| 2430TCA with Xmaru W (K243849) | Rayence Co., Ltd. | 2025-03-12 |
| RCT600 (K243903) | Ray Co., Ltd. | 2025-03-12 |
| Better Diagnostics Caries Assist (BDCA) Version 1.0 (K241725) | Better Diagnostics AI Corp. | 2025-03-11 |
| Cleerly LABS (v2.0) (K242338) | Cleerly, Inc. | 2025-03-07 |
| LVivo Seamless (K243331) | Dia Imaging Analysis, Ltd. | 2025-03-06 |
| Prostate MR AI (VA10A) (K241770) | Siemens Healthcare GmbH | 2025-03-05 |
| Ceevra Reveal 3+ (K243933) | Ceevra, Inc. | 2025-03-04 |
| HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow Reserve (CFR) Version 4 (K243881) | Bracco Diagnostics, Inc. | 2025-03-03 |
| LVivo Software Application (K243235) | Dia Imaging Analysis, Ltd. | 2025-03-03 |
| JLK-SDH (K243611) | JLK, Inc. | 2025-03-03 |
| Titanium Flexible Geometry FSD Applicator Set (GM11013400) (K243939) | Varian Medical Systems, Inc. | 2025-03-03 |
| 16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247) (K244054) | Quality Electrodynamics | 2025-02-28 |
| Myomics (K241922) | Phantomics, Inc. | 2025-02-28 |
| ChestView US (K241620) | Gleamer Sas | 2025-02-27 |
| Ventripoint Medical System Plus (VMS+) 4.0 (K241222) | Ventripoint Diagnostics , Ltd. | 2025-02-26 |
| aiCockpit AI Viewer (K241546) | Fovia, Inc. | 2025-02-26 |
| JLK-AILink (K250348) | JLK, Inc. | 2025-02-25 |
| 3DXR (K243446) | GE Medical Systems SCS | 2025-02-25 |
| ART-Plan+ (v.3.0.0) (K242822) | Therapanacea Sas | 2025-02-25 |
| ExamVue Apex (K244010) | Jpi Healthcare Co, Ltd. | 2025-02-24 |
| OncoStudio (OS-01) (K242994) | Oncosoft. Co., Ltd. | 2025-02-24 |
| Sonio Suspect (K243614) | Sonio | 2025-02-21 |
| Green X 12 SE (PHT-40CHS) (K243088) | VATECH Co., Ltd. | 2025-02-21 |
| ScanDiags Ortho L-Spine MR-Q (K242607) | Scandiags AG | 2025-02-21 |
| QuickRad (K242838) | Aikenist Technologies Pvt, Ltd. | 2025-02-21 |
| CaRi-Plaque (K242240) | Caristo Diagnostics , Ltd. | 2025-02-20 |
| 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) (K250214) | Edan Instruments, Inc. | 2025-02-20 |
| EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100) (K242821) | Ever Fortune.Ai, Co., Ltd. | 2025-02-20 |
| NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUSONO Handheld Ultrasound Scanner (NUSONO-L75); NUSONO Handheld Ultrasound Scanner (NUSONO-P25) (K242681) | Nurodata, Inc. | 2025-02-20 |
| Brainomix 360 e-Lung (K242411) | Brainomix Limited | 2025-02-19 |
| BriefCase-Triage (K250248) | Aidoc Medical , Ltd. | 2025-02-14 |
| AVIEW CAC (K243696) | Coreline Soft Co., Ltd. | 2025-02-14 |
| Brainomix 360 e-ASPECTS (K243294) | Brainomix Limited | 2025-02-14 |
| Green X 21 (PHT-90CHO) (K243081) | VATECH Co., Ltd. | 2025-02-14 |
| NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime (K243523) | Siemens Medical Solutions USA, Inc. | 2025-02-12 |
| SureWave Elastography (Q7000225) (K242006) | Quality Electrodynamics, LLC | 2025-02-12 |
| SubtleHD (1.x) (K243250) | Subtle Medical, Inc. | 2025-02-12 |
| AspenView (K241425) | Aspen Imaging Healthcare, Inc. | 2025-02-12 |
| V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System (K243702) | Samsung Medison Co., Ltd. | 2025-02-12 |
| Vivid iq (K243620) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2025-02-11 |
| Vivid T9/Vivid T8 (K243628) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2025-02-11 |
| Ultrasound Workspace (UWS 6.0) (K241659) | Philips Ultrasound, LLC | 2025-02-10 |
| Identify (4.0) (K242957) | Varian Medical Systems, Inc. | 2025-02-07 |
| EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System (K243794) | Philips Ultrasound, LLC | 2025-02-06 |
| BoneMetrics (US) (K241593) | Gleamer Sas | 2025-02-05 |
| rTOP (K243333) | Roclub GmbH | 2025-02-04 |
| Contour ProtégéAI+ (K250035) | Mim Software, Inc. | 2025-02-03 |
| ZeTTA PACS (K241694) | Tae Young Soft Co., Ltd. | 2025-01-31 |
| Bunkerhill AVC (K243229) | BunkerHill Health | 2025-01-27 |
| Imaging system of positron emission and X-ray computed tomography (DigitMI 930) (K241266) | Raysolution Healthcare Co., Ltd. | 2025-01-27 |
| TeraRecon Aorta.CT (1.1.0) (K243158) | Terarecon,Inc. | 2025-01-23 |
| CephNinja (K241819) | Cyncronus, LLC | 2025-01-23 |
| Rapid Neuro3D (K243350) | Ischemaview, Inc. | 2025-01-22 |
| Ziehm Vision RFD 3D (K243303) | Ziehm Imaging GmbH | 2025-01-21 |
| TBS iNsight (V4) (K243218) | Medimaps Group SA | 2025-01-17 |
| Prenuvo Body Composition (K242825) | Prenuvo | 2025-01-17 |
| Digital Color Doppler Ultrasound System (P60 Series) (K241949) | Sonoscape Medical Corp. | 2025-01-17 |
| EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME3 (OLYMPUS EU-ME3) (K243502) | Olympus Medical Systems Corporation | 2025-01-17 |
| Aurora (K243605) | Ge Medical Systems Israel, Functional Imaging | 2025-01-17 |
| TechCare Trauma (K242171) | Milvue | 2025-01-17 |
| Second Opinion CC (K242522) | Pearl, Inc. | 2025-01-16 |
| VIVIX-M (K241113) | Vieworks Co., Ltd. | 2025-01-16 |
| Ziehm Vision RFD (K243328) | Ziehm Imaging GmbH | 2025-01-15 |
| Cardiac Guidance (K243065) | Caption Health, Inc. | 2025-01-15 |
| uCT 550 (K241166) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-01-14 |
| SpectoMed (v1.0) (K242205) | Specto Medical | 2025-01-14 |
| Orthoscan VERSA Mini C-Arm (K243452) | Ziehm-Orthoscan, Inc. | 2025-01-14 |
| SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option (K241200) | Arineta , Ltd. | 2025-01-13 |
| ScreenDx (K241891) | Imvaria, Inc. | 2025-01-10 |
| Mould Probe MR Safe (K241764) | Varian Medical Systems, Inc. | 2025-01-10 |
| INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator) (K241174) | Carl Zeiss Meditec, AG | 2025-01-10 |
| Dental Cone-beam Computed Tomography (FinScan F350) (K242805) | Changzhou Finno Medical Technology Co., Ltd. | 2025-01-09 |
| uCT 780 (K241079) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-01-07 |
| Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR (K243335) | Canon Medical Systems Corporation | 2025-01-07 |
| ApolloHipX (THR.SS.0001) (K241808) | Corin U.S.A. Limited | 2025-01-07 |
| GXR-Series Diagnostic X-Ray System (K242019) | DRGEM Corporation | 2025-01-07 |
| Soteria E-View (K242488) | Omega Medical Imaging, LLC | 2025-01-06 |
| Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E)) (K242499) | Shenzhen Sontu Medical Imaging Equipment Co., Ltd. | 2025-01-06 |
| Brainomix 360 e-CTA (K242123) | Brainomix Limited | 2025-01-06 |
| INNOVISION-EXII (K242119) | Dk Medical System | 2025-01-03 |
| Clarify DL (K241350) | Ge Medical Systems Israel, Functional Imaging | 2025-01-03 |
| syngo.CT Dual Energy (K241757) | Siemens Medical Solutions USA, Inc. | 2025-01-03 |
| JLK-ICH (K243363) | JLK, Inc. | 2025-01-03 |
| Ortho AI (K241696) | Ortho Ai, LLC | 2025-01-02 |
| Ezra Flash (K242334) | Ezra Ai, Inc. | 2025-01-02 |
| BioTraceIO Precision (2.0) (K243084) | Techsomed Medical Technologies , Ltd. | 2024-12-27 |
| OEC One ASD (K240828) | Ge Hualun Medical Systems Co. , Ltd. | 2024-12-27 |
| NIDO Baby Magnetic Resonance Imaging System (K242573) | Jiangsu Lici Medical Device Co., Ltd. | 2024-12-23 |
| Adora DRFi (04550010) (K242948) | Nrt X-Ray A/S | 2024-12-23 |
| Aquilion ONE (TSX-308A/3) V1.5 (K242403) | Canon Medical Systems Corporation | 2024-12-23 |
| Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 (K242168) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2024-12-20 |
| aprevo® Digital Planning (K242599) | Carlsmed, Inc. | 2024-12-20 |
| Lightning Viewer (K242362) | Nexsys Electronics Inc. Dba Medweb | 2024-12-20 |
| InkSpace Imaging Small Body Array (K243675) | Inkspace Imaging, Inc. | 2024-12-20 |
| OrthoNext Platform System (K242270) | Orthofix Srl | 2024-12-19 |
| Yushan X-Ray Flat Panel Detector (K243171) | Innocare Optoelectronics Corp. | 2024-12-19 |
| IQ-UIP (K242467) | Imbio, Inc. | 2024-12-19 |
| Saige-Density (2.5.0) (K243705) | DeepHealth, Inc. | 2024-12-19 |
| Saige-Dx (3.1.0) (K243688) | DeepHealth, Inc. | 2024-12-19 |
| MSKai (K240793) | Mskai | 2024-12-16 |