Review Panel
Radiology FDA 510(k) Clearances & Devices
- Cleared Devices
- 14,721
- Product Codes (page)
- 26
- Latest Decision
- 2007-11-02
Clearances · page 73 of 148
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K072532 | TRUEPIX LCD MEDICAL DISPLAY MONITOR, MODELS TX-5M, TX-3M, TX-2M | Dooyang Systems, Inc. | LLZ | Class II | 2007-11-02 |
| K072693 | CSNP-001A NEURO PACKAGE | Toshiba America Medical Systems, In.C | JAK | Class II | 2007-11-01 |
| K072998 | IDEAL SOFTWARE OPTION FOR GE MR SCANNERS | Ge Medical Systems, LLC | LNH | Class II | 2007-11-01 |
| K072935 | SPEEDER 1.5T WRIST ARRAY COIL | Quality Electrodynamics | MOS | Class II | 2007-10-31 |
| K072909 | 1.5T 32-CHANNEL HEAD COIL AND 3T 32-CHANNEL HEAD COIL | Siemens AG Medical Solutions | MOS | Class II | 2007-10-31 |
| K072567 | SYMBIA-E, MODEL 10275879 | Siemens Medical Solutions USA, Inc. | KPS | Class II | 2007-10-30 |
| K072931 | MC 3003G-32R HEAD COIL | Mr Instruments, Inc. | MOS | Class II | 2007-10-30 |
| K072557 | FAXITRON SPECIMEN RADIOGRAPHY SYSTEM, MODEL MX-20 | Faxitron X-Ray Corp. | MWP | Class II | 2007-10-30 |
| K072918 | MODEL SSA-680A XARIO XG DIAGNOSTIC ULTRASOUND SYSTEM, VERSION 1.00 | Toshibamedical Systems Corporation | ITX | Class II | 2007-10-29 |
| K071787 | BEMITT, MODEL 0001 | Dja Distributors, LLC | IZH | Class II | 2007-10-26 |
| K072529 | TRACKPORT | Direx Systems Corp. | IYE | Class II | 2007-10-26 |
| K072506 | EXACTRAC 5.5 | Brainlab AG | IYE | Class II | 2007-10-26 |
| K072898 | HEXAPOD EVO RT COUCH TOP | Medical Intelligence Medizintechnik GmbH | JAI | Class II | 2007-10-25 |
| K072191 | CLEARVISION NUCLEAR MEDICINE IMAGING SYSTEM | Gvi Technology Partners | KPS | Class II | 2007-10-25 |
| K072680 | DRYSTAR AXYS, MODEL EYZ4E | Agfa Healthcare Corporation | LMC | Class II | 2007-10-25 |
| K072826 | APLIO ARTIDA DIAGNOSTIC ULTRASOUND SYSTEM | Toshiba America Medical Systems, In.C | ITX | Class II | 2007-10-24 |
| K072574 | ALPHARD CONE BEAM CT, MODEL X178 | Takara Belmont Corp. | JAK | Class II | 2007-10-18 |
| K072365 | SEQUOIA PLUS DIAGNOSTIC ULTRASOUND SYSTEM | Siemens Medical Solutions USA, Inc., Ultrasound DI | IYN | Class II | 2007-10-17 |
| K072046 | EXACTRAC 3RD PARTY, EXACTRAC X-RAY 6D 3RD PARTY, EXACTRAC OEM | Brainlab AG | IYE | Class II | 2007-10-17 |
| K072797 | GE LOGIQ I COMAPACT ULTRASOUND, GE LOGIQ E COMPACT ULTRASOUND, GE VIVID E COMPACT ULTRASOUND | General Electric Co. | IYO | Class II | 2007-10-17 |
| K072454 | INTEGRA RADIONICS INTERFIX PATIENT ADAPTERS | Integra Radionics, Inc. | IYE | Class II | 2007-10-16 |
| K072841 | NEUVIZ SPIRAL CT SCANNER SYSTEM | Neusoft Medical Systems Co., Ltd. | JAK | Class II | 2007-10-16 |
| K070195 | BROADSOUND, AL3C34A,AL7L50A, AL3C79B,AL7L24B, AT3P42A, AT3C52B, ATL5L40B, AT3P32A, AT3C42B | Broadsound Corporation | ITX | Class II | 2007-10-15 |
| K072237 | MAGNETOM VERIO | Siemens Medical Solutions USA, Inc. | LNH | Class II | 2007-10-10 |
| K072591 | CARDIOP-B SYSTEM, VERSION 2.1 | Paieon, Inc. | IZI | Class II | 2007-10-10 |
| K072737 | CSCS-001A CALCIUM SCORING PACKAGE | Toshiba America Medical Systems, In.C | JAK | Class II | 2007-10-05 |
| K072665 | SUNIRAY 5.2 | Orangedental GmbH & Co. KG | LLZ | Class II | 2007-10-03 |
| K072606 | AQUILION ONE TSX-301A/2 COMPUTED TOMOGRAPHY SYSTEM | Toshiba America Medical Systems, In.C | JAK | Class II | 2007-10-02 |
| K071938 | MONACO RTP SYSTEM | Computerized Medical Systems, Inc. | MUJ | Class II | 2007-10-01 |
| K072468 | MODIFICATION TO D-SPECT CARDIAC SCANNER SYSTEM | Spectrum Dynamics , Ltd. | KPS | Class II | 2007-10-01 |
| K072171 | GATECT-RT | Vision RT Limited | IYE | Class II | 2007-10-01 |
| K072296 | POIINT OF CARE STRANDING SYSTEM, MODE 1004-00 | Theragenics Corp. | KXK | Class II | 2007-09-26 |
| K072517 | ILAB ULTRASOUND IMAGING SYSTEM, VERSION 1.3 | Boston Scientific Corp | IYO | Class II | 2007-09-26 |
| K071964 | MIM 4.1 (SEASTAR) | Mimvista Corp. | LLZ | Class II | 2007-09-26 |
| K072541 | SENOSONIX ULTRASOUND BREAST BIOPSY SYSTEM | Senorx, Inc. | ITX | Class II | 2007-09-25 |
| K072392 | OPDIMA DIGITAL MAMMOGRAPHIC X-RAY SYSTEM | Siemens Medical Solutions USA, Inc. | IZL | Class II | 2007-09-25 |
| K072279 | MAGNETIC RESONANCE DIAGNOSTIC DEVICE | Hitachi Medical Systems America, Inc. | LNH | Class II | 2007-09-21 |
| K072504 | CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM | Accuray Incorporated | IYE | Class II | 2007-09-21 |
| K072515 | EMBRACE GEL | Orison Corporation | MUI | Class II | 2007-09-20 |
| K071546 | EOS | Biospace Med | KPR | Class II | 2007-09-18 |
| K072090 | SIEMENS DIAGNOSTIC ULTRASOUND SYSTEMS | Siemens Medical Solutions USA, Inc., Ultrasound DI | IYN | Class II | 2007-09-14 |
| K072445 | INTEGRATED BRACHYTHERAPY UNIT - DIGITAL | Nucletron Corp. | KPQ | Class II | 2007-09-14 |
| K072439 | GE LUNAR DPX & PRODIGY SERIES DEXA BONE DENSITOMETERS WITH MOBILE KIT | Ge Medical Systems Ultrasound and Primary Care Dia | KGI | Class II | 2007-09-14 |
| K072242 | COR ANALYZER II, MODEL V1.7 | Rcadia Medical Imaging , Ltd. | LLZ | Class II | 2007-09-11 |
| K071614 | FIDUCIAL MARKERS | Civco | IYE | Class II | 2007-09-11 |
| K072222 | SPY FLUORESCENT IMAGING SYSTEM | Novadaq Technologies, Inc. | IZI | Class II | 2007-09-07 |
| K071966 | 1.5T MRGFUS PELVIC COIL | Insightec-Txsonics, Inc. | MOS | Class II | 2007-09-05 |
| K072164 | DC-6 DIAGNOSTIC ULTRASOUND SYSTEM | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | ITX | Class II | 2007-09-05 |
| K071299 | IP SYSTEM, OCULAB IP, OPTOMIZE IP, RETASURE IP | Digital Healthcare, Ltd. | NFJ | Class II | 2007-08-31 |
| K071584 | OASIS RELEASE 1.0 | Segami Corporation | LLZ | Class II | 2007-08-31 |
| K072006 | DAR-9400F | Shimadzu Corp. | IZI | Class II | 2007-08-31 |
| K072285 | ALOKA SSD-ALPHA 7 ULTRASOUND SYSTEM | Aloka Co., Ltd. | ITX | Class II | 2007-08-30 |
| K072047 | MHI-TM2000 LINEAR ACCELERATOR SYSTEM | Mitsubishi Heavy Industries, Ltd. | IYE | Class II | 2007-08-29 |
| K072075 | MODIFICATION TO GE LOGIQ A3 | General Electric Co. | IYN | Class II | 2007-08-29 |
| K072266 | ACUSON P50 DIAGNOSTIC ULTRASOUND SYSTEM | Siemens Medical Solutions USA, Inc. | ITX | Class II | 2007-08-29 |
| K072205 | VISAGE PACS/CS, RELEASE VERSION 5.0 | Mercury Computer Systems, Inc. | LLZ | Class II | 2007-08-29 |
| K071806 | ECLOS COMPUTED TOMOGRAPHY X-RAY SYSTEM | Hitachi Medical Systems America, Inc. | JAK | Class II | 2007-08-28 |
| K071492 | FIRSTVIEW | Riverain Medical Group,Llc | LLZ | Class II | 2007-08-28 |
| K072210 | CHISON, MODEL 8300 | Chison Medical Imaging Co., Ltd. | IYO | Class II | 2007-08-24 |
| K071531 | MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM | Accuray Incorporated | IYE | Class II | 2007-08-22 |
| K062623 | AXIOM LUMINOS DRF | Siemens Medical Solutions USA, Inc. | OWB | Class II | 2007-08-22 |
| K071985 | GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND | General Electric Co. | IYN | Class II | 2007-08-17 |
| K071894 | XEBRA DICOM IMAGE BROWSER | Hx Technologies, Inc. | LLZ | Class II | 2007-08-16 |
| K071308 | MODIFICATION TO NEUVIZ DUAL MULTI-SLICE CT SCANNER SYSTEM | Neusoft Medical Systems Co., Ltd. | JAK | Class II | 2007-08-16 |
| K071992 | HIGH-DEFINITION 120 MULTILEAF COLLIMATOR (HD120 MLC) | Varian Medical Systems | IYE | Class II | 2007-08-15 |
| K071682 | CRYSTALVIEW T-SERIES COMPUTED RADIOGRAPHY SYSTEM, MODELS T110 (WITH ERASER) AND T100 (WITHOUT ERASER) | Alara, Inc. | MQB | Class II | 2007-08-15 |
| K072079 | IGUIDE SYSTEM | Medical Intelligence Medizintechnik-GmbH-An Elekta | IYE | Class II | 2007-08-14 |
| K072065 | 20.8-INCH (53CM) COLOR LCD MONITOR CDL2119A (CCL352I2) | Totoku Electric Co., Ltd. | LLZ | Class II | 2007-08-14 |
| K072066 | 1.3M MONOCHROME LCD MONITOR MDL1908A | Totoku Electric Co., Ltd. | LLZ | Class II | 2007-08-14 |
| K071925 | MAGNETOM ESSENZA | Siemens Medical Solutions USA, Inc. | LNH | Class II | 2007-08-14 |
| K071873 | MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEM | Varian Medical Systems, Inc. | MUJ | Class II | 2007-08-09 |
| K071636 | CODIAGNOSTIX (R) 5.72 | Ivs Solutions AG | LLZ | Class II | 2007-08-09 |
| K072010 | QUANTUM DIREX SYSTEM | Quantum Medical Imaging, LLC | KPR | Class II | 2007-08-07 |
| K071392 | PXS-810, PODIATRY X-RAY SYSTEM | Source-Ray, Inc. | KPR | Class II | 2007-08-03 |
| K071996 | MYLAB30, MODEL 7300 | Esaote, S.p.A. | IYO | Class II | 2007-08-03 |
| K063066 | AXIS-V MONOCHROME 5 MP DISPLAY | National Display Systems | LLZ | Class II | 2007-08-03 |
| K070515 | A-VIEW BASIC AND PLUS | Cordatec N.V. | ITX | Class II | 2007-07-30 |
| K071972 | ORTHOPEDIC SOFTWARE FOR IMPAX WORKSTATIONS | Agfa Healthcare Corp. | LLZ | Class II | 2007-07-30 |
| K072000 | APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-790A VERSION 2.0 | Toshiba America Medical Systems, In.C | IYN | Class II | 2007-07-30 |
| K071950 | SYNGO TRUED | Siemens Medical Solutions USA, Inc. | LLZ | Class II | 2007-07-27 |
| K071503 | SYSTEM, TOMOGRAPHY, COMPUTED EMISSION | Syntermed, Inc. | KPS | Class II | 2007-07-26 |
| K071166 | UNIWEB, VERSION 5.0 | Electronic Business Machine Co., Ltd. (Ebm) | LLZ | Class II | 2007-07-23 |
| K071602 | IMAGIC V2.0 | Ashva Technologies, Pvt., Ltd. | LLZ | Class II | 2007-07-23 |
| K071847 | MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL CG-KFC18-H150-AP - KNEE/FOOT/ANKLE COIL | Shanghai Chenguang Medical Technologies Co, Ltd. | MOS | Class II | 2007-07-23 |
| K071701 | TRACKLEAF-10 | Direx Systems Corp. | IYE | Class II | 2007-07-23 |
| K071550 | PRE-WAXED NEEDLES WITH GOLD FIDUCIARY MARKERS | Cp Medical | KXK | Class II | 2007-07-18 |
| K071673 | ONC SOLUTIONS MARKER, MODELS 001001 TO 001012 AND 001021 TO 001032 | Onc Solutions, Inc. | IYE | Class II | 2007-07-18 |
| K071381 | GAMMAMEDPLUS IX SERIES HDR AFTERLOADER | Varian Medical Systems | JAQ | Class II | 2007-07-18 |
| K071882 | MODEL CG-WHC18-H150-AP - WRIST HAND COIL 1.5T 4 CH, | Shanghai Chenguang Medical Technologies Co, Ltd. | MOS | Class II | 2007-07-18 |
| K063710 | SATURN 9000 | New Medical Co., Ltd. | MQB | Class II | 2007-07-16 |
| K071467 | VARISOURCE IX HDR AFTERLOADER | Varian Medical Systems, Inc. | JAQ | Class II | 2007-07-16 |
| K071599 | EASYGUIDE | Keystone Dental, Inc. | LLZ | Class II | 2007-07-11 |
| K070634 | SOYEE PORTABLE X-RAY UNIT, MODEL SY-HF-110 | Soyee Product, Inc. | IZL | Class II | 2007-07-11 |
| K070611 | BAT ULTRASOUND LOCALIZATION AND POSITIONING SYSTEM, VERSION 6 | Nomos Corp. | IYE | Class II | 2007-07-11 |
| K071534 | CONFIRMA BREAST MRI INTERVENTIONAL COMPONENTS | Confirma, Inc. | MOS | Class II | 2007-07-09 |
| K071870 | HEXAPOD RT COUCH TOP | Medical Intelligence Medizintechnik GmbH | JAI | Class II | 2007-07-08 |
| K071717 | GE OEC ALTITUDE | Shimadzu Corp. | IZI | Class II | 2007-07-05 |
| K071542 | DIGITAL STEREOLOC II | Lorad, A Hologic Co. | IZH | Class II | 2007-07-05 |
| K070983 | OLYMPUS XBF-UC180F-DT8 ULTRASONIC BRONCHOFIBERVIDEOSCOPE USED WITH ALOKA SSD-ALPHA 5/10 ULTRASOUND SYSTEM | Olympus Medical Systems Corporation | PSV | Class II | 2007-07-05 |
| K071156 | SOUNMED SD-2000 PLUS PORTABLE ULTRASOUND SCANNER | Sounmed, Inc. | IYO | Class II | 2007-07-03 |
14,721 clearances in the Radiology panel. Data: openFDA.