| X1-FFR (K251355) | Spectrawave, Inc. | 2025-10-17 |
| Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout (K252476) | Brainlab AG | 2025-10-16 |
| AGFA HealthCare Enterprise Imaging (K252199) | Agfa Healthcare N.V. | 2025-10-15 |
| syngo.CT Dual Energy (K251805) | Siemens Medical Solutions USA, Inc. | 2025-10-15 |
| Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (K251602) | Canon Medical Systems Corporation | 2025-10-10 |
| EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System (K251651) | Philips Ultrasound, LLC | 2025-10-09 |
| Lux HD 2530 detector (Lux HD 2530) (K252911) | Iray Imaging Technology (Haining) Limited | 2025-10-09 |
| GT300; GT300-C (K250060) | Genoray Co., Ltd. | 2025-10-08 |
| ProKnow DS (K251363) | Elekta Solutions AB | 2025-10-08 |
| AIAS Cephalon (K252214) | Metamorphosis GmbH | 2025-10-07 |
| TrueBeam, TrueBeam STX, Edge and VitalBeam (K252948) | Varian Medical Systems, Inc. | 2025-10-07 |
| deepLive (OSP12 + DMS) (K252851) | Damae Medical | 2025-10-07 |
| BlineSlide (K252007) | Deep Breathe, Inc. | 2025-10-06 |
| HPACS (K250039) | Healthhub | 2025-10-03 |
| Bunkerhill MAC (K250662) | BunkerHill Health | 2025-10-03 |
| Philips IntelliSpace Cardiovascular (K251215) | Philips Medical Systems Nederland B.V. | 2025-10-02 |
| LungQ 4 (K250766) | Thirona BV | 2025-10-02 |
| Shear Wave Quantificational Ultrasound Diagnostic System (FH9000/FH7000/FH6000/FH5000/FH3000/FH1000) (K250026) | Wuxi Hisky Medical Technologies Co., Ltd. | 2025-10-01 |
| PRO-DOSE System (K250083) | Nu-Rise, SA | 2025-10-01 |
| Astrasono A3Pro Bladder Scanner (A3Pro) (K250331) | Astrasono Technology Co., Ltd. | 2025-09-30 |
| SMART PCFD (K250023) | Disior, Ltd. | 2025-09-29 |
| Ligence Heart (K252105) | Ligence Uab | 2025-09-26 |
| Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 with Calculated DAP (K251645) | Canon Medical Systems Corporation | 2025-09-26 |
| Planmed XFI (K250318) | Planmed OY | 2025-09-26 |
| Brain WMH (K251527) | Quantib B.V. | 2025-09-25 |
| uMR 680 (K252371) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-09-25 |
| uWS-Angio Pro (K250045) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-09-24 |
| Rapid Aortic Measurements (K251987) | Ischemaview, Inc. | 2025-09-23 |
| SwiftSight-Brain (K251483) | Airs Medical, Inc. | 2025-09-23 |
| IC-Flow™ Imaging System 2.0 (K243645) | Diagnostic Green GmbH | 2025-09-22 |
| Videa Dental AI (K251002) | Videahealth, Inc. | 2025-09-19 |
| uDR Aurora CX (K251167) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-09-19 |
| ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R) (K250883) | Olympus Medical Systems Corporation | 2025-09-18 |
| Axial3D Insight (K250369) | Axial Medical Printing Limited | 2025-09-18 |
| ECHELON Synergy (K251386) | Fujifilm Corporation | 2025-09-17 |
| Insight Enhanced™ DRF (EN-1002-01) (K251650) | Imaging Engineering, LLC | 2025-09-16 |
| InferOperate Suite (K250237) | Beijing Infervision Healthcare Medical Technology Co., Ltd. | 2025-09-15 |
| BONX805 (K243864) | Bontech Co., Ltd. | 2025-09-12 |
| ViewMateTM Ultrasound System (K251820) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025-09-12 |
| uWS-Angio (K250040) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-09-12 |
| S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) (K250986) | Mevion Medical Systems, Inc. | 2025-09-12 |
| FETOLY (K251368) | Diagnoly | 2025-09-12 |
| SIGNA™ Sprint (K251399) | Ge Medical Systems, LLC | 2025-09-11 |
| Minimally Invasive Prostate Surgery Navigation System(Model:AmaKris SR1-A-2) (K242314) | Augment Intelligent Medical System (China) Co., Ltd. | 2025-09-11 |
| AngioWaveNet (K244002) | Angiowave Imaging, Inc. | 2025-09-10 |
| Segmentron Viewer (K251072) | DGNCT, LLC | 2025-09-09 |
| AI-Rad Companion Prostate MR (K252608) | Siemens Healthcare GmbH | 2025-09-09 |
| MuscleView 2.0 (K251682) | Springbok, Inc. (Dba Springbok Analytics) | 2025-09-09 |
| Hybrid Viewer (00859873006240) (K252477) | Hermes Medical Solutions AB | 2025-09-09 |
| qER-CTA (v1.0) (K251610) | Qure.Ai Technologies | 2025-09-08 |
| BioTraceIO Vision (V1.7) (K251931) | Techsomed Medical Technologies | 2025-09-08 |
| OmniTom Elite with PCD (K250928) | Neurologica Corporation | 2025-09-08 |
| 3D-SHAPER (K251022) | 3D-Shaper Medical S.L | 2025-09-05 |
| ViewMate™ Multi Ultrasound System (VMM-ICE-01); ViewMate™ Multi Ultrasound System (VMM-ICE-02) (K251250) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025-09-05 |
| Rapid Obstructive Hydrocephalus, Rapid OH (K251533) | Ischemaview, Inc. | 2025-09-04 |
| Image Suite (K251168) | Carestream Health, Inc. | 2025-09-04 |
| Dose+ (1.0) (K250064) | Mvision AI OY | 2025-09-04 |
| Careverse CoronaryDoc (Careverse CoronaryDoc) (K251656) | Careverse Technology Pte. , Ltd. | 2025-09-04 |
| AquaCast Mask (K252174) | Blessing Cathay Corporation | 2025-09-03 |
| Tempus Pixel (K252539) | Arterys, Inc. | 2025-09-03 |
| VELMENI for DENTISTS (V4D) (K250753) | Velmeni, Inc. | 2025-09-02 |
| OsteoSight™ Hip (v1) (K251408) | Naitive Technologies, Ltd. | 2025-09-02 |
| SurgiTwin (K250290) | Twinsight | 2025-08-29 |
| PRAEVAorta®2 (K243859) | Nurea | 2025-08-29 |
| Sonosite LX and Sonosite PX Ultrasound Systems (K251106) | FUJIFILM Sonosite, Inc. | 2025-08-29 |
| RadiForce GX570; RadiForce GX570-AR (K252030) | Eizo Corporation | 2025-08-28 |
| Definium Tempo Select (K250788) | Ge Hualun Medical Systems Co. , Ltd. | 2025-08-28 |
| CT:VQ (K251484) | 4Dmedical Limited | 2025-08-28 |
| VistaSoft 4.0 and VisionX 4.0 (K250947) | Durr Dental SE | 2025-08-27 |
| Rapid DeltaFuse (K252526) | Ischemaview, Inc. | 2025-08-26 |
| Brainomix 360 Triage Stroke (K251983) | Brainomix Limited | 2025-08-26 |
| Neurovascular Insight V1.0 (K243680) | Olea Medical S.A.S. | 2025-08-25 |
| GBrain MRI (K252362) | Galileo Cds, Inc. | 2025-08-22 |
| MammoScreen BD (K243685) | Therapixel | 2025-08-22 |
| PROMO (K251443) | DRGEM Corporation | 2025-08-22 |
| Diagnostic Ultrasound System (MX7); Diagnostic Ultrasound System (MX7T); Diagnostic Ultrasound System (Vaus7); Diagnostic Ultrasound System (Zeus); Diagnostic Ultrasound System (ME7); Diagnostic Ultrasound System (Anesus ME7); Diagnostic Ultrasound System (Anesus ME7T); Diagnostic Ultrasound System (MX7P); Diagnostic Ultrasound System (MX7W); Diagnostic Ultrasound System (MX8); Diagnostic Ultrasound System (MX8T); Diagnostic Ultrasound System (Vaus8); Diagnostic Ultrasound System (ME8) (K251192) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025-08-22 |
| Vista OS, Vista AI Scan, RTHawk (K251029) | Vista AI, Inc. | 2025-08-21 |
| ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound System (K251481) | Siemens Medical Solutions USA, Inc. | 2025-08-20 |
| Methinks CTA Stroke (K251590) | Methinks Software, S.L | 2025-08-20 |
| Salix Coronary Plaque (V1.0.0) (K251837) | Artrya Limited | 2025-08-20 |
| PHAROS (K250170) | Brightonix Imaging | 2025-08-15 |
| VEA Align; spineEOS (K251747) | Eos Imaging | 2025-08-15 |
| DS Core Diagnosis (K250755) | Dentsply Sirona, Inc. | 2025-08-12 |
| RW-1 (K232456) | Mediott, Inc. | 2025-08-11 |
| Saige-Dx (K251873) | DeepHealth, Inc. | 2025-08-11 |
| Navigo Workstation 2.3 (FPRMC00039) (K250664) | UC-CARE , Ltd. | 2025-08-07 |
| UNiD™ Spine Analyzer (K251629) | Medicrea International S.A.S. (Medtronic) | 2025-08-07 |
| InVision™ 3T Recharge Operating Suite (K252239) | Imris Imaging, Inc. | 2025-08-06 |
| Digital Radiographic Imaging Acquisition Software - DR (RiasDR) (K251038) | Shen Zhen Cambridge-Hit Co., Ltd. | 2025-08-06 |
| trophon2 (K250434) | Nanosonics | 2025-08-05 |
| uMR Jupiter (K250246) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-08-05 |
| iPETcertum (v1.0) (K244016) | Claritas Healthtech Pte, Ltd. | 2025-08-05 |
| HnX-P1, HnX-PB (K251223) | H&abyz Co., Ltd. | 2025-08-04 |
| Revolution Vibe (K250941) | Ge Medical Systems, LLC | 2025-08-01 |
| INNOVISION-DXII (K250790) | Dk Medical Systems Co., Ltd. | 2025-08-01 |
| Deepsight NeedleVue LC1 Ultrasound System (K250381) | DeepSight Technology, Inc. | 2025-08-01 |
| Biograph Trinion (K251561) | Siemens Medical Solutions USA, Inc. | 2025-07-31 |
| REMEX Xcam6 (K250597) | Remedi, Inc. | 2025-07-31 |
| Genius AI Detection 2.0 (K243341) | Hologic, Inc. | 2025-07-31 |
| YSIO X.pree (K250738) | Siemens Medical Solutions | 2025-07-31 |