| Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30D (K222208) | Qingdao Hisense Medical Equipment Co., Ltd. | 2022-11-17 |
| Multitom Rax (K221281) | Siemens Medical Solutions | 2022-11-17 |
| OmegaAI Image Viewer (K222476) | Ramsoft, Inc. | 2022-11-17 |
| BoneMRI v1.4 (K221762) | Mrlguidance B.V. | 2022-11-16 |
| uPMR 790 (K222540) | Shanghai United Imaging Healthcare Co., Ltd. | 2022-11-14 |
| Syngo Dynamics (Version VA40F) (K222428) | Siemens Medical Solutions USA, Inc. | 2022-11-14 |
| ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging System (K220983) | Imsonic Medical China, Inc. | 2022-11-11 |
| Synapse 3D Base Tools v6.6 (K221677) | Fujifilm Corporation | 2022-11-10 |
| AVIEW RT ACS (K220408) | Coreline Soft Co., Ltd. | 2022-11-10 |
| Exo Iris (El2001) (K222198) | Exo Imaging, Inc. | 2022-11-09 |
| GammaTile (K221539) | Gt Medical Technologies | 2022-11-09 |
| ViewMate Multi Ultrasound System (K222754) | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. | 2022-11-09 |
| Hisense LCD monitor HMD2G21S, HMD3G21S (K222132) | Qingdao Hisense Medical Equipment Co., Ltd. | 2022-11-08 |
| EFAI ChestSuite XR Pneumothorax Assessment System (K221552) | Ever Fortune.Ai, Co., Ltd. | 2022-11-08 |
| VHA Radiotherapy Bolus (K222639) | Vha Dean | 2022-11-04 |
| Dolphin Blue Imaging (K221478) | Patterson Dental Supply, Inc. | 2022-11-01 |
| Combined High Frequency X-ray Source (K222258) | Suzhou Powersite Electric Co., Ltd. | 2022-11-01 |
| Klarity SRS Baseplate, Klarity Promise Baseplate (K220539) | Klarity Medical & Equipment (GZ) Co., Ltd. | 2022-11-01 |
| CW60N (K222722) | Wide Corporation | 2022-10-31 |
| CL24N (K222717) | Wide Corporation | 2022-10-31 |
| Excelsior (K220929) | Merit Cro, Inc. | 2022-10-31 |
| Stage (K223079) | Spintech, Inc. | 2022-10-28 |
| Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC MACH40 (K222191) | Supersonic Imagine | 2022-10-28 |
| uMR Omega with uWS-MR-MRS (K220332) | Shanghai United Imaging Healthcare Co., Ltd. | 2022-10-27 |
| DigiX FDX (K223060) | Allengers Medical Systems Limited | 2022-10-26 |
| Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant) (K222047) | Elekta Solutions AB | 2022-10-26 |
| Leltek Ultrasound Imaging System (Model: LU700 Series) (K222365) | Leltek, Inc. | 2022-10-25 |
| Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR (K222968) | Canon Medical Systems Corporation | 2022-10-25 |
| 3Dicom MD (K222470) | Singular Health Pty, Ltd. | 2022-10-25 |
| EndoNaut (K222070) | Therenva Sas | 2022-10-25 |
| Viz LVO ContaCT (K223042) | Viz. Ai, Inc. | 2022-10-21 |
| IntraOp VSP Software Device (K213128) | Xironetic, LLC | 2022-10-21 |
| Mercu 1717V (K222886) | Iray Technology Taicang , Ltd. | 2022-10-20 |
| AI-Rad Companion (Musculoskeletal) (K222361) | Siemens Medical Solutions USA, Inc. | 2022-10-20 |
| Spine CAMP™ (K221632) | Medical Metrics, Inc. | 2022-10-18 |
| Digital Radiography CXDI-Pro, Digital Radiography D1 (K222855) | Canon, Inc. | 2022-10-17 |
| X-CUBE 70, X-CUBE 90 (K221093) | Alpinion Medical Systems Co., Ltd. | 2022-10-14 |
| 16ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T 16ch Breast Coil, 1.5T 16ch Breast Coil, 3T 16ch Breast Coil (K222407) | Neocoil, LLC | 2022-10-14 |
| AI-Rad Companion Organs RT (K221305) | Siemens Medical Solutions USA, Inc. | 2022-10-14 |
| Vitrea CT Cardiac Analysis (K222662) | Canon Medical Informatics, Inc. | 2022-10-14 |
| syngo.via View&GO (K221501) | Siemens Healthcare GmbH | 2022-10-14 |
| X-CUBE 50, X-CUBE 60 (K220857) | Alpinion Medical Systems Co., Ltd. | 2022-10-13 |
| Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL) (K211321) | Guangzhou Sonostar Technologies Co., Ltd. | 2022-10-13 |
| SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SonoFinder Wireless Probe Type Ultrasound Scanner (Model: SF14L25) (K220169) | Bionet Co., Ltd. | 2022-10-11 |
| MIM-Ablation (K220256) | Mim Software, Inc. | 2022-10-07 |
| BriefCase (K220709) | Aidoc Medical , Ltd. | 2022-10-07 |
| Genius AI Detection 2.0 (K221449) | Hologic, Inc. | 2022-10-06 |
| Garion Image-Intensified Fluoroscopic X-Ray System, Mobile (K222080) | Sg Healthcare Co, Ltd. | 2022-10-06 |
| e-Ortho Shoulder Software v1.1 (K220758) | FH Industrie | 2022-09-30 |
| QIR Suite (K211611) | Casis Cardiac Simulation & Imaging Software | 2022-09-30 |
| Shield System (K222625) | Radiaction , Ltd. | 2022-09-30 |
| uDR 380i Pro (K222339) | Shanghai United Imaging Healthcare Co., Ltd. | 2022-09-30 |
| CogNet QmTRIAGE (K220080) | Medcognetics, Inc. | 2022-09-29 |
| Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI, Consona NT, Nuewa N9, Recho N9, Consona N9 Exp, Consona N9 Elite, Resona N9, Consona N9T, Consona N8, Consona N8 Pro, Consona N8 Super, Consona OR, Consona N8S, Consona OI, Consona OT, Consona N8 Exp, Consona N8 Elite, Consona N8T, Consona N7, Consona N7 Pro, Consona N7 Super, Consona VR, Consona N7S, Consona VI, Consona VT, Consona N7 Exp, Consona N7 Elite, Consona N7T Diagnostic Ultrasound System (K221300) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2022-09-29 |
| Digital Radiography CXDI-Elite, Digital Radiography E1 (K222687) | Canon, Inc. | 2022-09-29 |
| GM85 (K222353) | Samsung Electronics Co., Ltd. | 2022-09-29 |
| Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S, Consona AE, Consona AT, Consona N6 Exp Diagnostic Ultrasound System, Consona N6 Elite, Consona N6T Diagnostic Ultrasound System (K221496) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2022-09-29 |
| BriefCase (K222329) | Aidoc Medical , Ltd. | 2022-09-28 |
| Digital Radiography CXDI-CS01 (K222661) | Canon, Inc. | 2022-09-27 |
| 5000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500 P, Ultrasound System 5500 W, Ultrasound System 5500 CV, Ultrasound System 5300 G, Ultrasound System 5300 P, Ultrasound System 5300 W) (K222648) | Philips Ultrasound, LLC | 2022-09-27 |
| NS-HGlio (K221738) | Neosoma, Inc. | 2022-09-27 |
| XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3 (K220342) | Canon Medical Systems Corporation | 2022-09-27 |
| OtoSight Middle Ear Scope (K222655) | Photonicare, Inc. | 2022-09-26 |
| XACT Robotic System, ACE Model (K213759) | Xact Robotics, Ltd. | 2022-09-23 |
| Aorta-CAD (K213353) | Imagen Technologies, Inc. | 2022-09-20 |
| C630G LCD monitor, JUSHA-C630G LCD monitor, C630 LCD monitor, JUSHA-C630 LCD monitor (K222121) | Nanjing Jusha Display Technology Co., Ltd. | 2022-09-19 |
| P12 Elite Series Digital Color Doppler Ultrasound System (K221089) | Sonoscape Medical Corp. | 2022-09-15 |
| BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes and Length Assessment Device (K221797) | Varian Medical Systems, Inc. | 2022-09-14 |
| MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola Fit (K221733) | Siemens Medical Solutions USA, Inc. | 2022-09-13 |
| P20 Elite Series Digital Color Doppler Ultrasound System (K221140) | Sonoscape Medical Corp. | 2022-09-13 |
| Solid State X-ray Imager(Model: FXRD-4386WB) (K220239) | Vieworks Co., Ltd. | 2022-09-13 |
| CLAROX plus (Model: VX-100) (K221417) | Vsi Co., Ltd. | 2022-09-13 |
| Aquilion Precision (TSX-304A/4) V10.10 with AiCE (K220986) | Canon Medical Systems Corporation | 2022-09-12 |
| KOLO Evolution XHD Series Ultrasound Diagnostic System (K221568) | Kolo Medical (Suzhou) Co., Ltd. | 2022-09-12 |
| Rapid ICH (K221456) | Ischemaview, Inc. | 2022-09-12 |
| EFAI ChestSuite XR Pleural Effusion Assessment System (K222076) | Ever Fortune.Ai, Co., Ltd. | 2022-09-08 |
| syngo.via RT Image Suite (K220783) | Siemens Medical Solutions USA, Inc. | 2022-09-07 |
| LiverMultiScan v5 (LMSv5) (K213960) | Perspectum | 2022-09-06 |
| Ez3D-i/E3 (K222069) | Ewoosoft Co., Ltd. | 2022-09-06 |
| Omni Legend (K221932) | GE Healthcare | 2022-09-02 |
| DrAid for Radiology v1 (K221241) | Vinbrain Joint Stock Company | 2022-09-01 |
| Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR (K222387) | Canon Medical Systems Corporation | 2022-08-31 |
| QT Scanner 2000 Model A (K220933) | Qt Imaging, Inc. | 2022-08-31 |
| 8ch Wrist Coil (K222325) | Invivo Corporation (Business Trade Name: Philips) | 2022-08-31 |
| Ultrasound Transmission Gels (K221999) | Hony Medical Co., Ltd. | 2022-08-30 |
| Viz RV/LV (K221100) | Viz. Ai, Inc. | 2022-08-29 |
| TCL3 Motion Tracking System (K221785) | Tracinnovations A/S | 2022-08-29 |
| BriefCase (K222277) | Aidoc Medical , Ltd. | 2022-08-26 |
| MRI Planner (K211841) | Spectronic Medical AB | 2022-08-25 |
| AutoContour Model RADAC V2 (K220598) | Radformation, Inc. | 2022-08-24 |
| ClearCheck Model RADCC V2 (K220583) | Radformation, Inc. | 2022-08-23 |
| 1.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil (K222257) | Invivo Corporation (Business Trade Name: Philips) | 2022-08-23 |
| ClearCalc Model RADCA V2 (K220582) | Radformation, Inc. | 2022-08-22 |
| HS40 Diagnostic Ultrasound System (K221599) | Samsung Medison Co., Ltd. | 2022-08-22 |
| AXIR-CX (K213520) | Radisen Co., Ltd. | 2022-08-19 |
| MI View&GO (K222172) | Siemens Medical Solutions USA, Inc. | 2022-08-19 |
| WebCeph (K220903) | Assemblecircle Corp. | 2022-08-17 |
| syngo Application Software (VE21) (K220433) | Siemens Medical Solution USA, Inc. | 2022-08-16 |
| ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic Ultrasound System (K221190) | Siemens Medical Solutions USA, Inc. | 2022-08-16 |
| FORUM (K213527) | Carl Zeiss Meditec, AG | 2022-08-15 |