meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
28
Latest Decision
1999-07-02

Clearances · page 99 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K983768 MODIFICATION TO GAMMA GUIDANCE SYSTEM Radiation Monitoring Devices, Inc. IZD Class I 1999-07-02
K991626 WEBRAD COMPUTED RADIOGRAPHY QUALITY ASSURANCE WORKSTATION Analogic Corp. LLZ Class II 1999-07-02
K991282 COLORPOINT 1720 MEDICAL IMAGERS AND VIDEO CAPTURE BOX CX-1000 SERIES Seiko Instruments USA, Inc. LMC Class II 1999-06-30
K991107 SHADOW TRAYS Mick Radio-Nuclear Instruments, Inc. IYE Class II 1999-06-29
K990198 AMIB7 Alliance Medical, Inc. IYO Class II 1999-06-29
K991257 FUJI WAVELET COMPRESSION OR FFCOMP IRREVERSIBLE COMPRESSION Fujifilm Medical System U.S.A., Inc. LLZ Class II 1999-06-25
K990238 LONGPORT MODEL LDS -1 Longport, Inc. IYO Class II 1999-06-23
K990997 AKTINA MEDICALPHYSICS CORPORATION MECHANICAL FRONTPOINTER Aktina Medical Physics Corp. IYE Class II 1999-06-22
K991243 NORMA 10 Odin Technologies , Ltd. LNH Class II 1999-06-18
K990969 KONICA SRX- 701 AUTOMATIC X-RAY FILM PROCESSOR Konica Medical Corp. IXW Class II 1999-06-18
K991318 CONVERGENCE NUA FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS Hitachi Medical Corp. of America KPS Class II 1999-06-18
K991716 HISPEED NX/I CT SCANNER SYSTEM Ge Medical Systems, Inc. JAK Class II 1999-06-18
K991671 HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM Advanced Technology Laboratories, Inc. IYO Class II 1999-06-18
K991526 ISOSTAR I-125 INTERSTITIAL SEED, MODEL IS-12501 Imagyn Medical Technologies, Inc. KXK Class II 1999-06-17
K991872 LYNX ULTRASOUND SYSTEM Ecton, Inc. IYN Class II 1999-06-16
K991858 SSA-390A/POWER VISION 8000 Toshiba America Medical Systems, In.C IYN Class II 1999-06-16
K991842 SYSTEM FIVE/ECHOPAC WITH STRAIN RATE IMAGING Ge Vingmed Ultrasound IYO Class II 1999-06-11
K991113 `INEAR WRIST COIL, MODEL 440GE-09 Medical Advances, Inc. MOS Class II 1999-06-10
K984235 INTERSOURCE 125, MODEL 1251L International Brachytherapy, Inc. KXK Class II 1999-06-09
K991600 SOMATOM PLUS 4 WITH SLIDING GANTRY OPTION Siemens Corp. JAK Class II 1999-06-09
K991611 GE LOGIQ 500 General Electric Co. IYO Class II 1999-06-09
K984562 VIVOSONIC Sonotech, Inc. ITX Class II 1999-06-08
K990833 DOSE CALC, MODEL VS. 1.02 Integrity Medical Software, Inc. IYE Class II 1999-06-08
K991115 LINEAR SHOULDER COIL, MODEL 414GE-09 Medical Advances, Inc. MOS Class II 1999-06-08
K991553 SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TS W/FLUORO OPTION Shimadzu Corp. JAK Class II 1999-06-08
K991643 IDS4 V3.2 IMAGE DISPLAY SYSTEM O Tech, Inc. LLZ Class II 1999-06-08
K983629 RPM RESPIRATORY GATING SYSTEM Varian Medical Systems, Inc. LHN Class II 1999-06-08
K991710 SSA-370A/POWERVISION 6000 Toshiba America Medical Systems, In.C IYO Class II 1999-06-03
K991578 SMARTSPOT 2000 Cmt Medical Technologies, Ltd. LLZ Class II 1999-06-03
K991236 GENERAL PURPOSE NEOFLEX TRANSDUCER COVER, EDOCAVITY NEOFLEX TRANSDUCER COVER, SURGI-TIP INTRAOPERATIVE TRANSDUCER COVER, CIVCO Medical Instruments Co., Inc. ITX Class II 1999-06-02
K991302 SMARTLIGHT DIGITAL FILM VIEWER, MODELS SL 4000PLUS, SL 2000PLUS Smartlight, Inc. IXC Class I 1999-06-01
K990734 DPD-12PCC Scanditronix Medical AB IYE Class II 1999-05-28
K990753 GRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER Cook, Inc. JAQ Class II 1999-05-27
K990968 E-SCAN Biosound Esaote, Inc. LNH Class II 1999-05-27
K991231 HITACHI VERSIFLEX Hitachi Medical Systems America, Inc. IZI Class II 1999-05-24
K984328 LEKSELL GAMMA KNIFE TARGET SYSTEM, MODEL 24001 Elekta Instrument AB IWB Class II 1999-05-21
K991057 EXTRA LARGE BODY COIL FOR OPART (MRT-600) Toshiba America Mri, Inc. MOS Class II 1999-05-20
K990193 IODINE BRACHYTHERAPY SEEDS, MODEL 3000 Implant Sciences Corp. KXK Class II 1999-05-20
K990560 LIFE IMAGING SYSTEMS, MODEL L3DI Life Imaging Systems, Inc. IYO Class II 1999-05-20
K991435 AII-PRO 100 PLUS AND ALL-PRO 200 All-Pro Imaging Corp. IXW Class II 1999-05-20
K984285 OSTEOGRAM BONE DENSITOMETER Compumed, Inc. KGI Class II 1999-05-19
K990620 EXCELART Toshiba America Mri, Inc. LNH Class II 1999-05-14
K991278 PHILIPS TOMOSCAN AV-NT Philips Medical Systems North America, Inc. JAK Class II 1999-05-13
K991129 HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERA SYSTEM WITH THICK NAL(TI) CRYSTAL Hitachi Medical Corp. of America KPS Class II 1999-05-13
K982226 UROMED BRACHYTHERAPHY IODINE-125 SOURCES Uromed Corp. KXK Class II 1999-05-13
K984241 ROCS ULTRASEED Radiation Oncology Computer Systems IYE Class II 1999-05-12
K990426 CALCIUM SCORING Siemens Medical Solutions USA, Inc. JAK Class II 1999-05-12
K990455 PHILIPS EASY VISION FAMILY WORKSTATION LEGS OPTION Philips Medical Systems, Inc. LLZ Class II 1999-05-12
K990550 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM Ge Medical Systems, Inc. LNH Class II 1999-05-11
K990442 ADVANCED DIAGNOSTIC VIEWER (AOX), MODEL VITRED 1.3 Vital Images, Inc. LLZ Class II 1999-05-11
K983691 SCANFLEX SOLID COUPLANT MEMBRANE Sonotech, Inc. ITX Class II 1999-05-05
K984161 CTS-310(B) Shantou Institute of Ultrasonic Instuments IYO Class II 1999-05-05
K990383 APOLLO 5, APOLLO 10 Precitron A.B. IYE Class II 1999-05-05
K990360 AU6 Biosound Esaote, Inc. IYN Class II 1999-04-30
K983732 THORAX FD AND MULTIX FD Siemens Medical Solutions USA, Inc. MQB Class II 1999-04-21
K990175 SHEATHES (NON-LATEX), STERILE Sheathing Technologies, Inc. ITX Class II 1999-04-21
K984156 SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TX W/FLURO OPTION Shimadzu Medical Systems JAK Class II 1999-04-21
K983338 FREIBURG FLAP APPLICATOR SET, PART NUMBER 089.095 Nucletron Corp. JAQ Class II 1999-04-20
K984446 `BI I-125 BRACHYTHERAPHY SEED, MODEL 125SL & 125SH Urocor, Inc. KXK Class II 1999-04-16
K990248 DICOM IMAGE MANAGER, MODEL 3-D VISUALIZATION OPTION Dicomit Imaging Systems Corp. IYO Class II 1999-04-16
K990715 SHIMADZU CEILING TUBE SUPPORT CH-30GH Shimadzu Corp. KPR Class II 1999-04-16
K983948 BEACON, MODEL 211060 Philips Medical Systems (Cleveland), Inc. KPS Class II 1999-04-16
K990260 OPART Toshiba America Mri, Inc. LNH Class II 1999-04-15
K990759 VIEW COM Electromed Intl., Ltd. LLZ Class II 1999-04-15
K983341 STANDARD CT/MR APPLICATOR SET,RING CT/MR APPLICATOR SET, VAGINAL CT/MR APPLICATOR SET, FLETCHER WILLIAMSON APPLICATOR SE Nucletron Corp. JAQ Class II 1999-04-15
K990919 STRAIGHT ASPIRATOR, 90 DEGREE ASPIRATOR,45 DEGREE ASPIRATOR,7 FRENCH ASPIRATOR,EXTENDED STRAIGHT ASPIRATOR,13.9 CM STRAG Visualization Technology, Inc. LLZ Class II 1999-04-15
K990970 SONOACE 6000C DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS, ALSO CALLED ULTRASOUND SYSTEM AND TRANSDUCERS Medison America, Inc. IYN Class II 1999-04-07
K990491 ANGIO-CT MIYABI Siemens Medical Solutions USA, Inc. IXI Class II 1999-04-05
K983343 PLATO BRACHYTHERAPHY, MODEL V. 14.0 Nucletron Corp. MUJ Class II 1999-04-02
K983115 TREATMENT CONTROL STATION - MICROSELECTRON-HDR CLASSIC UPGRADE, VERSION 1.20 Nucletron Corp. JAQ Class II 1999-04-02
K981535 FOCUS PILOT CONTOURING WORKSTATION Computerized Medical Systems, Inc. IYE Class II 1999-04-02
K983337 ROTTERDAM NASOPHAYRNX MOULD SET, PART #089.068 Nucletron Corp. JAQ Class II 1999-04-02
K982696 INTERPLANT Burdette Medical Systems, Inc. MUJ Class II 1999-04-01
K990007 OPART, MODEL MRT-600 Toshiba America Mri, Inc. MOS Class II 1999-04-01
K990806 C1 ULTRASOUND SYSTEM Sonosite,Inc. IYN Class II 1999-03-26
K983879 ALOKA SSD-900 DIAGNOSTIC ULTRASOUND SYSTEM Aloka Co., Ltd. IYO Class II 1999-03-22
K990134 MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER, TSX-101A (AQUILION,MULTI) Toshiba America Medical Systems, In.C JAK Class II 1999-03-19
K981153 OSIRIS Huestis Medical IYE Class II 1999-03-17
K983945 CORTEX DERMASCAN C ULTRASONIC SYSTEM Cortex Technology Aps IYO Class II 1999-03-17
K990066 CCD CAMERA, MODEL 9000 Camtronics, Ltd. LMA Class II 1999-03-17
K984466 DILON 2000, MODEL 2000-6X8 AND DILON 2000, MODEL 2000-5X5 Dilon Technologies, Inc. IYX Class I 1999-03-16
K990423 PHILIPS NICOL COLLIMATOR FAMILY Philips Medical Systems, Inc. IZW Class II 1999-03-15
K984634 3D-ANGIO Siemens Medical Corp. JAK Class II 1999-03-12
K983918 RADIOLUCENT CASSETTE LIMB POSITIONER (R-CLIP) Mastek, Inc. IXA Class II 1999-03-12
K990192 BIOPSY-DIGIT Sitco, Inc. IZH Class II 1999-03-12
K984382 ACCU GUIDE Tayman Medical, Inc. IYO Class II 1999-03-05
K982952 IMFAST Siemens Medical Solutions USA, Inc. LHN Class II 1999-03-05
K990298 TOPOGRAPHIC IMAGING MARKER I.Z.I. Medical Products Corp. KPR Class II 1999-03-03
K990242 TOPOGRAPHIC IMAGING MARKER I.Z.I. Medical Products Corp. KPR Class II 1999-03-03
K990490 SSA-320A JUST VISION 200/ SSA-325A JUST VISION Toshiba America Medical Systems, In.C IYO Class II 1999-03-02
K983985 HYBRISONIC SHEATH Sonotech, Inc. ITX Class II 1999-02-25
K984545 RELEASE 2 OF PHILIPS INTEGRIS SERIES (V5000, BV5000, H5000, BH5000, HM2000) SYSTEMS Philips Medical Systems North America, Inc. IZI Class II 1999-02-25
K983110 FLEXART,FLEXART/HYPER, VISART, VISART/HYPER Toshiba America Mri, Inc. LNH Class II 1999-02-25
K990400 LINEAR ARRAY TRANSDUCER,MODEL HP 21376, M2410A ULTRASOUND IMAGING SYSTEM Hewlett-Packard Co. ITX Class II 1999-02-24
K983139 SIGNA 1.5T PHOSPHORUS (P) TRANSMIT/RECEIVE FLEX COIL GE Medical Systems MOS Class II 1999-02-19
K990052 TEL-ECHO SYSTEM Innovative Medical Solutions, Inc. LLZ Class II 1999-02-19
K990339 SONOS 5500 IMAGING SYSTEM M2424A VERSION B.O Hewlett-Packard Co. IYN Class II 1999-02-18
K984178 PRONOSCO X-POSURE SYSTEM Torsana Osteoporosis Diagnostics A/S KGI Class II 1999-02-18
K984221 FUNCTIONAL MRI PACKAGE FOR MAGETETOM VISION MR Siemens Corp. LNH Class II 1999-02-12
K984409 ELK LASER FILM DIGITIZER Nishimoto Sangyo Co., Ltd. LMA Class II 1999-02-12

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