Review Panel
Radiology FDA 510(k) Clearances & Devices
- Cleared Devices
- 14,721
- Product Codes (page)
- 25
- Latest Decision
- 2008-10-10
Clearances · page 70 of 148
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K082350 | PAX-500 | VATECH Co., Ltd. | OAS | Class II | 2008-10-10 |
| K082220 | SOMATOM FLASH DS | Siemens Medical Solutions USA, Inc. | JAK | Class II | 2008-10-10 |
| K082816 | GE BRIGHTSPEED DELIGHT CT SCANNER SYSTEM | Ge Medical Systems, LLC | JAK | Class II | 2008-10-08 |
| K082761 | GE LIGHTSPEED 7.2 CT SCANNER SYSTEM | Ge Medical Systems, LLC | JAK | Class II | 2008-10-08 |
| K082326 | ZONARE ULTRA ULTRASOUND SYSTEM | Zonare Medical Systems, Inc. | IYN | Class II | 2008-10-08 |
| K082229 | S5/S5I SERIES INTRAVASCULAR IMAGING AND PRESSURE SYSTEM, COMBOMAP PRESSURE AND FLOW SYSTEM | Volcano Corporation | IYO | Class II | 2008-10-08 |
| K081935 | STEREOTACTIC HEAD AND NECK LOCALIZER, MODEL 50-100 | Aktina Medical Physics Corp. | IYE | Class II | 2008-10-07 |
| K082663 | COLOR LCD MONITOR | Eizo Nanao Corporation | LLZ | Class II | 2008-10-06 |
| K082331 | MAGNETOM C! | Siemens Medical Solutions USA, Inc. | LNH | Class II | 2008-10-01 |
| K082510 | IMAGE-ARENA APPLICATIONS, MODEL IMAGE-ARENA VA PLATFORM 1.0, 4D LV-ANALYSIS 2.5, 4D LV-ANALYSIS MR 1.0 | Tomtec Imaging Systems GmbH | LLZ | Class II | 2008-10-01 |
| K082159 | CIVASTRING PD-103 | Civatech Oncology, Inc. | KXK | Class II | 2008-09-30 |
| K082656 | MODEL FF SONIC US-750 XT DIAGNOSTIC ULTRASOUND SYSTEM 3D IMAGING UNIT | Fukuda Denshi USA, Inc. | IYN | Class II | 2008-09-30 |
| K082364 | IMAGENET PROFESSIONAL PC SOFTWARE SYSTEM OR IMAGENET PROFESSIONAL, OR IMAGENET PRO, OR DIGITAL IMAGING SOFTWARE FOR | Topcon Corp. | NFJ | Class II | 2008-09-30 |
| K082317 | GE LUNAR FRAX 10-YEAR FRACTURE RISK SOFTWARE OPTION | General Electric Co. | KGI | Class II | 2008-09-26 |
| K081987 | UNISYN IMAGE FUSION, VERSION 1.0 | Convergent Imaging Solutions | LLZ | Class II | 2008-09-26 |
| K081985 | AW SERVER | Ge Medical Systems, LLC | LLZ | Class II | 2008-09-25 |
| K082636 | TXRX 15CH KNEE COIL (1.5T AND 3T), TXRX CP EXTREMITY COIL 3T | Quality Electrodynamics | MOS | Class II | 2008-09-25 |
| K081386 | MODEL 6150 (MYLAB70) AND MODEL 6100 (MYLAB90) | Esaote, S.p.A. | IYN | Class II | 2008-09-25 |
| K082596 | ULTRAEXTEND USWS-900A | Toshiba America Medical Systems, In.C | LLZ | Class II | 2008-09-23 |
| K082228 | PLANISIGHT LINASYS | Pathfinder Therapeutics, Inc. | LLZ | Class II | 2008-09-22 |
| K081948 | RAYPAX SYSTEM | Raypax, Inc. | LLZ | Class II | 2008-09-19 |
| K081792 | SPY ANALYSIS TOOLKIT, MODEL SA9000 | Novadaq Technologies, Inc. | LLZ | Class II | 2008-09-17 |
| K082386 | INREACH PLANNING LAPTOP | Superdimension, Ltd. | LLZ | Class II | 2008-09-16 |
| K073425 | MODIFICATION TO AURORA MRI SYSTEM | Aurora Imaging Technology, Inc. | LNH | Class II | 2008-09-16 |
| K082494 | DRAD3000E/RADREX-I | Toshiba America Medical Systems, In.C | MQB | Class II | 2008-09-12 |
| K082264 | CONTURA LUMEN MARKER | Senorx, Inc. | JAQ | Class II | 2008-09-12 |
| K081945 | 21.3-INCH (54CM) MONOCHROME LCD MONITOR MS21I2 (MDL2127A) | Totoku Electric Co., Ltd. | LLZ | Class II | 2008-09-12 |
| K082483 | QUANTRA | Hologic, Inc. | LLZ | Class II | 2008-09-12 |
| K082368 | CARDIUS-1, -2, -3, AND CARDIUS 1,2,3 XPO SPECT IMAGING SYSTEMS, 2020TC SPECT IMAGING SYSTEM | Digirad Corp. | KPS | Class II | 2008-09-12 |
| K081656 | VISUALASE THERMAL THERAPY SYSTEM | Biotex, Inc. | LLZ | Class II | 2008-09-10 |
| K081557 | PORTABLE SUPINE PATIENT SUPPORT AND CASSETTE HOLDER | Jddb Manufacturing, Inc. | IXA | Class II | 2008-09-10 |
| K073328 | CARDIOP-B SYSTEM, VERSION 2.1 WITH LVA | Paieon, Inc. | IZI | Class II | 2008-09-09 |
| K081919 | UF-870 AG DIAGNOSTIC ULTRASOUND SYSTEM | Fukuda Denshi Co., Ltd. | ITX | Class II | 2008-09-09 |
| K082496 | PACSMATE MMD-3213M MONITOR | Iei Technology Corp. | LLZ | Class II | 2008-09-09 |
| K082485 | MODIFICATION TO SUPEROPEN 0.23T MRI SYSTEM, MODEL NAM-P023A | Neusoft Medical Systems Co., Ltd. | LNH | Class II | 2008-09-09 |
| K082144 | AMICAS PACS, VERSION 6.0 | Amicas, Inc. | LLZ | Class II | 2008-09-05 |
| K080196 | Z3D CONTRAST ACUITY | Clario Medical Imaging, Inc. | LLZ | Class II | 2008-09-05 |
| K081357 | 5MP GRAYSCALE FLAT PANEL DISPLAY, MODEL, 6GF6201-5C$2# (WHERE $ = A-Z AND # = 0-9) | Eizo GmbH | LLZ | Class II | 2008-09-05 |
| K082104 | GE LIGHTSPEED RT16 / LIGHTSPEED XTRA V2 CT SYSTEM (AKA GE LIGHTSPEED RT16 / LIGHTSPEED XTRA CT SYSTEM | Ge Medical Systems, Inc. | JAK | Class II | 2008-09-02 |
| K082374 | VIVID I AND VIVID Q | Ge Medical Systems Israel, Ultrasound, Ltd. | IYN | Class II | 2008-09-02 |
| K080711 | 1.10-YEAR FRACTURE RISK QUESTIONNAIRE OPTION FOR QDR X-RAY BONE DENSITOMETER, MODEL QDR OPTION | Hologic, Inc. | KGI | Class II | 2008-09-02 |
| K080529 | STEREOS WORKSTATION | Biospace Med | LLZ | Class II | 2008-08-29 |
| K082373 | NORAS MR-BI320-PA 3T | Noras Mri Products GmbH | MOS | Class II | 2008-08-29 |
| K082341 | DSA 2000EX | Eigen, LLC | LLZ | Class II | 2008-08-29 |
| K082122 | MLCI2 | Elekta , Ltd. | IYE | Class II | 2008-08-29 |
| K081215 | VOLUMINA | Kjaya Medical, LLC | LLZ | Class II | 2008-08-26 |
| K082005 | MODIFICATION TO HI-ART TREATMENT SYSTEM | Tomotherapy Incorporated | MUJ | Class II | 2008-08-25 |
| K082098 | SONOSITE MAXX SERIES ULTRASOUND SYSTEM | Sonosite,Inc. | IYN | Class II | 2008-08-25 |
| K082318 | CENTRICITY PACS IW | Ge Healthcare Dynamic Imaging Solutions | LLZ | Class II | 2008-08-25 |
| K082064 | RADVISION ET DIAGNOSTIC X-RAY SYSTEM | Almana Medical Imaging | KPR | Class II | 2008-08-22 |
| K081722 | YSIO | Siemens Medical Solutions USA, Inc. | KPR | Class II | 2008-08-22 |
| K082244 | PCA-8000A, MARK 11, PET / CT SYSTEM | Toshiba America Medical Systems, In.C | KPS | Class II | 2008-08-21 |
| K081847 | PICASSO MASTER, ECT AND MASTER 3D | E-Woo Technology | JAK | Class II | 2008-08-21 |
| K082185 | GE LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS 5205000, 5205000-2 | Ge Medical Systems Ultrasound and Primary Care Dia | IYO | Class II | 2008-08-15 |
| K081672 | C-INSIGHT | Mazor Surgical Technologies , Ltd. | LLZ | Class II | 2008-08-15 |
| K081757 | VERISTA IMAGING ISOCAM II GAMMA CAMERA | Verista Imaging, Inc. | IYX | Class I | 2008-08-15 |
| K082119 | APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A VERSION 3.0 | Toshiba America Medical Systems, In.C | IYN | Class II | 2008-08-12 |
| K081745 | ECHELON RAPID PV COIL, MODEL MR-PVC-150, ECHELON RAPID FOOT COIL, MODEL MR-RFC-150 AND ECHELON RAPID KNEE COIL | Hitachi Medical Systems America, Inc. | MOS | Class II | 2008-08-12 |
| K080930 | MODIFICATION TO AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS | U-System, Inc. | IYO | Class II | 2008-08-07 |
| K080799 | ATLAS-BASED AUTOSEGMENTATION | Computerized Medical Systems, Inc. | LHN | Class II | 2008-08-07 |
| K080935 | SONIX MDP ULTRASOUND SCANNER | Ultrasonix Medical Corporation | IYN | Class II | 2008-08-06 |
| K080847 | RFVISION, MODEL 9.9D | Almana Medical Imaging | OWB | Class II | 2008-08-06 |
| K081752 | EDGE PACS | Ashva Technologies, Pvt., Ltd. | LLZ | Class II | 2008-08-06 |
| K082100 | ALLTECH ECHOSTAR 1.5 T MR SYSTEM | Alltech Medical Systems America, Inc. | LNH | Class II | 2008-08-06 |
| K081921 | GE VIVID E9 ULTRASOUND | General Electric Co. | IYN | Class II | 2008-08-06 |
| K081859 | MODIFICATION TO ONEDOSE PATIENT DOSIMETRY SYSTEM | Sicel Technologies, Inc. | IYE | Class II | 2008-08-04 |
| K082041 | FIATLUX VISUALIZE | Fiatlux Imaging, Inc. | LLZ | Class II | 2008-08-01 |
| K081429 | THD SLIDE | Thd Spa | JAF | Class II | 2008-07-30 |
| K081836 | CARESTREAM DR LONG LENGTH IMAGING SYSTEM FOR DR 7500 SYSTEM | Carestream Health, Inc. | KPR | Class II | 2008-07-30 |
| K081760 | RSVP PHANTOM PELVIS, MODEL TLP260 | The Phantom Laboratory, Inc. | IYE | Class II | 2008-07-29 |
| K081112 | FLEXIPLAN BRACHYTHERAPY TREATMENT PLANNING SYSTEM | Isodose Control B.V. | MUJ | Class II | 2008-07-29 |
| K081630 | MAMMO WORKSTATION | Image Diagnost International GmbH | LLZ | Class II | 2008-07-29 |
| K081976 | IMPAX MA3000 DIAGNOSTIC PACS WORKSTATION | Agfa Healthcare Corporation | LLZ | Class II | 2008-07-28 |
| K081963 | AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX2008 WORKSTATIONS | Agfa Healthcare Corporation | MQB | Class II | 2008-07-25 |
| K081916 | GE SIGNA MR ONCOLOGY PACKAGE | Ge Medical Systems, LLC | LNH | Class II | 2008-07-22 |
| K081677 | SAVI APPLICATOR KIT | Cianna Medical, Inc. | JAQ | Class II | 2008-07-22 |
| K081218 | BELLYSTEP, HEADSTEP, BREASTSTEP, PROSTEP, WINGSTEP AND ICAST | It-V Medizintechnik, GmbH | IYE | Class II | 2008-07-21 |
| K081402 | SIMPLANT ORTHO ; VISTADENT 3D | Materialise Dental NV | LLZ | Class II | 2008-07-18 |
| K081512 | STEALTHVIZ ADVANCED PLANNING APPLICATION WITH STEALTHDTI PACKAGE | Medtronic Navigation, Inc. | LLZ | Class II | 2008-07-18 |
| K080905 | QUANTUM/ CANON CXDI INTEGRATION SYSTEM, MODEL QG-DIG-CXDI | Quantum Medical Imaging, LLC | LLZ | Class II | 2008-07-16 |
| K081873 | EMP-2100 FULL DIGITAL ULTRASOUND DIAGNOSTIC DEVICE | Shenzhen Emperor Electronic Technology Co. , Ltd. | IYO | Class II | 2008-07-16 |
| K081843 | ULTRASOUND DATA ANALYSIS SYSTEM, MODEL DAS-RS1 | Aloka Co., Ltd. | LLZ | Class II | 2008-07-15 |
| K081188 | TRILOGY WITH EXTERNAL SYSTEM GATING INTERFACE | Varian Medical Systems, Inc. | IYE | Class II | 2008-07-14 |
| K081802 | CX50 DIAGNOSTIC ULTRASOUND SYSTEM | Philips Ultrasound, Inc. | ITX | Class II | 2008-07-11 |
| K081829 | CAPIMAGE | Danish Diagnostic Development A/S | IYX | Class I | 2008-07-11 |
| K081794 | MODEL 7340 ULTRASOUND SYSTEM | Esaote, S.p.A. | IYN | Class II | 2008-07-10 |
| K081781 | NUWAV | Laborie Medical Technologies, Corp. | IYO | Class II | 2008-07-09 |
| K081734 | SYNGO IMAGING (VERSION V31) | Siemens AG Medical Solutions | LLZ | Class II | 2008-07-03 |
| K081676 | SONOACE X6 DIAGNOSTIC ULTRASOUND SYSTEM | Medison Co., Ltd. | IYN | Class II | 2008-07-02 |
| K081637 | LASER IMAGER DRYPRO MODEL 873 | Konica Minolta Medical & Graphic, Inc. | LMC | Class II | 2008-07-01 |
| K080223 | ZURA TEE SYSTEM | Imacor, LLC | IYO | Class II | 2008-06-24 |
| K081648 | DIGITAL RADIOGRAPHY CXDI-60G | Canon, Inc. | MQB | Class II | 2008-06-24 |
| K081661 | HD15 DIAGNOSTIC ULTRASOUND SYSTEM | Philips Ultrasound, Inc. | IYN | Class II | 2008-06-24 |
| K080886 | IPLAN RT IMAGE | Brainlab AG | LHN | Class II | 2008-06-24 |
| K081621 | INFX-8000C (INFINIX CC-I AND VC-I) | Toshiba America Medical Systems, In.C | JAA | Class II | 2008-06-23 |
| K081453 | BIOGRAPH HD FAMILY | Siemens Medical Solutions USA, Inc. | KPS | Class II | 2008-06-23 |
| K081624 | INFX-8000F (INFINIX CSI AND INFINIX DPI) | Toshiba America Medical Systems, In.C | MQB | Class II | 2008-06-23 |
| K081076 | VELOCITYAIS, VELOCITY AI, VELOCITYVX, VELOCITYRT, V-RESPONSE | Velocity Medical Solutions, LLC | LLZ | Class II | 2008-06-20 |
| K080614 | DR VISION NEO, DR VISION DOU | Almana Medical Imaging | KPR | Class II | 2008-06-20 |
| K081491 | SMITH & NEPHEW CDS SYSTEM | Smith & Nephew, Inc. | JAA | Class II | 2008-06-19 |
14,721 clearances in the Radiology panel. Data: openFDA.