| uMI Panorama (K231572) | Shanghai United Imaging Healthcare Co., Ltd. | 2023-07-26 |
| Patient Specific Planning Solution™ 3D Bone Models (K230540) | Biomet Manufacturing Corp | 2023-07-25 |
| Sonio Detect (K230365) | Sonio | 2023-07-25 |
| MOBILETT Impact (K231577) | Siemens Medical Solutions | 2023-07-25 |
| IDENTIFY (K230576) | Varian Medical Systems, Inc. | 2023-07-25 |
| ANDI (K230913) | Imeka Solutions, Inc. | 2023-07-25 |
| Argus Cognitive ReVISION Software (K223322) | Argus Cognitive, Inc. | 2023-07-24 |
| UltraSight AI Guidance (K223347) | Ultrasight, Inc. | 2023-07-24 |
| OptimMRI (K230150) | Rebrain, Sas | 2023-07-21 |
| AccuCheck (K223834) | Manteia Technologies Co., Ltd. | 2023-07-20 |
| IGAR System (1001.A) (K223484) | Insight Medbotics, Inc. | 2023-07-20 |
| uOmnispace (K230039) | Shanghai United Imaging Healthcare Co., Ltd. | 2023-07-20 |
| Oscar 15 & Oscar 15i (K230787) | Genoray Co., Ltd. | 2023-07-20 |
| Grreen X 12 (Model: PHT-75CHS) (K231796) | VATECH Co., Ltd. | 2023-07-19 |
| syngo.CT Lung CAD (Version VD30) (K231157) | Siemens Healthcare GmbH | 2023-07-19 |
| Fibroid Mapping Reviewer Application (FMRA) (K222683) | Nesa Medtech Private Limited | 2023-07-17 |
| JiveX (Model Number / Release: 5.4) (K231041) | Visus Health IT GmbH | 2023-07-14 |
| Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking (2.0);BOLD MRI Mapping (1.0);Image Fusion Angio (1.0) (K223106) | Brainlab AG | 2023-07-14 |
| Cercare Medical Neurosuite (K230016) | Cercare Medical A/S | 2023-07-14 |
| CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02) (K223290) | Sentiar, Inc. | 2023-07-14 |
| Ez3D-i /E3 (K231757) | Ewoosoft Co., Ltd. | 2023-07-14 |
| XR90 (XR90-SYS) (K223125) | Mediview Xr, Inc. | 2023-07-13 |
| Chondral Quant (K231351) | Siemens Medical Soultions USA, Inc. | 2023-07-13 |
| ECHELON Synergy MRI system (K223426) | Fujifilm Healthcare Corporation | 2023-07-13 |
| Spine Auto Views (K223424) | GE Medical Systems SCS | 2023-07-13 |
| X80 / RADiant / PhotoElectric Therapy System (RADiant Aura) (K230611) | Xstrahl, Ltd. | 2023-07-13 |
| Biograph Vision.X and Biograph Vision.X Edge (K231833) | Siemens Medical Solutions USA, Inc. | 2023-07-13 |
| Open Rib (K223261) | Canon Medical Informatics, Inc. | 2023-07-13 |
| AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4 (K231709) | Radmedix, LLC | 2023-07-12 |
| Ziehm Vision RFD 3D (K231701) | Ziehm Imaging GmbH | 2023-07-10 |
| MOZI TPS (K223724) | Manteia Technologies Co., Ltd. | 2023-07-10 |
| X-View 3D Pan/X-View 2D Pan (K222666) | Trident S.R.L | 2023-07-10 |
| Spine CAMP™ (1.1) (K231668) | Medical Metrics, Inc. | 2023-07-07 |
| Bladder Scanner Model: BVT02 (K223448) | Xuzhou Kaixin Electronic Instrument Co., Ltd. | 2023-07-07 |
| Axial3D Insight (K222745) | Axial Medical Printing Limited | 2023-07-03 |
| Pixyl.Neuro (K213253) | Pixyl SA | 2023-06-30 |
| XENOVIEW 3.0T Chest Coil (K231647) | Polarean, Inc. | 2023-06-29 |
| Radixact Treatment Delivery System (K223159) | Accuray Incorporated | 2023-06-23 |
| Medisystem Pacs (K223048) | Medilab Manutencao E Sitemas Ltda | 2023-06-23 |
| VINNO G86,VINNO G86E,VINNO G65,VINNO G65P,VINNO G65E,VINNO G65D,VINNO M86, VINNO M86E,VINNO G90,VINNO G90E (K230160) | Vinno Technology (Suzhou) Co.,Ltd | 2023-06-23 |
| MapRT (K231185) | Vision Rt, Ltd. | 2023-06-23 |
| Bladder AI (AIBV01) (K230497) | Exo, Inc. | 2023-06-22 |
| 1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF (K231467) | Rayence Co., Ltd. | 2023-06-21 |
| Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option) (K231075) | Carl Zeiss Meditec, Inc. | 2023-06-20 |
| F3 (K222998) | Acrew Imaging, Inc. | 2023-06-20 |
| HepaFatSmart (V2.0.0) (K231459) | Resonance Health Analysis Services Pty, Ltd. | 2023-06-20 |
| Voluson SWIFT; Voluson SWIFT+ (K230346) | Ge Medical Systems Ultrasound & Primary Care Diagnostic, LLC | 2023-06-20 |
| VINNO E20, VINNO E10,VINNO E10P,VINNO E10E, VINNO X1,VINNO X1E,VINNO X1P, VINNO X2,VINNO X2E,VINNO X2P (K223917) | Vinno Technology (Suzhou) Co.,Ltd | 2023-06-17 |
| VINNO G50, VINNO G55, VINNO M50, VINNO E30, VINNO X5, VINNO X6, VINNO X7, VINNO M55, VINNO E35, VINNO X65, VINNO X55, VINNO X35, VINNO G55E, VINNO G55P, VINNO M55E, VINNO M55P, VINNO E35E, VINNO E35P (K223920) | Vinno Technology (Suzhou) Co.,Ltd | 2023-06-17 |
| IB Lab LAMA (K223646) | Ib Lab GmbH | 2023-06-16 |
| DeepCatch (K223556) | Medical IP Co., Ltd. | 2023-06-16 |
| SOMATOM Edge Plus, SOMATOM Confidence, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATOM Drive, SOMATOM Force, SOMATOM Definition Flash (K230421) | Siemens Medical Solutions USA, Inc. | 2023-06-16 |
| CAC Software (K230112) | Imbio, Inc. | 2023-06-13 |
| JUSHA-C810G/C810G LCD Monitor, JUSHA-C660/JUSHA-C660G/C660/C660G LCD Monitor (K230728) | Nanjing Jusha Display Technology Co., Ltd. | 2023-06-09 |
| M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System (K230768) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2023-06-09 |
| CT Perfusion V1.0 (K223091) | Olea Medical | 2023-06-09 |
| Orthopantomograph™ OP 3D LX (K230505) | Palodex Group OY | 2023-06-09 |
| SIDDHARTH-II;IMPACT (K222762) | Panacea Medical Technologies Pvt. , Ltd. | 2023-06-08 |
| Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide Cleaner/High-Level Disinfectant and QwikCheck Chemical Indicator (K230381) | Cs Medical, LLC | 2023-06-07 |
| Ambra PACS (K231360) | Dicom Grid Dba Ambra Health | 2023-06-07 |
| C350/C350G LCD Monitor; M550/M550G LCD Monitor (K231170) | Nanjing Jusha Display Technology Co., Ltd. | 2023-06-07 |
| HyperVue™ Imaging System (K230691) | Spectrawave, Inc. | 2023-06-07 |
| FEops HEARTguideTM, FEops HEARTguideTM ALPACA (K223855) | Feops NV | 2023-06-06 |
| Olea S.I.A. Neurovascular V1.0 (K223532) | Olea Medical | 2023-06-06 |
| SPY Portable Handheld Imaging (SPY-PHI) System (K230727) | Novadaq Technologies Ulc (A Part of Stryker) | 2023-06-05 |
| OmniTom Elite (K223447) | Neurologica Corporation, A Subsidiary of Samsung | 2023-06-01 |
| Brainomix 360 e-CTP (K223555) | Brainomix Limited | 2023-06-01 |
| ANT-X System (K230185) | Ndr Medical Technology Pte. , Ltd. | 2023-06-01 |
| KBA3D (K223841) | S.M.A.I.O | 2023-05-30 |
| Quicktome Software Suite (K222359) | Omniscient Neurotechnology Pty Ltd (O8t) | 2023-05-30 |
| Sonic DL (K223523) | Ge Medical Systems,Llc (Ge Healthcare) | 2023-05-30 |
| Eclipse Treatment Planning System (v18.0) (K230557) | Varian Medical Systems, Inc. | 2023-05-26 |
| Pre-Sure (K230044) | Lazarus 3D | 2023-05-26 |
| Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite (K223491) | Ge Medical Systems, LLC | 2023-05-25 |
| Avatar Medical Software V1 (K222035) | Avatar Medical | 2023-05-24 |
| ROSA Hip System (K231162) | Orthosoft Inc (D/B/A Zimmer Cas) | 2023-05-23 |
| uMR Omega (K230152) | Shanghai United Imaging Healthcare Co., Ltd. | 2023-05-23 |
| ADAS 3D (K230803) | Adas3D Medical S.L. | 2023-05-23 |
| Genius AI Detection 2.0 with CC-MLO Correlation (K230096) | Hologic, Inc. | 2023-05-23 |
| TrueBeam, TrueBeam STx, Edge, VitalBeam (K223839) | Varian Medical Systems, Inc. | 2023-05-22 |
| VirtuOst (K220402) | O.N. Diagnostics | 2023-05-19 |
| Autoplaque (K212758) | Cedars-Sinai Medical Center: Aim | 2023-05-19 |
| C510G/JUSHA-C510G/C510/JUSHA- C510 LCD Monitor (K230723) | Nanjing Jusha Display Technology Co., Ltd. | 2023-05-18 |
| uMR 570 (K230758) | Shanghai United Imaging Healthcare Co., Ltd. | 2023-05-18 |
| Radiation Planning Assistant (RPA) (K222728) | University of Texas, MD Anderson Cancer Center | 2023-05-17 |
| Symbia Pro.specta VA20A Family (K231102) | Siemens Medical Solutions USA, Inc. | 2023-05-17 |
| EPIQ Series Diagnostic Ultrasound System (K231190) | Philips Ultrasound, LLC | 2023-05-12 |
| iTFlow (K222854) | Cardio Flow Design, Inc. | 2023-05-12 |
| Intraoperative Ultrasound Probe Cover (K222460) | Exact Medical Manufacturing | 2023-05-12 |
| RadiForce MX217 (K230684) | Eizo Corporation | 2023-05-12 |
| SubtleMR (2.3.x) (K223623) | Subtle Medical, Inc. | 2023-05-11 |
| ExacTrac Dynamic 1.1.2 (K231052) | Brainlab AG | 2023-05-11 |
| Akunah REFLECT (K222987) | Akunah Pty, Ltd. | 2023-05-10 |
| Neurophet AQUA (K220437) | Neurophet., Inc. | 2023-05-10 |
| CX50N (K222719) | Wide Corporation | 2023-05-09 |
| MX50N (K222716) | Wide Corporation | 2023-05-08 |
| Lumify Diagnostic Ultrasound System (K223771) | Philips Ultrasound | 2023-05-04 |
| Auto Segmentation (K230082) | Ge Medical Systems, LLC | 2023-05-04 |
| Epione (K223758) | Quantum Surgical Sas | 2023-05-03 |
| 3D Anatomic Model (K230119) | Ricoh USA, Inc. | 2023-05-02 |