Review Panel
Radiology FDA 510(k) Clearances & Devices
- Cleared Devices
- 14,721
- Product Codes (page)
- 26
- Latest Decision
- 2007-07-03
Clearances · page 74 of 148
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K062824 | AOS UNIVERSAL CONECTING GUIDE TUBE | Alpha-Omega Services, Inc. | JAQ | Class II | 2007-07-03 |
| K070903 | MYLAB40 | Esaote Europe B.V. | ITX | Class II | 2007-07-02 |
| K071396 | CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORS | Capintec, Inc. | KPT | Class II | 2007-06-28 |
| K071611 | NEOCOIL 3.0T 8-CHANNEL SHOULDER ARRAY COIL | Neocoil | MOS | Class II | 2007-06-28 |
| K071506 | ECHELON SPECTROSCOPY PACKAGE | Hitachi Medical Systems America, Inc. | LNI | Class II | 2007-06-28 |
| K071436 | REGIUS UNITEA | Konica Minolta Medical & Graphic, Inc. | LLZ | Class II | 2007-06-27 |
| K062878 | EZPACS, VERSION 3.0 | Advanced Imaging Solutions, LLC | LLZ | Class II | 2007-06-27 |
| K071570 | GE LUNAR BODY COMPOSITION SOFTWARE | Ge Medical Systems Lunar | KGI | Class II | 2007-06-27 |
| K071513 | INSPACE 4D SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY | Siemens Medical Solutions | JAK | Class II | 2007-06-26 |
| K071401 | X3C 2200 DIGITAL RADIOGRAPHIC SYSTEM | Imaging Dynamics Company , Ltd. | KPR | Class II | 2007-06-22 |
| K071297 | IMPAX SE SIGMACOM CLIENT (PACS WORKSTATION) | Agfa Healthcare Corp. | LLZ | Class II | 2007-06-22 |
| K071430 | SYNERAD OMNI, MODELS AN6255 AND AN6265 | Analogic Corp. | KPR | Class II | 2007-06-21 |
| K071195 | KHBS (KRISHNAMURTHY HEPATO-BILIARY SOFTWARE), MODEL VERSION 1.5 | Ani-Kal Ii, LLC | IYX | Class I | 2007-06-20 |
| K071399 | DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODEL DVS-I-11: DVS INSERTION TOOL, DVS-D-A: DVS DOSIMETER, DVS-R-100 | Sicel Technologies, Inc. | LHN | Class II | 2007-06-20 |
| K071233 | XPERT 40 SPECIMEN RADIOGRAPHY SYSTEM | Kub Technologies, Inc. | MWP | Class II | 2007-06-20 |
| K070815 | THD | G.F. S.R.L. | JAF | Class II | 2007-06-20 |
| K071232 | IMAGE-ARENA APPLICATIONS AND RESEARCH-ARENA APPLICATIONS | Tomtec Imaging Systems GmbH | LLZ | Class II | 2007-06-20 |
| K071408 | X3C 1100 RADIOGRAPHIC TABLE WITH DIGITAL RADIOGRAPHIC DETECTOR | Imaging Dynamics Company , Ltd. | KPR | Class II | 2007-06-13 |
| K071179 | NORAS OR HEAD HOLDER | Siemens Medical Solutions USA, Inc. | MOS | Class II | 2007-06-13 |
| K071378 | MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIES | E-Z-Em, Inc. | JAK | Class II | 2007-06-13 |
| K071403 | X3C 1600 DIGITAL RADIOGRAPHIC SYSTEM | Imaging Dynamics Company , Ltd. | KPR | Class II | 2007-06-11 |
| K071402 | X3C 1600 PLUS DIGITAL RADIOGRAPHIC SYSTEM | Imaging Dynamics Company , Ltd. | KPR | Class II | 2007-06-08 |
| K071360 | OPTICAL GUIDANCE PLATFORM | Varian Medical Systems, Inc. | IYE | Class II | 2007-06-08 |
| K071241 | LMS-LIVER | Median Technologies | LLZ | Class II | 2007-06-08 |
| K071310 | SYNGO CT ONCOLOGY SOFTWARE PACKAGE | Siemens AG | JAK | Class II | 2007-06-08 |
| K071409 | X3C 1590 DIGITAL RADIOGRAPHIC SYSTEM | Imaging Dynamics Company , Ltd. | KPR | Class II | 2007-06-08 |
| K071086 | RESOLUTIONMD CARDIAC PRODUCT FAMILY, MODEL: RELEASE 1.0 | Calgary Scientific, Inc. | LLZ | Class II | 2007-06-01 |
| K071193 | VIDAR VISION 3000 AND 4000 X-RAY SYSTEMS | Vidar Systems Corp. | MQB | Class II | 2007-05-30 |
| K071181 | DIRECT DIGITIZER, REGIUS MODEL 110 | Konica Minolta Medical & Graphic, Inc. | MQB | Class II | 2007-05-30 |
| K071362 | VITAL CONNECT 4.1 | Vital Images, Inc. | LLZ | Class II | 2007-05-30 |
| K062823 | AOS INTERSTITIAL TEMPLATES, NEEDLES & ACCESSORIES | Alpha-Omega Services, Inc. | JAQ | Class II | 2007-05-29 |
| K071331 | VITREA VERSION 4.0 | Vital Images, Inc. | LLZ | Class II | 2007-05-25 |
| K063269 | 5MP MEDICAL MONOCHROME REFERENCE DISPLAY, MODEL MDM2010-5NC | Chi Lin Technology Co., Ltd. | LLZ | Class II | 2007-05-23 |
| K071054 | RADIODEXTER, DEXTROSCOPE, DEXTROBEAM, MODELS 1.0, MK10, MK3 & MK4 | Volume Interactions Pte, Ltd. | LLZ | Class II | 2007-05-22 |
| K062825 | AOS MARKER SEEDS | Alpha-Omega Services, Inc. | KXK | Class II | 2007-05-22 |
| K071078 | .DECIMAL RANGE COMPENSATOR | .Decimal, Inc. | IXI | Class II | 2007-05-22 |
| K071314 | SONOLINE G20 DIAGNOSTIC ULTRASOUND SYSTEMS | Siemens Medical Solutions USA, Inc. | IYO | Class II | 2007-05-22 |
| K070831 | VOXAR 3D ENTERPRISE WITH COLONMETRIX AND PET/CT PERFUSION | Barcoview Mis Edinburgh | LLZ | Class II | 2007-05-22 |
| K071099 | NEURO II-SE, MODELS: OR-DR-OR, OR-MB | Imris, Inc. | LNH | Class II | 2007-05-22 |
| K062826 | AOS IMPLANT TUBES, IMPLANT NEEDLES & RETAINING BOTTONS | Alpha-Omega Services, Inc. | JAQ | Class II | 2007-05-22 |
| K070920 | FUJI IP CASSETTE TYPE PC | Fujifilm Medical Systems U.S.A, Inc. | IYE | Class II | 2007-05-22 |
| K071114 | SYNGO IMAGING (VERSION V30) | Siemens AG Medical Solutions | LLZ | Class II | 2007-05-22 |
| K071311 | NEOCOIL 1.5T 8-CHANNEL SHOULDER ARRAY COIL | Neocoil | MOS | Class II | 2007-05-22 |
| K071077 | .DECIMAL APERTURE | .Decimal, Inc. | IXI | Class II | 2007-05-18 |
| K070834 | CS-SERIES FLUOROSCOPY SYSTEM, CS-10 THROUGH CS-65 (11 CONFIGURATIONS) | Omega Medical Imaging, Inc. | OWB | Class II | 2007-05-18 |
| K071229 | SENORAD MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRANCHYTHERAPY | Senorx, Inc. | JAQ | Class II | 2007-05-18 |
| K071204 | SITE-RITE 6 ULTRASOUND SYSTEM, MODEL SITE-RITE 6 | C.R. Bard, Inc. | IYO | Class II | 2007-05-18 |
| K071217 | BLADDERSCAN BVI 9400 ULTRASOUND | Verathon Incorporated | IYO | Class II | 2007-05-17 |
| K071036 | MODIFICATION TO ACUSON X300 ULTRASOUND SYSTEM | Siemens Medical Solutions USA, Inc., Ultrasound DI | IYN | Class II | 2007-05-16 |
| K070868 | LMS-LUNG/TRACK | Median Technologies | LLZ | Class II | 2007-05-15 |
| K071000 | MYRIAN | Intrasense | LLZ | Class II | 2007-05-14 |
| K071068 | BIOGRAPH 6 TRUEPOINT, MODEL BIOGRAPH 6 - P/N 10238197 | Siemens Medical Solutions USA, Inc. | KPS | Class II | 2007-05-14 |
| K071037 | SPY INTRA-OPERATIVE IMAGING SYSTEM, MODEL SP2000 | Novadaq Technologies, Inc. | IZI | Class II | 2007-05-10 |
| K071015 | OPDIMA DIGITAL MAMMOGRAPHIC X-RAY SYSTEM | Siemens Medical Solutions USA, Inc. | IZL | Class II | 2007-05-10 |
| K071154 | SUPERSTAR 0.35T MRI SYSTEM | Neusoft Medical Systems Co., Ltd. | LNH | Class II | 2007-05-10 |
| K070829 | SYNEPIX 4600 DETECTOR | Analogic Corporation | MQB | Class II | 2007-05-09 |
| K070755 | INTERWORKS | Avreo, Inc. | LLZ | Class II | 2007-05-08 |
| K071162 | AGFA COMPUTED RADIOGRAPHY SYSTEM WITH NX2.X WORKSTATIONS | Agfa Healthcare Corp. | MQB | Class II | 2007-05-08 |
| K071134 | SONOSITE MAXX SERIES DIAGNOSTIC ULTRASOUND SYSTEM | Sonosite,Inc. | IYO | Class II | 2007-05-08 |
| K070678 | DDRCOMPACT, DDRCOMPACT PLUS AND DDRCOMPACT CHEST | Swissray International, Inc. | KPR | Class II | 2007-05-02 |
| K070982 | CTS-7700 DIGITAL ULTRASOUND IMAGING SYSTEM | Shantou Institute of Ultrasonic Instuments | IYO | Class II | 2007-05-02 |
| K070726 | NIO COLOR 3MP AND MDNC 3120 | Barcoview, Medical Imaging Systems | LLZ | Class II | 2007-05-02 |
| K070713 | IMPLANT LOCATION SOFTWARE-T | Tactile Technologies, Ltd. | LLZ | Class II | 2007-05-02 |
| K063391 | SAPHENEIA CLARITY | Sapheneia Commercial Products AB | LLZ | Class II | 2007-04-26 |
| K070618 | DICOMPACS, MODEL 5 | Oehm Und Rehbein GmbH | LLZ | Class II | 2007-04-25 |
| K070606 | VISIO+CD VIEWER# KPSCDVE01 | Keosys Sas | LLZ | Class II | 2007-04-24 |
| K070589 | C! | Transphoton Corporation | KPS | Class II | 2007-04-24 |
| K070954 | PATIENTGALLERY IMAGING SOFTWARE | Raster Builders, Inc. | LLZ | Class II | 2007-04-20 |
| K070943 | B-SCAN PLUS | Accutome Ultrasound, Inc. | IYO | Class II | 2007-04-19 |
| K070907 | INTERSON USB ULTRASOUND PROBE SYSTEM | Regulatory Management Services | IYO | Class II | 2007-04-17 |
| K070574 | FLEXITRON | Isodose Control B.V. | JAQ | Class II | 2007-04-13 |
| K070397 | DGSCOPE, RELEASE 1.0 | Segami Corporation | LLZ | Class II | 2007-04-13 |
| K070683 | MIRAGE CEDARS OPTION | Segami Corporation | LLZ | Class II | 2007-04-12 |
| K070778 | NEOCOIL 3.0T 6-CHANNEL CAROTID ARRAY COIL | Neocoil | MOS | Class II | 2007-04-11 |
| K070884 | POD B-SCAN | Starfish Product Engineering, Inc. | IYO | Class II | 2007-04-11 |
| K070813 | ACCUVIX V10 DIAGNOSTIC ULTRASOUND SYSTEM | Medison Co., Ltd. | IYN | Class II | 2007-04-10 |
| K070796 | CHILI PACS | Chili GmbH | LLZ | Class II | 2007-04-06 |
| K070792 | QLAB QUANTIFICATION | Philips Ultrasound, Inc. | LLZ | Class II | 2007-04-06 |
| K070803 | INVIVODENTAL | Anatomage, Inc. | LLZ | Class II | 2007-04-06 |
| K070658 | DENTAL DIGITAL PANORAMIC/3D IMAGING SYSTEM | E-Woo Technology | JAK | Class II | 2007-04-05 |
| K070390 | FLUOROPRO RF DIGITAL IMAGING SYSTEM | Virtual Imaging, Inc. | JAA | Class II | 2007-04-05 |
| K070659 | BIOLUCENT APPLICATOR KIT | Biolucent, Inc. | JAQ | Class II | 2007-04-04 |
| K070394 | CERNER PROVISION WORKSTATION | Cerner Corp. | LLZ | Class II | 2007-03-27 |
| K070629 | FLEX AND LOOP COIL SET 1.5 T | Siemens Medical Solutions | MOS | Class II | 2007-03-26 |
| K070576 | ACUSON X150 ULTRASOUND SYSTEM | Siemens Medical Solutions USA, Inc. | IYN | Class II | 2007-03-26 |
| K070468 | IMPLANT SCIENCES CORP. MODEL HDR 4454 | Implant Sciences Corp. | KXK | Class II | 2007-03-23 |
| K063324 | PET VCAR | GE Healthcare | JAK | Class II | 2007-03-23 |
| K070205 | ZIOSTATION | Ziosoft, Inc. | LLZ | Class II | 2007-03-23 |
| K070542 | CARDIUS 1, 2 AND 3 XPO AND 2020TC SPECT IMAGING SYSTEMS | Digirad Corp. | KPS | Class II | 2007-03-23 |
| K070526 | DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYO | Class II | 2007-03-23 |
| K062621 | NIO 5MP-21 AND MDNG-5121 CB | Barcoview | LLZ | Class II | 2007-03-19 |
| K070464 | ONDEMAND3D | Cybermed, Inc. | LLZ | Class II | 2007-03-16 |
| K070563 | VIDAR VISION 2000 | Vidar Systems Corp. | MQB | Class II | 2007-03-16 |
| K070123 | TCA 5R / 5S | Dornier Medtech America, Inc. | OWB | Class II | 2007-03-09 |
| K070370 | 21.3 INCH (54CM) MONOCHROME LCD MONITOR MDL2122A | Totoku Electric Co., Ltd. | LLZ | Class II | 2007-03-09 |
| K070528 | PHILIPS ESSENTA DR | Philips Medical Systems GmbH, Dmc | MQB | Class II | 2007-03-09 |
| K070226 | CARDIOCT | Shina Systems , Ltd. | LLZ | Class II | 2007-03-09 |
| K070477 | ORISON EMBRACE SYSTEM | Orison Corporation | IYO | Class II | 2007-03-09 |
| K070344 | LIV BREAST SELF EXAMINATION AID | Liv International USA, Inc. | IZH | Class II | 2007-03-08 |
| K070305 | PRE-LOADED VISICOIL | Radiomed Corporation | IYE | Class II | 2007-03-07 |
14,721 clearances in the Radiology panel. Data: openFDA.