| PVmed Contouring Software (K210916) | Perception Vision Medical Technologies Ltd.Co. | 2021-12-03 |
| ImplaStation (K210241) | Prodigident, Inc. | 2021-12-03 |
| Clivia series Diagnostic Ultrasound System (K211886) | Shenzhen Wisonic Medical Technology Co. , Ltd. | 2021-12-02 |
| Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR (K213305) | Canon Medical Systems Corporation | 2021-12-01 |
| dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T (K212864) | Philips Healthcare (Suzhou) Co., Ltd. | 2021-12-01 |
| RCT700 (K213226) | Ray Co., Ltd. | 2021-11-29 |
| MammoScreen 2.0 (K211541) | Therapixel | 2021-11-26 |
| AMRA Profiler (K211983) | Amra Medical AB | 2021-11-24 |
| ControlRad Select Model Z (K213455) | Controlrad, Inc. | 2021-11-24 |
| Myomics Q (K211432) | Phantomics, Inc. | 2021-11-23 |
| Philips Incisive CT on Trailer (K211168) | Philips Healthcare (Suzhou) Co., Ltd. | 2021-11-22 |
| MR 5300 (K212673) | Philips Medical Systems Nederland B.V. | 2021-11-19 |
| OnQ Neuro (K210831) | Cortechs Labs, Inc. | 2021-11-19 |
| VALORY (K213469) | Agfa N.V. | 2021-11-18 |
| MD-320W Ultrasound Biomicroscope (K213070) | MEDA Co., Ltd. | 2021-11-18 |
| Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System (K212456) | Hyperfine, Inc. | 2021-11-17 |
| Lunit INSIGHT MMG (K211678) | Lunit, Inc. | 2021-11-17 |
| Soteria.AI (K212336) | Omega Medical Imaging, LLC | 2021-11-17 |
| TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System (K212265) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2021-11-16 |
| ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW) (K213497) | H&abyz Co., Ltd. | 2021-11-15 |
| Clarius Ultrasound Scanner (K213436) | Clarius Mobile Health Corp. | 2021-11-15 |
| Axialis Ophthalmic Ultrasound System (K213254) | Quantel Medical | 2021-11-15 |
| MiPACS HTML5 Web Viewer (K212984) | Lead Technologies, Inc. | 2021-11-12 |
| MAMMOVISTA B.smart (K212621) | Siemens Medical Solutions USA, Inc. | 2021-11-12 |
| Intellijoint VIEW (K211876) | Intellijoint Surgical, Inc. | 2021-11-12 |
| Lunit INSIGHT CXR Triage (K211733) | Lunit, Inc. | 2021-11-10 |
| inVisionOS (K210344) | Precisionos Technology, Inc. | 2021-11-10 |
| AlignRT Plus (K212583) | Vision Rt, Ltd. | 2021-11-10 |
| RTapp (K212887) | Segana, Inc. | 2021-11-10 |
| Hura CTP v1.0 (K212550) | Hura Imaging, Inc. | 2021-11-08 |
| GIQuant (K211356) | Motilent, Ltd. | 2021-11-08 |
| FDR Cross (DR-XD 3000) (K212956) | Fujifilm Corporation | 2021-11-08 |
| VFSS Pro Mobile Digital Imaging System (K212523) | Imagexray, LLC | 2021-11-05 |
| Visible Patient Suite (K212896) | Visible Patient, Sas | 2021-11-05 |
| Acuson SC2000 Diagnostic Ultrasound System (K211726) | Siemens Medical Solutions USA, Inc. | 2021-11-05 |
| MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System (K212900) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2021-11-05 |
| LELTEK Ultrasound Imaging System (Model: LU700 Series) (K210432) | Leltek, Inc. | 2021-11-03 |
| MOVIX DReamy (K212515) | Stephanix | 2021-11-03 |
| SyMRI (K203372) | Syntheticmr AB | 2021-11-03 |
| TaiChiB (K210921) | Our United Corporation | 2021-11-02 |
| VisionX 3.0 (K213326) | Durr Dental SE | 2021-11-02 |
| ATEC Alignment App (K211987) | Alphatec Spine, Inc. | 2021-10-29 |
| Critical Care Suite with Endotracheal Tube Positing AI algorithm (K211161) | Ge Medical Systems, LLC | 2021-10-29 |
| ds Head 32ch 3.0T (K213351) | Invivo Corporation (Business Trade Name: Philips) | 2021-10-29 |
| nView s1 with nav option (K211064) | Nview Medical | 2021-10-29 |
| CLISIS SYSTEMS, Discovery RF180 (K213081) | General Medical Merate S.P.A | 2021-10-26 |
| Advanced Algorithms for Treatment Management Applications (AATMA) (K212218) | Elekta Solutions AB | 2021-10-25 |
| FlightPlan for Liver (K210807) | GE Medical Systems SCS | 2021-10-22 |
| Orthoscan Tau Mini C-Arm (K213113) | Orthoscan, Inc. | 2021-10-21 |
| iRAD (K212470) | Claritas Healthtech Pte, Ltd. | 2021-10-20 |
| Contour ProtegeAI (K210632) | Mim Software, Inc. | 2021-10-20 |
| DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa) (K212254) | Hdx Will Corp. | 2021-10-19 |
| Change Healthcare Cardiology (K212528) | Change Healthcare Israel , Ltd. | 2021-10-18 |
| 0909FCB, 1212FCA (K212753) | Rayence Co., Ltd. | 2021-10-18 |
| SwiftMR (K210999) | Airs Medical, Inc. | 2021-10-14 |
| Brainance MD (K202808) | Advantis Medical Imaging Single Member P.C. | 2021-10-14 |
| StrokeSENS LVO (K212261) | Circle Neurovascular Imaging, Inc. | 2021-10-14 |
| VBrain-OAR (K212116) | Vysioneer, Inc. | 2021-10-12 |
| OASIS MRI System (K211406) | Hitachi Healthcare Americas | 2021-10-07 |
| RTHawk, HeartVista Cardiac Package (K212233) | Heartvista, Inc. | 2021-10-05 |
| NAVIPLAN - CT Planning Software for Total Hip Replacement (K211429) | Naviswiss AG | 2021-10-05 |
| EzDent-i/ E2/ Prora View/ Smart M Viewer (K211795) | Ewoosoft Co., Ltd. | 2021-10-04 |
| Elekta Unity (K212114) | Elekta Solutions AB | 2021-10-01 |
| Zenition 70 (K212813) | Philips Medical Systems Nederland B.V. | 2021-10-01 |
| NAEOTOM Alpha, Scan&GO (K211591) | Siemens Medical Solutions USA, Inc. | 2021-09-30 |
| Accuray Precision Treatment Planning System (K212794) | Accuray Incorporated | 2021-09-30 |
| ImmersiveTouch (K210726) | Immersivetouch, Inc. | 2021-09-29 |
| EzDent Web (K211700) | Ewoosoft Co., Ltd. | 2021-09-28 |
| SIDDHARTH-II; IMPACT (K210894) | Panacea Medical Technologies Pvt. , Ltd. | 2021-09-28 |
| Panther OIS (K211760) | Prowess, Inc. | 2021-09-28 |
| SubtlePET (K211964) | Subtle Medical, Inc. | 2021-09-28 |
| Collaboration Live (K212777) | Philips Ultrasound, Inc. | 2021-09-24 |
| Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System (K212704) | Philips Medical Systems | 2021-09-24 |
| Virtual C DRF-NEO Digital Imaging System (K212557) | Portavision Medical, LLC | 2021-09-24 |
| JiveX (Model Number / Release: 5.3) (K212321) | Visus Health IT GmbH | 2021-09-23 |
| ProxiDiagnost N90 (K212837) | Philips Medical Systems Dmc GmbH | 2021-09-21 |
| T2 (K212303) | Osstem Implant Co., Ltd. | 2021-09-21 |
| Kubtec Mozart Supra (XPERT 84) Radiography System (K210955) | Kub Technologies, Inc. | 2021-09-20 |
| Intelligent NR (K212269) | Canon, Inc. | 2021-09-17 |
| Deep Learning Image Reconstruction (K212067) | Ge Healthcare Japan Corporation | 2021-09-17 |
| Symbia VA10A Family (K212604) | Siemens Medical Solutions USA, Inc. | 2021-09-16 |
| 6430 MyLabX75, 6430 MyLab XPro75 (K212021) | Esaote, S.p.A. | 2021-09-16 |
| HealthCCSng (K210085) | Zebra Medical Vision, Ltd. | 2021-09-15 |
| BeamSite (K212606) | Doseoptics, LLC | 2021-09-15 |
| PHOENIX (K212291) | Sedecal., Sa. | 2021-09-14 |
| Harmony Referral System (K210396) | Topcon Healthcare Solutions EMEA Oy | 2021-09-13 |
| CIV-Clear cover (K211270) | CIVCO Medical Instruments Co., Inc. | 2021-09-13 |
| KONICAMINOLTA DI-X1 (K212685) | Konica Minolta, Inc. | 2021-09-13 |
| LOGIQ E10 (K211488) | GE Healthcare | 2021-09-10 |
| Versana Premier (K210438) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2021-09-10 |
| Aquilion Exceed LB (K211828) | Canon Medical Systems Corporation | 2021-09-10 |
| ClariSIGMAM (K203785) | Claripi, Inc. | 2021-09-10 |
| EFAI PACS Picture Archiving and Communication System (K211257) | Ever Fortune.Ai, Co., Ltd. | 2021-09-10 |
| AccuFFRangio (K210093) | ArteryFlow Technology Co., Ltd. | 2021-09-10 |
| Kinepict Medical Imaging Tool 4.0 (K202056) | Kinepict Health, Ltd. | 2021-09-10 |
| HERA W9, HERA W10 Diagnostic Ultrasound System (K211824) | Samsung Medison Co., Ltd. | 2021-09-09 |
| DIGITAL RADIOGRAPHY CXDI-Pro, D1 (K212553) | Canon, Inc. | 2021-09-09 |
| V8 Diagnostic Ultrasound System (K211945) | Samsung Medison Co., Ltd. | 2021-09-08 |
| RayStation 11.0 (K211867) | RaySearch Laboratories AB (PUBL) | 2021-09-08 |
| EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System (K211597) | Philips Medical Systems | 2021-09-08 |