| Swoop® Portable MR Imaging® System (K251276) | Hyperfine, Inc. | 2025-05-21 |
| SMARTDent (K251109) | Ray Co., Ltd. | 2025-05-21 |
| SCENARIA View Phase 5.0 (K250370) | Fujifilm Corporation | 2025-05-20 |
| MapRT (K243301) | Vision Rt, Ltd. | 2025-05-19 |
| Diagnostic X-ray System (K243411) | Nanjing Perlove Medical Equipment Co., Ltd. | 2025-05-19 |
| Diagnostic Ultrasound System (Recho R9W); Diagnostic Ultrasound System (Recho R9); Diagnostic Ultrasound System (Recho R9 Pro); Diagnostic Ultrasound System (Recho R9 Exp); Diagnostic Ultrasound System (Recho R9S); Diagnostic Ultrasound System (Recho R9T); Diagnostic Ultrasound System (Crius R9 CV); Diagnostic Ultrasound System (Anesus R9 CV); Diagnostic Ultrasound System (Recho R9 Super); Diagnostic Ultrasound System (Recho R9 Lumi); Diagnostic Ultrasound System (Recho R CV); Diagnost (K250020) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025-05-19 |
| InferRead Lung CT.AI (K240554) | Infervision Medical Technology Co., Ltd. | 2025-05-16 |
| Mobius3D (4.1) (K250099) | Varian Medical Systems | 2025-05-16 |
| MasteRad MiniX Mobile Digital Imaging System (Mini-X) (K242731) | Medicatech USA, Inc. | 2025-05-16 |
| 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) (K241671) | Esaote, S.p.A. | 2025-05-16 |
| uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy Analysis (K243617) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-05-16 |
| Diagnostic Ultrasound System (MX6); Diagnostic Ultrasound System (MX6S); Diagnostic Ultrasound System (MX6T); Diagnostic Ultrasound System (MX6 Exp); Diagnostic Ultrasound System (MX6 Pro); Diagnostic Ultrasound System (MX6 Super); Diagnostic Ultrasound System (MXG); Diagnostic Ultrasound System (Emerus MX6); Diagnostic Ultrasound System (Emerus MX6 Exp); Diagnostic Ultrasound System (Anesus MX6); Diagnostic Ultrasound System (Anesus MX6 Exp); Diagnostic Ultrasound System (Crius MX6); (K250110) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025-05-16 |
| Spectral CT (K244008) | Philips Medical Systems Technologies , Ltd. | 2025-05-16 |
| Lumify Diagnostic Ultrasound System (K242519) | Philips Ultrasound | 2025-05-15 |
| Smile Dx® (K242437) | Cube Click, Inc. | 2025-05-14 |
| Medical Image Post-processing Software (uOmnispace.CT) (K242624) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-05-14 |
| Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5 (K242808) | Canon Medical Systems Corporation | 2025-05-13 |
| uWS-Angio Basic (K243632) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-05-12 |
| P-Cure Proton Therapy System (PPTS) (K242418) | P-Cure, Ltd. | 2025-05-12 |
| Second Opinion® BLE (K243230) | Pearl, Inc. | 2025-05-09 |
| EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems (K251110) | Philips Ultrasound, LLC | 2025-05-09 |
| CT/ MR Tandem and Ovoid Set (K250299) | Varian Medical Systems, Inc. | 2025-05-09 |
| Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series); Ultrasound Imaging System (LX Series) (K243226) | Leltek, Inc. | 2025-05-08 |
| Lumify Diagnostic Ultrasound System (K242670) | Philips Ultrasound | 2025-05-08 |
| Clarius Median Nerve AI (K250226) | Clarius Mobile Health Corp. | 2025-05-08 |
| BrightHeart View Classifier (K243684) | Brightheart | 2025-05-07 |
| !M1 (K241980) | Solutions For Tomorrow AB | 2025-05-06 |
| ANKYRAS (K250160) | Mentice Spain S.L. | 2025-05-06 |
| Second Opinion® Pediatric (K243893) | Pearl, Inc. | 2025-05-05 |
| Fetal EchoScan (v1.1) (K251071) | Brightheart | 2025-05-02 |
| LUMYS (V1) (K243069) | Intradys | 2025-05-02 |
| Vscan Air (K250087) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2025-05-01 |
| UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program (K250328) | Canon Medical Systems Corporation | 2025-04-30 |
| Persona C HR (K250282) | A.T.S. Applicazione Tecnologie Speciali S.R.L. | 2025-04-30 |
| uAngio AVIVA CX (K243376) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-04-28 |
| Flash Ultrasound System 5100 Point of Care (K250030) | Philips Ultrasound, LLC | 2025-04-28 |
| Intracavitary/Interstitial System (K250289) | Varian Medical Systems | 2025-04-25 |
| Kosmos (K242321) | EchoNous, Inc. | 2025-04-25 |
| Lung AI (LAI001) (K243239) | Exo, Inc. | 2025-04-24 |
| EchoGuide (Version 1) (K243479) | Sonavex, Inc. | 2025-04-23 |
| MySpine WebPlanner (K243697) | Medacta International S.A. | 2025-04-23 |
| eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R, eHertz S) (K250228) | Esonic Technology (Wuhan) Co., Ltd. | 2025-04-23 |
| Annalise Enterprise (K250831) | Annalise-Ai | 2025-04-23 |
| VersaViewer (K243651) | GE Medical Systems SCS | 2025-04-21 |
| Wireless/ Wired X-Ray Flat Panel Detectors (K243734) | Allengers Medical Systems Limited | 2025-04-18 |
| ULTRA 1040 (K241996) | Ecoray Co., Ltd. | 2025-04-18 |
| Dental Cone Beam Computed Tomography System (K243337) | Yofo Medical Technology Co., Ltd. | 2025-04-17 |
| RayCare (2024A SP1) (K242992) | RaySearch Laboratories AB (PUBL) | 2025-04-17 |
| LARALAB (K242500) | Laralab GmbH | 2025-04-16 |
| Nanox.ARC X (K250850) | Nano-X Imaging , Ltd. | 2025-04-16 |
| Clarius Prostate AI (K243853) | Clarius Mobile Health Corp. | 2025-04-16 |
| MySegmenter (v2.0.0) (K242647) | Mysegmenter Technologies, Inc. | 2025-04-16 |
| SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option (K250650) | Arineta , Ltd. | 2025-04-15 |
| Merge Universal Viewer (MUV) (K250301) | Merge Healthcare Incorporated | 2025-04-14 |
| OTOPLAN (K242120) | Cascination AG | 2025-04-11 |
| Oncospace (K242748) | Oncospace, Inc. | 2025-04-11 |
| Second Opinion Periapical Radiolucency Contours (K242600) | Pearl, Inc. | 2025-04-11 |
| Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2) (K242098) | Shenzhen Vivolight Medical Device & Technology Co., Ltd. | 2025-04-11 |
| GBrain MRI (K250416) | Galileo Cds, Inc. | 2025-04-11 |
| syngo.CT LVO Detection (K243145) | Siemens Medical Solutions USA, Inc. | 2025-04-10 |
| EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System (K250177) | Philips Ultrasound, LLC | 2025-04-10 |
| Vitrea CT VScore (K243240) | Canon Medical Informatics, Inc. | 2025-04-10 |
| cmAngio® (V1.6) (K250754) | Curemetrix, Inc. | 2025-04-10 |
| Horos Mobile (K242552) | Icat Solutions, Ltd. | 2025-04-08 |
| BunkerHill BMD (K242295) | BunkerHill Health | 2025-04-08 |
| QFR (3.0) (K243769) | Qfr Solutions BV | 2025-04-04 |
| HeartFocus (V.1.1.1) (K242807) | Deski | 2025-04-04 |
| DeepFoqus (DeepFoqus-Accelerate) (K241982) | Foqus Technologies, Inc. | 2025-04-04 |
| RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3 (K240398) | RaySearch Laboratories AB (PUBL) | 2025-04-04 |
| Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound System (K243298) | Carbon (Shenzhen) Medical Device Co., Ltd. | 2025-04-03 |
| syngo Dynamics (Version VA41D) (K242551) | Siemens Healthcare GmbH | 2025-04-03 |
| Hi-D Imaging 4TAVR (K241984) | Hi-D Imaging AG | 2025-04-02 |
| MR Contour DL (K242925) | GE Healthcare | 2025-04-01 |
| TribusConnect (K242166) | Tribusmed Beheer BV | 2025-03-31 |
| 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 (K243178) | Shantou Institute of Ultrasonic Instruments Co., Ltd. | 2025-03-31 |
| ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version 2.0) (K234067) | Medphoton GmbH | 2025-03-28 |
| Salix Central (K243038) | Artrya Limited | 2025-03-27 |
| AI-Rad Companion Organs RT (K242745) | Siemens Healthcare GmbH | 2025-03-27 |
| V5med Lung AI (K242919) | V5med, Inc. | 2025-03-27 |
| Rayvolve LN (K243831) | AZmed | 2025-03-26 |
| Rayvolve PTX-PE (K243808) | AZmed | 2025-03-21 |
| brAIn™ Shoulder Positioning (K243292) | Avatar Medical | 2025-03-20 |
| Vent Creativity Knee v1.0 (Hermes) (K241961) | Vent Creativity | 2025-03-20 |
| EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG (K242770) | DRTECH Corporation | 2025-03-20 |
| Starlight Imaging Catheter (K243016) | Spectrawave, Inc. | 2025-03-20 |
| AVIEW (K243689) | Coreline Soft Co., Ltd. | 2025-03-19 |
| PeekMed web (K250042) | Peek Health, S.A. | 2025-03-19 |
| 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 (K250429) | Macromedics BV | 2025-03-19 |
| EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1; EXPD 3643NU; EXPD 3643NP (K243443) | DRTECH Corporation | 2025-03-19 |
| Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43) (K243556) | Iray Imaging Technology (Haining) Limited | 2025-03-18 |
| Radlink GPS Pro Imaging (K242161) | Radlink, Inc. | 2025-03-18 |
| QP-Prostate® CAD (K242683) | Quibim S.L. | 2025-03-18 |
| Klarity SGRT System (ARSG-E1A, ARSG-E3A) (K241937) | Klarity Medical & Equipment (GZ) Co., Ltd. | 2025-03-18 |
| SERV MEDICAL CDSS (K241975) | Serv Medical Pte., Ltd. | 2025-03-17 |
| LVivo Software Application (K243862) | Dia Imaging Analysis, Ltd. | 2025-03-17 |
| Ziehm Solo FD (K243646) | Ziehm Imaging GmbH | 2025-03-17 |
| SIGNA Prime Elite (K250379) | Ge Medical Systems, LLC | 2025-03-17 |
| BodyTom 64 (K242811) | Neurologica Corporation, A Subsidiary of Samsung | 2025-03-14 |
| PLANET Onco Dose (3.2) (K241765) | Dosisoft SA | 2025-03-14 |
| Ziehm Vision FD (K243735) | Ziehm Imaging GmbH | 2025-03-13 |