| mdprostate (K252571) | Mediaire GmbH | 2026-08-07 |
| Zenition 30 (K254205) | Philips Medical Systems Nederland B.V. | 2026-08-07 |
| Venue Go (K261668) | GE Medical Systems Ultrasound and Primary care Diagnostics, LLC | 2026-08-07 |
| Overjet Multi-Image Caries and Charting Assist (K261059) | Overjet, Inc. | 2026-08-06 |
| RealGUIDE (K253902) | 3DIEMME SRL | 2026-08-04 |
| Alturion Series Diagnostic Ultrasound System (K262311) | Philips Ultrasound, LLC | 2026-08-04 |
| Halcyon, Ethos Radiotherapy System (5.0) (K261856) | Varian Medical Systems, Inc. | 2026-08-03 |
| XLITE (K260236) | GEMSS HEALTHCARE CO., LTD. | 2026-08-03 |
| I-Genius (100019400) (K261331) | Esaote, S.p.A. | 2026-07-31 |
| 0909FCE, 0909FCE-HS (K253800) | Rayence Co., Ltd. | 2026-07-31 |
| Affinity (K253835) | Hermes Medical Solutions AB | 2026-07-31 |
| MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.Pure (K260852) | Siemens Healthineers AG | 2026-07-31 |
| Shield System (Siemens 30x40) (K260607) | Radiaction , Ltd. | 2026-07-31 |
| RadioViewAI (K260936) | Neurocareai, Inc. (Dba Savelife.Ai) | 2026-07-31 |
| dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0T (K262330) | Philips Medical Systems Nederland B.V. | 2026-07-30 |
| cmAngio® V2.0 (K260980) | Curemetrix, Inc. | 2026-07-30 |
| SmartGuide Disposable Guides and Grids (K260161) | UC-CARE , Ltd. | 2026-07-30 |
| LOGIQ Focus (K261835) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2026-07-30 |
| Handheld Ultrasound Scanner (K261288) | IMGFAX CO., LTD. | 2026-07-30 |
| Cleerly Plaque (K261210) | Cleerly, Inc. | 2026-07-29 |
| Cleerly LABS (K260588) | Cleerly, Inc. | 2026-07-29 |
| BodyTom Elite (NL4000) (K253450) | NeuroLogica Corp., a Samsung Company | 2026-07-28 |
| V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System; V7/XV7/XH7/H7/cV7/V7 ONE/XV7 ONE/H7 ONE/XH7 ONE/cV7 ONE Diagnostic Ultrasound System; V6/XV6/XH6/H6/cV6/V6 ONE/XV6 ONE/H6 ONE/XH6 ONE/cV6 ONE Diagnostic Ultrasound System; V5/XV5/XH5/H5/cV5 Diagnostic Ultrasound System; V4/XV4/XH4/H4/cV4 Diagnostic Ultrasound System; (K261412) | Samsung Medison Co., Ltd. | 2026-07-28 |
| uMI Panvivo (uMI Panvivo M) (K261427) | Shanghai United Imaging Healthcare Co., Ltd. | 2026-07-28 |
| See-Mode Augmented Reporting Tool, Breast (SMART-B) (K260303) | See-Mode Technologies Pty, Ltd. | 2026-07-28 |
| Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic Ultrasound System (K261211) | Philips Ultrasound, LLC | 2026-07-27 |
| ND Needle Guidance System (K262474) | Accurate Access, LLC | 2026-07-27 |
| DIANA (K260192) | ROPCA ApS | 2026-07-24 |
| TheraSphere 360™ Y-90 Management Platform (K262462) | Boston Scientific Corporation | 2026-07-24 |
| LumenCare Azure (K262383) | Nucletron B.V. | 2026-07-24 |
| Accuro® 3S Needle Guide Kit (K261014) | Rivanna Medical, Inc. | 2026-07-24 |
| Accuro 3S (K253452) | Rivanna Medical, Inc. | 2026-07-24 |
| SwiftMR (K261349) | Airs Medical, Inc. | 2026-07-24 |
| dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes Hand/Wrist 16CH 3.0T;dS Small Extremity 16Ch 1.5T;dS Small Extremity 16Ch 3.0T (K262294) | Philips Medical Systems Nederland B.V. | 2026-07-24 |
| Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro) (K261081) | Beijing Konted Medical Technology Co.,Ltd | 2026-07-23 |
| ImageGrid StreamVue (K262143) | Candelis, Inc. | 2026-07-23 |
| VELMENI for DENTISTS (V4D) 3D (K254096) | Velmeni, Inc. | 2026-07-23 |
| Dental Cone-beam Computed Tomography (mDX-15P Series) (K261748) | Hefei Meyer Optoelectronic Technology, Inc. | 2026-07-23 |
| ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/ MOZI-X1/ MOZI-X12/ DF-41E Diagnostic ultrasound system (K261272) | Esonic Technology (Wuhan) Co., Ltd. | 2026-07-23 |
| ResolutionMD (K260500) | ResolutionMD, Inc. | 2026-07-21 |
| CardIQ Suite (K253770) | GE Medical Systems SCS | 2026-07-21 |
| Hi-D Imaging 4TAVR (K261535) | Hi-D Imaging AG | 2026-07-20 |
| ZEISS CLINIC 360 (K260694) | Carl Zeiss Meditec, AG | 2026-07-17 |
| Cubresa BrainPET (K253963) | Cubresa, Inc. | 2026-07-17 |
| ThinkSono Guidance (K260338) | ThinkSono GmbH | 2026-07-15 |
| SkeletonPlanner (K260206) | UPlanner B.V. - Presurgeo | 2026-07-15 |
| Better Diagnostics Dental Assist (BDDA) Version 1.0 (K260851) | Better Diagnostics AI Corp. | 2026-07-15 |
| Rapid Vessel Occlusion (Rapid VO) (K261085) | iSchemaview | 2026-07-13 |
| Avara Viewer (K262120) | Avara Software | 2026-07-10 |
| SmartCT (R3.0 (L10)) (K253670) | Philips Medical Systems B.V. | 2026-07-10 |
| AI Contouring (VA10A) (K261306) | Varian Medical Systems | 2026-07-10 |
| 3D-Anywhere (K253899) | Provect.AI | 2026-07-09 |
| CXRDetectAI (K253751) | Neurocareai, Inc. (Dba Savelife.Ai) | 2026-07-08 |
| Virtual Cone (1.0) (K260750) | Varian Medical Systems, Inc. | 2026-07-08 |
| Pulmonex II Xenon System (132-503) (K253942) | Mirion Technologies (Capintec), Inc. | 2026-07-07 |
| InferOperate Suite (K260973) | Beijing Infervision Healthcare Medical Technology Co., Ltd. | 2026-07-07 |
| INDIRA CLOUD VIEWER (K261465) | INDIGO TECHNOLOGIES | 2026-07-06 |
| Koios DS (3.8) (K253884) | Koios Medical, Inc. | 2026-07-02 |
| OncoStudio (K260528) | Oncosoft. Inc., | 2026-07-02 |
| MeVis AVM Contour (K260576) | MeVis Medical Solutions AG | 2026-06-30 |
| Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012) (K253628) | Agada Medical, Ltd. | 2026-06-29 |
| Alturion Series Diagnostic Ultrasound System (K260667) | Philips Ultrasound, LLC | 2026-06-29 |
| ADAS 3D (K253969) | Adas3D Medical S.L. | 2026-06-29 |
| MammoScreen® (5) (K260714) | Therapixel | 2026-06-26 |
| syngo.CT Coronary Cockpit (K253786) | Siemens Medical Solutions USA, Inc. | 2026-06-25 |
| MiPACS V5 (1.0.0) (K260231) | Apryse Software Corp | 2026-06-25 |
| Enhanced Boundary for PCCT (K253560) | Ge Medical Systems, LLC | 2026-06-24 |
| Perfusion Measurement Platform v1 (K253421) | Quantified Imaging Limited | 2026-06-22 |
| CMN Capillary Function with Oncology Virtual Expert (K260316) | Cercare Medical A/S | 2026-06-22 |
| ARTHUR (K260190) | ROPCA ApS | 2026-06-18 |
| RadOncAI (K253050) | Informai | 2026-06-18 |
| Portable DR Imaging System (K253058) | Shantou Institute of Ultrasonic Instruments Co., Ltd. | 2026-06-18 |
| VIVIX-S 4386W (FXRD-4386WA) (K260820) | Vieworks Co., Ltd. | 2026-06-18 |
| Vascular Assist Occlusion Triage (VAOT) (v1.0) (K260729) | GuideAI Health | 2026-06-18 |
| Synapse PACS (7.6.0) (K261713) | FUJIFILM Healthcare Americas Corporation | 2026-06-18 |
| MAMMOMAT B.brilliant (11372950) (K253678) | Siemens Medical Solutions USA, Inc. | 2026-06-18 |
| Non-Sterile Ultrasound Gel Sterile Ultrasound Gel (K253255) | Foshan Pingchuang Medical Technology Co., Ltd. | 2026-06-17 |
| myAblation Guide (VC10A) (K253264) | Siemens Healthcare GmbH | 2026-06-16 |
| ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound System (K260844) | Siemens Medical Solutions USA, Inc. | 2026-06-16 |
| Saige-Dx (K253825) | DeepHealth, Inc. | 2026-06-15 |
| LungMaps (K253690) | Siemens Healthineers AG | 2026-06-15 |
| MediAI-OA (K253172) | Crescom Co., Ltd. | 2026-06-15 |
| DRE Duo (K260482) | Jpi Healthcare Co, Ltd. | 2026-06-15 |
| WatchMate Software (K260300) | Anumana, Inc. | 2026-06-15 |
| ThinkQA 3 (K252937) | Dosisoft SA | 2026-06-12 |
| Medical Monitor (40HT513D) (K261213) | Lg Electronics.Inc | 2026-06-12 |
| Brainomix 360 Hyperdensity (K260406) | Brainomix Limited | 2026-06-12 |
| Universal 1417PI (K252996) | Konica Minolta Healthcare Americas, Inc. | 2026-06-12 |
| PROBEAT-CR (K260174) | Hitachi High-Tech Corp. | 2026-06-11 |
| Dental X-ray System (K250839) | Changzhou Boen Zhongding Medical Technology Co., Ltd. | 2026-06-11 |
| Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) (K260322) | Mighty Oak Medical | 2026-06-11 |
| DeepXray Spina (K253192) | Alpha Intelligence Manifolds, Inc. | 2026-06-10 |
| ES-Series (K260748) | E-Scopics | 2026-06-09 |
| 2D Hip Planning Software (K261352) | One Ortho | 2026-06-08 |
| Digital C-ARM with 3D (K253296) | Allengers Medical Systems Limited | 2026-06-05 |
| LUNA 3D (K253004) | Lap GmbH Laser Applikationen | 2026-06-04 |
| Respiratory Gating for Scanners (2.1) (K253026) | Varian Medical Systems, Inc. | 2026-06-04 |
| Dental Cone Beam Computed Tomography System (K260662) | Yofo Medical Technology Co., Ltd. | 2026-06-04 |
| Sonio Suspect (K261519) | Sonio | 2026-06-04 |
| Harmony Referral System with Harmony OCT Viewer (Octave) (K253893) | Topcon Healthcare Solutions EMEA Oy | 2026-06-04 |