meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
28
Latest Decision
1998-10-21

Clearances · page 101 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K982862 RADWORKS MEDICAL IMAGING SOFTWARE WITH QUALITY CONTROL MODULE Applicare Medical Imaging, B.V. LLZ Class II 1998-10-21
K982787 ASTEION CT SCANNER, TSX-021A Toshiba America Medical Systems, In.C JAK Class II 1998-10-21
K981880 DX-480, ADD ON DIGITAL IMAGER Wuestec Medical, Inc. KPR Class II 1998-10-20
K982772 SIGNA PROFILE QUADRATURE THORACIC/LUMBAR SPINE PHASED ARRAY COIL Ge Medical Systems, Inc. MOS Class II 1998-10-15
K982785 FILM DIGITIZER MODEL 2905 Array Corp. LMA Class II 1998-10-15
K981597 RADIONICS SLICE EDITOR IMAGING SOFTWARE UTILITY Radionics, Inc. IYE Class II 1998-10-09
K983327 ACTIVE ECG ELECTRODES MAGNETOM VISION SYSTEMS Siemens Medical Solutions USA, Inc. LNH Class II 1998-10-09
K982820 BARCO MEDIS 5MP 5 MEGAPIXEL MEDICAL DIAGNOSTIC DISPLAY SYSTEM Barco NV Display Systems LLZ Class II 1998-10-08
K983222 PHASED ARRAY CERVICAL SPINE COIL, MODEL #125GE-64 Medical Advances, Inc. MOS Class II 1998-10-08
K983109 MODEL 545G-64 PAHASED ARRAY MUSCULOSKELETAL FLEX COIL PACKAGE MODEL 543GE-64: PHASED ARRAY UPPER EXTRENITY FLEX COIL ANY Medical Advances, Inc. MOS Class II 1998-10-06
K982387 E.CAM EXTRA HIGH ENERGY COLLIMATOR Siemens Medical Solutions USA, Inc. KPS Class II 1998-10-06
K982690 BARCO MEDICAL DISPLAY CONFORMITY AND CONSISTENCY SOFTWARE Barco N.V. LLZ Class II 1998-10-06
K982631 PHILIPS TOMOSCAN CS Philips Medical Systems, Inc. JAK Class II 1998-10-06
K982444 7250 ULTRASOUND IMAGING SYSTEM Biosound Esaote, Inc. IYO Class II 1998-10-06
K982563 ULTRAPRO MODEL 98 Ramsoft, Inc. LLZ Class II 1998-10-06
K982196 DIGITAL RADIOGRAPHIC IMAGING SYSTEM GE Medical Systems KPR Class II 1998-10-06
K982583 SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TXL Shimadzu Corp. JAK Class II 1998-10-05
K982422 EAGLESOFT CHAIRSIDE Eaglesoft, A Patterson Co. LLZ Class II 1998-09-30
K982349 SOMATOM PLUS 4WITH VOLUME ZOOM CT SCANNERS Siemens Medical Solutions USA, Inc. JAK Class II 1998-09-30
K982463 EXTRACRANIAL RADIOTHERAPY SYSTEM Howmedica, Inc. IYE Class II 1998-09-30
K981834 PERCEPTION INC, GPS-6TBMD DIAGNOSTIC ULTRASOUND SYSTEM Perception, Inc. IYN Class II 1998-09-29
K982446 DYNAMIC SHIELDING RADIATION TABLE American Biophysics, Inc. JAI Class II 1998-09-29
K981553 AUTOMATED MEDICAL REPORT WRITER Woodson and Associates, LLC KPS Class II 1998-09-29
K974813 COMBISON 530D WITH POWER DOPPLER MODE Medison America, Inc. IYN Class II 1998-09-29
K982993 PHILIPS OMNIDIAGNOST Philips Medical Systems, Inc. OWB Class II 1998-09-29
K981055 XKNIFE-4 Radionics, Inc. IYE Class II 1998-09-29
K980997 PGK DEVICE (MODIFIED) Pgk, Inc. IWJ Class I 1998-09-28
K982300 TRANSVIEW (TRANSMISSION SYSTEM),MODEL NDTR-701A Toshiba America Medical Systems, In.C KPS Class II 1998-09-25
K982427 TREX TILT C-ARM/TABLE MULTIPURPOSE RADIOGRAPHIC/FLUOROSCOPIC POSITIONING SYSTEM, TREX TILT-C Trex Medical Corp. OWB Class II 1998-09-23
K981069 ULTRA-COVER PU-TRANSDUCER COVER International Medical Products B.V. ITX Class II 1998-09-23
K983088 INSTACINE D-2000 Fidelity Medical, Inc. LLZ Class II 1998-09-22
K982319 CAREGRAPH Siemens Medical Solutions USA, Inc. JAA Class II 1998-09-22
K982800 ECTON LYNX ULTRASOUND SYSTEM Ecton, Inc. IYO Class II 1998-09-22
K982496 QUADRATURE LOWER EXTREMITY COIL, MODEL # 473SI-42D Medical Advances, Inc. MOS Class II 1998-09-18
K982171 HAMAMATSU PET SCANNER, MODEL SHR-22000 Hamamatsu Photonics K.K. KPS Class II 1998-09-17
K982146 PICTOOLS MEDICAL TOOL KIT MODEL 1.0 Pegasus Imaging Corp. LLZ Class II 1998-09-14
K982120 DIGITAL IMAGING SYSTEM, MODELS DIGITREX-1000 AND DIGITREX-2000 (DIGITREX-X000 FAMILY) Trex Medical Corp. LLZ Class II 1998-09-10
K982339 FLOW 7000 PERIPHERAL VASCULAR COIL Usa Instruments, Inc. MOS Class II 1998-09-04
K974770 ACQPLAN Philips Medical Systems (Cleveland), Inc. MUJ Class II 1998-09-02
K982044 NUCAMMA R+ Is2 Research, Inc. KPS Class II 1998-09-02
K982045 NUCAMMA RX Is2 Research, Inc. KPS Class II 1998-09-02
K982060 VOLUMAX CT IMAGING SYSTEM Elscint, Inc. JAK Class II 1998-09-02
K982706 PHILIPS BV300 SERIES RELEASE 2.1 Philips Medical Systems, Inc. OXO Class II 1998-09-02
K982157 TREX MRI MAGNETIC RESONANCE DIAGNOSTIC DEVICE Field Effects LNH Class II 1998-09-02
K982345 VASCO SCANNING BEAM DIGITAL X-RAY SYSTEM Cardiac Mariners, Inc. JAA Class II 1998-09-01
K980831 IMAGE POST-PROCESSING TECHNIQUES Philips Medical Systems (Cleveland), Inc. LNH Class II 1998-08-27
K980468 AU5 ULTRASOUND IMAGING SYSTEM Biosound Esaote, Inc. IYN Class II 1998-08-26
K982265 AQUILION CT SCANNER, MODEL TSX-101A Toshiba America Medical Systems, In.C JAK Class II 1998-08-26
K982442 C-TRAK AUTOMATIC ANALYZER (NAME CHANGE FROM ONCOPROBE II TO C-TRAK) Care Wise Medical Products Corp. IZD Class I 1998-08-25
K974269 SA8800 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS, Medison America, Inc. IYN Class II 1998-08-21
K981028 ULTRA IMAGE AND ULTRA SCAN Sonotech, Inc. ITX Class II 1998-08-21
K981998 PEDIATRIC INSTATRAK SYSTEM Visualization Technology, Inc. LLZ Class II 1998-08-21
K982004 CT CORONARY ARTERY CALCIFICATION SCORING (CACS) OPTION FOR ADVANTAGE WINDOWS General Electric Co. JAK Class II 1998-08-18
K982267 DPX-RX BONE DENSITOMETER Lunar Corp. KGI Class II 1998-08-18
K982498 DIAGNOSTIC ULTRASOUND SYSTEM Volumetrics Medical Imaging, Inc. IYN Class II 1998-08-07
K982635 CAREDOP II Nicolet Biomedical JAF Class II 1998-08-07
K974588 INTRA-VIEW BILATERAL TRANSCRANIAL DOPPLER DEVICE, SMART-LITE PORTABLE BILATERAL TRANSCRANIAL DOPPLER DEVICE, COMPACT MOD Rimed , Ltd. IYN Class II 1998-08-07
K980423 SONOPSY LA SYSTEM Neovision Corp. IYO Class II 1998-08-07
K981790 IVIEW ELECTRONIC PORTAL IMAGING DEVICE (EPID) MODEL NUMBER IVEW Elekta Oncology Systems, Ltd. IYE Class II 1998-08-07
K981898 ORTHOVU-1000 Magnevu LNH Class II 1998-08-03
K982513 MX MEVATRON Siemens Medical Solutions USA, Inc. IYE Class II 1998-07-31
K981959 OUTLOOK LARGE PHASED ARRAY NECK COIL Philips Medical Systems (Cleveland), Inc. MOS Class II 1998-07-31
K981397 HARMONIC IMAGING AND FLASH ECHO IMAGING FUNCTION FOR THE DIAGNOSTIC ULTRASOUND SYSTEM SSA-380A, POWERVISION 7000 Toshiba America Medical Systems, In.C IYN Class II 1998-07-31
K982502 GENESIS IMRT LINEAR ACCELERATOR Siemens Medical Solutions USA, Inc. IYE Class II 1998-07-31
K982421 IMAGYN 125 I SEED, MODEL IS 125 International Isotopes, Inc. IWG Class II 1998-07-31
K974707 IMAGEQUEST Visual Med, Inc. LMD Class I 1998-07-31
K981434 EUP-OL334 LAPARASCOPICPROBE Hitachi Medical Corp. of America ITX Class II 1998-07-27
K980526 PHOTON RADIOSURGERY SYSTEM PRS400 Pec Photoelectron Corp. JAD Class II 1998-07-27
K981112 MOBETRON Intraop Medical, Inc. LHN Class II 1998-07-24
K980648 PRO VISION Algotec Systems, Ltd. LLZ Class II 1998-07-20
K981641 MAMMOGRAPHY X-RAY EQUIPMENT MODELS MGF101 AND MGF110, ALPHA III, ALPHA ST, ALPHA RT AND ALPHA IQ Instrumentarium Corp. IZH Class II 1998-07-17
K981424 NOMOS BAT ULTRASOUND LOCALIZATION AND POSITIONING SYSTEM Nomos Corp. IYE Class II 1998-07-17
K981406 CERVIX COIL LATEX SHEATH Philips Medical Systems (Cleveland), Inc. MOS Class II 1998-07-16
K981414 LC POSITIONER Fischer Imaging Corp. JAA Class II 1998-07-16
K981466 XR-910 Imaging Sciences Intl., Inc. IZL Class II 1998-07-14
K974457 SCOUT 3.2/45 MHZ CORONARY IMAGING CATHETER, SCOUT 3.2/45 MHZ CORONARY IMAGING CATHETER, SCOUT IMAGING CATHETER PATIENT T Hewlett-Packard Co. IYO Class II 1998-07-14
K982028 FLUOROSPOT COMPACT Siemens Medical Solutions USA, Inc. JAA Class II 1998-07-14
K982049 BIOPSY M Sitco, Inc. IZH Class II 1998-07-14
K981475 OPART (MRT-600) VERSIONS 2 SOFTWARE UPGRADE Toshiba America Mri, Inc. LNH Class II 1998-07-14
K982203 CAAS II LVA BIPLANE OPTION Pie Medical Equipment B.V. IZI Class II 1998-07-14
K981352 VPC-94 ULTRA HIGH ENERGY COLLIMATERS MODEL NUMBERS 480-685-9402 Ge Medical Systems F.I. Haifa KPS Class II 1998-07-13
K981358 ARTOSCAN S Biosound Esaote, Inc. LHN Class II 1998-07-13
K981346 RADIOCAMERAS BITEBLOCK LOCALIZATION AND POSITIONING SYSTEM Surgical Navigation Technologies, Inc. IYE Class II 1998-07-10
K981313 SEQUENCER Impac Medical Systems, Inc. IYE Class II 1998-07-09
K974715 ADVANTAGE 3D XR GE Medical Systems JAK Class II 1998-07-06
K973363 NORTH AMERICAN SCIENTIFIC(NASI)PD-103 RADIONUCLIDE BRACHYTHERAPY SOURCE-MODEL MED3633 Ml Strategies, Inc. IWI Class II 1998-07-02
K981410 HAMMERSMITH ENDOCAVITARY COILS Philips Medical Systems (Cleveland), Inc. LNH Class II 1998-06-30
K981293 7200 ULTRASOUND IMAGING SYSTEM Biosound Esaote, Inc. IYO Class II 1998-06-30
K981227 SYMPHONY 360 REMOTE CONTROL TABLE Acoma Medical Imaging, Inc. JAA Class II 1998-06-30
K981190 HIGH IMPEDANCE CARDIAC GATING CABLE GE Medical Systems LNH Class II 1998-06-30
K965223 RESOLVE OPTION FOR THE ORACLE IN VISION INTRAVASCULAR ULTRASONIC IMAGING SYSTEM Endosonics Corp. IYO Class II 1998-06-29
K981291 VANTAGE 3.0 INSYNCH Adac Laboratories KPS Class II 1998-06-29
K981131 PATHFINDER MOBILE C ARM Acoma Medical Imaging, Inc. OXO Class II 1998-06-26
K981115 RADIO-PLAST Smith & Nephew, Inc. LHN Class II 1998-06-25
K980873 KONICA DIRECT DIGITIZER REGIUS MODEL 330 Konica Corp. LMA Class II 1998-06-19
K981470 WORLDWIDE MEDICAL TECHNOLOGIES NEEDLE GUIDE Worldwide Medical Technologies, LLC IZH Class II 1998-06-19
K981053 KODAK DIGITAL SCIENCES (KDS) IMAGE VIEW Eastman Kodak Company LMD Class I 1998-06-18
K981657 PHILIPS THORAVISION Philips Medical Systems North America, Inc. KPR Class II 1998-06-18
K981217 PLATINUM READING, REVIEW & ANALYSIS WORKSTATION GE Medical Systems LLZ Class II 1998-06-18
K981094 MEDRAD NEUROVASCULAR COIL Medrad, Inc. MOS Class II 1998-06-18

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