Radiation Technology, Inc. JAI Class II 1991-07-22
K910002 GENESYS AND THE ROI The Complete Systems Corp. Genesys JAI Class II 1991-07-22
K912225 3M DIGITAL RECORDING AUTOMATIC FILM HANDLING UNIT 3M Medical Products Group IXW Class II 1991-07-22
K911873 X-MARX Macbrud Corp. Medical Div. JAC Class I 1991-07-19
K912380 LASER BEAM LOCALIZER FOR SIREMOBIL 4 Siemens Medical Solutions USA, Inc. JAA Class II 1991-07-19
K911991 MAGNETOM P8 MAGNETIC RESONANCE DIAGNOSTIC DEVICE Siemens Medical Solutions USA, Inc. LNH Class II 1991-07-19
K911501 SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-5000TX Shimadzu Medical Systems JAK Class II 1991-07-17
K912135 XY IMAGING TABLE Med-Tron Products, Inc. IYZ Class I 1991-07-17
K911500 SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-5000TH Shimadzu Medical Systems JAK Class II 1991-07-17
K912181 E-Z LIFT CRANK IMAGING TABLE Med-Tron Products, Inc. IYZ Class I 1991-07-17
K911564 E-Z LIFT IMAGING TABLE WITH FOOT PUMP Med-Tron Products, Inc. IYZ Class I 1991-07-15
K905578 VIEWNET Imagenet LNH Class II 1991-07-15
K911561 XYZ IMAGING TABLE WITH FOOT PUMP Med-Tron Products, Inc. IYZ Class I 1991-07-15
K911454 FC2000 S & S Inficon, Inc. JAA Class II 1991-07-15
K911291 ALL-PRO 100 All-Pro Imaging Corp. IXW Class II 1991-07-03
K911098 PHILIPS URO DIAGNOST MRF Philips Medical Systems, Inc. IXR Class II 1991-07-03
K910967 NEUROCAM GE Medical Systems IYX Class I 1991-07-03
K911800 COIL FIELD EXTENDER Resonex, Inc. LNH Class II 1991-07-03
K912466 OLDELFT SIMULIX-MC Oldelft Corp. of America KPQ Class II 1991-06-28
K911773 PHILIPS TELESCAN Philips Medical Systems, Inc. LMD Class I 1991-06-28
K911806 MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY General Electric Co. LNH Class II 1991-06-28
K911276 MAGNETIC RESONANCE DEVICE ACCESSORY Toshiba America Mri, Inc. LNH Class II 1991-06-28
K904676 NDI MODEL IRS-TD National Diagnostic Imaging, Inc. KPR Class II 1991-06-21
K911348 RIGID ENDOSCOPE Bruel & Kjaer LNH Class II 1991-06-21
K911495 MAGNETIC RESONANCE DEVICE ACCESSORY (MRT-50A) Toshiba America Mri, Inc. LNH Class II 1991-06-21
K905518 BERLEX BOLUS/INFUSION(TM) INTRAVENOUS ADMIN SET Venusa , Ltd. IZI Class II 1991-06-21
K905074 MICRODELTA, TC-99M-MAG3 RENAL PROCESSING PROGRAM Siemens Gammasonics, Inc. IYX Class I 1991-06-21
K904519 AGFA DIAGNOSTIC CENTER (ADC) Enhanced Imaging Technologies, Inc. LLZ Class II 1991-06-21
K911892 RX-5000 MRI SYSTEM Resonex, Inc. LNH Class II 1991-06-20
K911695 VARIOUS X-RAY TUBES Comet Ltd. C/O Radiology Resources, Inc. ITY Class I 1991-06-19
K911280 SHIMADZU X-RAY HIGH-VOLTAGE GENERATOR XUD150B Shimadzu Medical Systems IZO Class I 1991-06-17
K911078 MULTISPECT 3 TRIPLE DETECTOR CAMERA SYSTEM Siemens Gammasonics, Inc. KPS Class II 1991-06-17
K911200 SI-1200 / ILUS Siemens Ultrasound, Inc. IYO Class II 1991-06-17
K903984 CW DOPPLER/4.5 MHZ Diasonics, Inc. ITX Class II 1991-06-14
K911612 NUCLETRON PLANNING SYSTEM Nucletron-Oldelft Corp. IYE Class II 1991-06-13
K905522 LABSONICS MAMM-O-MATE MODEL NO. 918084-1, MODIFIED Laboratory Equipment Corp. IYO Class II 1991-06-11
K905753 QDR-1000 AND QDR-1000/W X-RAY BONE DENSITOMETER Hologic, Inc. KGI Class II 1991-06-10
K910710 RADIOACTIVE SEEDS Best Assoc. Corp. KXK Class II 1991-06-10
K911107 SONARSCAN 128 ULTRASOUND SCANNER Diagnostic Sonar USA IYO Class II 1991-06-10
K910715 VISTA HPQ SYSTEM Philips Medical Systems (Cleveland), Inc. LNH Class II 1991-06-07
K911713 KODAK 100-J & 100-K CHEMICAL MIXERS Eastman Kodak Company IXW Class II 1991-06-07
K911714 KODAK M35-MX-0MAT PROCESSOR Eastman Kodak Company IXW Class II 1991-06-07
K911711 KODAK AUTOMATIC FILM FEEDER, MODEL RA Eastman Kodak Company IXW Class II 1991-06-07
K910650 SELECTOR MD (50KW AND 80 KW) Hofmann-Nagel Medical Systems, Inc. IZO Class I 1991-06-06
K910654 CINEMEASURE (TM) Syracuse Research Corp. IZI Class II 1991-06-06
K904908 STEREOTACTIC IRRADIATION SYSTEM Northwest Medical Physics Center IYE Class II 1991-06-06
K911073 PROBE REFILL KIT Interspec, Inc. ITX Class II 1991-06-06
K911041 INVOTEC X-RAY CASSETTE EQUIPMENT DRAPE Invotec International, Inc. IXA Class II 1991-06-04
K896596 ALPHA III PLUS AND MODEL P2500F/101 W/OPTIONAL Instrumentarium Imaging, Inc. IZH Class II 1991-05-30
K911642 MRP-5000 AND MRP-7000 MULTIPLANAR RECONSTRUCTION Hitachi Medical Systems America, Inc. LNH Class II 1991-05-30
K910367 COMPUTE-RX-COMP (TM) Medicalibration Physics Consultant Services, Inc. KPQ Class II 1991-05-30
K911667 HITACHI MRP-7000 MAGNETIC ROSONANCE DEVICE Hitachi Medical Systems America, Inc. LNH Class II 1991-05-30
K910370 PHILIPS INTEGRIS V3000 AND V4000 Philips Medical Systems, Inc. IZI Class II 1991-05-28

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