Review Panel
Radiology FDA 510(k) Clearances & Devices
- Cleared Devices
- 14,721
- Product Codes (page)
- 27
- Latest Decision
- 2019-04-15
Clearances · page 33 of 148
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K190320 | PreXion3D Explorer | Prexion Corporation | OAS | Class II | 2019-04-15 |
| K183548 | SOMATOM Perspective, SOMATOM Scope/Scope Power, SOMATOM Emotion 16 | Siemens Medical Solutions USA, Inc. | JAK | Class II | 2019-04-15 |
| K190420 | NDOHD High Definition Imaging System (NDOHD) | Altaravision, Inc. | LLZ | Class II | 2019-04-15 |
| K182891 | TEEClean(R) Automated TEE Probe Cleaner Disinfector with TEEZyme(R) Cleaner and TD-5(R) or TD-8(R) High Level Disinfectants | Cs Medical, LLC | PSW | Class II | 2019-04-12 |
| K190664 | RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review | Brainlab AG | MUJ | Class II | 2019-04-12 |
| K183202 | Deep Learning Image Reconstruction | Ge Medical Systems, LLC | JAK | Class II | 2019-04-12 |
| K190626 | SyncVision System | Volcano Corporation | OWB | Class II | 2019-04-12 |
| K182737 | 3T 32 Channel Head Coil | Nova Medical, Inc. | MOS | Class II | 2019-04-12 |
| K182572 | InstaRISPACS / InstaZFP / InstaMobi v5.0 | Meddiff Technologies Pvt. , Ltd. | LLZ | Class II | 2019-04-12 |
| K190786 | Eye Prime | Ellex Medical Pty, Ltd. | IYO | Class II | 2019-04-11 |
| K183660 | DP-10/DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | Class II | 2019-04-09 |
| K183496 | JUSHA-C350G LCD Monitor, JUSHA-C350 LCD Monitor, C350G LCD Monitor, C350 LCD Monitor | Nanjing Jusha Display Technology Co., Ltd. | PGY | Class II | 2019-04-08 |
| K183204 | Bone VCAR (BVCAR) | GE Medical Systems SCS | JAK | Class II | 2019-04-08 |
| K183606 | Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW) | Scandidos AB | IYE | Class II | 2019-04-08 |
| K190611 | VIVIX-S 1751S | Vieworks Co., Ltd. | MQB | Class II | 2019-04-08 |
| K182175 | TCD-X | Atys | IYN | Class II | 2019-04-05 |
| K183494 | R190/R191 LCD Monitor | Nanjing Jusha Display Technology Co., Ltd. | PGY | Class II | 2019-04-05 |
| K190691 | Pixx2430 Digital Diagnostic X-Ray Receptor Panel | Pixxgen Corporation | MQB | Class II | 2019-04-04 |
| K183377 | DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | Class II | 2019-04-04 |
| K190248 | ARIETTA 50 | Hitachi Healthcare Americas | IYN | Class II | 2019-04-02 |
| K183320 | Ilumien Optis, Optis Integrated, Optis Mobile | St. Jude Medical (Now Abbott Medical) | NQQ | Class II | 2019-04-02 |
| K190447 | 7400 Ultrasound Systems | Navigant Consulting - on Behalf of Esaote S.P.A. | IYN | Class II | 2019-04-01 |
| K190629 | DBSWIN and VISTAEASY Imaging Software | Durr Dental SE | LLZ | Class II | 2019-04-01 |
| K182834 | CS-series-FP with Optional ROI Accessory CA-100S | Omega Medical Imaging, LLC | JAA | Class II | 2019-03-29 |
| K183210 | Thoracic VCAR with GSI Pulmonary Perfusion | GE Medical Systems SCS | LLZ | Class II | 2019-03-29 |
| K190178 | Monaco RTP System | Elekta, Inc. | MUJ | Class II | 2019-03-29 |
| K190186 | Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound System | Edan Instruments, Inc. | IYO | Class II | 2019-03-28 |
| K183105 | Mimics Medical | Materialise NV | LLZ | Class II | 2019-03-27 |
| K190404 | OTIS Optical Coherence Tomography SYstem | Perimeter Medical Imaging, Inc. | NQQ | Class II | 2019-03-26 |
| K190232 | Synapse PACS | Fujifilm Corporation | LLZ | Class II | 2019-03-26 |
| K182395 | OARtrac System | Radialdyne, LLC | NZT | Class II | 2019-03-22 |
| K183164 | uWS-MR | Shanghai United Imaging Healthcare Co., Ltd. | LLZ | Class II | 2019-03-22 |
| K183414 | ABSOLU | Quantel Medical | IYO | Class II | 2019-03-20 |
| K183575 | ACUSON S3000, S2000 Diagnostic Ultrasound System | Siemens Healthineers | IYN | Class II | 2019-03-20 |
| K183019 | SIS Software version 3.3.0 | Surgical Information Sciences, Inc. | LLZ | Class II | 2019-03-19 |
| K190379 | MIM on Linux | Mim Software, Inc. | LLZ | Class II | 2019-03-19 |
| K190476 | FUJIFILM Sonosite Vevo MD Imaging System | FUJIFILM Sonosite, Inc. | IYN | Class II | 2019-03-15 |
| K190373 | SonialVision G4 | Shimadzu Corporation | JAA | Class II | 2019-03-15 |
| K183657 | Vantage Galan 3T, MRT-3020/A9, V5.0 | Canon Medical Systems Corporation | LNH | Class II | 2019-03-15 |
| K182639 | MOBILETT Elara Max | Siemens Medi Cal Solutions, Inc. | IZL | Class II | 2019-03-15 |
| K183142 | PathVisionXL | Faxitron Bioptics, LLC | MWP | Class II | 2019-03-14 |
| K190311 | BIOK7600 Flat Panel Detector | Biokinemetrics, Inc. | MQB | Class II | 2019-03-13 |
| K183492 | JUSHA-C620G LCD Monitor, JUSHA-C620 LCD Monitor, C620G LCD Monitor, C620 LCD Monitor | Nanjing Jusha Display Technology Co., Ltd. | PGY | Class II | 2019-03-13 |
| K190368 | Enhanced Feature Software Pack CXDI Series | Canon, Inc. | MQB | Class II | 2019-03-13 |
| K190300 | BIOK7600W Wireless Flat Panel Detector | Biokinemetrics, Inc. | MQB | Class II | 2019-03-13 |
| K190296 | GammaTile | Gt Medical Technologies | KXK | Class II | 2019-03-13 |
| K182537 | RADMAX Digital Imaging Software | DRGEM Corporation | LLZ | Class II | 2019-03-08 |
| K190146 | Nexus DR Digital X-ray Imaging System | Varex Imaging Corporation | MQB | Class II | 2019-03-08 |
| K190206 | DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | Class II | 2019-03-08 |
| K183448 | NewTom 5G XL | Cefla S.C. | JAK | Class II | 2019-03-08 |
| K183285 | cmTriage | Curemetrix, Inc. | QFM | Class II | 2019-03-08 |
| K190039 | EchoSure Diagnostic Ultrasound System | Sonavex, Inc. | IYO | Class II | 2019-03-08 |
| K190153 | RadiForce MX216 | Eizo Corporation | PGY | Class II | 2019-03-08 |
| K181859 | Visualase Thermal Therapy System | Medtronic Navigation, Inc. | LLZ | Class II | 2019-03-06 |
| K182966 | PLANET Onco Dose | Dosisoft | LLZ | Class II | 2019-03-06 |
| K182628 | Imagio Ultrasound Imaging System | Seno Medical Instruments, Inc. | IYN | Class II | 2019-03-05 |
| K183478 | ClearON Mobile | Rayence Co., Ltd. | LLZ | Class II | 2019-03-01 |
| K183014 | uPMR 790 | Shanghai United Imaging Healthcare Co., Ltd. | OUO | Class II | 2019-02-27 |
| K190087 | EzDent-i / E2 / Prora View | Ewoosoft Co., Ltd. | LLZ | Class II | 2019-02-27 |
| K190155 | FibermarX Radiopaque Tissue Marker | Viscus Biologics, LLC | IYE | Class II | 2019-02-27 |
| K183374 | GrayDuck Stent | Poll Medical, LLC | IYE | Class II | 2019-02-26 |
| K183698 | Zap-X Radiosurgery System | Zap Surgical Systems | IYE | Class II | 2019-02-25 |
| K182643 | IRIS 1.0 System | Intuitive Surgical | LLZ | Class II | 2019-02-22 |
| K183621 | EMMA 1.5T MRI System | Time Medical Limited | LNH | Class II | 2019-02-22 |
| K182665 | Sensus TPS Workstation | Sensus Healthcare, Inc. | MUJ | Class II | 2019-02-21 |
| K190255 | Sensus Healthcare TVM Balloon Applicator | Sensus Healthcare, Inc. | JAD | Class II | 2019-02-21 |
| K182641 | Sensus IORT System | Sensus Healthcare, Inc. | JAD | Class II | 2019-02-21 |
| K181989 | MRIdian Linac System | Viewray, Incorporated | IYE | Class II | 2019-02-20 |
| K182332 | PhantomMSK | OrthoGrid Systems, Inc. | LLZ | Class II | 2019-02-15 |
| K182932 | RS85 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | 2019-02-15 |
| K190138 | MAGNETOM Aera | Siemens Medical Solutions USA, Inc. | LNH | Class II | 2019-02-15 |
| K183222 | MAGNETOM Terra | Siemens Medical Solutions USA, Inc. | LNH | Class II | 2019-02-15 |
| K183063 | Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems | Philips Medical Systems Nederland B.V. | LNH | Class II | 2019-02-14 |
| K182756 | MyoStrain 5.1 | Myocardial Solutions | LNH | Class II | 2019-02-14 |
| K183221 | MAGNETOM Amira, MAGNETOM Sempra | Siemens Medical Solutions USA, Inc. | LNH | Class II | 2019-02-14 |
| K190074 | Presero 3D Scanning System | Certis Health | LLZ | Class II | 2019-02-14 |
| K183161 | SnapShot Freeze 2 | Ge Medical Systems, LLC | JAK | Class II | 2019-02-13 |
| K190056 | KOWA VK-2s | Kowa Co. Ltd. Chofu | NFJ | Class II | 2019-02-12 |
| K183186 | Head Coil 12, Head Coil 32, Carotid Coil 8, Temporomandibular Joint Coil 4, Infant Coil 24, Cardiac Coil 24, Foot & Ankle Coil - 24 | Shanghai United Imaging Healthcare Co., Ltd. | MOS | Class II | 2019-02-08 |
| K183245 | Carestream DRX-1 System with DRX Plus 2530 Detectors | Carestream Health, Inc. | MQB | Class II | 2019-02-08 |
| K183235 | SonoSite SII Ultrasound System | FUJIFILM Sonosite, Inc. | IYN | Class II | 2019-02-07 |
| K183498 | JUSHA-C270G/ JUSHA-C270/ C270G/ C270 LCD Monitor | Nanjing Jusha Display Technology Co., Ltd. | PGY | Class II | 2019-02-05 |
| K183388 | JADE Mobile X-Ray | DRGEM Corporation | IZL | Class II | 2019-02-05 |
| K183499 | JUSHA-M350G/JUSHA-M350/M350G/M350 LCD Monitor | Nanjing Jusha Display Technology Co., Ltd. | PGY | Class II | 2019-02-04 |
| K183272 | AI Rad Companion (Engine) | Siemens Medical Solutions USA, Inc. | LLZ | Class II | 2019-02-01 |
| K183275 | DR 800 with Tomosynthesis | Agfa N.V. | IZF | Class II | 2019-02-01 |
| K183291 | Supria True64 Whole-Body X-Ray CT System | Hitachi Healthcare Americas | JAK | Class II | 2019-02-01 |
| K182648 | X5 Series Digital Color Doppler Ultrasound System | Sonoscape Medical Corp. | IYN | Class II | 2019-01-29 |
| K183362 | Venue GO | GE Medical Systems Ultrasound and Primary Care Diagnostics | IYN | Class II | 2019-01-28 |
| K183456 | Aloka Arietta 850 | Hitachi Healthcare Americas | IYN | Class II | 2019-01-28 |
| K183244 | MAGNETOM Lumina | Siemens Medical Solutions USA, Inc. | LNH | Class II | 2019-01-24 |
| K183541 | ProRad 2FC and ProRad 3NC Stationary Radiographic Systems | Prognosys Medical Systems Private Limited | KPR | Class II | 2019-01-24 |
| K182594 | E-CUBE i7 | Alpinion Medical Systems Co., Ltd. | IYN | Class II | 2019-01-24 |
| K182907 | SPY Elite Intraoperative Perfusion Assessment System | Novadaq Technologies Ulc. (Now A Part of Stryker) | IZI | Class II | 2019-01-23 |
| K182894 | HM70A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | 2019-01-22 |
| K183685 | O-Scan | Esaote, S.p.A. | LNH | Class II | 2019-01-22 |
| K183231 | SIGNA Premier | Ge Medical Systems, LLC | LNH | Class II | 2019-01-18 |
| K183254 | Magnetom Vida | Siemens Medical Solutions USA, Inc. | LNH | Class II | 2019-01-18 |
| K182951 | Pristina Serena 3D | GE Healthcare | MUE | Class II | 2019-01-18 |
| K183474 | Carestream DRX-1 System with DRX Core Detectors | Carestream Health, Inc. | MQB | Class II | 2019-01-16 |
14,721 clearances in the Radiology panel. Data: openFDA.