Review Panel
Radiology FDA 510(k) Clearances & Devices
- Cleared Devices
- 14,721
- Product Codes (page)
- 29
- Latest Decision
- 2025-05-05
Clearances · page 8 of 148
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K243893 | Second Opinion® Pediatric | Pearl, Inc. | MYN | Class II | 2025-05-05 |
| K251071 | Fetal EchoScan (v1.1) | Brightheart | POK | Class II | 2025-05-02 |
| K243069 | LUMYS (V1) | Intradys | LLZ | Class II | 2025-05-02 |
| K250087 | Vscan Air | GE Medical Systems Ultrasound and Primary Care Diagnostics | IYN | Class II | 2025-05-01 |
| K250282 | Persona C HR | A.T.S. Applicazione Tecnologie Speciali S.R.L. | OWB | Class II | 2025-04-30 |
| K250328 | UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program | Canon Medical Systems Corporation | QIH | Class II | 2025-04-30 |
| K243376 | uAngio AVIVA CX | Shanghai United Imaging Healthcare Co., Ltd. | OWB | Class II | 2025-04-28 |
| K250030 | Flash Ultrasound System 5100 Point of Care | Philips Ultrasound, LLC | IYN | Class II | 2025-04-28 |
| K250289 | Intracavitary/Interstitial System | Varian Medical Systems | JAQ | Class II | 2025-04-25 |
| K242321 | Kosmos | EchoNous, Inc. | IYN | Class II | 2025-04-25 |
| K243239 | Lung AI (LAI001) | Exo, Inc. | MYN | Class II | 2025-04-24 |
| K243697 | MySpine WebPlanner | Medacta International S.A. | LLZ | Class II | 2025-04-23 |
| K250228 | eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R, eHertz S) | Esonic Technology (Wuhan) Co., Ltd. | IYN | Class II | 2025-04-23 |
| K243479 | EchoGuide (Version 1) | Sonavex, Inc. | IYO | Class II | 2025-04-23 |
| K250831 | Annalise Enterprise | Annalise-Ai | QFM | Class II | 2025-04-23 |
| K243651 | VersaViewer | GE Medical Systems SCS | LLZ | Class II | 2025-04-21 |
| K243734 | Wireless/ Wired X-Ray Flat Panel Detectors | Allengers Medical Systems Limited | MQB | Class II | 2025-04-18 |
| K241996 | ULTRA 1040 | Ecoray Co., Ltd. | IZL | Class II | 2025-04-18 |
| K242992 | RayCare (2024A SP1) | RaySearch Laboratories AB (PUBL) | MUJ | Class II | 2025-04-17 |
| K243337 | Dental Cone Beam Computed Tomography System | Yofo Medical Technology Co., Ltd. | OAS | Class II | 2025-04-17 |
| K242647 | MySegmenter (v2.0.0) | Mysegmenter Technologies, Inc. | LLZ | Class II | 2025-04-16 |
| K243853 | Clarius Prostate AI | Clarius Mobile Health Corp. | QIH | Class II | 2025-04-16 |
| K250850 | Nanox.ARC X | Nano-X Imaging , Ltd. | IZF | Class II | 2025-04-16 |
| K242500 | LARALAB | Laralab GmbH | QIH | Class II | 2025-04-16 |
| K250650 | SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option | Arineta , Ltd. | JAK | Class II | 2025-04-15 |
| K250301 | Merge Universal Viewer (MUV) | Merge Healthcare Incorporated | LLZ | Class II | 2025-04-14 |
| K242748 | Oncospace | Oncospace, Inc. | MUJ | Class II | 2025-04-11 |
| K242120 | OTOPLAN | Cascination AG | QQE | Class II | 2025-04-11 |
| K242098 | Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2) | Shenzhen Vivolight Medical Device & Technology Co., Ltd. | NQQ | Class II | 2025-04-11 |
| K242600 | Second Opinion Periapical Radiolucency Contours | Pearl, Inc. | MYN | Class II | 2025-04-11 |
| K250416 | GBrain MRI | Galileo Cds, Inc. | QIH | Class II | 2025-04-11 |
| K250754 | cmAngio® (V1.6) | Curemetrix, Inc. | QIH | Class II | 2025-04-10 |
| K243145 | syngo.CT LVO Detection | Siemens Medical Solutions USA, Inc. | QAS | Class II | 2025-04-10 |
| K250177 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | IYN | Class II | 2025-04-10 |
| K243240 | Vitrea CT VScore | Canon Medical Informatics, Inc. | JAK | Class II | 2025-04-10 |
| K242552 | Horos Mobile | Icat Solutions, Ltd. | LLZ | Class II | 2025-04-08 |
| K242295 | BunkerHill BMD | BunkerHill Health | KGI | Class II | 2025-04-08 |
| K241982 | DeepFoqus (DeepFoqus-Accelerate) | Foqus Technologies, Inc. | QIH | Class II | 2025-04-04 |
| K243769 | QFR (3.0) | Qfr Solutions BV | QHA | Class II | 2025-04-04 |
| K242807 | HeartFocus (V.1.1.1) | Deski | QJU | Class II | 2025-04-04 |
| K240398 | RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3 | RaySearch Laboratories AB (PUBL) | MUJ | Class II | 2025-04-04 |
| K243298 | Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound System | Carbon (Shenzhen) Medical Device Co., Ltd. | IYN | Class II | 2025-04-03 |
| K242551 | syngo Dynamics (Version VA41D) | Siemens Healthcare GmbH | QIH | Class II | 2025-04-03 |
| K241984 | Hi-D Imaging 4TAVR | Hi-D Imaging AG | QIH | Class II | 2025-04-02 |
| K242925 | MR Contour DL | GE Healthcare | QKB | Class II | 2025-04-01 |
| K243178 | Digital Color Doppler Ultrasound Imaging System (Apogee C1); Digital Color Doppler Ultrasound Imaging System (Apogee C2); Digital Color Doppler Ultrasound Imaging System (Apogee C3); Digital Color Doppler Ultrasound Imaging System (Apogee C5); Digital Color Doppler Ultrasound Imaging System (Apogee K1); Digital Color Doppler Ultrasound Imaging System (Apogee K2); Digital Color Doppler Ultrasound Imaging System (Apogee K3); Digital Color Doppler Ultrasound Imaging System (Apogee K5); Di | Shantou Institute of Ultrasonic Instruments Co., Ltd. | IYN | Class II | 2025-03-31 |
| K242166 | TribusConnect | Tribusmed Beheer BV | QIH | Class II | 2025-03-31 |
| K234067 | ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version 2.0) | Medphoton GmbH | OWB | Class II | 2025-03-28 |
| K242745 | AI-Rad Companion Organs RT | Siemens Healthcare GmbH | QKB | Class II | 2025-03-27 |
| K243038 | Salix Central | Artrya Limited | QIH | Class II | 2025-03-27 |
| K242919 | V5med Lung AI | V5med, Inc. | OEB | Class II | 2025-03-27 |
| K243831 | Rayvolve LN | AZmed | MYN | Class II | 2025-03-26 |
| K243808 | Rayvolve PTX-PE | AZmed | QFM | Class II | 2025-03-21 |
| K243016 | Starlight Imaging Catheter | Spectrawave, Inc. | NQQ | Class II | 2025-03-20 |
| K241961 | Vent Creativity Knee v1.0 (Hermes) | Vent Creativity | QIH | Class II | 2025-03-20 |
| K242770 | EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG | DRTECH Corporation | MQB | Class II | 2025-03-20 |
| K243292 | brAIn Shoulder Positioning | Avatar Medical | LLZ | Class II | 2025-03-20 |
| K250042 | PeekMed web | Peek Health, S.A. | QIH | Class II | 2025-03-19 |
| K243443 | EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1; EXPD 3643NU; EXPD 3643NP | DRTECH Corporation | MQB | Class II | 2025-03-19 |
| K243689 | AVIEW | Coreline Soft Co., Ltd. | QIH | Class II | 2025-03-19 |
| K250429 | DSPS-Prominent® baseplate, MR (113820); DSPS-Prominent® baseplate (113120); DSPS-Prominent® Cradle-I (113140); DSPS-Prominent® Cradle-II (113150); DSPS-Prominent® Cradle-III (113160); DSPS-Prominent® Cradle-IV (113170); DSPS-Prominent® Cradle-VI (113180); DSPS-Prominent® Cradle-VII (113260); Mask DSPS®-PROSCVRL set/5 (113760); Mask DSPS®-PROSC set/5 (113770); Mask DSPS®-PROSCVR set/5 (113780); Mask DSPS®-PROSCL set/5 (113790); Mask DSPS®-PROSHVRL set/5 (113890); Mask DSPS®-PROSH set | Macromedics BV | IYE | Class II | 2025-03-19 |
| K242683 | QP-Prostate® CAD | Quibim S.L. | QDQ | Class II | 2025-03-18 |
| K242161 | Radlink GPS Pro Imaging | Radlink, Inc. | LLZ | Class II | 2025-03-18 |
| K243556 | Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43) | Iray Imaging Technology (Haining) Limited | MQB | Class II | 2025-03-18 |
| K241937 | Klarity SGRT System (ARSG-E1A, ARSG-E3A) | Klarity Medical & Equipment (GZ) Co., Ltd. | IYE | Class II | 2025-03-18 |
| K250379 | SIGNA Prime Elite | Ge Medical Systems, LLC | LNH | Class II | 2025-03-17 |
| K241975 | SERV MEDICAL CDSS | Serv Medical Pte., Ltd. | LLZ | Class II | 2025-03-17 |
| K243862 | LVivo Software Application | Dia Imaging Analysis, Ltd. | QIH | Class II | 2025-03-17 |
| K243646 | Ziehm Solo FD | Ziehm Imaging GmbH | OWB | Class II | 2025-03-17 |
| K242811 | BodyTom 64 | Neurologica Corporation, A Subsidiary of Samsung | JAK | Class II | 2025-03-14 |
| K241765 | PLANET Onco Dose (3.2) | Dosisoft SA | LLZ | Class II | 2025-03-14 |
| K243735 | Ziehm Vision FD | Ziehm Imaging GmbH | OWB | Class II | 2025-03-13 |
| K243849 | 2430TCA with Xmaru W | Rayence Co., Ltd. | MUE | Class II | 2025-03-12 |
| K243903 | RCT600 | Ray Co., Ltd. | OAS | Class II | 2025-03-12 |
| K241725 | Better Diagnostics Caries Assist (BDCA) Version 1.0 | Better Diagnostics AI Corp. | MYN | Class II | 2025-03-11 |
| K242338 | Cleerly LABS (v2.0) | Cleerly, Inc. | QIH | Class II | 2025-03-07 |
| K243331 | LVivo Seamless | Dia Imaging Analysis, Ltd. | QIH | Class II | 2025-03-06 |
| K241770 | Prostate MR AI (VA10A) | Siemens Healthcare GmbH | QDQ | Class II | 2025-03-05 |
| K243933 | Ceevra Reveal 3+ | Ceevra, Inc. | QIH | Class II | 2025-03-04 |
| K243881 | HeartSee Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow Reserve (CFR) Version 4 | Bracco Diagnostics, Inc. | KPS | Class II | 2025-03-03 |
| K243939 | Titanium Flexible Geometry FSD Applicator Set (GM11013400) | Varian Medical Systems, Inc. | JAQ | Class II | 2025-03-03 |
| K243611 | JLK-SDH | JLK, Inc. | QAS | Class II | 2025-03-03 |
| K243235 | LVivo Software Application | Dia Imaging Analysis, Ltd. | QIH | Class II | 2025-03-03 |
| K241922 | Myomics | Phantomics, Inc. | QIH | Class II | 2025-02-28 |
| K244054 | 16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247) | Quality Electrodynamics | MOS | Class II | 2025-02-28 |
| K241620 | ChestView US | Gleamer Sas | MYN | Class II | 2025-02-27 |
| K241222 | Ventripoint Medical System Plus (VMS+) 4.0 | Ventripoint Diagnostics , Ltd. | QIH | Class II | 2025-02-26 |
| K241546 | aiCockpit AI Viewer | Fovia, Inc. | LLZ | Class II | 2025-02-26 |
| K242822 | ART-Plan+ (v.3.0.0) | Therapanacea Sas | MUJ | Class II | 2025-02-25 |
| K250348 | JLK-AILink | JLK, Inc. | LLZ | Class II | 2025-02-25 |
| K243446 | 3DXR | GE Medical Systems SCS | OWB | Class II | 2025-02-25 |
| K242994 | OncoStudio (OS-01) | Oncosoft. Co., Ltd. | QKB | Class II | 2025-02-24 |
| K244010 | ExamVue Apex | Jpi Healthcare Co, Ltd. | MQB | Class II | 2025-02-24 |
| K243614 | Sonio Suspect | Sonio | POK | Class II | 2025-02-21 |
| K243088 | Green X 12 SE (PHT-40CHS) | VATECH Co., Ltd. | OAS | Class II | 2025-02-21 |
| K242607 | ScanDiags Ortho L-Spine MR-Q | Scandiags AG | QIH | Class II | 2025-02-21 |
| K242838 | QuickRad | Aikenist Technologies Pvt, Ltd. | LLZ | Class II | 2025-02-21 |
| K242240 | CaRi-Plaque | Caristo Diagnostics , Ltd. | LLZ | Class II | 2025-02-20 |
| K250214 | Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8, Acclarix AX75, Acclarix AX78, Acclarix AX8 Exp, Acclarix AX8 Super), Acclarix AX9 Series Diagnostic Ultrasound Szystem (Model: Acclarix AX9 Basic, Acclarix AX9, Acclarix AX9 Exp, Acclarix AX9 Super, Acclarix AX85, Acclarix AX88) | Edan Instruments, Inc. | IYN | Class II | 2025-02-20 |
| K242821 | EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100) | Ever Fortune.Ai, Co., Ltd. | QAS | Class II | 2025-02-20 |
14,721 clearances in the Radiology panel. Data: openFDA.