| AmCAD-UT (K203555) | Amcad Biomed Corporation | 2021-09-08 |
| ADAS 3D (K212421) | Adas3D Medical S.L. | 2021-09-03 |
| AI Segmentation (K211881) | Varian Medical Systems, Inc. | 2021-09-02 |
| RayPilot System (K203722) | Micropos Medical AB | 2021-09-02 |
| Lung Image Analysis (K212494) | Pulmonx Corporation | 2021-09-02 |
| Kubtec Mozart (XPERT42) (K210956) | Kub Technologies, Inc. | 2021-08-31 |
| Kubec Xpert 80 Radiography System (K210957) | Kub Technologies, Inc. | 2021-08-31 |
| Auto Lung Nodule Detection (K201560) | Samsung Electronics Co., Ltd. | 2021-08-31 |
| DR 800 with DSA, DR 800 (K212145) | Agfa N.V. | 2021-08-31 |
| EndoNaut (K212383) | Therenva Sas | 2021-08-31 |
| LOGIQ E10s, LOGIQ Fortis (K211524) | GE Healthcare | 2021-08-27 |
| SOMATOM go.Platform Scanners - SOMATOM go.Now, go.Up, go.All, go.Top, SOMATOM X. Platform Scanners - SOMATOM X.cite and SOMATOM X.ceed, Scan&GO Software (K211373) | Siemens Medical Solutions USA, Inc. | 2021-08-27 |
| RBknee (K203696) | Radiobotics Aps | 2021-08-27 |
| MyoSPECT, MyoSpect ES (K212004) | GE Healthcare | 2021-08-27 |
| RFA-1717DIG, RFA-1717DIC (K212051) | Astel, Inc. | 2021-08-25 |
| Diagnostic X-ray System/PLX5200A (K212134) | Nanjing Perlove Medical Equipment Co., Ltd. | 2021-08-25 |
| SKR 3000 (K210619) | Konica Minolta, Inc. | 2021-08-24 |
| IMRIS iMRI 3T V (K212367) | Deerfield Imaging, Inc. | 2021-08-23 |
| EzOrtho (K211793) | Ewoosoft Co., Ltd. | 2021-08-23 |
| 6543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, 3025ZF (K212105) | Pzmedical Technology Co., Ltd. | 2021-08-23 |
| Exo Iris (K211527) | Exo Imaging, Inc. | 2021-08-20 |
| Discovery MI Gen2 (K211846) | Ge Medical Systems, LLC | 2021-08-20 |
| Ez3D-i/E3 (K211791) | Ewoosoft Co., Ltd. | 2021-08-20 |
| Otoplan (K203486) | Cascination AG | 2021-08-20 |
| Ethos Treatment Management, Ethos Treatment Planning (K212294) | Varian Medical Systems, Inc. | 2021-08-20 |
| Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W / Apogee 1U/ Apogee 1T/ Apogee 1G Digital Color Doppler Ultrasound Imaging System (K210317) | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) | 2021-08-19 |
| Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging System (K210318) | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) | 2021-08-18 |
| ROSA Hip System (K210998) | Orthosoft D/B/A Zimmer Cas | 2021-08-17 |
| Brain Perfusion (BP) application (K201573) | Philips Medical Systems Nederland B.V. | 2021-08-17 |
| TruSPECT Radiological Image Processing Station (K212230) | Spectrum Dynamics Medical, Ltd. | 2021-08-16 |
| ARCO FP-S (K211777) | A.T.S. Applicazione Tecnologie Speciali S.R.L. | 2021-08-13 |
| EMM Ultrasonic Transducer Cover (K211969) | Exact Medical Manufacturing | 2021-08-13 |
| NFLK-2501 Portable X-ray Unit (K211383) | Neuf, Inc. | 2021-08-13 |
| eVolve PACS (K211863) | Evolve Pacs, Inc. | 2021-08-12 |
| InferRead CT Stroke.AI (K211179) | Infervision Medical Technology Co., Ltd. | 2021-08-12 |
| Excelsius3D (K210912) | Globus Medical, Inc. | 2021-08-12 |
| uCT ATLAS with uWS-CT-Dual Energy Analysis (K203448) | Shanghai United Imaging Healthcare Co., Ltd. | 2021-08-11 |
| EAGLE EDGE AXR90 and AXR120 (K210820) | Alliage S/A Industrias Medico Odontológica | 2021-08-10 |
| X-CUBE 90 (K211300) | Alpinion Medical Systems Co., Ltd. | 2021-08-09 |
| X-CUBE 70 (K211299) | Alpinion Medical Systems Co., Ltd. | 2021-08-09 |
| Senographe Pristina (K211725) | GE Healthcare | 2021-08-06 |
| Vereos PET/CT (K211764) | Philips Medical Systems Nederland B.V. | 2021-08-06 |
| Kosmos (K212100) | EchoNous, Inc. | 2021-08-06 |
| Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR (K212056) | Canon Medical Systems Corporation | 2021-08-04 |
| Remex KA6 (K212144) | Remedi Co., Ltd. | 2021-08-03 |
| DynaCAD (K212175) | Invivo Corporation | 2021-08-02 |
| breastscape v1.0 (K211431) | Olea Medical | 2021-08-02 |
| qER-Quant (K211222) | Qure.Ai Technologies | 2021-07-30 |
| Labat series Diagnostic Ultrasound System (K210154) | Shenzhen Wisonic Medical Technology Co. , Ltd. | 2021-07-30 |
| syngo.via RT Image Suite (K211379) | Siemens Medical Solutions USA, Inc. | 2021-07-30 |
| FibroScan 230 (K212035) | Echosens | 2021-07-30 |
| DX-D Imaging Package with XD Detectors (K211790) | Agfa N.V. | 2021-07-30 |
| Zap-X Radiosurgical System (K211663) | Zap Surgical Systems, Inc. | 2021-07-29 |
| Us2.v1 (K210791) | Eko.Ai Pte Ltd. D/B/A Us2.Ai | 2021-07-27 |
| Volpara Imaging Software (K211279) | Volpara Health Technologies Limited | 2021-07-27 |
| PET VCAR (K211247) | GE Medical Systems SCS | 2021-07-27 |
| Insight Agile DRF (K210469) | Imaging Engineering, LLC | 2021-07-27 |
| ClariCT.AI (K212074) | Claripi, Inc. | 2021-07-27 |
| aPROMISE (K211655) | Exini Diagnostics AB | 2021-07-27 |
| SC1 Handheld Ultrasound Imaging System (Model: SC1) (K210468) | Fcu Co., Ltd. | 2021-07-23 |
| MySpine WebPlanner & MyBalance (K211386) | Medacta International S.A. | 2021-07-23 |
| Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR (K211633) | Canon Medical Systems Corporation | 2021-07-22 |
| ExacTrac Dynamic (K211939) | Brainlab AG | 2021-07-22 |
| QSM software, QSMetric (K210415) | Medimagemetric, LLC | 2021-07-22 |
| syngo.CT Skull Unfolding (K203411) | Siemens Medical Solutions USA, Inc. | 2021-07-22 |
| Change Healthcare Anatomical AI (K210719) | Change Healthcare Canada Company | 2021-07-20 |
| Chest-CAD (K210666) | Imagen Technologies, Inc. | 2021-07-20 |
| ACUSON Sequoia Diagnostic Ultrasound System (K211859) | Siemens Medical Solutions USA, Inc. | 2021-07-20 |
| ZIRKONZAHN.Implant-Planner, ZIRKONZAHN.Implant-Planner Practice, CAD/CAM STL Converter, CAD/CAM Z-Tray (K203765) | Zirkonzahn Srl | 2021-07-20 |
| SMART FINDER (K203509) | Ims Giotto S.P.A. | 2021-07-14 |
| RadiForce RX370 (K211491) | Eizo Corporation | 2021-07-12 |
| PowerLook Density Assessment V4.0 (K211506) | Icad, Inc. | 2021-07-12 |
| PRIMO S (K211542) | A.T.S. Applicazione Tecnologie Speciali S.R.L. | 2021-07-09 |
| HM70 EVO Diagnostic Ultrasound System (K210713) | Samsung Medison Co., Ltd. | 2021-07-09 |
| PRE-SURE (K201835) | Lazarus 3D, Inc. | 2021-07-08 |
| iSR'obot Mona Lisa 1.0 (K203659) | Biobot Surgical Pte., Ltd. | 2021-07-08 |
| NubeX (K211480) | Techheim Co., Ltd. | 2021-07-08 |
| HALO (K211788) | Nicolab B.V. | 2021-07-08 |
| Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System (K211818) | Hyperfine, Inc. | 2021-07-07 |
| ONE Planner Hip (K210653) | Orthosoft D/B/A Zimmer Cas | 2021-07-07 |
| ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9 (K211782) | Controlrad, Inc. | 2021-07-01 |
| DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System (K211337) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2021-07-01 |
| decimal Bolus (K211511) | .Decimal, LLC | 2021-07-01 |
| MAGNETOM Free.Max (K210611) | Siemens Medical Solutions USA, Inc. | 2021-07-01 |
| Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC MACH40 (K203645) | Supersonic Imagine | 2021-06-29 |
| 12MP Color Digital Mammography LCD Monitor CL-S1200 (K203733) | Jvckenwood Corporation | 2021-06-29 |
| RayStation 10.1 (K210645) | RaySearch Laboratories AB (PUBL) | 2021-06-29 |
| STAGE (K210843) | Spintech, Inc. | 2021-06-29 |
| Apache Ultrasound System (K211232) | Aco Healthcare Co., Ltd. | 2021-06-25 |
| BD Prevue II Peripheral Vascular Vascular Access System (K211193) | Bard Access Systems, Inc. (C.R. Bard, Inc.) | 2021-06-25 |
| Vu-Path Ultrasound System (K203657) | Crystalline Medical | 2021-06-25 |
| 3D Echo v1.1 (K211656) | Jointvue, LLC | 2021-06-25 |
| THD Procto Software System (K211623) | Thd Spa | 2021-06-24 |
| Virtual C DRF Digital Imaging System (K211191) | Portavision Medical, LLC | 2021-06-24 |
| RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound System (K210959) | Samsung Medison Co., Ltd. | 2021-06-24 |
| MICROMATE (K203720) | Isys Medizintechnik GmbH | 2021-06-22 |
| SenoBright HD (K211215) | GE Healthcare | 2021-06-22 |
| 2430MCA with Xmaru W (K202902) | Rayence Co., Ltd. | 2021-06-21 |
| Precise Position (K203514) | Philips Healthcare (Suzhou) Co., Ltd. | 2021-06-17 |
| Qmenta Care Platform Family (K202718) | Mint Labs, Inc., D/B/A. Qmenta | 2021-06-16 |