| Ultrasound System 1300 (K231764) | Bk Medical Aps | 2023-10-23 |
| AI-Rad Companion Brain MR (K232305) | Siemens Medical Solutions U.S.A. | 2023-10-23 |
| MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit (K231560) | Siemens Medical Solutions USA, Inc. | 2023-10-23 |
| Sonix Health (K230209) | Ontact Health Co., Ltd. | 2023-10-20 |
| R2GATE Lite TM (K223909) | Megagen Implant Co., Ltd. | 2023-10-20 |
| CombiDiagnost R90 (K232910) | Philips Medical Systems Dmc GmbH | 2023-10-19 |
| EConsole1 (K231225) | DRTECH Corporation | 2023-10-18 |
| Ikshana (K230249) | Immersivetouch | 2023-10-16 |
| Veuron-Brain-pAb3 (K231642) | Heuron Co., Ltd. | 2023-10-13 |
| SpotLight/SpotLight Duo (with DLIR option) (K230370) | Arineta , Ltd. | 2023-10-13 |
| Scenaria View 4.2 (K231574) | FUJIFILM Healthcare Americas Corporation | 2023-10-12 |
| Artemis, Artemis TPO, Artemis MX (K222222) | Eigen | 2023-10-12 |
| Synq Software Version 1.3 (K232981) | Synaptive Medical, Inc. | 2023-10-11 |
| Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR (K232344) | GE Medical Systems SCS | 2023-10-11 |
| NeuViz 128 Multi-Slice CT Scanner System (K230220) | Neusoft Medical Systems Co., Ltd. | 2023-10-11 |
| Micromate™ Navi+ (K230130) | Isys Medizintechnik GmbH | 2023-10-10 |
| Swoop® Portable MR Imaging System® (K232760) | Hyperfine, Inc. | 2023-10-06 |
| ProBeam 360° Proton Therapy System v2.0 (Multiroom) (K231863) | Varian Medical Systems, Inc. | 2023-10-06 |
| Denti.AI Detect (K230144) | Denti.Ai Technology, Inc. | 2023-10-06 |
| Clarius Ultrasound Scanner (K232704) | Clarius Mobile Health Corp. | 2023-10-05 |
| DeepTek CXR Analyzer v1.0 (K231001) | Deeptek Medical Imaging Pvt, Ltd. | 2023-10-05 |
| cmAngio® V1.0 (K232367) | Curemetrix, Inc. | 2023-10-05 |
| EFAI NeuroSuite CT ICH Assessment System (K231025) | Ever Fortune.Ai, Co., Ltd. | 2023-10-04 |
| VUNO Med-DeepBrain (K231398) | Vuno, Inc. | 2023-10-04 |
| V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic Ultrasound System (K231772) | Samsung Medison Co., Ltd. | 2023-10-03 |
| uMI Panorama (K232712) | Shanghai United Imaging Healthcare Co., Ltd. | 2023-10-03 |
| Lung-CAD (K230085) | Imagen Technologies, Inc. | 2023-10-03 |
| dS Breast Coil 7ch 1.5T (K232762) | Invivo Corporation (Business Trade Name: Philips) | 2023-10-03 |
| Terran NM-101 (K230187) | Terran Biosciences, Inc. | 2023-09-29 |
| HipCheck (K230045) | Stryker Corp. | 2023-09-29 |
| Brainomix 360 Triage LVO (K231837) | Brainomix Limited | 2023-09-28 |
| OFIX MIS App (K230252) | Orthofix US, LLC | 2023-09-26 |
| ES Series V2 (K232336) | E-Scopics | 2023-09-26 |
| ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound System (K232617) | Siemens Medical Solutions USA, Inc. | 2023-09-26 |
| EFAI RTSUITE CT HCAP-Segmentation System (K231928) | Ever Fortune.Ai, Co., Ltd. | 2023-09-25 |
| Annalise Enterprise CTB Triage Trauma (K231767) | Annalise-Ai Pty , Ltd. | 2023-09-22 |
| qXR-CTR (K231149) | Qure.Ai Technologies | 2023-09-22 |
| Jazz (K223659) | Ai Medical AG | 2023-09-22 |
| Annalise Enterprise CTB Triage Trauma (K231384) | Annalise-Ai Pty , Ltd. | 2023-09-22 |
| Overjet Periapical Radiolucency Assist (K231678) | Overjet, Inc. | 2023-09-21 |
| CAREMIBRAIN (K232569) | General Equipment For Medical Imaging, S.A. | 2023-09-21 |
| Rology Teleradiology Platform (v.1.22.1103) (K231385) | Rology, Inc. | 2023-09-20 |
| GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series) (K232178) | DRGEM Corporation | 2023-09-19 |
| Aquilion Serve (TSX-307A/1) V1.3 (K231281) | Canon Medical Systems Corporation | 2023-09-19 |
| Carnation series Diagnostic Ultrasound System (K230066) | Shenzhen Wisonic Medical Technology Co. , Ltd. | 2023-09-15 |
| cNeuro cPET (K231576) | Combinostics OY | 2023-09-14 |
| NEUROShield (K220034) | In-Med Prognostics L3c | 2023-09-14 |
| Provecta 3D Prime and Provecta 3D Prime Ceph (K232487) | Durr Dental SE | 2023-09-14 |
| AccuCTP Pro (K231353) | ArteryFlow Technology Co., Ltd. | 2023-09-14 |
| OrionXR (K232189) | Hoth Intelligence, Inc. | 2023-09-14 |
| Lung-CAD (K223811) | Imagen Technologies, Inc. | 2023-09-13 |
| Definium Pace Select (K231892) | Ge Hualun Medical Systems Co. , Ltd. | 2023-09-12 |
| TrueBeam, TrueBeam STx, Edge, VitalBeam (K231317) | Varian Medical Systems, Inc. | 2023-09-12 |
| XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5 (K232526) | Canon Medical Systems Corporation | 2023-09-12 |
| Velacur (K232459) | Sonic Incytes | 2023-09-12 |
| Cartesion Prime (PCD-1000A/3) V10.15 (K231748) | Canon Medical Systems Corporation | 2023-09-12 |
| Ablation-fit (K222938) | R.A.W. S.R.L | 2023-09-12 |
| SiteRite™ 9 Ultrasound System (K231283) | Bard Access Systems, Inc. (C.R. Bard, Inc.) | 2023-09-11 |
| VariSeed (v10) (K232400) | Varian Medical Systems | 2023-09-08 |
| PreXion3D Expedition (K232166) | Prexion Corporation | 2023-09-08 |
| DeepXray (K223621) | Alpha Intelligence Manifolds, Inc. | 2023-09-08 |
| ILUMIEN™ OPTIS™ System, OPTIS™ Integrated System, OPTIS™ Mobile System, with AptiVue™ Imaging Software version E.6 (K232386) | ABBOTT MEDICAL | 2023-09-08 |
| MAGNETOM Viato.Mobile (K232482) | Siemens Medical Solutions USA, Inc. | 2023-09-06 |
| Promaxo MRI System II (K232361) | Promaxo, Inc. | 2023-09-05 |
| UniSyn Molecular Imaging (6-3-1) (K231047) | Convergent Imaging Solutions | 2023-09-01 |
| MasterX 800 Series (K230918) | Medicatech USA | 2023-09-01 |
| Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T (K232021) | Philips Healthcare (Suzhou) Co., Ltd. | 2023-09-01 |
| RAYSCAN a-Expert3D (K232287) | Ray Co., Ltd. | 2023-08-31 |
| Mick Valencia Applicator Set (K230155) | Mick Radio-Nuclear Instruments, Inc. | 2023-08-30 |
| Brainomix 360 e-MRI (K231656) | Brainomix Limited | 2023-08-30 |
| Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR (K230355) | Canon Medical Systems Corporation | 2023-08-30 |
| CALLISTO eye (K231676) | Carl Zeiss Meditec, AG | 2023-08-28 |
| VisAble.IO (K223639) | Techsomed | 2023-08-28 |
| QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy) (K230221) | Versant Medical Physics and Radiation Safety | 2023-08-28 |
| BioProtect Balloon Implant™ System (K222972) | Bioprotect, Ltd. | 2023-08-25 |
| AIRAscore (K223180) | Airamed GmbH | 2023-08-25 |
| BrachyGel Vaginal Hydrogel Packing System (DEN220052) | Brachyfoam, Inc. D/B/A Advaray | 2023-08-22 |
| qXR-PTX-PE (K230899) | Qure.Ai Technologies | 2023-08-22 |
| CUPTIMIZE™ Advanced (K231503) | DePuy Orthopaedics, Inc. | 2023-08-22 |
| Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4 (K231731) | Mcgovern Medical School | 2023-08-21 |
| SM-IV (K232185) | Sedecal., Sa. | 2023-08-21 |
| 12MP Color LCD Monitor C1216W, C12*** (* = 0 to 9, A to Z or blank, and the difference among models means the product is named according to different appearance colors and customer models) (K231026) | Shenzhen Beacon Display Technology Co., Ltd. | 2023-08-18 |
| 1.5T HD T/R Knee Array (10-F34127) (K231085) | Shenzhen RF Tech Co., Ltd. | 2023-08-18 |
| EXTRON 5; EXTRON 7 (K230871) | DRTECH Corporation | 2023-08-17 |
| TOPA12 Portable X-ray Unit (K230581) | Neuf, Inc. | 2023-08-16 |
| Vscan Air (K231301) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2023-08-15 |
| Annalise Enterprise CTB Triage-OH (K231094) | Annalise-Ai Pty , Ltd. | 2023-08-15 |
| 21HQ513D, 32HL512D, 31HN713D, 32HQ713D (K232127) | Lg Electronics.Inc | 2023-08-15 |
| SaintView (K223660) | Inviz Corporation | 2023-08-14 |
| Aura 10 PET/CT (K231420) | Xeos Medical | 2023-08-10 |
| Efai Pacs Picture Archiving and Communication System Pro (K232100) | Ever Fortune.Ai, Co., Ltd. | 2023-08-08 |
| VisiRad XR (K223133) | Imidex, Inc. | 2023-08-03 |
| YosemiteView 4343W/YosemiteView 3643W (K232058) | Careray Digital Medical Technology Co., Ltd. | 2023-08-03 |
| Disposable Needle Guides and Grids (K223689) | Advance Medical Designs, Inc. | 2023-08-02 |
| Ingenia Elition R5.7.1 SP4 MR Systems (K232030) | Philips Medical Systems Nederland B.V. | 2023-08-02 |
| uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy Analysis (K230162) | Shanghai United Imaging Healthcare Co., Ltd. | 2023-08-01 |
| EXPD 4357; EXPD 4357P (K231959) | DRTECH Corporation | 2023-08-01 |
| Altris IMS (K232088) | Altris, Inc. | 2023-07-31 |
| Brainomix 360 Triage ICH (K231195) | Brainomix Limited | 2023-07-27 |
| Rapid Aneurysm Triage and Notification (K230074) | Ischemaview, Inc. | 2023-07-27 |