| CellChek 20 rc (K203244) | Konan Medical, Inc. | 2021-06-15 |
| Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD (K210500) | Elekta Limited | 2021-06-11 |
| Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus I9 Diagnostic Ultrasound System (K210699) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2021-06-10 |
| syngo.via MI WorkFlows, Scenium, syngo MBF (K211459) | Siemens Medical Solutions USA, Inc. | 2021-06-10 |
| M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System (K210416) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2021-06-10 |
| Fiducial Marker (K211590) | Carbon Medical Technologies, Inc. | 2021-06-10 |
| Palm Bladder Scanner - PBSV7.1 (K210591) | Mianyang Meike Electronic Equipment Co., Ltd. | 2021-06-09 |
| Vivid S60N / Vivid S70N (K211216) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2021-06-09 |
| OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System (K210458) | ABBOTT MEDICAL | 2021-06-08 |
| Prudent 1717, Prudent 1417, Prudent 1212 (K211108) | Pixxgen Corporation | 2021-06-04 |
| Micro C Medical Imaging System, M01 (K211473) | Oxos Medical, Inc. | 2021-06-04 |
| Transpara 1.7.0 (K210404) | Screenpoint Medical B.V. | 2021-06-02 |
| ZedView (K200704) | Lexi Co., Ltd. | 2021-05-27 |
| Breast Volume Navigator (BVN) Model G-2000 (K211098) | Metritrack, Inc. | 2021-05-26 |
| Rover (K211423) | Micro-X Limited | 2021-05-21 |
| Universal Viewer (K211312) | GE Healthcare | 2021-05-21 |
| C-Qual M™ Breastboard; Monarch™ Overhead Arm Positioner (K211001) | Medtec, Inc. Dba Civco Medical Solutions and Civco | 2021-05-20 |
| Xoran Workstation, Model 10050 (K210257) | Xoran Technologies, LLC | 2021-05-20 |
| CINA CHEST (K210237) | Avicenna.Ai | 2021-05-19 |
| Overjet Dental Assist (K210187) | Overjet, Inc. | 2021-05-19 |
| Vereos PET/CT (K210880) | Philips Medical Systems Nederland B.V. | 2021-05-19 |
| Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR (K211037) | Canon Medical Systems Corporation | 2021-05-17 |
| Cercare Medical Neurosuite (K202793) | Cercare Medical Aps | 2021-05-17 |
| Klarity Bolus (K202747) | Klarity Medical & Equipment (GZ) Co., Ltd. | 2021-05-14 |
| HOLOSCOPE-i (K210072) | Real View Imaging , Ltd. | 2021-05-14 |
| SIGNA 7.0T (K211118) | Ge Medical Systems, LLC | 2021-05-13 |
| HS40 Diagnostic Ultrasound System (K210426) | Samsung Medison Co., Ltd. | 2021-05-13 |
| Symbia VA10A Family (K210557) | Siemens Medical Solutions USA, Inc. | 2021-05-12 |
| Corvus Radiation Therapy Planning System (K211034) | Best Nomos | 2021-05-06 |
| ImagePilot (K210066) | Konica Minolta, Inc. | 2021-05-06 |
| SOTA Cloud Imaging (K210682) | Sota Precision Optics, Inc. Dba Sota Imaging | 2021-05-04 |
| PtoleMedic System (K202521) | Lento Medical Innovation, Inc. | 2021-05-04 |
| syngo. CT Extended Functionalities (K203699) | Siemens Medical Solutions USA, Inc. | 2021-04-30 |
| HYPER AiR (K210001) | Shanghai United Imaging Healthcare Co., Ltd. | 2021-04-30 |
| AcuityDRe (K210919) | Radmedix, LLC | 2021-04-30 |
| 1717FCC (K210985) | Rayence Co., Ltd. | 2021-04-28 |
| Trinias (K203535) | Shimadzu Corporation Medical Systems | 2021-04-28 |
| AMX Navigate (K210982) | Ge Medical Systems, LLC | 2021-04-28 |
| TCL3 Motion Tracking System (K203451) | Tracinnovations Aps | 2021-04-28 |
| Cartesion Prime (PCD-1000A/3) V10.8 (K203314) | Canon Medical Systems Corporation | 2021-04-23 |
| MEDO-Thyroid (K203502) | Medo DX Pte. , Ltd. | 2021-04-23 |
| 2MP Monochrome LCD Monitor MS-S200 (K210345) | Jvckenwood Corporation | 2021-04-23 |
| Preview Shoulder (K210556) | Genesis Software Innovations | 2021-04-21 |
| Yushan X-Ray Flat Panel Detector with DROC (K210988) | Innocare Optoelectronics Corp. | 2021-04-21 |
| Identify (K210835) | Varian Medical Systems, Inc. | 2021-04-20 |
| Automatic Anatomy Recognition (AAR) (K203610) | Quantitative Radiology Solutions, LLC | 2021-04-20 |
| AI Segmentation (K203469) | Varian Medical Systems, Inc. | 2021-04-19 |
| rainbow MCT (K200270) | Dentium Co., Ltd (Ict Branch) | 2021-04-16 |
| rainbow CT (K200271) | Dentium Co., Ltd (Ict Branch) | 2021-04-16 |
| Saige-Q (K203517) | DeepHealth, Inc. | 2021-04-16 |
| CX30N (CX30PQX) (K210493) | Wide Corporation | 2021-04-14 |
| BriefCase, RIB Fractures Triage (RibFx) (K202992) | Aidoc Medical , Ltd. | 2021-04-14 |
| Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2 (K210900) | Canon Medical Systems Corporation | 2021-04-12 |
| Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3 (K202679) | Mcgovern Medical School | 2021-04-12 |
| HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound System (K210068) | Samsung Medison Co., Ltd. | 2021-04-09 |
| HYPER Focus (K210418) | Shanghai United Imaging Healthcare Co., Ltd. | 2021-04-09 |
| RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT QA, Dose Review (K203681) | Brainlab AG | 2021-04-09 |
| DeepLook PRECISE (K202084) | Deeplook, Inc. | 2021-04-09 |
| CW120N (K210491) | Wide Corporation | 2021-04-08 |
| Resona R9,Resona R9 Exp,Resona R9 Pro,Resona R9S, Nuewa R9,Nuewa R9 Exp,Nuewa R9 Pro,Nuewa R9S,Resona 7,Resona 7CV,Resona 7EXP,Resona 7S, Resona 7OB,Resona 7PRO,Imagyn 7,Resona Y Diagnostic Ultrasound System (K202785) | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. | 2021-04-08 |
| StentBoost Mobile (K203623) | Philips India Limited | 2021-04-05 |
| ADAS 3D (K210850) | Adas3D Medical S.L. | 2021-04-05 |
| Eclipse II with Smart Noise Cancellation (K202441) | Carestream Health, Inc. | 2021-04-02 |
| DigitalDiagnost (K210692) | Philips Medical Systems Dmc GmbH | 2021-04-02 |
| DV. Target (K202928) | Deepvoxel, Inc. | 2021-04-02 |
| ACUSON Redwood Diagnostic Ultrasound System (K210743) | Siemens Medical Solutions USA, Inc. | 2021-04-01 |
| Nanox Cart X-ray System (K203782) | Nano-X Imaging , Ltd. | 2021-04-01 |
| Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR (K210340) | Canon Medical Systems Corporation | 2021-04-01 |
| Simpleware ScanIP Medical (K203195) | Synopsys (Northern Europe) , Ltd. | 2021-04-01 |
| syngo.CT Lung CAD (K203258) | Siemens Healthcare GmbH | 2021-03-31 |
| SIS System (Version 5.1.0) (K210071) | Surgical Information Sciences, Inc. | 2021-03-31 |
| MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea (K203443) | Siemens Medical Solutions USA, Inc. | 2021-03-31 |
| StarGuide (K210173) | GE Healthcare | 2021-03-29 |
| Surgivisio system (K202547) | Surgivisio | 2021-03-26 |
| FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630) (K203273) | Echosens | 2021-03-25 |
| Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System (K203225) | Canon Medical Systems Corporation | 2021-03-24 |
| I-Q View (K203703) | First Source, Inc. | 2021-03-24 |
| Viz ICH (K210209) | Viz. Ai, Inc. | 2021-03-23 |
| TE7/TE5/TE7 Max/TE5 Max/TE9 Diagnostic Ultrasound System (K203391) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2021-03-23 |
| IMPACT and X-Ranger (K210479) | Minxray, Inc. | 2021-03-19 |
| VBrain (K203235) | Vysioneer, Inc. | 2021-03-19 |
| BBX-PET Scanner (K210450) | Prescient Imaging, LLC | 2021-03-17 |
| Ziehm Vision RFD (K203428) | Ziehm Imaging GmbH | 2021-03-17 |
| Oncospace (K202284) | Oncospace, Inc. | 2021-03-12 |
| TaiChiC (K203250) | Our United Corporation | 2021-03-12 |
| ProFound AI Software V3.0 (K203822) | Icad, Inc. | 2021-03-12 |
| ADD (K203188) | H&abyz Co., Ltd. | 2021-03-12 |
| Vantage Elan 1.5T, MRT-2020, V6.0 (K210164) | Canon Medical Systems Corporation | 2021-03-10 |
| Imbio RV/LV Software (K203256) | Imbio, LLC | 2021-03-09 |
| Quicktome (K203518) | Omniscient Neurotechnology Pty Ltd (O8t) | 2021-03-09 |
| Cios Select (VA21) Flat Panel (K210309) | Siemens Medical Solutions USA, Inc. | 2021-03-05 |
| Akesis Galaxy RTi (K203146) | Akesis, Inc. | 2021-03-05 |
| Vivid E80/ Vivid E90/ Vivid E95 (K202658) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2021-03-05 |
| Optellum Virtual Nodule Clinic, Optellum software, Optellum platform (K202300) | Optellum, Ltd. | 2021-03-05 |
| OEC 3D (K203346) | Ge Oec Medical Systems, Inc. | 2021-03-05 |
| Cios Select (VA21) Image Intensifier (K210307) | Siemens Medical Solutions USA, Inc. | 2021-03-04 |
| Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR (K203323) | Canon Medical Systems Corporation | 2021-03-04 |
| AlignRT Plus (K203387) | Vision Rt, Ltd. | 2021-03-04 |
| Promaxo MRI System (K202518) | Promaxo, Inc. | 2021-03-03 |
| Biograph Vision Quadra PET/CT System (K210262) | Siemens Medical Solutions USA, Inc. | 2021-03-03 |