Review Panel
Radiology FDA 510(k) Clearances & Devices
- Cleared Devices
- 14,721
- Product Codes (page)
- 24
- Latest Decision
- 2024-11-27
Clearances · page 10 of 148
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K242444 | HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | 2024-11-27 |
| K242258 | MROpen Evo (03-2000-00); MROpen Evo (03-4000-00) | Asg Superconductors S.P.A. | LNH | Class II | 2024-11-26 |
| K242810 | RadUnity (Version 1.0.0) | Radunity Corp. | LLZ | Class II | 2024-11-26 |
| K242961 | Intraluminal Applicator Set | Varian Medical Systems | JAQ | Class II | 2024-11-26 |
| K241831 | Transpara (2.1.0) | Screenpoint Medical B.V. | QDQ | Class II | 2024-11-25 |
| K242203 | BriefCase-Quantification | Aidoc Medical , Ltd. | QIH | Class II | 2024-11-22 |
| K241495 | Jazz Classic | Jazz Imaging | LLZ | Class II | 2024-11-21 |
| K241319 | SKR 3000 | Konica Minolta, Inc. | MQB | Class II | 2024-11-21 |
| K242874 | Gating Reflector Block | Varian Medical Systems, Inc. | JAK | Class II | 2024-11-21 |
| K242359 | Strain AI (SAI001) | Exo, Inc. | QIH | Class II | 2024-11-20 |
| K243045 | BRAXX Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002) | Braxx Biotech Co., Ltd. | JAQ | Class II | 2024-11-19 |
| K242523 | ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | IYN | Class II | 2024-11-19 |
| K243316 | XENOVIEW 3.0T Chest Coil | Polarean, Inc. | MOS | Class II | 2024-11-19 |
| K242496 | Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C) | Eieling Technology (Shenzhen) Limited | IYO | Class II | 2024-11-19 |
| K242329 | CT Collaboration Live | Philips Healthcare (Suzhou) Co., Ltd. | LLZ | Class II | 2024-11-18 |
| K241747 | Saige-Dx | DeepHealth, Inc. | QDQ | Class II | 2024-11-18 |
| K243299 | ACUSON Redwood Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | IYN | Class II | 2024-11-15 |
| K242062 | 1CMR Pro | Mycardium AI Limited | LLZ | Class II | 2024-11-15 |
| K241439 | VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage | Vuno, Inc. | QFM | Class II | 2024-11-15 |
| K242800 | The 5000 Compact Series Ultrasound Systems | Philips Ultrasound, LLC | IYN | Class II | 2024-11-15 |
| K242130 | Koios DS | Koios Medical, Inc. | POK | Class II | 2024-11-15 |
| K241125 | VIVIX-S 1751S | Vieworks Co., Ltd. | MQB | Class II | 2024-11-15 |
| K242342 | Fetal EchoScan | Brightheart | POK | Class II | 2024-11-14 |
| K241981 | Change Healthcare Stratus Imaging PACS | Change Healthcare Canada Company | LLZ | Class II | 2024-11-12 |
| K240771 | PRORAD X-Ray Flat Panel Detector with DROC | Prognosys Medical Systems Private Limited | MQB | Class II | 2024-11-12 |
| K240417 | ProFound Detection (V4.0) | Icad, Inc. | QDQ | Class II | 2024-11-08 |
| K241364 | Hybrid Viewer (00859873006189) | Hermes Medical Solutions AB | KPS | Class II | 2024-11-08 |
| K242231 | Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | Class II | 2024-11-08 |
| K241853 | Titanium Fletcher-Style Applicator Set Defined Geometry; Smit Cervical Sleeve | Varian Medical Systems, Inc. | JAQ | Class II | 2024-11-07 |
| K241719 | NeuroICH | Neurocareai, Inc. | QAS | Class II | 2024-11-07 |
| K241346 | IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector) | Aspen Imaging Healthcare, Inc. | MQB | Class II | 2024-11-07 |
| K240712 | icobrain aria | Icometrix NV | QBS | Class II | 2024-11-07 |
| K241312 | TeraRecon Cardiac.Chambers.MR (1.0.0) | Terarecon,Inc. | QIH | Class II | 2024-11-05 |
| K242709 | JLK-PWI | JLK, Inc. | LLZ | Class II | 2024-11-04 |
| K241068 | uDR 780i | Shanghai United Imaging Healthcare Co., Ltd. | KPR | Class II | 2024-11-01 |
| K241223 | eRAD PACS | Erad, Inc. | LLZ | Class II | 2024-10-31 |
| K241108 | RemedyLogic AI MRI Lumbar Spine Reader | Remedy Logic, Inc. | QIH | Class II | 2024-10-30 |
| K243186 | Symbia Pro.specta Q3 (11364751); Symbia Pro.specta X3 (11364752); Symbia Pro.specta X7 (11364753); Symbia Pro.specta VA30A Family | Siemens Medical Solutions USA, Inc. | KPS | Class II | 2024-10-30 |
| K241965 | Catheter Surface Flap Applicator Set (GM11011830) | Varian Medical Systems | JAQ | Class II | 2024-10-29 |
| K243031 | LCD Monitors C310S, G310S, C316S, G316S, C616W | Shenzhen Beacon Display Technology Co., Ltd. | PGY | Class II | 2024-10-25 |
| K243189 | TumorSight Viz | SimBioSys, Inc. | QIH | Class II | 2024-10-25 |
| K242215 | Neurophet AQUA (V3.1) | Neurophet., Inc. | QIH | Class II | 2024-10-25 |
| K241554 | Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L) | Telefield Medical Imaging (Shenzhen) Limited | IYN | Class II | 2024-10-24 |
| K242512 | ROCC Console | Philips Medical Systems Nederland B.V. | LLZ | Class II | 2024-10-24 |
| K243057 | TrueFit Bolus; TrueFlex Bolus | Adaptiiv Medical Technologies, Inc. | MUJ | Class II | 2024-10-23 |
| K243012 | MIM Symphony HDR Fusion | Mim Software, Inc. | LLZ | Class II | 2024-10-23 |
| K241876 | Vitesse (5.0) | Varian Medical Systems | MUJ | Class II | 2024-10-23 |
| K242847 | EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DEXi-D503T-FRM); EXSYS DEXi (EXSYS DEXi-A503T-FRM); EXSYS DEXi (EXSYS DEXi-D401S-FRA); EXSYS DEXi (EXSYS DEXi-D402S-FRA); EXSYS DEXi (EXSYS DEXi-D401P-FRA); EXSYS DEXi (EXSYS DEXi-D402P-FRA); | DRTECH Corporation | KPR | Class II | 2024-10-23 |
| K241572 | ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A) (ceiling); ARTIS pheno (VE40A) | Siemens Medical Solutions USA, Inc. | OWB | Class II | 2024-10-22 |
| K243209 | nordicMEDiVA | Nordicneurolab AS | LLZ | Class II | 2024-10-22 |
| K241490 | Contour+ (MVision AI Segmentation) | Mvision AI OY | QKB | Class II | 2024-10-18 |
| K243033 | dS Wrist coil 8ch 1.5T | Philips Medical Systems Nederland B.V. | MOS | Class II | 2024-10-18 |
| K242837 | BriefCase-Triage | Aidoc Medical , Ltd. | QAS | Class II | 2024-10-18 |
| K240844 | Spectral CT 7500 RT | Philips Medical Systems Technologies , Ltd. | JAK | Class II | 2024-10-18 |
| K242879 | dS Knee Coil 8ch 1.5T | Philips Medical Systems Nederland B.V. | MOS | Class II | 2024-10-18 |
| K241242 | SIGNA MAGNUS | Ge Medical Systems, LLC | LNH | Class II | 2024-10-17 |
| K242556 | JLK-CTP | JLK, Inc. | LLZ | Class II | 2024-10-16 |
| K242781 | cvi42 Software Application | Circle Cardiovascular Imaging, Inc. | QIH | Class II | 2024-10-15 |
| K240385 | VINT | Mediimg Corporation | LLZ | Class II | 2024-10-15 |
| K241971 | HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | 2024-10-11 |
| K241569 | syngo Application Software | Siemens Medical Solutions USA, Inc. | LLZ | Class II | 2024-10-11 |
| K242515 | uDR 380i Pro | Shanghai United Imaging Healthcare Co., Ltd. | IZL | Class II | 2024-10-10 |
| K240786 | AutoChamber | HeartLung Corporation | QIH | Class II | 2024-10-10 |
| K241430 | EchoMeasure | Icardio.Ai | QIH | Class II | 2024-10-10 |
| K241837 | Limbus Contour | Limbus Ai, Inc. | QKB | Class II | 2024-10-09 |
| K240980 | EPIQ Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | IYN | Class II | 2024-10-07 |
| K241029 | SpineUs System | Verdure Imaging | IYO | Class II | 2024-10-07 |
| K242652 | Lunit INSIGHT DBT v1.1 | Lunit, Inc. | QDQ | Class II | 2024-10-04 |
| K240553 | LVivo Software Application | Dia Imaging Analysis, Ltd. | QIH | Class II | 2024-10-04 |
| K241245 | EchoSolv AS | Echo IQ, Ltd. | POK | Class II | 2024-10-04 |
| K241925 | VitruvianScan (v1.0) | Perspectum, Ltd. | LNH | Class II | 2024-10-02 |
| K241561 | MammoScreen BD | Therapixel | QIH | Class II | 2024-10-02 |
| K242005 | Versana Premier; Versana Premier Lotus; LOGIQ F | GE Medical Systems Ultrasound and Primary Care Diagnostics | IYN | Class II | 2024-10-02 |
| K240943 | LungVision | Bodyvision Medical , Ltd. | QIH | Class II | 2024-10-01 |
| K242678 | Definium Pace Select ET | Ge Hualun Medical Systems Co. , Ltd. | KPR | Class II | 2024-10-01 |
| K241331 | MuscleView | Springbok, Inc. | LNH | Class II | 2024-10-01 |
| K242651 | GM85 | Samsung Electronics Co., Ltd. | IZL | Class II | 2024-10-01 |
| K241536 | trophon Wireless Ultrasound Probe Holder | Nanosonics Limited | OUJ | Class II | 2024-09-27 |
| K240369 | CAC (gated) Algorithm | BunkerHill Health | JAK | Class II | 2024-09-27 |
| K241480 | JBS-LVO | JLK, Inc. | QAS | Class II | 2024-09-27 |
| K242292 | uAI Easy Triage ICH | Shanghai United Imaging Intelligence Co., Ltd. | QAS | Class II | 2024-09-24 |
| K240243 | EConsole2 | DRTECH Corporation | LLZ | Class II | 2024-09-23 |
| K242223 | SuperSonic HepaVu | Supersonic Imagine | IYN | Class II | 2024-09-20 |
| K234108 | ERI Portable X-ray System (CVX-air); ERI Portable X-ray System (CVX-lite); ERI Portable X-ray System (CVX-E) | Energy Resources International Co., Ltd. | IZL | Class II | 2024-09-20 |
| K240036 | PIUR tUS Infinity | Piur Imaging GmbH | QIH | Class II | 2024-09-20 |
| K242478 | GF85 (models GF85-3P, GF85-SP) | Samsung Electronics Co., Ltd. | KPR | Class II | 2024-09-19 |
| K242167 | Sterile and Non-Sterile Ultrasonic Coupling Agent | Anhui Deepblue Medical Technology Co., Ltd. | MUI | Class II | 2024-09-19 |
| K234153 | EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220) | Edgelife Technologies, LLC | IYN | Class II | 2024-09-18 |
| K241201 | TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite/Anesus TEX20 Pro/Eagus TEX20/Eagus TEX20T/Eagus TEX21/Eagus TEX21T/Eros/TE X Plus/Anesus TEX10 Pro/TEX9U/TEX9M/Eagus TEX11/Eagus TEX11T/EagusTEX10/Eagus TEX10T/Eagus TEX/Ares Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | Class II | 2024-09-16 |
| K241582 | Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800, TUS-AI700) | Canon Medical Systems Corporation | IYN | Class II | 2024-09-12 |
| K240942 | CINA-CSpine | Avicenna.Ai | QAS | Class II | 2024-09-12 |
| K241432 | MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | Class II | 2024-09-12 |
| K241280 | Constellation (CON-001) | Q Bio, Inc. | QIH | Class II | 2024-09-12 |
| K241524 | Elucid PlaqueIQ | Elucid Bioimaging, Inc. | LLZ | Class II | 2024-09-12 |
| K241249 | Orthopantomograph OP 3D LX (PAN 3D); Orthopantomograph OP 3D LX (PAN CEPH 3D) | Palodex Group OY | OAS | Class II | 2024-09-12 |
| K241161 | Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound Imaging System (LK128C); Ultrasound Imaging System (LK128M); Ultrasound Imaging System (LK128PA); Ultrasound Imaging System (LK128E); Ultrasound Imaging System (LU700C); Ultrasound Imaging System (LU700L); Ultrasound Imaging System (LU710L); Ultrasound Imaging System (LU710LH); Ultrasound Imaging System (LU710C); Ultrasound Imaging System (LU710M); Ultrasound Imaging System (LU710PA); Ultrasound Imaging | Leltek, Inc. | IYN | Class II | 2024-09-11 |
| K241380 | FETOLY-HEART | Diagnoly | IYN | Class II | 2024-09-11 |
| K240094 | LumiNE US; Lumi | Augmedit B.V. | QIH | Class II | 2024-09-10 |
| K242394 | Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF) | Rayence Co., Ltd. | MQB | Class II | 2024-09-09 |
| K240697 | See-Mode Augmented Reporting Tool, Thyroid (SMART-T) | See-Mode Technologies Pte, Ltd. | QDQ | Class II | 2024-09-09 |
14,721 clearances in the Radiology panel. Data: openFDA.