Review Panel
Radiology FDA 510(k) Clearances & Devices
- Cleared Devices
- 14,721
- Product Codes (page)
- 34
- Latest Decision
- 2023-04-11
Clearances · page 17 of 148
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K230753 | RCT800 | Ray Co., Ltd. | OAS | Class II | 2023-04-11 |
| K222781 | Augmento | Deeptek Medical Imaging Private Limited | LLZ | Class II | 2023-04-11 |
| K230699 | ARIA Radiation Therapy Management (v18.0) | Varian Medical Systems, Inc. | IYE | Class II | 2023-04-10 |
| K223550 | DMX | Del Medical, Inc. | KPR | Class II | 2023-04-10 |
| K230575 | Limbus Contour | Limbus Ai, Inc. | LLZ | Class II | 2023-04-07 |
| K223816 | Dental CT Scanner AXR | Alliage S/A Industrias Medico Odontológica | OAS | Class II | 2023-04-07 |
| K222360 | AI-Rad Companion (Cardiovascular) | Siemens Medical Solutions U.S.A. | JAK | Class II | 2023-04-06 |
| K223774 | Contour ProtégéAI | Mim Software, Inc. | QKB | Class II | 2023-04-06 |
| K223458 | Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems | Philips Medical Systems Nederland B.V. | LNH | Class II | 2023-04-06 |
| K223240 | Annalise Enterprise CTB Triage Trauma | Annalise-Ai Pty , Ltd. | QAS | Class II | 2023-04-03 |
| K223570 | SonoAir Series Digital Color Doppler Ultrasound System | CHISON Medical Technologies Co., Ltd. | IYN | Class II | 2023-03-31 |
| K213660 | RadAlly | Imaging Wave, LLC | LLZ | Class II | 2023-03-31 |
| K223017 | Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 | Canon Medical Systems Corporation | IYN | Class II | 2023-03-31 |
| K211059 | CereFlow V1.2 | Translational Mri, LLC | LLZ | Class II | 2023-03-31 |
| K220068 | Butterfly iQ/iQ+ Ultrasound System | Butterfly Network, Inc. | IYO | Class II | 2023-03-31 |
| K213272 | Formus Hip | Formus Labs, Ltd. | QIH | Class II | 2023-03-31 |
| K230312 | Iris AirShuttle | Qfix | IYE | Class II | 2023-03-31 |
| K222112 | Comfort Marker 2.0 | Medical Precision BV | QRN | Class II | 2023-03-30 |
| K223422 | Emory Cardiac Toolbox 4.3 | Syntermed | KPS | Class II | 2023-03-30 |
| K222312 | RayStation 12A | RaySearch Laboratories AB (PUBL) | MUJ | Class II | 2023-03-29 |
| K221984 | InterView XP; InterView FUSION | Mediso Medical Imaging Systems, Lttd. | LLZ | Class II | 2023-03-29 |
| K221921 | DTX Studio Clinic 3.0 | Nobel Biocare AB | MYN | Class II | 2023-03-28 |
| K222179 | Annalise Enterprise CXR Triage Trauma | Annalise-Ai Pty , Ltd. | QFM | Class II | 2023-03-28 |
| K222268 | Annalise Enterprise CXR Triage Trauma | Annalise-Ai Pty , Ltd. | QFM | Class II | 2023-03-28 |
| K223343 | MAGNETOM Amira; MAGNETOM Sempra | Siemens Medical Solutions USA, Inc. | LNH | Class II | 2023-03-28 |
| K222174 | RadioLens v1.0 | Synapsica | QIH | Class II | 2023-03-28 |
| K222746 | Overjet Caries Assist | Overjet, Inc. | MYN | Class II | 2023-03-27 |
| K222036 | MPXA-2000 | Medipixel, Inc. | QIH | Class II | 2023-03-22 |
| K223490 | FlightPlan for Embolization | GE Medical Systems SCS | LLZ | Class II | 2023-03-21 |
| K230561 | Syngo Carbon Space VA30A | Siemens Healthcare GmbH | LLZ | Class II | 2023-03-21 |
| K230520 | Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521) | Barco N.V. | PGY | Class II | 2023-03-21 |
| K221996 | P-Cure Proton Beam Therapy System | P-Cure, Ltd. | LHN | Class II | 2023-03-20 |
| K223875 | MOBINEURO Alita Intraoperative MRI System | Sino Canada Health Engineering Research Institute (Hefei) | LNH | Class II | 2023-03-20 |
| K223443 | Viz AAA | Viz. Ai, Inc. | QFM | Class II | 2023-03-17 |
| K223279 | RT Elements (4.0) | Brainlab AG | MUJ | Class II | 2023-03-14 |
| K222775 | Aarhus Applicator Set | Varian Medical Systems, Inc. | JAQ | Class II | 2023-03-13 |
| K223325 | uMI Panorama | Shanghai United Imaging Healthcare Co., Ltd. | KPS | Class II | 2023-03-10 |
| K223514 | Spectral Bone Marrow | Ge Medical Systems, LLC | JAK | Class II | 2023-03-09 |
| K221706 | AccuContour | Manteia Technologies Co., Ltd. | QKB | Class II | 2023-03-09 |
| K223726 | Aquilion Precision (TSX-304A/4) V10.14 with AiCE | Canon Medical Systems Corporation | JAK | Class II | 2023-03-07 |
| K223930 | A1417MCW/A1717MCW/F1417MCW | H&abyz Co., Ltd. | MQB | Class II | 2023-03-06 |
| K222819 | Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i | Canon Medical Systems Corporation | JAK | Class II | 2023-03-03 |
| K230294 | CoverScan (CoverScan v1.1) | Perspectum | LLZ | Class II | 2023-03-03 |
| K223203 | 1.5T 24E Posterior Array | Shenzhen RF Tech Co., Ltd. | LNH | Class II | 2023-03-02 |
| K222176 | BoneView | Gleamer | QBS | Class II | 2023-03-02 |
| K230303 | AccuFFRangio Plus | ArteryFlow Technology Co., Ltd. | QHA | Class II | 2023-03-02 |
| K223902 | FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630) | Echosens | IYO | Class II | 2023-03-02 |
| K222884 | Rapid NCCT Stroke | Ischemaview, Inc. | QAS | Class II | 2023-03-02 |
| K221680 | Xeleris V Processing and Review System | GE Healthcare | LLZ | Class II | 2023-03-01 |
| K223423 | 32HQ713D | Lg Electronics.Inc | PGY | Class II | 2023-03-01 |
| K222975 | Advantis Platform | Advantis Medical Imaging Single Member P.C. | LLZ | Class II | 2023-03-01 |
| K222240 | EXPLORER AIR® II | Surgvision GmbH | IZI | Class II | 2023-02-28 |
| K221711 | AccuICAS | ArteryFlow Technology Co., Ltd. | QHA | Class II | 2023-02-28 |
| K221257 | SpectraWAVE Imaging System | Spectrawave, Inc. | NQQ | Class II | 2023-02-28 |
| DEN220063 | Caption Interpretation Automated Ejection Fraction Software | Caption Health, Inc. | QVD | Class II | 2023-02-24 |
| K213805 | MAGNETOM Vida | Siemens Medical Solutions USA, Inc. | LNH | Class II | 2023-02-24 |
| K222757 | Clarus Viewer | Clarus Viewer Corporation | LLZ | Class II | 2023-02-24 |
| K213891 | RealNow | Yiwei Medical Technology Co., Ltd. | LLZ | Class II | 2023-02-24 |
| K221592 | AVIEW Lung Nodule CAD | Coreline Soft Co., Ltd. | OEB | Class II | 2023-02-24 |
| K223233 | Monaco RTP System | Elekta Solutions AB | MUJ | Class II | 2023-02-23 |
| K223209 | Elekta Unity | Elekta Solutions AB | IYE | Class II | 2023-02-23 |
| K221564 | Brainomix 360 e-ASPECTS | Brainomix Limited | POK | Class II | 2023-02-23 |
| K230241 | Jumong General | Sg Healthcare Co, Ltd. | KPR | Class II | 2023-02-23 |
| K223229 | MOSAIQ® OIS (Oncology Information System) | Elekta Solutions AB | IYE | Class II | 2023-02-23 |
| K230208 | Swoop® Portable MR Imaging System | Hyperfine, Inc. | LNH | Class II | 2023-02-22 |
| K230197 | BoneMRI v1.6 | Mriguidance B.V. | QIH | Class II | 2023-02-22 |
| K212587 | 3D-RD-S | Radiopharmaceutical Imaging and Dosimetry, LLC | IYX | Class I | 2023-02-22 |
| K222259 | NEONA 1.5T MRI System | Time Medical Limited | LNH | Class II | 2023-02-21 |
| K223820 | EzDent-i / E2 / Prora View/ Smart M Viewer | Ewoosoft Co., Ltd. | LLZ | Class II | 2023-02-17 |
| K222977 | DSPS-Prominent Masks; DSPS-Prominent Baseplate, MR; CouchStrip | Macromedics BV | IYE | Class II | 2023-02-17 |
| K223832 | Vivid S60N, Vivid S70N | Ge Medical System Ultrasound and Primary Care Diagnostics | IYN | Class II | 2023-02-16 |
| K223028 | uCT ATLAS Astound with uWS-CT-Dual Energy Analysis | Shanghai United Imaging Healthcare Co., Ltd. | JAK | Class II | 2023-02-16 |
| K222755 | uMR 680 | Shanghai United Imaging Intelligence Co., Ltd. | LNH | Class II | 2023-02-16 |
| K223407 | Versana Essential | GE Medical Systems Ultrasound and Primary Care Diagnostics | IYN | Class II | 2023-02-15 |
| K230175 | Digital Radiography CXDI-CS01 | Canon, Inc. | MQB | Class II | 2023-02-15 |
| K223225 | 8ch T/R Knee Coil | Shenzhen RF Tech Co., Ltd. | MOS | Class II | 2023-02-14 |
| K223387 | V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | 2023-02-13 |
| K230196 | syngo.via View&GO VA40A | Siemens Healthcare GmbH | LLZ | Class II | 2023-02-13 |
| K230207 | ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | IYN | Class II | 2023-02-13 |
| K223439 | SIGNA Victor | Ge Healthcare (Tianjin) Company Limited | LNH | Class II | 2023-02-13 |
| K223249 | Pro-Tx Endorectal Balloon (PROT-25) | Dxtx Medical, Inc. | PCT | Class II | 2023-02-10 |
| K223425 | MD.ai Viewer | Mdai, Inc. | LLZ | Class II | 2023-02-10 |
| K222596 | S90 Exp Series Digital Color Doppler Ultrasound System | Sonoscape Medical Corp. | IYN | Class II | 2023-02-10 |
| K222928 | Resona R9/ Resona R9 Exp/ Resona R9 Pro/ Resona R9S/ Nuewa R9/ Nuewa R9 Exp Diagnostic Ultrasound Sysem, Nuewa R9 Pro/ Nuewa R9S/ Resona 7/ Resona 7CV/Resona 7EXP/Resona 7S/ Resona 70B Diagnostic Ultrasound System, Resona 7PRO/Imagyn 7/ Resona Y/Resona R9W/Resona R7W Nuewa R9W/Nuewa R7W Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | Class II | 2023-02-07 |
| K223735 | ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | IYN | Class II | 2023-02-06 |
| K223296 | Videa Perio Assist | Videahealth, Inc. | QIH | Class II | 2023-02-06 |
| K230059 | Digital Flat Panel Detector | Ray Imaging Technology (Haining) Limited | MQB | Class II | 2023-02-03 |
| K222803 | Oncospace | Oncospace, Inc. | MUJ | Class II | 2023-02-02 |
| K230012 | Atomica Planner | Atomica Technology, Inc. | LLZ | Class II | 2023-02-02 |
| K223396 | Rapid RV/LV | Ischemaview, Inc. | QIH | Class II | 2023-02-01 |
| K222970 | LVivo IQS | Dia Imaging Analysis, Ltd. | QIH | Class II | 2023-02-01 |
| K230020 | BriefCase | Aidoc Medical , Ltd. | QFM | Class II | 2023-02-01 |
| DEN220014 | RefleXion Medical Radiotherapy System (RMRS) | Reflexion Medical, Inc. | QVA | Class II | 2023-02-01 |
| K213480 | 31P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head Coil | Rapid Biomedical GmbH | MOS | Class II | 2023-02-01 |
| K222664 | Sim&Size | Sim&Cure | PZO | Class II | 2023-01-27 |
| K221868 | QOCA image Smart CXR Image Processing System | Quanta Computer, Inc. | QFM | Class II | 2023-01-27 |
| K223546 | 14HQ721G-B | Lg Electronics.Inc | MQB | Class II | 2023-01-27 |
| K220073 | RMF-2000 | DRTECH Corporation | MUE | Class II | 2023-01-26 |
| K221949 | Ortho Device, ADAPTIX 3D Orthopedic Imaging System | Pausch Medical GmbH | IZF | Class II | 2023-01-26 |
| K221619 | ECHELON Oval V6.2 MRI System | Fujifilm Healthcare Corporation | LNH | Class II | 2023-01-26 |
14,721 clearances in the Radiology panel. Data: openFDA.