meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
25
Latest Decision
2000-06-27

Clearances · page 96 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K001517 SHIMADZU MOBILE X-RAY SYSTEM MUX-100 SERIES Shimadzu Corp. IZL Class II 2000-06-27
K001643 VARIS 1.4G Varian Medical Systems, Inc. IYE Class II 2000-06-23
K001088 ULTRASIM CT SYSTEM Philips Medical Systems (Cleveland), Inc. JAK Class II 2000-06-22
K990209 NOVAC7 Hitesys S.P.A. IYE Class II 2000-06-22
K001303 BREAST IMMOBILIZATION DEVICE MR-BY 160 Mri Devices Corp. MOS Class II 2000-06-20
K993176 MULTI-RACIAL REFERENCE POPULATION FOR PDEXA AND DISCOVERY Norland Medical Systems, Inc. KGI Class II 2000-06-20
K001026 3D-MSPECT The Reagents of the University of Michigan KPS Class II 2000-06-20
K001312 MODEL 473SI-64E QUADRATURE LOWER EXTREMITY COIL Igc-Medical Advances, Inc. MOS Class II 2000-06-20
K001711 M2410B IMAGEPOINT HX MULTISPECIALTY SYSTEM, VERSION B.1 Agilent Technologies, Inc. IYN Class II 2000-06-20
K001713 HRW-42 WRIST ARRAY COIL FOR 1.0 TESLA Mri Devices Corp. MOS Class II 2000-06-14
K001012 DIGITAL INTEGRATION SYSTEM, DIS2000 Wellington Medical Systems, Inc. LLZ Class II 2000-06-13
K001331 SYNERGY HEAD/NECK COIL Philips Medical Systems North America, Inc. MOS Class II 2000-06-09
K001210 HI-RES 9000 PHASED ARRAY CAROTID COIL Usa Instruments, Inc. MOS Class II 2000-06-09
K993701 PHARMASEED, MODEL BT-125-2 Syncor International, Inc. KXK Class II 2000-06-09
K000931 AU5 ULTRASOUND IMAGING SYSTEM Biosound Esaote, Inc. IYN Class II 2000-06-08
K001336 DR9000 DIGITAL RADIOGRAPHY X-RAY SYSTEM Analogic Corp. KPR Class II 2000-06-02
K994106 OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR BRONCHIAL USE Olympus America, Inc. ITX Class II 2000-06-02
K993700 PHARMASEED, MODEL BT-103-2 Syncor International, Inc. KXK Class II 2000-06-02
K994069 OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR URINARY USE Olympus America, Inc. ITX Class II 2000-06-02
K993895 OPTIRAD Permedics, Inc. MUJ Class II 2000-06-02
K001341 DR5000 DEDICATED CHEST X-RAY SYSTEM Analogic Corp. KPR Class II 2000-06-02
K992955 XPLORER 1000 Imaging Dynamics Corp. MQB Class II 2000-06-02
K001209 INSIGHT PLUS 9000 PHASED ARRAY TORSO AND PELVIS COIL Usa Instruments, Inc. MOS Class II 2000-06-01
K000976 DIAMOND (MAMMOGRAPHIC X-RAY SYSTEM) Instrumentarium Imaging, Inc. IZH Class II 2000-06-01
K001201 MULTIX COMPACT K AND MULTIX L RADIOGRAPHIC X-RAY SYSTEMS Siemens Medical Solutions USA, Inc. KPR Class II 2000-06-01
K000987 VFSS IMAGER, MODEL SIS-300 Lifecare Imaging Intl., Ltd. JAA Class II 2000-06-01
K001203 OLYMPUS UM 2R/3R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR FEMALE REPRODUCTIVE TRACT The Olympus Optical Co. ITX Class II 2000-05-26
K001429 MODIFICATION TO ACCUDEXA BONE DENSITOMETER Schick Technologies, Inc. KGI Class II 2000-05-26
K000993 LIBERTY 9000 BREAST COIL Usa Instruments, Inc. MOS Class II 2000-05-26
K000802 SPIRAL IMAGING OPTION GE Medical Systems LNH Class II 2000-05-26
K994329 IIVS INTEGRATED IMAGE VIEWING STATION Terarecon,Inc. LMD Class I 2000-05-26
K000960 BARZELL-WHITMORE MAROON BELLS, INC. COLO-RECTAL MOVER, MODEL 3900 Barzell-Whitmore Maroon Bells, Inc. IYO Class II 2000-05-26
K000922 PROTON VISION Varian Assoc., Inc. MUJ Class II 2000-05-24
K001321 ALL-PRO 2010 All-Pro Imaging Corp. IXW Class II 2000-05-16
K993337 APOLLO MULTI-RACIAL REFERENCE POPULATION Norland Medical Systems, Inc. KGI Class II 2000-05-16
K000770 PROVIEW MEDICAL IMAGE DISPLAY MODULE Cerner Corp. LLZ Class II 2000-05-16
K001171 DELTA 16 TACT Instrumentarium Imaging, Inc. IZH Class II 2000-05-12
K001267 GE SYSTEM FIVE Ge Medical Systems, Inc. IYN Class II 2000-05-12
K992178 BALLOON FOR ULTRASONIC ENDOSCOPES N.M. Beale Co., Inc. ITX Class II 2000-05-12
K000819 PHILIPS CT SECURA MV Philips Medical Systems North America, Inc. JAK Class II 2000-05-12
K000162 METRISCAN BONE DENSITY SYSTEM Alara, Inc. KGI Class II 2000-05-12
K000630 MODELS PRIAM (FAMILY OF DEVICES) DIGITAL IMAGING SYSTEM Hopkins Imaging Systems, Inc. LLZ Class II 2000-05-12
K000380 FOTOMASTER Hamilton Thorne Research LLZ Class II 2000-05-03
K000395 EINSTEIN PROCESSING AND REVIEW WORKSTATION Ge Medical Systems F.I. Haifa LLZ Class II 2000-05-03
K000349 MOTORIZED MICRO MULTILEAF COLLIMATOR Stryker Leibinger IXI Class II 2000-05-03
K000681 AU5, AU6 Biosound Esaote, Inc. IYO Class II 2000-05-03
K001140 IDS5 IMAGE DISPLAY SYSTEM Sectra AB LLZ Class II 2000-05-03
K000320 SONOS AIRES 600 (SA-600) Kpi Ultrasound, LLC IYO Class II 2000-05-02
K000832 STEROTACTIC LOCALIZATION DEVICE (SLD) Philips Medical Systems North America, Inc. LNH Class II 2000-04-27
K001006 THERATRON 780C/1000 WITH COMPUTERIZED CONSOLE UPGRADE Mds Nordion IWB Class II 2000-04-27
K000443 REMOTE FETAL MEDICINE ULTRASOUND SYSTEM R4 Telemedicine, Inc. LLZ Class II 2000-04-24
K000412 VISION R/F TILTING TABLE Villa Sistemi Medicali S.P.A. IXR Class II 2000-04-24
K001016 GE LOGIQ 700 GE Medical Systems ITX Class II 2000-04-24
K000557 MEDVIZER PACS, MODEL RELEASE 2000 Vitel Net LLZ Class II 2000-04-24
K000448 PACSSTATION Fernandez Industries, Inc. LLZ Class II 2000-04-20
K000549 OPART, MODEL MRT-600 Toshiba America Mri, Inc. MOS Class II 2000-04-20
K000474 VIEW NT Electromed Intl., Ltd. LLZ Class II 2000-04-19
K000516 GE LOGIQ 700 Ge Medical Systems, Inc. IYO Class II 2000-04-19
K000478 THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/ RADIOTHERAPY V2.1 Accuray, Inc. IWB Class II 2000-04-19
K000571 GE LOGIQ 700 GE Medical Systems IYO Class II 2000-04-18
K000137 ENHANCED COMPENSATING FILTER Computerized Medical Systems, Inc. IXI Class II 2000-04-17
K000437 INTERVENTIONAL BODY COIL Usa Instruments, Inc. MOS Class II 2000-04-14
K993092 SONADA ULTRASOUND SYSTEM Sonovision Corp. OXO Class II 2000-04-14
K000411 CHILI VIDEO, CHILI VIDEOPRO Steinbeis-Transferzentrum Medizinische Informatik LMA Class II 2000-04-14
K000826 PRODIGY LATERAL VIEW SOFTWARE Lunar Corp. KGI Class II 2000-04-14
K000345 MULTI PURPOSE FLEX ARRAY COIL : MODEL 235 SERIES Medical Advances, Inc. MOS Class II 2000-04-11
K000415 OIS-2500 DIAGNOSTIC ULTRASOUND SYSTEM Optimal Imaging Systems, Inc. IYN Class II 2000-04-11
K000221 SERIES 7700 MOBILE C-ARM, COMPACT 7700 MOBILE C-ARM, COMPACT 7700 PLUS MOBILE C-ARM Ge Dec Medical Systems OWB Class II 2000-04-11
K000935 KFA-63 KNEE AND FOOT ARRAY Mri Devices Corp. MOS Class II 2000-04-07
K993923 ADAC PINNACLE3TM RADIATION THERAPY PLANNING SYSTEM Adac Laboratories MUJ Class II 2000-04-07
K000908 SKYLIGHT IMAGING SYSTEM Adac Laboratories KPS Class II 2000-04-05
K993552 ISOSEED PD-103 Bebig Isotopentechnik GmbH KXK Class II 2000-03-31
K000292 BARCO MWD 321 PLUS MEDICAL WORKSTATION DISPLAY Barco N.V. LLZ Class II 2000-03-29
K994026 EUB-6000 ULTRASOUND DIAGNOSTIC SCANNER Hitachi Medical Corp. of America IYN Class II 2000-03-29
K000293 BARCO MGD 221 2 MEGAPIXEL DIAGNOSTIC DISPLAY Barco N.V. LLZ Class II 2000-03-29
K991133 MLC FIT Impac Medical Systems, Inc. IYE Class II 2000-03-27
K000294 MFCD 120 Barco N.V. LLZ Class II 2000-03-27
K993896 MCA-601, C-ARM MOBILE Medison Radiology Systems, Inc. JAA Class II 2000-03-27
K992303 SONOGRAPHIC PLANNING OF ONCOLOGY TREATMENTS (SPOT), MODEL V.. 1.0 Nucletron Corp. MUJ Class II 2000-03-27
K000315 VENTRICULAR ANALYSIS TOOLKIT OPTION GE Medical Systems LNH Class II 2000-03-27
K000291 MFCD 118 Barco N.V. LLZ Class II 2000-03-27
K994373 HDI 1500/SA 8800 ULTRASOUND SYSTEM WITH MULTIPLANE TRANSESOPHAGEAL ULTRASOUND TRANSDUCER (MTP7-4) Atl Ultrasound, Inc. ITX Class II 2000-03-24
K994431 SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7800 SERIES Shimadzu Medical Systems JAK Class II 2000-03-23
K994355 RADIOCAMERAS SYSTEM HEAD/NECK APPLICATION Surgical Navigation Technologies, Inc. IYE Class II 2000-03-22
K994351 M.R. VISION 2000 ULTRA AUDIO VISUAL SYSTEM / COMMANDER X6 SYSTEM Resonance Technology, Inc. LNH Class II 2000-03-22
K994317 I-PLANT, MODEL 3500 Implant Sciences Corp. KXK Class II 2000-03-21
K000359 EBT ULTRAFAST CT SCANNER SYSTEM; ULTRAFAST CT SCANNER SYSTEM; C-100, C-150. C-150LXP OR C-150XP SCANNER SYSTEMS; ELECTRO Imatron, Inc. JAK Class II 2000-03-17
K994385 BABY FACE Sonora Medical Systems IYO Class II 2000-03-16
K994287 FONAR 360 DEGREE MAGNETIC RESONANCE IMAGING SCANNER Fonar Corp. LNH Class II 2000-03-16
K991881 125-IMPLANT SEEDS, MODEL STM1250 Sourcetech Medical, LLC KXK Class II 2000-03-16
K000695 GE DOLPHIN DIAGNOSTIC ULTRASOUND SYSTEM, ULTRASONIC PULSED DOPPLER IMAGING SYSTEM Ge Medical Systems, Inc. IYO Class II 2000-03-16
K000014 BARCOMED 5MP1H Barco N.V. LLZ Class II 2000-03-14
K993280 PROSTEC 125I BRACHYTHERAPY SEEDS Prostec, LLC KXK Class II 2000-03-14
K000554 POCKET ULTRASONIC OPHTHALMIC PACHYMETER, BIOMETRY TRANSDUCER FOR POCKET Quantel Medical IYO Class II 2000-03-14
K994436 SURGI-VISION ESOPHAGEAL STYLET COIL Surgi-Vision, Inc. MOS Class II 2000-03-14
K000589 MODEL 445SI-64E QUADRATURE WRIST COIL Igc-Medical Advances, Inc. MOS Class II 2000-03-14
K000016 BARCOMED 5MP2 Barco N.V. LLZ Class II 2000-03-14
K992762 BRACHYVISION 6.0 Varian Assoc., Inc. MUJ Class II 2000-03-09
K994270 INSTATRAK 3000 SYSTEM WITH FLUOROTRAK MODULE, MODEL IT3000 Visualization Technology, Inc. LLZ Class II 2000-03-09
K000567 ULTRASOUND SCANNER TYPE 2102 B & K Medical A/S IYO Class II 2000-03-09

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