Review Panel
Radiology FDA 510(k) Clearances & Devices
- Cleared Devices
- 14,721
- Product Codes (page)
- 24
- Latest Decision
- 2023-07-12
Clearances · page 16 of 148
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K231709 | AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4 | Radmedix, LLC | MQB | Class II | 2023-07-12 |
| K231701 | Ziehm Vision RFD 3D | Ziehm Imaging GmbH | OWB | Class II | 2023-07-10 |
| K223724 | MOZI TPS | Manteia Technologies Co., Ltd. | MUJ | Class II | 2023-07-10 |
| K222666 | X-View 3D Pan/X-View 2D Pan | Trident S.R.L | OAS | Class II | 2023-07-10 |
| K223448 | Bladder Scanner Model: BVT02 | Xuzhou Kaixin Electronic Instrument Co., Ltd. | IYO | Class II | 2023-07-07 |
| K231668 | Spine CAMP (1.1) | Medical Metrics, Inc. | QIH | Class II | 2023-07-07 |
| K222745 | Axial3D Insight | Axial Medical Printing Limited | QIH | Class II | 2023-07-03 |
| K213253 | Pixyl.Neuro | Pixyl SA | LLZ | Class II | 2023-06-30 |
| K231647 | XENOVIEW 3.0T Chest Coil | Polarean, Inc. | MOS | Class II | 2023-06-29 |
| K223048 | Medisystem Pacs | Medilab Manutencao E Sitemas Ltda | LLZ | Class II | 2023-06-23 |
| K231185 | MapRT | Vision Rt, Ltd. | IYE | Class II | 2023-06-23 |
| K230160 | VINNO G86,VINNO G86E,VINNO G65,VINNO G65P,VINNO G65E,VINNO G65D,VINNO M86, VINNO M86E,VINNO G90,VINNO G90E | Vinno Technology (Suzhou) Co.,Ltd | IYN | Class II | 2023-06-23 |
| K223159 | Radixact Treatment Delivery System | Accuray Incorporated | IYE | Class II | 2023-06-23 |
| K230497 | Bladder AI (AIBV01) | Exo, Inc. | QIH | Class II | 2023-06-22 |
| K231467 | 1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF | Rayence Co., Ltd. | MQB | Class II | 2023-06-21 |
| K230346 | Voluson SWIFT; Voluson SWIFT+ | Ge Medical Systems Ultrasound & Primary Care Diagnostic, LLC | IYN | Class II | 2023-06-20 |
| K222998 | F3 | Acrew Imaging, Inc. | OWB | Class II | 2023-06-20 |
| K231459 | HepaFatSmart (V2.0.0) | Resonance Health Analysis Services Pty, Ltd. | LNH | Class II | 2023-06-20 |
| K231075 | Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option) | Carl Zeiss Meditec, Inc. | IZI | Class II | 2023-06-20 |
| K223920 | VINNO G50, VINNO G55, VINNO M50, VINNO E30, VINNO X5, VINNO X6, VINNO X7, VINNO M55, VINNO E35, VINNO X65, VINNO X55, VINNO X35, VINNO G55E, VINNO G55P, VINNO M55E, VINNO M55P, VINNO E35E, VINNO E35P | Vinno Technology (Suzhou) Co.,Ltd | IYN | Class II | 2023-06-17 |
| K223917 | VINNO E20, VINNO E10,VINNO E10P,VINNO E10E, VINNO X1,VINNO X1E,VINNO X1P, VINNO X2,VINNO X2E,VINNO X2P | Vinno Technology (Suzhou) Co.,Ltd | IYN | Class II | 2023-06-17 |
| K223556 | DeepCatch | Medical IP Co., Ltd. | QIH | Class II | 2023-06-16 |
| K230421 | SOMATOM Edge Plus, SOMATOM Confidence, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATOM Drive, SOMATOM Force, SOMATOM Definition Flash | Siemens Medical Solutions USA, Inc. | JAK | Class II | 2023-06-16 |
| K223646 | IB Lab LAMA | Ib Lab GmbH | QIH | Class II | 2023-06-16 |
| K230112 | CAC Software | Imbio, Inc. | JAK | Class II | 2023-06-13 |
| K230728 | JUSHA-C810G/C810G LCD Monitor, JUSHA-C660/JUSHA-C660G/C660/C660G LCD Monitor | Nanjing Jusha Display Technology Co., Ltd. | PGY | Class II | 2023-06-09 |
| K223091 | CT Perfusion V1.0 | Olea Medical | LLZ | Class II | 2023-06-09 |
| K230505 | Orthopantomograph OP 3D LX | Palodex Group OY | OAS | Class II | 2023-06-09 |
| K230768 | M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | Class II | 2023-06-09 |
| K222762 | SIDDHARTH-II;IMPACT | Panacea Medical Technologies Pvt. , Ltd. | IYE | Class II | 2023-06-08 |
| K231360 | Ambra PACS | Dicom Grid Dba Ambra Health | LLZ | Class II | 2023-06-07 |
| K230381 | Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide Cleaner/High-Level Disinfectant and QwikCheck Chemical Indicator | Cs Medical, LLC | PSW | Class II | 2023-06-07 |
| K231170 | C350/C350G LCD Monitor; M550/M550G LCD Monitor | Nanjing Jusha Display Technology Co., Ltd. | PGY | Class II | 2023-06-07 |
| K230691 | HyperVue Imaging System | Spectrawave, Inc. | NQQ | Class II | 2023-06-07 |
| K223532 | Olea S.I.A. Neurovascular V1.0 | Olea Medical | LLZ | Class II | 2023-06-06 |
| K223855 | FEops HEARTguideTM, FEops HEARTguideTM ALPACA | Feops NV | QIH | Class II | 2023-06-06 |
| K230727 | SPY Portable Handheld Imaging (SPY-PHI) System | Novadaq Technologies Ulc (A Part of Stryker) | IZI | Class II | 2023-06-05 |
| K223555 | Brainomix 360 e-CTP | Brainomix Limited | LLZ | Class II | 2023-06-01 |
| K223447 | OmniTom Elite | Neurologica Corporation, A Subsidiary of Samsung | JAK | Class II | 2023-06-01 |
| K230185 | ANT-X System | Ndr Medical Technology Pte. , Ltd. | OWB | Class II | 2023-06-01 |
| K223841 | KBA3D | S.M.A.I.O | LLZ | Class II | 2023-05-30 |
| K222359 | Quicktome Software Suite | Omniscient Neurotechnology Pty Ltd (O8t) | LLZ | Class II | 2023-05-30 |
| K223523 | Sonic DL | Ge Medical Systems,Llc (Ge Healthcare) | LNH | Class II | 2023-05-30 |
| K230557 | Eclipse Treatment Planning System (v18.0) | Varian Medical Systems, Inc. | MUJ | Class II | 2023-05-26 |
| K230044 | Pre-Sure | Lazarus 3D | LLZ | Class II | 2023-05-26 |
| K223491 | Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite | Ge Medical Systems, LLC | QBS | Class II | 2023-05-25 |
| K222035 | Avatar Medical Software V1 | Avatar Medical | LLZ | Class II | 2023-05-24 |
| K230152 | uMR Omega | Shanghai United Imaging Healthcare Co., Ltd. | LNH | Class II | 2023-05-23 |
| K231162 | ROSA Hip System | Orthosoft Inc (D/B/A Zimmer Cas) | LLZ | Class II | 2023-05-23 |
| K230096 | Genius AI Detection 2.0 with CC-MLO Correlation | Hologic, Inc. | QDQ | Class II | 2023-05-23 |
| K230803 | ADAS 3D | Adas3D Medical S.L. | LLZ | Class II | 2023-05-23 |
| K223839 | TrueBeam, TrueBeam STx, Edge, VitalBeam | Varian Medical Systems, Inc. | IYE | Class II | 2023-05-22 |
| K220402 | VirtuOst | O.N. Diagnostics | KGI | Class II | 2023-05-19 |
| K212758 | Autoplaque | Cedars-Sinai Medical Center: Aim | LLZ | Class II | 2023-05-19 |
| K230758 | uMR 570 | Shanghai United Imaging Healthcare Co., Ltd. | LNH | Class II | 2023-05-18 |
| K230723 | C510G/JUSHA-C510G/C510/JUSHA- C510 LCD Monitor | Nanjing Jusha Display Technology Co., Ltd. | PGY | Class II | 2023-05-18 |
| K222728 | Radiation Planning Assistant (RPA) | University of Texas, MD Anderson Cancer Center | MUJ | Class II | 2023-05-17 |
| K231102 | Symbia Pro.specta VA20A Family | Siemens Medical Solutions USA, Inc. | KPS | Class II | 2023-05-17 |
| K230684 | RadiForce MX217 | Eizo Corporation | PGY | Class II | 2023-05-12 |
| K231190 | EPIQ Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | IYN | Class II | 2023-05-12 |
| K222854 | iTFlow | Cardio Flow Design, Inc. | LLZ | Class II | 2023-05-12 |
| K222460 | Intraoperative Ultrasound Probe Cover | Exact Medical Manufacturing | ITX | Class II | 2023-05-12 |
| K231052 | ExacTrac Dynamic 1.1.2 | Brainlab AG | IYE | Class II | 2023-05-11 |
| K223623 | SubtleMR (2.3.x) | Subtle Medical, Inc. | LLZ | Class II | 2023-05-11 |
| K220437 | Neurophet AQUA | Neurophet., Inc. | LLZ | Class II | 2023-05-10 |
| K222987 | Akunah REFLECT | Akunah Pty, Ltd. | LLZ | Class II | 2023-05-10 |
| K222719 | CX50N | Wide Corporation | PGY | Class II | 2023-05-09 |
| K222716 | MX50N | Wide Corporation | PGY | Class II | 2023-05-08 |
| K230082 | Auto Segmentation | Ge Medical Systems, LLC | QKB | Class II | 2023-05-04 |
| K223771 | Lumify Diagnostic Ultrasound System | Philips Ultrasound | IYN | Class II | 2023-05-04 |
| K223758 | Epione | Quantum Surgical Sas | JAK | Class II | 2023-05-03 |
| K230119 | 3D Anatomic Model | Ricoh USA, Inc. | LLZ | Class II | 2023-05-02 |
| K230977 | SIS System | Surgical Information Sciences, Inc. | QIH | Class II | 2023-05-02 |
| K221870 | CarnaLife Holo | Medapp S.A. | LLZ | Class II | 2023-05-01 |
| K230643 | CP620G LCD monitor, CP620 LCD monitor | Nanjing Jusha Display Technology Co., Ltd. | PGY | Class II | 2023-05-01 |
| K230972 | Ingenia Elition and MR 7700 MR Systems | Philips Medical Systems Nederland B.V. | LNH | Class II | 2023-04-28 |
| K230600 | VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464) | Spectrum Dynamics Medical, Ltd. | KPS | Class II | 2023-04-28 |
| K222934 | Nanox.ARC | Nano-X Imaging , Ltd. | IZF | Class II | 2023-04-28 |
| K230845 | 32HL512D, 31HN713D, 32HQ713D | Lg Electronics.Inc | PGY | Class II | 2023-04-27 |
| K223212 | Precision DL | GE Healthcare | KPS | Class II | 2023-04-27 |
| K230552 | MR DWI/FLAIR Measurement V1.0 | Olea Medical | LLZ | Class II | 2023-04-26 |
| K222676 | Ceevra Reveal 3 | Ceevra, Inc. | QIH | Class II | 2023-04-25 |
| K230223 | iCAC Device | Bunkerhill, Inc. | JAK | Class II | 2023-04-25 |
| K230906 | Konicaminolta DI-X1 | Konica Minolta, Inc. | LLZ | Class II | 2023-04-25 |
| K230140 | TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US) | Compai Healthcare (Suzhou) Co.,Ltd | MWP | Class II | 2023-04-24 |
| K230136 | TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US) | Compai Healthcare (Suzhou) Co.,Ltd | MWP | Class II | 2023-04-24 |
| K230468 | EzDent Web | Ewoosoft Co., Ltd. | LLZ | Class II | 2023-04-21 |
| K223501 | ViewFinder Software Version 1.1 | Elaitra, Ltd. | QIH | Class II | 2023-04-21 |
| K230084 | HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | 2023-04-21 |
| K223287 | Velacur | Sonic Incytes | IYO | Class II | 2023-04-20 |
| K230807 | Deep Learning Image Reconstruction | Ge Healthcare Japan Corporation | JAK | Class II | 2023-04-20 |
| K223768 | RadiForce RX270 | Eizo Corporation | PGY | Class II | 2023-04-20 |
| K230023 | ART-Plan | Therapanacea Sas | QKB | Class II | 2023-04-19 |
| K223564 | X-CUBE 50, X-CUBE 60 | Alpinion Medical Systems Co., Ltd. | IYN | Class II | 2023-04-17 |
| K230772 | Quantib Prostate | Quantib B.V. | LLZ | Class II | 2023-04-17 |
| K230685 | AutoContour Model RADAC V3 | Radformation, Inc. | QKB | Class II | 2023-04-14 |
| K230264 | Ezra Flash | Ezra Ai, Inc. | LLZ | Class II | 2023-04-13 |
| K213986 | CerebralGo Plus | Yukun (Beijing) Technology Co., Ltd. | QIH | Class II | 2023-04-13 |
| K230393 | UniCam Evo Software | Inter Medical Medizintechnik GmbH | LLZ | Class II | 2023-04-13 |
| K223830 | Ultrasound System 2300 | Bk Medical Aps | IYN | Class II | 2023-04-11 |
14,721 clearances in the Radiology panel. Data: openFDA.