Review Panel
Radiology FDA 510(k) Clearances & Devices
- Cleared Devices
- 14,721
- Product Codes (page)
- 26
- Latest Decision
- 2015-06-03
Clearances · page 48 of 148
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K151115 | MR Core Software | Vital Images, Inc. | LLZ | Class II | 2015-06-03 |
| K143397 | ICIS View | Agfa Healthcare N.V. | LLZ | Class II | 2015-06-01 |
| K151132 | PROBEAT-V | Hitachi, Ltd., Health Care Company | LHN | Class II | 2015-06-01 |
| K151134 | 21.3 inch (54cm) Color LCD Monitor CCL210 (CL21210) | Jvckenwood Corporation | PGY | Class II | 2015-05-27 |
| K150707 | IntelePACS | Intelerad Medical Systems Incorporated | LLZ | Class II | 2015-05-27 |
| K150420 | Centricity Universal Viewer | GE Healthcare | LLZ | Class II | 2015-05-26 |
| K142648 | SPINEDESIGN Spine Surgery Planning (Software Application) | Medtronic Sofamor Danek USA, Inc. | LLZ | Class II | 2015-05-22 |
| K150628 | VentriPoint Medical System | Ventripoint, Inc. | IYN | Class II | 2015-05-22 |
| K150069 | Fine Structure Analysis(fineSA) | Acuitas Medical , Ltd. | LLZ | Class II | 2015-05-22 |
| K150467 | Retina Workplace | Carl Zeiss Meditec, AG | NFJ | Class II | 2015-05-21 |
| K141900 | SAGIPLAN, SAGIPLAN PROSTATE MODULE ADD ON, SAGIPLAN INCLUDING PROSTATE MODULE | Eckert & Ziegler Bebig GmbH | MUJ | Class II | 2015-05-20 |
| K150848 | Dose Calculator | Sun Nuclear Corporation | IYE | Class II | 2015-05-20 |
| K142719 | E-App | Gc Medtech, LLC | JAQ | Class II | 2015-05-20 |
| K150785 | syngo.CT Dental | Siemens Medical Solutions USA, Inc. | JAK | Class II | 2015-05-18 |
| K151175 | ZONARE ZS3 Diagnostic Ultrasound System | Zonare Medical Systems, Inc. | IYN | Class II | 2015-05-15 |
| K150547 | .decimal Astroid Dosimetry App | .Decimal, Inc. | MUJ | Class II | 2015-05-15 |
| K143294 | Adaptive Motion Correction (AMC), CSMC-001A and 4D Airways | Toshibamedical Systems Corporation | JAK | Class II | 2015-05-15 |
| K151097 | Active Breathing Coordinator | Aktina Medical Corporation | IYE | Class II | 2015-05-15 |
| K143435 | Planmed Verity | Planmed OY | OAS | Class II | 2015-05-14 |
| K143196 | syngo.CT Lung CAD | Siemens AG Medical Solutions | OEB | Class II | 2015-05-12 |
| K150533 | Terason uSmart3200T Ultrasound System | Teratech Corp. | IYN | Class II | 2015-05-09 |
| K150217 | ORTHOPHOS SL | Sirona Dental Systems GmbH | OAS | Class II | 2015-05-08 |
| K150816 | Jumong Series | Sg Healthcare Co, Ltd. | KPR | Class II | 2015-05-08 |
| K150636 | VariSeed 9.0 | Varian Medical Systems, Inc. | KXK | Class II | 2015-05-08 |
| K151007 | 21.3 inch (54 cm) Color Digital Mammography LCD Monitor CCL550i2(CL21550) | Jvckenwood Corporation | PGY | Class II | 2015-05-08 |
| K150706 | VitalBeam | Varian Medical Systems, Inc. | IYE | Class II | 2015-05-08 |
| K143606 | MultiBand SENSE | Philips Medical Systems Nethrlands BV | LNH | Class II | 2015-05-08 |
| K150342 | Touch Ultrasound | Carestream Health, Inc. | IYO | Class II | 2015-05-08 |
| K150663 | Diagnostic X-ray System | Osko, Inc. | KPR | Class II | 2015-05-07 |
| K150999 | Acclarix Diagnostic Ultrasound System | Edan Instruments, Inc. | IYO | Class II | 2015-05-06 |
| K150237 | ILUMIEN, Drageonfly OPTIS Imaging Catheter | Lightlab Imaging, Inc. | NQQ | Class II | 2015-05-05 |
| K150045 | S30/S40 Digital Color Doppler Ultraound System | Sonoscape Company Limited | IYN | Class II | 2015-04-28 |
| K150842 | JUSHA-M53 Medical Display | Nanjing Jusha Display Technology Co., Ltd. | PGY | Class II | 2015-04-28 |
| K142196 | Visage Ease Pro | Visage Imaging GmbH | LLZ | Class II | 2015-04-28 |
| K150843 | syngo®.via (version VB10A) | Siemens AG | LLZ | Class II | 2015-04-24 |
| K142779 | SCANIP; SCANIP: MEDICAL EDITION; SCANIP: MED | Simpleware , Ltd. | LLZ | Class II | 2015-04-17 |
| K150191 | GammaBeam 500 | Best Theratronics Limited | IWB | Class II | 2015-04-17 |
| K142930 | Exam Vue DR | Jpi Healthcare Co, Ltd. | KPR | Class II | 2015-04-17 |
| K150427 | Vantage Titan 1.5T, V3.1, MRT-1510 | Toshibamedical Systems Corporation | LNH | Class II | 2015-04-17 |
| K142247 | RAYSCAN A-EXPERT 3D | Ray Co., Ltd. | OAS | Class II | 2015-04-17 |
| K150104 | Vitrea CT Myocardial Perfusion | Vital Images, Inc. | JAK | Class II | 2015-04-17 |
| K142986 | SagiNova | Eckert & Ziegler Bebig GmbH | JAQ | Class II | 2015-04-17 |
| K143416 | SOMATOM Definition Flash (VA48) | Siemens Medical Solutions USA, Inc. | JAK | Class II | 2015-04-16 |
| K150746 | JUSHA-M52C Medical Display | Nanjing Jusha Display Technology Co., Ltd. | PGY | Class II | 2015-04-14 |
| K143269 | Delivery Analysis | Accuray Incorporated | MUJ | Class II | 2015-04-14 |
| K143664 | HeartSee | University of Texas Medical School AT Houston | KPS | Class II | 2015-04-14 |
| K142647 | mint Lesion | Mint Medical GmbH | LLZ | Class II | 2015-04-13 |
| K150204 | DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound Systems | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | Class II | 2015-04-10 |
| K150821 | MDNG-3220 (Nio 3MP LED) | Barco | PGY | Class II | 2015-04-10 |
| K143253 | O-MAR | Philips Medical Systems Nederland B.V. | LNH | Class II | 2015-04-09 |
| K143008 | Vantage Titan 3T | Toshibamedical Systems Corporation | LNH | Class II | 2015-04-09 |
| K150331 | 18ch T/R Knee Coil | Quality Electrodynamics, LLC | MOS | Class II | 2015-04-09 |
| K142330 | Kobold Ring and Tandem Applicator Set | Kobold, LLC | JAQ | Class II | 2015-04-09 |
| K142421 | G-scan Brio | Esaote, S.p.A. | LNH | Class II | 2015-04-09 |
| K150506 | ELIAN Digital Diagnostic X-ray System | Osko, Inc. | KPR | Class II | 2015-04-08 |
| K143400 | SOMATOM Definition AS/AS+ | Siemens Medical Solutions USA, Inc. | JAK | Class II | 2015-04-08 |
| K150580 | UltraVision 2 Diagnostic Ultrasound System | Winprobe Corporation | IYO | Class II | 2015-04-07 |
| K142740 | Ziehm Vision RFD 3D | Ziehm Imaging GmbH | OWB | Class II | 2015-04-06 |
| K150738 | VitreaView | Vital Images, Inc. | LLZ | Class II | 2015-04-06 |
| K143401 | SOMATOM Definition Edge | Siemens Medical Solutions USA, Inc. | JAK | Class II | 2015-04-06 |
| K150106 | 2MP Color LCD Monitor, RadiForce RS240 | Eizo Corporation | PGY | Class II | 2015-04-03 |
| K150165 | GC85A | Samsung Electronics Co., Ltd. | KPR | Class II | 2015-04-02 |
| K150747 | EzDent-i /E2/Prora View | LK Consulting Group USA, Inc. | LLZ | Class II | 2015-04-02 |
| DEN140030 | SpaceOAR System | Augmenix, Inc. | OVB | Class II | 2015-04-01 |
| K150234 | Myriad Prostate Caddy¿ Immobilization Rectal Balloon Item #9901,3301 | Myriad Medical, LLC | PCT | Class II | 2015-03-31 |
| K150529 | Site-Rite Prevue Ultrasound System, Site-Rite Prevue+ Ultrasound System | C.R. Bard, Inc. | IYO | Class II | 2015-03-30 |
| K150192 | Scenium | Siemens Medical Solutions USA, Inc. | LLZ | Class II | 2015-03-29 |
| K142420 | Patient Positioning Devices | Macromedics BV | IYE | Class II | 2015-03-27 |
| K150150 | 1717SGN / 1717SCN Digital Flat Panel X-ray Detector | Rayence Co., Ltd. | MQB | Class II | 2015-03-27 |
| K143361 | Mammo Workstation | GE Healthcare | LLZ | Class II | 2015-03-26 |
| K143409 | SOMATOM Definition AS Open (VA48) | Siemens Medical Solutions USA, Inc. | JAK | Class II | 2015-03-26 |
| K150478 | A35 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | 2015-03-26 |
| K142294 | FlexiMarc Marker | Cortex Manufacturing, Inc. | IYE | Class II | 2015-03-26 |
| K150193 | Customer Remote Console (CRC) | Ge Medical Systems, LLC | LLZ | Class II | 2015-03-24 |
| K150441 | Volcano iFR Modality, iFR Scout feature | Volcano Corporation | IYO | Class II | 2015-03-20 |
| K143128 | mDIXON XD | Philips Medical Systems Nederlands B.V. | LNH | Class II | 2015-03-20 |
| K142337 | Blackford Analysis Registration Product Family | Blackford Analysis, Ltd. | LLZ | Class II | 2015-03-19 |
| K150003 | Aquilion LB, TSX-201A/3, V6.0 | Toshibamedical Systems Corporation | JAK | Class II | 2015-03-19 |
| K143601 | U-Lite | Sonoscanner Sarl | IYN | Class II | 2015-03-18 |
| K141837 | DRX-EVOLUTION | Carestream Health, Inc. | KPR | Class II | 2015-03-11 |
| K142736 | XIDF-AWS801, Angio Workstation, v5.31 | Toshibamedical Systems Corporation | OWB | Class II | 2015-03-11 |
| K142439 | Martinez Prostate Template Set | Nucletron B.V. | JAQ | Class II | 2015-03-10 |
| K143318 | DR Systems Zero Download 3D Viewer (Z3D) | Dr Systems, Inc. | LLZ | Class II | 2015-03-10 |
| K142465 | Aquilion ONE Vision, v7.0 | Toshibamedical Systems Corporation | JAK | Class II | 2015-03-10 |
| K141624 | PLASTIC NEEDLE WITH MANDRIN, 2.0 MM DIAMETER, LENGTH, BLUNT TIP,PLASTIC NEEDLE WITH MANDRIN, 2.0 MM DIAMETER, LENGTH 113 | Varian Medical Systems, Inc. | JAQ | Class II | 2015-03-10 |
| K141536 | VIEWING CLIENT MOBILE | Axon Medical Technologies Corp. | LLZ | Class II | 2015-03-06 |
| K143537 | Sirius Starmobile tiara | Hitachi Medical Systems America, Inc. | IZL | Class II | 2015-03-06 |
| K142341 | X-RAY TV SYSTEM SONIALVISION G4 | Shimadzu Corp. | JAA | Class II | 2015-03-06 |
| K143389 | 3.0T GEM RT Open Array | Ge Healthcare Coils (Usa Instruments, Inc.) | MOS | Class II | 2015-03-06 |
| K142923 | TraumaCad Mobile Release 1.0 | Voyant Health, Ltd. | LLZ | Class II | 2015-03-05 |
| K150258 | Vitrea, Version 7.0 Medical Image Processing Software | Vital Images, Inc. | LLZ | Class II | 2015-03-05 |
| K150249 | ZONARE ZS3 and Z.Onepro Diagnostic Ultrasound System | Zonare Medical Systems, Inc. | IYN | Class II | 2015-03-04 |
| K150087 | Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging System, Vivid E95 Diagnostic Ultrasound Imaging System | Ge Vingmed Ultrasound AS | IYN | Class II | 2015-03-04 |
| K143485 | iGuide 2.1 | Medical Intelligence Medizintechnik GmbH | IYE | Class II | 2015-03-04 |
| K150085 | GE EchoPAC | Ge Vingmed Ultrasound AS | LLZ | Class II | 2015-03-02 |
| K142734 | TRILLIUM Oval MR System | Hitachi Medical Systems America, Inc. | LNH | Class II | 2015-03-02 |
| K141922 | IRIS INTELLIGENT RETINAL IMAGING SYSTEM | Intelligent Retinal Imaging Systems, LLC | NFJ | Class II | 2015-02-27 |
| K141657 | THD REVOLUTION | Thd Spa | JAF | Class II | 2015-02-24 |
| K143319 | Syngo X-workplace SW VD10 | Siemens Medi Cal Solutions, Inc. | LLZ | Class II | 2015-02-24 |
| K142511 | U50 Diagnostic Ultrasound System | Edan Instruments, Inc. | IYN | Class II | 2015-02-20 |
14,721 clearances in the Radiology panel. Data: openFDA.