| Versana Premier; Versana Premier Lotus; LOGIQ F (K242005) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2024-10-02 |
| MuscleView (K241331) | Springbok, Inc. | 2024-10-01 |
| LungVision (K240943) | Bodyvision Medical , Ltd. | 2024-10-01 |
| GM85 (K242651) | Samsung Electronics Co., Ltd. | 2024-10-01 |
| Definium Pace Select ET (K242678) | Ge Hualun Medical Systems Co. , Ltd. | 2024-10-01 |
| CAC (gated) Algorithm (K240369) | BunkerHill Health | 2024-09-27 |
| JBS-LVO (K241480) | JLK, Inc. | 2024-09-27 |
| trophon Wireless Ultrasound Probe Holder (K241536) | Nanosonics Limited | 2024-09-27 |
| uAI Easy Triage ICH (K242292) | Shanghai United Imaging Intelligence Co., Ltd. | 2024-09-24 |
| EConsole2 (K240243) | DRTECH Corporation | 2024-09-23 |
| SuperSonic HepaVu (K242223) | Supersonic Imagine | 2024-09-20 |
| ERI Portable X-ray System (CVX-air); ERI Portable X-ray System (CVX-lite); ERI Portable X-ray System (CVX-E) (K234108) | Energy Resources International Co., Ltd. | 2024-09-20 |
| PIUR tUS Infinity (K240036) | Piur Imaging GmbH | 2024-09-20 |
| Sterile and Non-Sterile Ultrasonic Coupling Agent (K242167) | Anhui Deepblue Medical Technology Co., Ltd. | 2024-09-19 |
| GF85 (models GF85-3P, GF85-SP) (K242478) | Samsung Electronics Co., Ltd. | 2024-09-19 |
| EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220) (K234153) | Edgelife Technologies, LLC | 2024-09-18 |
| TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite/Anesus TEX20 Pro/Eagus TEX20/Eagus TEX20T/Eagus TEX21/Eagus TEX21T/Eros/TE X Plus/Anesus TEX10 Pro/TEX9U/TEX9M/Eagus TEX11/Eagus TEX11T/EagusTEX10/Eagus TEX10T/Eagus TEX/Ares Diagnostic Ultrasound System (K241201) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2024-09-16 |
| Orthopantomograph™ OP 3D LX (PAN 3D); Orthopantomograph™ OP 3D LX (PAN CEPH 3D) (K241249) | Palodex Group OY | 2024-09-12 |
| MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System (K241432) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2024-09-12 |
| Constellation (CON-001) (K241280) | Q Bio, Inc. | 2024-09-12 |
| Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800, TUS-AI700) (K241582) | Canon Medical Systems Corporation | 2024-09-12 |
| CINA-CSpine (K240942) | Avicenna.Ai | 2024-09-12 |
| Elucid PlaqueIQ (K241524) | Elucid Bioimaging, Inc. | 2024-09-12 |
| FETOLY-HEART (K241380) | Diagnoly | 2024-09-11 |
| Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound Imaging System (LK128C); Ultrasound Imaging System (LK128M); Ultrasound Imaging System (LK128PA); Ultrasound Imaging System (LK128E); Ultrasound Imaging System (LU700C); Ultrasound Imaging System (LU700L); Ultrasound Imaging System (LU710L); Ultrasound Imaging System (LU710LH); Ultrasound Imaging System (LU710C); Ultrasound Imaging System (LU710M); Ultrasound Imaging System (LU710PA); Ultrasound Imaging (K241161) | Leltek, Inc. | 2024-09-11 |
| LumiNE US; Lumi (K240094) | Augmedit B.V. | 2024-09-10 |
| See-Mode Augmented Reporting Tool, Thyroid (SMART-T) (K240697) | See-Mode Technologies Pte, Ltd. | 2024-09-09 |
| Overjet Image Enhancement Assist (K241681) | Overjet, Inc. | 2024-09-09 |
| ADAS 3D (K240791) | Adas3D Medical S.L. | 2024-09-09 |
| Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF) (K242394) | Rayence Co., Ltd. | 2024-09-09 |
| uAI Portal (K240411) | Shanghai United Imaging Intelligence Co., Ltd. | 2024-09-06 |
| T2 Plus (K233806) | Osstem Implant Co., Ltd. | 2024-09-06 |
| TRAQinform IQ (K233998) | Aiq Global, Inc. | 2024-09-05 |
| Velacur (K233977) | Sonic Incytes | 2024-09-04 |
| SOMATOM On.site (K241295) | Siemens Medical Solutions USA, Inc. | 2024-09-03 |
| Ultrasound Transducer Cover (K241662) | Vitrolife Sweden AB | 2024-08-30 |
| Vave Wireless Ultrasound System (K241051) | Vave Health, Inc. | 2024-08-30 |
| Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA) (K241318) | Adaptiiv Medical Technologies, Inc. | 2024-08-30 |
| Velmeni for Dentists (V4D) (K240003) | Velmeni, Inc. | 2024-08-30 |
| syngo.via MI Workflows; Scenium; syngo MBF (K242275) | Siemens Medical Solutions USA, Inc. | 2024-08-30 |
| Imbio PHA (4.0.0) (K241847) | Imbio, Inc. | 2024-08-30 |
| uMI Panorama (K241585) | Shanghai United Imaging Healthcare Co., Ltd. | 2024-08-30 |
| MI View&GO (K242300) | Siemens Medical Solutions USA, Inc. | 2024-08-30 |
| Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5 (K233107) | Canon Medical Systems Corporation | 2024-08-30 |
| Heyman Packing Applicator Set (GM11004580) (K241386) | Varian Medical Systems, Inc. | 2024-08-30 |
| Kosmos (K233826) | EchoNous, Inc. | 2024-08-29 |
| Overjet Charting Assist (K241684) | Overjet, Inc. | 2024-08-27 |
| MyoStrain (6.0) (K241607) | Myocardial Solutions, Inc. | 2024-08-26 |
| SonoSync (K241302) | Samsung Medison Co., Ltd. | 2024-08-23 |
| NeuroQuant (K241098) | Cortechs Labs, Inc. | 2024-08-22 |
| Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro) (K241979) | Beijing Konted Medical Technology Co.,Ltd | 2024-08-22 |
| iCare ALTIUS CW (K234076) | Centervue S.P.A. | 2024-08-22 |
| AiMIFY (1.x) (K240290) | Subtle Medical, Inc. | 2024-08-21 |
| Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR (K241496) | Canon Medical Systems Corporation | 2024-08-20 |
| HealthCCSng (K241440) | Nano-X AI , Ltd. | 2024-08-19 |
| HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter)) (K242239) | Gentuity, LLC | 2024-08-16 |
| qCT LN Quant (K240740) | Qure.Ai Technologies | 2024-08-16 |
| uMI Panvivo (K241596) | Shanghai United Imaging Healthcare Co., Ltd. | 2024-08-15 |
| UltraDrape UGPIV Barrier and Securement (34-15) (K233965) | Parker Laboratories, Inc. | 2024-08-15 |
| CoLumbo (K241211) | Smart Soft Healthcare | 2024-08-15 |
| ECHELON Synergy MRI System (K241429) | Fujifilm Healthcare Corporation | 2024-08-13 |
| Bullsai (K241094) | Turing Medical Technologies, Inc. | 2024-08-13 |
| OptimMRI (v2) (K242054) | Rebrain, Sas | 2024-08-12 |
| dS FootAnkle Coil 8ch 1.5T (K242096) | Philips Medical Systems Nederland B.V. | 2024-08-12 |
| SonoMax Series Digital Color Doppler Ultrasound System (K233697) | CHISON Medical Technologies Co., Ltd. | 2024-08-09 |
| SynthVISION 1.0.0 (K240724) | Synthesis Health Intelligence, Inc. | 2024-08-08 |
| i2Contour (K233822) | Mrimath, LLC | 2024-08-08 |
| Omni Legend (K241665) | Ge Medical Systems Israel, Functional Imaging | 2024-08-08 |
| EOSedge (K233920) | Eos Imaging | 2024-08-06 |
| myAblation Guide (VB80A) (K240796) | Siemens Healthcare GmbH | 2024-08-06 |
| AI Platform 2.0 (AIP002) (K240953) | Exo Imaging | 2024-08-05 |
| Orthopaedic Surgery Planning Software (AIJOINT) (K233761) | Longwood Valley Medical , Ltd. | 2024-08-05 |
| Coronis OneLook (K242008) | Barco N.V. | 2024-08-02 |
| CardIQ Suite (K233731) | GE Medical Systems SCS | 2024-08-01 |
| 3MP Color LCD Monitor (CL-S301) (K241105) | Jvckenwood Corporation | 2024-08-01 |
| AISAP Cardio V1.0 (K234141) | Aisap | 2024-08-01 |
| MammoScreen® (3) (K240301) | Therapixel | 2024-08-01 |
| EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DEXi-D503T-FRM); EXSYS DEXi (EXSYS DEXi-A503T-FRM) (K233530) | DRTECH Corporation | 2024-07-26 |
| Symbia SPECT and SPECT/CT Systems (K241898) | Siemens Healthineers | 2024-07-26 |
| ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface (K240431) | Brainlab AG | 2024-07-24 |
| Non-Sterile Ultrasound Transmission Gels (K241789) | Hony Medical Co., Ltd. | 2024-07-24 |
| EzDent-i / E2 / Prora View / Smart M Viewer (v3.5) (K241114) | Ewoosoft Co., Ltd. | 2024-07-23 |
| TE Air Diagnostic Ultrasound System (K240906) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2024-07-23 |
| neo315 (K231133) | Neoscan Solution GmbH | 2024-07-22 |
| ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System, ACUSON Origin ICE Diagnostic Ultrasound System (K240704) | Siemens Medical Solutions USA, Inc. | 2024-07-22 |
| vRad Viewer (K241879) | Virtual Radiologic Corporation | 2024-07-18 |
| Rayvolve (K240845) | Azmed Sas | 2024-07-17 |
| Vitrea Software Package, VSTP-002A V2.0 (K240705) | Canon Medical Systems Corporation | 2024-07-17 |
| MICSI-RMT (K241121) | Microstructure Imaging, Inc. | 2024-07-17 |
| RadiForce RX670; RadiForce RX670-AR (K241441) | Eizo Corporation | 2024-07-16 |
| Swoop® Portable MR Imaging® System (K240944) | Hyperfine, Inc. | 2024-07-16 |
| NeuroLF (Basic); NeuroLF (Pro); NeuroLF (Advanced); NeuroLF Seat (K241751) | Positrigo AG | 2024-07-15 |
| BriefCase-Triage (K241727) | Aidoc Medical , Ltd. | 2024-07-12 |
| RUS (K233457) | Hutom, Inc. | 2024-07-12 |
| HiRise (1040-230) (K241713) | Curvebeam, LLC | 2024-07-12 |
| Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) (K234009) | Mighty Oak Medical | 2024-07-12 |
| SubtleSYNTH (1.x) (K241329) | Subtle Medical, Inc. | 2024-07-11 |
| AOS Interstitial Templates, Needles, and Accessories (K233628) | Alpha-Omega Services, Inc. | 2024-07-10 |
| deepLive (K240610) | Damae Medical | 2024-07-09 |
| Transducer Probe Cover (K241615) | Hony Medical Co., Ltd. | 2024-07-03 |