| Monaco RTP System (K213787) | Elekta Solutions AB | 2022-05-17 |
| Rapid PE Triage and Notification (PETN) (K220499) | Ischemaview, Inc. | 2022-05-17 |
| syngo.CT CaScoring (K221219) | Siemens Medical Solutions USA, Inc. | 2022-05-17 |
| SONON Ultrasound Imaging System, Model: SONON300C (K211665) | Healcerion Co., Ltd. | 2022-05-16 |
| Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems (K213583) | Philips Medical Systems Nederland B.V. | 2022-05-16 |
| Caas Qardia (K212376) | Pie Medical Imaging BV | 2022-05-16 |
| XACT ACE Robotic System (K221116) | Xact Robotics, Ltd. | 2022-05-13 |
| PEDRA-1417MC, PEDRA-1417MG, PEDRA-1417FC, PEDRA-1417FG (K221144) | Radisen Co., Ltd. | 2022-05-13 |
| Quantib Prostate (K221106) | Quantib B.V. | 2022-05-13 |
| INTDose (K213137) | Carina Medical, LLC | 2022-05-13 |
| MAGNETOM Skyra Fit (K220589) | Siemens Medical Solutions USA, Inc. | 2022-05-13 |
| Spectral CT on Rails (K212875) | Philips Medical Systems Nederland B.V. | 2022-05-13 |
| Saige-Dx (K220105) | DeepHealth, Inc. | 2022-05-12 |
| VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips (K212909) | Macromedics BV | 2022-05-11 |
| Versana Balance (K220446) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2022-05-11 |
| Overjet Caries Assist (K212519) | Overjet, Inc. | 2022-05-10 |
| inHEART MODELS (K220727) | Inheart, Sas | 2022-05-10 |
| RadiForce MX243W (K221136) | Eizo Corporation | 2022-05-10 |
| KEOPS Balance Analyzer 3D (K213975) | S.M.A.I.O | 2022-05-06 |
| Segment 3DPrint (K211966) | Medviso AB | 2022-05-06 |
| HM70 EVO Diagnostic Ultrasound System (K220269) | Samsung Medison Co., Ltd. | 2022-05-06 |
| NewTom 7G (K220664) | Cefla S.C. | 2022-05-06 |
| NAVIRFA Scope (K211529) | Navifus Corporation | 2022-05-05 |
| 17HQ901G-B (K220559) | Lg Electronics.Inc | 2022-05-05 |
| Aurora-RT (K213526) | Magnettx Oncology Solutions , Ltd. | 2022-05-04 |
| Heart5R-110 Portable X-Ray Machine, Heart3R-110 Portable X-ray Machine (K220700) | Yian Medical Technology (Haining) Co., Ltd. | 2022-05-04 |
| exoplan (K213302) | Exocad GmbH | 2022-05-03 |
| MVision AI Segmentation (K212915) | MVision AI | 2022-05-03 |
| Cardiovascular Angiography System (K220311) | Allengers Medical Systems Limited | 2022-05-03 |
| Liver Suite (K211180) | GE Medical Systems SCS | 2022-05-02 |
| Bindex BI-2 (K211350) | Bone Index Finland , Ltd. | 2022-04-29 |
| ARIETTA 50 (K220295) | Fujifilm Healthcare Corporation | 2022-04-29 |
| aPROMISE X (K220590) | Exini Diagnostics AB | 2022-04-29 |
| Hand Diagnostic Radiography Imaging System (K220271) | Nanoray Biotech Co., Ltd. | 2022-04-29 |
| ExacTrac Dynamic (K220338) | Brainlab AG | 2022-04-29 |
| BodyTom 64 (K213649) | Neurologica Corporation | 2022-04-29 |
| MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50A (K220939) | Siemens Medical Solutions USA, Inc. | 2022-04-29 |
| Oryx Cloud Imaging (K220684) | Oryx Dental Software, Inc. | 2022-04-29 |
| Digital flat panel detector (K220536) | Iray Technology Taicang , Ltd. | 2022-04-28 |
| AngioCloud Service (K211713) | Angiocloud, LLC | 2022-04-28 |
| EFAI RTSuite CT HN-Segmentation System (K220264) | Ever Fortune.Ai, Co., Ltd. | 2022-04-28 |
| RetinAI Discovery (K211715) | Retinai Medical AG | 2022-04-28 |
| Planmed Verity (K213278) | Planmed OY | 2022-04-28 |
| Philips Incisive CT (K212441) | Philips Healthcare (Suzhou) Co., Ltd. | 2022-04-27 |
| BriefCase (K213886) | Aidoc Medical , Ltd. | 2022-04-26 |
| SONON Ultrasound Imaging System, Model: SONON 500L (K212400) | Healcerion Co., Ltd. | 2022-04-22 |
| MirrorMe3D Modeling System (K212981) | Mirrorme3D, LLC | 2022-04-22 |
| HealthOST (K213944) | Nanoxai , Ltd. | 2022-04-22 |
| ATUSA™ Automated 3D Breast Ultrasound System (K213620) | Isono Health, Inc. | 2022-04-22 |
| Videa Caries Assist (K213795) | Videahealth, Inc. | 2022-04-21 |
| GM85 (K220175) | Samsung Electronics Co., Ltd. | 2022-04-21 |
| General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System (Model: GR10X 50K) (K220149) | Xera Medical Systems & Technology , Ltd. | 2022-04-19 |
| Nautilus (K220871) | Dornier Medtech America, Inc. | 2022-04-18 |
| XD (K220779) | Mirada Medical, Ltd. | 2022-04-15 |
| SURGIVISIO Device (K220946) | Ecential Robotics | 2022-04-15 |
| AI-Rad Companion Brain MR (K213706) | Siemens Healthcare GmbH | 2022-04-15 |
| RayStation 11B (K220141) | RaySearch Laboratories AB (PUBL) | 2022-04-15 |
| TeleScan (K220767) | Bb Imaging | 2022-04-14 |
| Yushan X-Ray Flat Panel Detector with DROC (K220510) | Innocare Optoelectronics Corp. | 2022-04-14 |
| Breast BI Coil Set 0.55T; Breast BI 7 MR Coil Set 1.5T; Breast BI 7 MR Coil Set 3T (K220144) | Noras Mri Products GmbH | 2022-04-08 |
| ImaCor Zura Handheld ZHH-010 (K220490) | Imacor, Inc. | 2022-04-08 |
| Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR (K220192) | Canon Medical Systems Corporation | 2022-04-08 |
| INT Contour (K212274) | Carina Medical, LLC | 2022-04-08 |
| ClariPulmo (K203783) | Claripi, Inc. | 2022-04-06 |
| MRCAT Head & Neck (K214081) | Philips OY | 2022-04-05 |
| HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound System (K220043) | Samsung Medison Co., Ltd. | 2022-04-05 |
| Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR (K220335) | Canon Medical Systems Corporation | 2022-04-05 |
| EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System (K212624) | Ever Fortune.Ai, Co., Ltd. | 2022-04-04 |
| SKANRAD 400 (K220518) | Skanray Technologies Limited | 2022-04-01 |
| Wireless Digital Flat Panel Detector (K220668) | Iray Technology Taicang , Ltd. | 2022-04-01 |
| MAGNETOM Avanto Fit (K220151) | Siemens Medical Solutions USA, Inc. | 2022-04-01 |
| APX-24 Portable X-ray System (K220678) | Aspenstate, Inc. | 2022-03-31 |
| Shield System (K212159) | Radiaction , Ltd. | 2022-03-30 |
| VERIQA (K213370) | Ptw-Freiburg Physikalisch-Technische-Werkstaetten | 2022-03-30 |
| VSP Bolus (K214093) | 3D Systems | 2022-03-30 |
| Focus HD 43 Detector (K213529) | Iray Technology Taicang , Ltd. | 2022-03-29 |
| Focus HD 35 Detector (K213646) | Iray Technology Taicang , Ltd. | 2022-03-29 |
| Syngo.CT Dual Energy (K212889) | Siemens Medical Solutions USA, Inc. | 2022-03-28 |
| C1210G LCD Monitor, JUSHA-C1210G LCD Monitor, C1210 LCD Monitor, JUSHA-C1210 LCD Monitor (K212231) | Nanjing Jusha Display Technology Co., Ltd. | 2022-03-25 |
| DTX Studio Clinic 3.0 (K213562) | Nobel Biocare AB | 2022-03-25 |
| TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System (K220242) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2022-03-25 |
| DRX-Rise Mobile X-ray System (K213568) | Carestream Health | 2022-03-23 |
| LOGIQ P10, LOGIQ P9, LOGIQ P8 (K214039) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2022-03-22 |
| Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5 (K212960) | Canon Medical Systems Corporation | 2022-03-22 |
| BriefCase (K213721) | Aidoc Medical , Ltd. | 2022-03-21 |
| SURGIVISIO Device (K220627) | Ecential Robotics | 2022-03-18 |
| Customize (K213779) | 3D-Side S.A. | 2022-03-16 |
| EchoSK and EchoSGyn modules for EchoS Family devices (K212851) | Echolight S.P.A | 2022-03-16 |
| Arterys MICA (K203744) | Arterys, Inc. | 2022-03-14 |
| BriefCase (K214043) | Aidoc Medical , Ltd. | 2022-03-14 |
| RI.HIP MODELER (K212040) | Blue Belt Technologies, Inc. | 2022-03-11 |
| CardIQ Suite (K213725) | GE Medical Systems SCS | 2022-03-11 |
| 32Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR Open Head Neck Posterior 9ch, 1.5T AIR Open Neck Chest Anterior 7ch / 3.0T AIR Open Neck Chest Anterior 7ch, 1.5T AIR Open Head Anterior 16ch / 3.0T AIR Open Head Anterior 16ch (K213687) | Neocoil, LLC | 2022-03-11 |
| MAGNETOM Vida, MAGNETOM Sola (K220425) | Siemens Medical Solutions USA, Inc. | 2022-03-11 |
| ClearRead Xray Pneumothorax (K213566) | Riverain Technologies, Inc. | 2022-03-10 |
| ZEN-2090 Turbo (K211780) | Genoray Co., Ltd. | 2022-03-09 |
| syngo.CT Applications (K220450) | Siemens Medical Solutions USA, Inc. | 2022-03-07 |
| TE Air Diagnostic Ultrasound System (K220051) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2022-03-04 |
| Skanmobile, Skanmobile-Dr (K212940) | Skanray Technologies Limited | 2022-03-04 |
| Second Opinion (K210365) | Pearl, Inc. | 2022-03-04 |