| Voxel Dosimetry (00859873006226) (K243919) | Hermes Medical Solutions AB | 2025-07-30 |
| Cios Spin (K251523) | Siemens Medical Solutions USA, Inc. | 2025-07-29 |
| PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTABLE PLUS (K243473) | Prognosys Medical Systems Private Limited | 2025-07-29 |
| NAEOTOM Alpha.Peak/NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime (K251061) | Siemens Medical Solutions USA, Inc. | 2025-07-28 |
| Venue; Venue Go; Venue Fit; Venue Sprint (K251322) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2025-07-25 |
| Marie (K250970) | Leo Cancer Care | 2025-07-25 |
| EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System (K251455) | Philips Ultrasound, LLC | 2025-07-24 |
| IMAGE ONE (K250716) | Infomed Software, S.L. | 2025-07-23 |
| Neuro Insight V1.0 (K243681) | Olea Medical S.A.S. | 2025-07-23 |
| GyriCalc (Version 1.0.0) (K250686) | Neurospectrum Insights Corp. | 2025-07-22 |
| Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR (K250901) | Canon Medical Systems Corporation | 2025-07-22 |
| Vascular Navigation PAD 2.0; Navigation Software Vascular PAD (K243432) | Brainlab AG | 2025-07-22 |
| Yushan X-Ray Flat Panel Detector (K250211) | Innocare Optoelectronics Corp. | 2025-07-22 |
| V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System; V5 Diagnostic Ultrasound System; cV5 Diagnostic Ultrasound System; V4 Diagnostic Ultrasound System; cV4 Diagnostic Ultrasound System (K250999) | Samsung Medison Co., Ltd. | 2025-07-18 |
| INNOVISION-P5 (K250750) | Dk Medical Systems Co., Ltd. | 2025-07-18 |
| uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) (K251839) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-07-17 |
| uMR Ultra (K243547) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-07-17 |
| HESTIA (K243420) | Genoray Co., Ltd. | 2025-07-17 |
| e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector (K243428) | Dxtx Medical, Inc. | 2025-07-17 |
| HyperVue™ Software (K251198) | Spectrawave, Inc. | 2025-07-16 |
| Rapid CTA 360 (K251151) | Ischemaview | 2025-07-16 |
| EchoPAC Software Only / EchoPAC Plug-in (K251342) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2025-07-16 |
| uMR 680 (K243397) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-07-16 |
| IsoSphere (K242818) | Isoaid, LLC | 2025-07-15 |
| AV Viewer (K250181) | Philips Medical Systems Nederland B.V. | 2025-07-15 |
| PeekMed web (K251096) | Peek Health, S.A. | 2025-07-14 |
| LUMINOS Q.namix T; LUMINOS Q.namix R (K250660) | Siemens Medical Solutions | 2025-07-14 |
| GECHO (K250120) | Narnar, LLC | 2025-07-14 |
| Achieva; Intera; Ingenia 1.5T; Ingenia 3.0T; Ingenia 1.5T CX; Ingenia 3.0T CX; Ingenia Elition S; Ingenia Elition X; Ingenia Ambition S; Ingenia Ambition X; and MR 5300 MR Systems (K251808) | Philips Medical Systems Nederland B.V. | 2025-07-11 |
| B-Scan (K243227) | Accutome, Inc. Doing Business AS Keeler USA | 2025-07-11 |
| ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R) (K250762) | Olympus Medical Systems Corporation | 2025-07-11 |
| Vivid Pioneer (K251169) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2025-07-10 |
| Sonosite LX Ultrasound System (K251830) | FUJIFILM Sonosite, Inc. | 2025-07-10 |
| Cios Alpha; Cios Flow (K251520) | Siemens Medical Solutions USA, Inc. | 2025-07-09 |
| TumorSight Viz (K251766) | SimBioSys, Inc. | 2025-07-08 |
| CustomSurg OrthoPlanner (K251863) | Customsurg AG | 2025-07-07 |
| TAVIPILOT (K243884) | Caranx Medical | 2025-07-07 |
| syngo.via MI Workflows; Scenium; syngo MBF (K251528) | Siemens Medical Solutions USA, Inc. | 2025-07-03 |
| MammoScreen® (4) (K243679) | Therapixel | 2025-07-03 |
| Biograph Vision PET/CT Systems; Biograph mCT PET/CT Systems (K251671) | Siemens Medical Solutions USA, Inc. | 2025-07-03 |
| SOMATOM go.Now; SOMATOM go.Up; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM Pro.Pulse (K250822) | Siemens Medical Solutions USA, Inc. | 2025-07-03 |
| Orthoscan TAU Mini C-Arm (K250587) | Ziehm-Orthoscan, Inc. | 2025-07-02 |
| Mendaera Guidance System (K250524) | Mendaera, Inc. | 2025-07-02 |
| OPUSWAVE Dual Sensor Imaging System (K250684) | Terumo Cardiovascular Systems Thi Plant | 2025-07-02 |
| Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™) (K250391) | Elekta Solutions AB | 2025-07-02 |
| Bunkerhill Abdominal Aortic Quantification (AAQ) (K243779) | BunkerHill Health | 2025-07-01 |
| StrokeSENS ASPECTS Software Application (K250221) | Circle Cardiovascular Imaging, Inc. | 2025-07-01 |
| PIUR tUS inside (K250484) | Piur Imaging GmbH | 2025-06-30 |
| EchoConfidence (USA) (K250670) | Mycardium AI Limited | 2025-06-30 |
| Synapse PACS (7.5) (K243647) | FUJIFILM Healthcare Americas Corporation | 2025-06-30 |
| Philips iCT CT system (K250648) | Philips Medical Systems Nederland B.V. | 2025-06-27 |
| Affirm 800 (K243077) | Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) | 2025-06-27 |
| Dental CBCT X-ray System (K251642) | Yian Medical Technology (Haining) Co., Ltd. | 2025-06-27 |
| eMotus Respiratory Motion Management System (K243900) | Empnia, Inc. | 2025-06-27 |
| Velacur One (LI-1100) (K251728) | Sonic Incytes Medical Corp | 2025-06-26 |
| Cranial 4Pi Immobilization (K243142) | Brainlab AG | 2025-06-23 |
| OPXION Optical Skin Viewer (OPXSV1-01F) (K242924) | Opxion Technology, Inc. | 2025-06-23 |
| CT Scanner TSX-501R/1 V11.1 (K243398) | Canon Medical Systems Corporation | 2025-06-20 |
| CardIQ Suite (K243672) | GE Medical Systems SCS | 2025-06-18 |
| 6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70) (K243253) | Esaote, S.p.A. | 2025-06-18 |
| EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems (K250886) | Philips Ultrasound, LLC | 2025-06-18 |
| SKR 3000 (K250665) | Konica Minolta, Inc. | 2025-06-17 |
| RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; (Elements) Spine SRS; (Elements) Cranial SRS w/ Cones; (Elements) RT Planning Platform; (Elements) Dose Review; (Elements) Retreatment Review; Elements Segmentation [Cranial , Basal Ganglia, Head & Neck, Pelvic, Spine, Thoracic & Spine, Extracranial] RT; Elements AI Tumor Segmentation RT; Elements SmartBrush [Angio, Spine] RT; Elements Object Management RT (K250440) | Brainlab AG | 2025-06-17 |
| Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100) (K243880) | Wuxi Hisky Medical Technologies Co., Ltd. | 2025-06-17 |
| uOmniscan (K243666) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-06-17 |
| MAGNETOM Flow.Ace; MAGNETOM Flow.Plus (K250436) | Siemens Shenzhen Magnetic Resonance , Ltd. | 2025-06-16 |
| Mosaic (V1.0.1) (K244012) | Navier Medical | 2025-06-16 |
| MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile (K250443) | Siemens Healthcare GmbH | 2025-06-16 |
| Methinks NCCT Stroke (K250685) | Methinks Software, S.L | 2025-06-16 |
| Accuro® 3S Needle Guide Kit (K250469) | Rivanna Medical, Inc. | 2025-06-13 |
| Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (1.0) (K243633) | Brainlab AG | 2025-06-13 |
| Aurora (K251153) | Ge Medical Systems Israel | 2025-06-12 |
| Second Opinion® CS (K243234) | Pearl, Inc. | 2025-06-12 |
| EXTRON 3; EXTRON 5; EXTRON 7 (K250010) | DRTECH Corporation | 2025-06-10 |
| Viz Subdural+, Viz SUBDURAL PLUS (K250354) | Viz. Ai, Inc. | 2025-06-10 |
| Cirrus Resting State fMRI Software (K251009) | Sora Neuroscience, Inc. | 2025-06-06 |
| TechLive (K243703) | DeepHealth, Inc. | 2025-06-05 |
| UroNav 4 (K250800) | Philips DS North America, LLC | 2025-06-05 |
| BrightHeart View Classifier (K251456) | Brightheart | 2025-06-05 |
| Sonic DL (K243667) | Ge Medical Systems, LLC | 2025-06-05 |
| Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System (K251397) | Philips Medical Systems Nederland B.V. | 2025-06-04 |
| TraumaCad Neo (1.1) (K243810) | Brainlab , Ltd. | 2025-06-04 |
| Swoop® Portable MR Imaging® System (V2) (K250236) | Hyperfine, Inc. | 2025-05-30 |
| TE Air Diagnostic Ultrasound System (K250024) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025-05-30 |
| AudaxCeph Cephalogram Analysis Software (K243005) | Audax D.O.O. | 2025-05-30 |
| Allix5 (DEN240047) | Clairity, Inc. | 2025-05-30 |
| BriefCase-Triage (K251406) | Aidoc Medical , Ltd. | 2025-05-30 |
| Opulus™ Lymphoma Precision (K243863) | Roche Molecular Systems, Inc. | 2025-05-30 |
| Voluson™ Performance 16; Voluson™ Performance 18 (K250543) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2025-05-29 |
| TAIMedImg DeepMets (K250427) | Taiwan Medical Imaging Co., Ltd. | 2025-05-28 |
| Rapid MLS (K243378) | Ischemaview, Inc. | 2025-05-28 |
| Europa (Alternative: AiRTouch) portable X-ray system (K244049) | Livermoretech, Inc. | 2025-05-28 |
| CoLumboX (K250367) | Smart Soft Healthcare AD | 2025-05-28 |
| Accuro 3S (K243937) | Rivanna Medical, Inc. | 2025-05-23 |
| Clever One (K250005) | Ewoosoft Co., Ltd. | 2025-05-23 |
| DEEPECHO (K242594) | Deepecho | 2025-05-23 |
| Second Opinion® 3D (K243989) | Pearl, Inc. | 2025-05-23 |
| EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System (K243793) | Philips Ultrasound, LLC | 2025-05-21 |
| uMR Omega (K243122) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-05-21 |
| Synapse 3D Base Tools (V7.0) (K243762) | Fujifilm Corporation | 2025-05-21 |