Review Panel
Radiology FDA 510(k) Clearances & Devices
- Cleared Devices
- 14,721
- Product Codes (page)
- 28
- Latest Decision
- 2024-06-10
Clearances · page 12 of 148
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K240111 | Venue | GE Medical Systems Ultrasound and Primary Care Diagnostics | IYN | Class II | 2024-06-10 |
| K240206 | Venue Sprint | GE Medical Systems Ultrasound and Primary Care Diagnostics | IYN | Class II | 2024-06-10 |
| K240053 | Venue Go | GE Medical Systems Ultrasound and Primary Care Diagnostics | IYN | Class II | 2024-06-10 |
| K241038 | Cardiac CT Function Software Application | Circle Cardiovascular Imaging | QIH | Class II | 2024-06-07 |
| K241069 | iLoop Interventional Coil 0.55T | Noras Mri Products GmbH | MOS | Class II | 2024-06-07 |
| K234042 | EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100) | Ever Fortune.Ai, Co., Ltd. | QIH | Class II | 2024-06-07 |
| K223427 | Mimics Enlight CMF | Materialise NV | LLZ | Class II | 2024-05-31 |
| K232738 | BeamDose software (S080053); BEAMSCAN software, option reference dosimetry (S080054.002) | Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla | IYE | Class II | 2024-05-31 |
| K240612 | CINA-VCF | Avicenna.Ai | QFM | Class II | 2024-05-31 |
| K240281 | Bone Suppression Software | Konica Minolta, Inc. | LLZ | Class II | 2024-05-31 |
| K240827 | SET-5002 | Shimadzu Corporation Medical Systems Division | KPS | Class II | 2024-05-24 |
| K234154 | uPMR 790 | Shanghai United Imaging Healthcare Co., Ltd. | OUO | Class II | 2024-05-24 |
| K240769 | LVivo IQS | Dia Imaging Analysis, Ltd. | QIH | Class II | 2024-05-24 |
| K240294 | Syngo Carbon Enterprise Access (VA40A) | Siemens Healthcare GmbH | LLZ | Class II | 2024-05-23 |
| K233108 | VinDr-Mammo | Vinbigdata Joint Stock Company | QFM | Class II | 2024-05-23 |
| K240199 | IntraOp Alignment System | Alphatec Spine, Inc. | OWB | Class II | 2024-05-22 |
| K240224 | Zenition 90 | Philips Medical Systems Nederlands B.V. | OWB | Class II | 2024-05-22 |
| K232759 | Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout | Brainlab AG | LLZ | Class II | 2024-05-21 |
| K233543 | YSIO X.pree | Siemens Medical Solutions | KPR | Class II | 2024-05-21 |
| K233336 | 21.3 3MP Color LCD Display UMD3-21B01 (MD3-21B01) | Acula Technology Corp. | PGY | Class II | 2024-05-21 |
| K233620 | MIM - Centiloid Scaling | Mim Software, Inc. | LLZ | Class II | 2024-05-20 |
| K233209 | uOmnispace.CT | Shanghai United Imaging Healthcare Co., Ltd. | QIH | Class II | 2024-05-17 |
| K233236 | Radiance V5 | Gmv Soluciones Globales Internet S.A.U. | MUJ | Class II | 2024-05-17 |
| K233841 | HD80 Series Ultrasound Diagnostic System | Qingdao Hisense Medical Equipment Co., Ltd. | IYN | Class II | 2024-05-16 |
| K233247 | Heuron ICH | Heuron Co., Ltd. | QAS | Class II | 2024-05-15 |
| K241112 | BriefCase-Quantification | Aidoc Medical , Ltd. | QIH | Class II | 2024-05-15 |
| K232862 | MIM Monte Carlo Dosimetry | Mim Software, Inc. | LLZ | Class II | 2024-05-13 |
| K233875 | Brainomix 360 e-Lung | Brainomix Limited | JAK | Class II | 2024-05-13 |
| K232410 | SmartChest | Milvue | QFM | Class II | 2024-05-10 |
| K233629 | APERTO Lucent MRI System | FUJIFILM Healthcare Americas Corporation | LNH | Class II | 2024-05-10 |
| K232976 | VUZE System | Vuze Medical , Ltd. | LLZ | Class II | 2024-05-09 |
| K240495 | Flexible Fixation Device for Gynecological Applicators (GM11001960) | Varian Medical Systems, Inc. | JAQ | Class II | 2024-05-09 |
| K231612 | Eve Patient Positioner System | Leo Cancer Care | JAI | Class II | 2024-05-07 |
| K232928 | DeepContour (V1.0) | Wisdom Technologies., Inc. | QKB | Class II | 2024-05-07 |
| K232514 | MIM Dose Analysis | Mim Software, Inc. | LLZ | Class II | 2024-05-06 |
| K232895 | B-Ultrasound Diagnostic System | Contec Medical Systems Co.,Ltd | IYO | Class II | 2024-05-03 |
| K233687 | ECHELON Synergy V10.0 | FUJIFILM Healthcare Americas Corporation | LNH | Class II | 2024-05-03 |
| K232491 | CT 5300 | Philips Healthcare (Suzhou) Co., Ltd. | JAK | Class II | 2024-05-03 |
| K232908 | Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound Diagnostic System (CMS1700C) | Contec Medical Systems Co.,Ltd | IYN | Class II | 2024-05-02 |
| K232923 | Ethos Treatment Management (3.0); Ethos Treatment Planning (2.0) | Varian Medical Systems, Inc. | IYE | Class II | 2024-04-30 |
| K233699 | SubtleREFORMAT (1.x) | Subtle Medical, Inc. | LLZ | Class II | 2024-04-29 |
| K232302 | Pocket III | Quantel Medical | IYO | Class II | 2024-04-26 |
| K233673 | uMR Jupiter | Shanghai United Imaging Healthcare Co., Ltd. | LNH | Class II | 2024-04-26 |
| K240406 | Sonio Detect | Sonio | IYN | Class II | 2024-04-26 |
| K232799 | syngo.via RT Image Suite | Siemens Medical Solutions USA, Inc. | MUJ | Class II | 2024-04-26 |
| K233583 | FCT iSTREAM Phase 1 | FUJIFILM Healthcare Americas Corporation | JAK | Class II | 2024-04-26 |
| K232298 | DIGITAL RADIOGRAPHY CXDI-RF Wireless Bl | Canon, Inc. | OWB | Class II | 2024-04-26 |
| K232331 | InVision Precision LVEF (LVEF) | InVision Medical Technology Corporation | QIH | Class II | 2024-04-25 |
| K240855 | Dental Cone-beam Computed Tomography | Yian Medical Technology (Haining) Co., Ltd. | OAS | Class II | 2024-04-25 |
| K240822 | Image Management V15 | Philips Medical Systems Technologies | LLZ | Class II | 2024-04-24 |
| K240850 | EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems | Philips Ultrasound, LLC | IYN | Class II | 2024-04-24 |
| K240839 | OpenRad Cloud | Openrad Services Uk, Ltd. | LLZ | Class II | 2024-04-24 |
| K234068 | ART-Plan (v.2.2.0) | Therapanacea Sas | MUJ | Class II | 2024-04-22 |
| K233582 | Rapid | Ischemaview, Inc. | LLZ | Class II | 2024-04-22 |
| K240115 | Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY,Resona I8 Easi, Eagus I8 Easi, Nuewa I8W, Nuewa I8, Nuewa I8 Exp, NuewaI8S, Nuewa I8T, Imagyn I8, Imagyn I8S, Imagyn I8T, Imagyn I8 Exp, Nuewa IY Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | Class II | 2024-04-22 |
| K233186 | uOmnispace.MR | Shanghai United Imaging Healthcare Co., Ltd. | QIH | Class II | 2024-04-17 |
| K240773 | VisAble.IO | Techsomed | QTZ | Class II | 2024-04-15 |
| K240238 | Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | LNH | Class II | 2024-04-12 |
| K232489 | VenusX | Linatech, LLC | IYE | Class II | 2024-04-12 |
| K240571 | OASIS MRI System | Fujifilm Healthcare Corporation | LNH | Class II | 2024-04-12 |
| K233698 | True Enhance DL | Ge Healthcare Japan Corporation | JAK | Class II | 2024-04-11 |
| K232641 | Neorad Pacs (Neorad Pacs) | Everrtech Software Pvt, Ltd. | LLZ | Class II | 2024-04-10 |
| K240744 | uMR 680 | Shanghai United Imaging Healthcare Co., Ltd. | LNH | Class II | 2024-04-10 |
| K232623 | Universal Endometrial Applicator Set (GM11009840) | Varian Medical Systems, Inc. | JAQ | Class II | 2024-04-09 |
| DEN230023 | Rho | 16 Bit, Inc. | SAO | Class II | 2024-04-09 |
| K232147 | CAAS Workstation | Pie Medical Imaging BV | QHA | Class II | 2024-04-09 |
| K240291 | EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM | Ever Fortune.Ai, Co., Ltd. | QAS | Class II | 2024-04-08 |
| K240172 | Preview Shoulder | Genesis Software Innovations | QIH | Class II | 2024-04-04 |
| K232227 | ABLATE-IQ | Neuwave Medical, Inc. | JAK | Class II | 2024-04-04 |
| K232899 | AI-Rad Companion Organs RT | Siemens Medical Solutions U.S.A. | QKB | Class II | 2024-04-03 |
| K232835 | Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System | Canon Medical Systems Corporation | JAK | Class II | 2024-04-02 |
| K233750 | ECG-less Cardiac | Ge Medical Systems, LLC | JAK | Class II | 2024-04-02 |
| K233676 | Us2.v2 | Eko.Ai Pte Ltd. D/B/A Us2.Ai | QIH | Class II | 2024-04-01 |
| K233622 | AlignRT Plus | Vision Rt, Ltd. | IYE | Class II | 2024-03-29 |
| K233211 | AVIEW CAC | Coreline Soft Co., Ltd. | QIH | Class II | 2024-03-29 |
| K240310 | LCD Monitors C310S, G310S, C316S, G316S, C616W | Shenzhen Beacon Display Technology Co., Ltd. | PGY | Class II | 2024-03-29 |
| K232031 | LUNA 3D | Lap GmbH Laser Applikationen | IYE | Class II | 2024-03-29 |
| K240608 | MAGNETOM Viato.Mobile | Siemens Medical Solutions USA, Inc. | LNH | Class II | 2024-03-29 |
| K233719 | FDR Visionary Suite | Shimadzu Corporation | KPR | Class II | 2024-03-28 |
| K240284 | Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H) | Shenzhen Browiner Tech Co., Ltd. | IZL | Class II | 2024-03-28 |
| K233669 | OEC 3D | Ge Oec Medical Systems, Inc. | OXO | Class II | 2024-03-28 |
| K233657 | NAEOTOM Alpha | Siemens Medical Solutions USA, Inc. | JAK | Class II | 2024-03-28 |
| K232891 | CARPL (CARPL) | Carpl Ai, Inc. | LLZ | Class II | 2024-03-27 |
| K233539 | MAMMOMAT B.brilliant | Siemens Medical Solutions USA, Inc. | MUE | Class II | 2024-03-27 |
| K233733 | SyMRI | Syntheticmr AB (Publ.) | LNH | Class II | 2024-03-26 |
| K233650 | SOMATOM go.Up; SOMATOM go.Now; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM X.cite; SOMATOM X.ceed | Siemens Medical Solutions USA, Inc. | JAK | Class II | 2024-03-26 |
| K240620 | Cube Navigator | Medical Templates AG | LLZ | Class II | 2024-03-25 |
| K231986 | Modus IR | Synaptive Medical, Inc. | IZI | Class II | 2024-03-25 |
| K240540 | uMR Omega | Shanghai United Imaging Healthcare Co., Ltd. | LNH | Class II | 2024-03-22 |
| K231930 | Digital Ultrasonic Diagnostic Imaging System (Model: F6) | Guangdong Youkey Medical Co., Ltd. | IYN | Class II | 2024-03-22 |
| K232431 | syngo.CT Brain Hemorrhage | Siemens Medical Solutions USA, Inc. | QAS | Class II | 2024-03-22 |
| K232322 | MAGNETOM Terra; MAGNETOM Terra.X | Siemens Medical Solutions USA, Inc. | LNH | Class II | 2024-03-22 |
| K233753 | AI-Rad Companion (Pulmonary) | Siemens Healthcare GmbH | JAK | Class II | 2024-03-21 |
| K234090 | EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004) | Surgvision GmbH | IZI | Class II | 2024-03-20 |
| K233599 | X-Clever (ASHK100G) | Lg Electronics.Inc | LLZ | Class II | 2024-03-18 |
| K233660 | nCommand Lite System | Ionic Health | LLZ | Class II | 2024-03-18 |
| K233342 | CINA-ASPECTS | Avicenna.Ai | POK | Class II | 2024-03-15 |
| K233748 | CIARTIC Move (VB10) | Siemens Medical Solutions USA, Inc. | OWB | Class II | 2024-03-15 |
| K232022 | CAS-One IR | Cascination AG | JAK | Class II | 2024-03-13 |
| K233968 | CINA-iPE | Avicenna.Ai | QAS | Class II | 2024-03-13 |
14,721 clearances in the Radiology panel. Data: openFDA.