Review Panel
Radiology FDA 510(k) Clearances & Devices
- Cleared Devices
- 14,721
- Product Codes (page)
- 21
- Latest Decision
- 2008-06-18
Clearances · page 71 of 148
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K081198 | ECHELON RAPID HEAD COIL, MODEL MR-RHC-150N, ECHELON RAPID TORSO COIL, MODEL MR-RBC-150N | Hitachi Medical Systems America, Inc. | MOS | Class II | 2008-06-18 |
| K081340 | PEDIATRIC BODY AND CARDIAC COIL, MODEL 01000140201 | Shanghai Chenguang Medical Technologies Co, Ltd. | MOS | Class II | 2008-06-18 |
| K081322 | MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL 0100140201, PEDIATRIC HEAD-SPINE COIL | Shanghai Chenguang Medical Technologies Co, Ltd. | MOS | Class II | 2008-06-18 |
| K081582 | INFX-8000V, INFINIX-CFI AND INFINIX VFI | Toshiba America Medical Systems, In.C | JAA | Class II | 2008-06-17 |
| K081262 | DC NEURO | Invivo Corporation | LLZ | Class II | 2008-06-17 |
| K081496 | OPTIMA PET/CT 560 | Ge Medical Systems, LLC | KPS | Class II | 2008-06-12 |
| K081469 | SECTRA WORKSTATION, IDS7 VERSION 11.3, IDS5 VERSION 11.1 P2 | Sectra Imtec AB | LLZ | Class II | 2008-06-12 |
| K081379 | MODIFICATION TO INREACH SYSTEM | Superdimension, Ltd. | JAK | Class II | 2008-06-11 |
| K080888 | MODEIFICATION TO IPLAN RT DOSE | Brainlab AG | MUJ | Class II | 2008-06-11 |
| K081242 | 21.3 INCH (53CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS51I2, (MDL2123A) | Tokotu Electric Co., Ltd. | LLZ | Class II | 2008-06-11 |
| K080585 | DESKTOP PRO | Elekta , Ltd. | IYE | Class II | 2008-06-11 |
| K081482 | CSBP-001A BODY ORGAN PERFUSION SYSTEM | Toshiba America Medical Systems, In.C | JAK | Class II | 2008-06-11 |
| K081091 | PRECISION 500D R&F X-RAY SYSTEM | GE Healthcare | JAA | Class II | 2008-06-11 |
| K081304 | ALZ WEB PACS, VERSION 1.0 | Alz, Inc. | LLZ | Class II | 2008-06-11 |
| K080970 | USHIFU STEPPER | Ushifu Development Company, LLC | ITX | Class II | 2008-06-11 |
| K080589 | SATURN 9000-810 | New Medical Co., Ltd. | MQB | Class II | 2008-06-11 |
| K080601 | ERGO++ VERSION 1.7 | 3D Line Medical Systems S.R.L. | MUJ | Class II | 2008-06-06 |
| K081065 | APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A, VERSION 2.2 | Toshiba America Medical Systems, In.C | IYN | Class II | 2008-06-06 |
| K081308 | FUJIFILM FCR VIEW, MODEL CR-VW674 | Fujifilm Medical Systems U.S.A, Inc. | LLZ | Class II | 2008-06-04 |
| K080072 | MRI PATIENT POSITIONING DEVICES | CIVCO Medical Instruments Co., Inc. | IYE | Class II | 2008-06-04 |
| K081426 | NEXSTAR LIFTOFF PET APPLICATION SOFTWARE SUITE | Philips Medical Systems (Cleveland), Inc. | KPS | Class II | 2008-06-04 |
| K080859 | DRF 4343 | Villa Sistemi Medicali S.P.A. | JAA | Class II | 2008-06-04 |
| K081056 | 21.3 (54CM) 3M COLOR LCD MONITOR CCL354I2 (CDL2126A) | Totoku Electric Co., Ltd. | LLZ | Class II | 2008-06-04 |
| K081121 | MODIFICATION TO ACUSON X150 ULTRASOUND SYSTEM | Siemens Medical Solutions USA, Inc., Ultrasound DI | IYO | Class II | 2008-06-04 |
| K081055 | 21.3 (54CM) 2M COLOR LCD MONITOR CCL254I2 (CDL2125A) | Totoku Electric Co., Ltd. | LLZ | Class II | 2008-06-04 |
| K080555 | SOFIA AUTOMATED TOMOGRAPHIC ULTRASOUND (ATUS) | Ivu Imaging Corporation | ITX | Class II | 2008-06-03 |
| K081022 | SOMATOM DEFINITION, MODEL AS/AS+ | Siemens Medical Solutions USA, Inc. | JAK | Class II | 2008-06-02 |
| K080951 | 19-INCH (48CM) 1.3M COLOR LCD MONITOR CDL1909A | Totoku Electric Co., Ltd. | LLZ | Class II | 2008-05-29 |
| K080952 | 15-INCH (38 CM) COLOR LCD MONITOR CDL1576A | Totoku Electric Co., Ltd. | LLZ | Class II | 2008-05-29 |
| K080934 | VIENNA RING CT/MR APPLICATOR SET, ROUND POINT TITANIUM NEEDLE SET, TROCAR POINT TITANIUM NEEDLE SET | Nucletron Corporation | JAQ | Class II | 2008-05-28 |
| K081201 | WBR XPRESS3.CARDIAC | Ultraspect , Ltd. | KPS | Class II | 2008-05-28 |
| K081347 | ILUMA VISION | Imtec Corp. | LLZ | Class II | 2008-05-28 |
| K081320 | DC-3, DC-3T DIAGNOSTIC ULTRASOUND SYSTEM | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | Class II | 2008-05-27 |
| K073362 | MROPEN | Paramed S.R.L. | LNH | Class II | 2008-05-23 |
| K081154 | ULTRASOUND SCANNER FLEX FOCUS, MODEL 1202 | B-K Medical Aps | IYO | Class II | 2008-05-23 |
| K081281 | OCENTRA MASTERPLAN 3.1 (OCENTRA BRACHY) | Nucletron Corporation | MUJ | Class II | 2008-05-20 |
| K072258 | BI-RADS COMPANION | Almen Laboratories, Inc. | LLZ | Class II | 2008-05-16 |
| K080515 | FMRI HARDWARE SYSTEM | Nordicneurolab | LNH | Class II | 2008-05-16 |
| K081110 | SIUI CTS-900 DIGITAL ULTRASOUND IMAGING SYSTEM | Shantou Institute of Ultrasonic Instuments | IYO | Class II | 2008-05-16 |
| K080582 | MEDICATECH, MODEL DDR MAK-800, DDT MAK-1000 FS, DDR MAK-1100 FA | Medicatech USA | KPR | Class II | 2008-05-15 |
| K080762 | IB NEURO, VERSION 1.0 | Imaging Biometrics, LLC | LNH | Class II | 2008-05-15 |
| K080701 | SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTION | Shimadzu Corp. | IZL | Class II | 2008-05-14 |
| K080726 | CALYPSO 4D LOCALIZATION SYSTEM | Calypso Medical Technologies, Inc. | IYE | Class II | 2008-05-14 |
| K080575 | CORRIDOR4DM | Invia | KPS | Class II | 2008-05-13 |
| K081179 | MAMMOSITE CAVITY EVALUATION DEVICE | Hologic, Inc. | JAQ | Class II | 2008-05-09 |
| K081105 | GE LIGHTSPEED CT750 HD (LIGHTSPEED 8.0) | GE Healthcare | JAK | Class II | 2008-05-09 |
| K081036 | 4D INTEGRATED TREATMENT CONSOLE WITH PATIENT ACCESSORY VERIFICATION SYSTEM (PAVS) | Varian Medical Systems, Inc. | IYE | Class II | 2008-05-09 |
| K072616 | AXXENT VAGINAL APPLICATOR | Xoft, Inc. | JAD | Class II | 2008-05-09 |
| K080612 | LEICA FL800 | Leica Microsystems (Schweiz) AG | IZI | Class II | 2008-05-09 |
| K080655 | CHRYSALIS | Meta Imaging Solutions, LLC | KPR | Class II | 2008-05-09 |
| K080742 | VERISUITE 1.6, VERISUITE-PARTICLE 1.6 | Medcom GmbH | IYE | Class II | 2008-05-09 |
| K081066 | BRACHYTHERAPY SOURCE DEVICE, MODEL 9011 | Medi-Physics, Inc., Dba GE Healthcare | IWG | Class II | 2008-05-05 |
| K081109 | CORONIS 5MP MAMMO SL, MODEL MDMG 6121 | Barcoview, Medical Imaging Systems | LLZ | Class II | 2008-05-02 |
| K081079 | CONTURA MLB SOURCE APPLICATOR FOR BRACHYTHERAPY | Senorx, Inc. | JAQ | Class II | 2008-05-02 |
| K073543 | OEC 9900 ELITE | Ge Oec Medical Systems | OWB | Class II | 2008-05-02 |
| K081118 | NORAS MR-BI320-PA 1.5T | Noras Mri Products GmbH | MOS | Class II | 2008-05-02 |
| K081093 | 3-D IMAGING WORKSTATION | Eigen, LLC | LLZ | Class II | 2008-05-01 |
| K080791 | CONTURA MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRACHYTHERAPY, MODELS B001-45 AND B011-45 | Senorx, Inc. | JAQ | Class II | 2008-04-30 |
| K080890 | SMARTSPOT PRIMAX | Cmt Medical Technologies, Ltd. | LLZ | Class II | 2008-04-29 |
| K080871 | TROCAR POINT TITANIUM NEEDLE SETS, ROUND POINT TITANIUM NEEDLE SETS | Nucletron Corporation | JAQ | Class II | 2008-04-29 |
| K080968 | S-SCAN, G-SCAN, DYNAMIC MRI SOFTWARE FOR C-SCAN, E-SCANXQ & E-SCAN OPERA | Esaote, S.p.A. | LNH | Class II | 2008-04-29 |
| K081135 | GEMINI CONDOR | Philips Medical Systems (Cleveland), Inc. | KPS | Class II | 2008-04-29 |
| K073358 | LUMIMED SERIES 5MP DIGITAL FLAT PANEL DISPLAY SYSTEM, MODEL MM50/MM50A | Heeyoung Co., Ltd. | LLZ | Class II | 2008-04-25 |
| K081018 | SYNGO DYNAMICS VERSION 7.0 | Siemens Medical Solutions | LLZ | Class II | 2008-04-25 |
| K081028 | SIGNA 3.0T MR750 SYSTEM | Ge Medical Systems, LLC | LNH | Class II | 2008-04-25 |
| K080760 | ACUSON X300 ULTRASOUND SYSTEM | Siemens Medical Solutions USA, Inc., Ultrasound DI | IYN | Class II | 2008-04-25 |
| K080351 | DEXELA DEX TOP MAMMOGRAPHY WORKSTATION, MODEL MAMWKVI | Dexela, Ltd. | LLZ | Class II | 2008-04-22 |
| K072728 | SYNGO MULTIMODALITY WORKPLACE | Siemens AG Medical Solutions | LLZ | Class II | 2008-04-22 |
| K080945 | FCR GO PORTABLE DIGITAL X-RAY SYSTEM | Fujifilm Medical Systems U.S.A, Inc. | IZL | Class II | 2008-04-18 |
| K080961 | NM APPLICATION SUITE | Philips Nuclear Medicine, Inc. | LLZ | Class II | 2008-04-18 |
| K080608 | DIGITAL LIGHTBOX | Brainlab AG | LLZ | Class II | 2008-04-17 |
| K073449 | SURGICASE | Materialise NV | LLZ | Class II | 2008-04-16 |
| K080553 | DIGITAL RADIOGRAPHY SYSTEM, MODEL QXR-16 | Vieworks Co., Ltd. | KPR | Class II | 2008-04-16 |
| K080929 | ONCENTRA GYN | Nucletron Corporation | MUJ | Class II | 2008-04-16 |
| K080927 | BRIGHTVIEW VCT IMAGING SYSTEM | Philips Medical Systems (Cleveland), Inc. | KPS | Class II | 2008-04-11 |
| K080624 | NAVSTATIONIRAD EMT, VERSION 1.1 | Cas Innovations AG | JAK | Class II | 2008-04-11 |
| K080770 | IMAGENMD WITH IMAGENQ | Cardiovascular Imaging Technologies, LLC | LLZ | Class II | 2008-04-09 |
| K073695 | 3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH, MODEL MCT-1F8/F17 | J. Morita USA, Inc. | JAK | Class II | 2008-04-09 |
| K080325 | IGROK | Igrok, LLC | LLZ | Class II | 2008-04-08 |
| K080800 | ACCUVIX V20 DIAGNOSTIC ULTRASOUND SYSTEM | Medison Co., Ltd. | IYN | Class II | 2008-04-07 |
| K080565 | MODIFICATION TO: SAVI APPLICATOR KIT | Cianna Medical, Inc. | JAQ | Class II | 2008-04-04 |
| K073468 | MIMICS | Materialise NV | LLZ | Class II | 2008-04-02 |
| K080820 | TEM 3002G- HN DUAL TUNE HEAD COIL | Mr Instruments, Inc. | MOS | Class II | 2008-04-02 |
| K080784 | WBR XPRESS.CARDIAC, WBR XPRESS.BONE; WBR XACT.CARDIAC, WBR XACT.BONE | Ultraspect , Ltd. | KPS | Class II | 2008-04-02 |
| K080271 | INREACH SYSTEM | Superdimension, Ltd. | JAK | Class II | 2008-03-31 |
| K072847 | APEX 2.0 SOFTWARE FOR QDR X-RAY BONE DENSITOMETERS | Hologic, Inc. | KGI | Class II | 2008-03-28 |
| K080548 | HD7 DIAGNOSTIC ULTRASOUND SYSTEM | Phillips Medical Systems | IYN | Class II | 2008-03-27 |
| K073262 | BELLA | Beekley Corp. | IZH | Class II | 2008-03-26 |
| K073346 | ZIEHM VISION 2 | Ziehm Imaging, Inc. | JAK | Class II | 2008-03-21 |
| K080640 | M5 DIAGNOSTIC ULTRASOUND SYSTEM | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | Class II | 2008-03-21 |
| K080457 | COLOR LCD MONITOR, MODEL RADIFORCE RX211 | Eizo Nanao Corporation | LLZ | Class II | 2008-03-20 |
| K073714 | TRAUMACAD VERSION 2.0 | Orthocrat, Ltd. | LLZ | Class II | 2008-03-19 |
| K073176 | KANTERON DICOM STATION (KDS), MODEL 3.0 | Monica Veytia | LLZ | Class II | 2008-03-19 |
| K080211 | MODEL TSX-101A/H/I AQUILION 32/64 SP CT SYSTEM | Toshiba America Medical Systems, In.C | JAK | Class II | 2008-03-14 |
| K072307 | QUANTITATIVE NEUROQ 3.0 | Syntermed, Inc. | KPS | Class II | 2008-03-14 |
| K073623 | ATLANTIS 018 PERIPHERAL IMAGING CATHETER | Boston Scientific Corp | ITX | Class II | 2008-03-13 |
| K080540 | NEUSOFT SPIRAL CT SCANNER SYSTEM, MODEL NEUVIZ VERSION 2.0 | Neusoft Medical Systems Co., Ltd. | JAK | Class II | 2008-03-13 |
| K073526 | AMICAS VISION SERIES PACS, MODEL 5.5 | Amicas, Inc. | LLZ | Class II | 2008-03-12 |
| K073709 | MODIFICATION TO VIEWMATE SYSTEM | Ep Medsystems | IYN | Class II | 2008-03-11 |
| K080272 | ATLANTIS PVIMAGING CATHETER, MODEL H749364560 | Boston Scientific Corp | ITX | Class II | 2008-03-11 |
14,721 clearances in the Radiology panel. Data: openFDA.