| EchoPAC Software Only / EchoPAC Plug-in (K251342) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2025-07-16 |
| PeekMed web (K251096) | Peek Health, S.A. | 2025-07-14 |
| TumorSight Viz (K251766) | SimBioSys, Inc. | 2025-07-08 |
| syngo.via MI Workflows; Scenium; syngo MBF (K251528) | Siemens Medical Solutions USA, Inc. | 2025-07-03 |
| Bunkerhill Abdominal Aortic Quantification (AAQ) (K243779) | BunkerHill Health | 2025-07-01 |
| PIUR tUS inside (K250484) | Piur Imaging GmbH | 2025-06-30 |
| EchoConfidence (USA) (K250670) | Mycardium AI Limited | 2025-06-30 |
| Synapse PACS (7.5) (K243647) | FUJIFILM Healthcare Americas Corporation | 2025-06-30 |
| Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (1.0) (K243633) | Brainlab AG | 2025-06-13 |
| Viz Subdural+, Viz SUBDURAL PLUS (K250354) | Viz. Ai, Inc. | 2025-06-10 |
| Cirrus Resting State fMRI Software (K251009) | Sora Neuroscience, Inc. | 2025-06-06 |
| BrightHeart View Classifier (K251456) | Brightheart | 2025-06-05 |
| TraumaCad Neo (1.1) (K243810) | Brainlab , Ltd. | 2025-06-04 |
| AudaxCeph Cephalogram Analysis Software (K243005) | Audax D.O.O. | 2025-05-30 |
| Opulus™ Lymphoma Precision (K243863) | Roche Molecular Systems, Inc. | 2025-05-30 |
| Rapid MLS (K243378) | Ischemaview, Inc. | 2025-05-28 |
| CoLumboX (K250367) | Smart Soft Healthcare AD | 2025-05-28 |
| Clever One (K250005) | Ewoosoft Co., Ltd. | 2025-05-23 |
| Second Opinion® 3D (K243989) | Pearl, Inc. | 2025-05-23 |
| Synapse 3D Base Tools (V7.0) (K243762) | Fujifilm Corporation | 2025-05-21 |
| Medical Image Post-processing Software (uOmnispace.CT) (K242624) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-05-14 |
| Second Opinion® BLE (K243230) | Pearl, Inc. | 2025-05-09 |
| Clarius Median Nerve AI (K250226) | Clarius Mobile Health Corp. | 2025-05-08 |
| BrightHeart View Classifier (K243684) | Brightheart | 2025-05-07 |
| UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program (K250328) | Canon Medical Systems Corporation | 2025-04-30 |
| LARALAB (K242500) | Laralab GmbH | 2025-04-16 |
| Clarius Prostate AI (K243853) | Clarius Mobile Health Corp. | 2025-04-16 |
| GBrain MRI (K250416) | Galileo Cds, Inc. | 2025-04-11 |
| cmAngio® (V1.6) (K250754) | Curemetrix, Inc. | 2025-04-10 |
| DeepFoqus (DeepFoqus-Accelerate) (K241982) | Foqus Technologies, Inc. | 2025-04-04 |
| syngo Dynamics (Version VA41D) (K242551) | Siemens Healthcare GmbH | 2025-04-03 |
| Hi-D Imaging 4TAVR (K241984) | Hi-D Imaging AG | 2025-04-02 |
| TribusConnect (K242166) | Tribusmed Beheer BV | 2025-03-31 |
| Salix Central (K243038) | Artrya Limited | 2025-03-27 |
| Vent Creativity Knee v1.0 (Hermes) (K241961) | Vent Creativity | 2025-03-20 |
| AVIEW (K243689) | Coreline Soft Co., Ltd. | 2025-03-19 |
| PeekMed web (K250042) | Peek Health, S.A. | 2025-03-19 |
| LVivo Software Application (K243862) | Dia Imaging Analysis, Ltd. | 2025-03-17 |
| Cleerly LABS (v2.0) (K242338) | Cleerly, Inc. | 2025-03-07 |
| LVivo Seamless (K243331) | Dia Imaging Analysis, Ltd. | 2025-03-06 |
| Ceevra Reveal 3+ (K243933) | Ceevra, Inc. | 2025-03-04 |
| LVivo Software Application (K243235) | Dia Imaging Analysis, Ltd. | 2025-03-03 |
| Myomics (K241922) | Phantomics, Inc. | 2025-02-28 |
| Ventripoint Medical System Plus (VMS+) 4.0 (K241222) | Ventripoint Diagnostics , Ltd. | 2025-02-26 |
| ScanDiags Ortho L-Spine MR-Q (K242607) | Scandiags AG | 2025-02-21 |
| AVIEW CAC (K243696) | Coreline Soft Co., Ltd. | 2025-02-14 |
| SubtleHD (1.x) (K243250) | Subtle Medical, Inc. | 2025-02-12 |
| Ultrasound Workspace (UWS 6.0) (K241659) | Philips Ultrasound, LLC | 2025-02-10 |
| BoneMetrics (US) (K241593) | Gleamer Sas | 2025-02-05 |
| TeraRecon Aorta.CT (1.1.0) (K243158) | Terarecon,Inc. | 2025-01-23 |
| Rapid Neuro3D (K243350) | Ischemaview, Inc. | 2025-01-22 |
| Ortho AI (K241696) | Ortho Ai, LLC | 2025-01-02 |
| Ezra Flash (K242334) | Ezra Ai, Inc. | 2025-01-02 |
| OrthoNext Platform System (K242270) | Orthofix Srl | 2024-12-19 |
| Saige-Density (2.5.0) (K243705) | DeepHealth, Inc. | 2024-12-19 |
| MSKai (K240793) | Mskai | 2024-12-16 |
| IRISeg (K242461) | Intuitive Surgical, Inc. | 2024-12-10 |
| CDM Insights (K240680) | Oxford Brain Diagnostics, Ltd. | 2024-12-06 |
| DrAid™ for Liver Segmentation (K241543) | Vinbrain Joint Stock Company | 2024-12-06 |
| Sonix Health (K240645) | Ontact Health Co., Ltd. | 2024-11-27 |
| BriefCase-Quantification (K242203) | Aidoc Medical , Ltd. | 2024-11-22 |
| Strain AI (SAI001) (K242359) | Exo, Inc. | 2024-11-20 |
| TeraRecon Cardiac.Chambers.MR (1.0.0) (K241312) | Terarecon,Inc. | 2024-11-05 |
| RemedyLogic AI MRI Lumbar Spine Reader (K241108) | Remedy Logic, Inc. | 2024-10-30 |
| Neurophet AQUA (V3.1) (K242215) | Neurophet., Inc. | 2024-10-25 |
| TumorSight Viz (K243189) | SimBioSys, Inc. | 2024-10-25 |
| cvi42 Software Application (K242781) | Circle Cardiovascular Imaging, Inc. | 2024-10-15 |
| EchoMeasure (K241430) | Icardio.Ai | 2024-10-10 |
| AutoChamber (K240786) | HeartLung Corporation | 2024-10-10 |
| LVivo Software Application (K240553) | Dia Imaging Analysis, Ltd. | 2024-10-04 |
| MammoScreen BD (K241561) | Therapixel | 2024-10-02 |
| LungVision (K240943) | Bodyvision Medical , Ltd. | 2024-10-01 |
| PIUR tUS Infinity (K240036) | Piur Imaging GmbH | 2024-09-20 |
| Constellation (CON-001) (K241280) | Q Bio, Inc. | 2024-09-12 |
| LumiNE US; Lumi (K240094) | Augmedit B.V. | 2024-09-10 |
| Overjet Image Enhancement Assist (K241681) | Overjet, Inc. | 2024-09-09 |
| ADAS 3D (K240791) | Adas3D Medical S.L. | 2024-09-09 |
| uAI Portal (K240411) | Shanghai United Imaging Intelligence Co., Ltd. | 2024-09-06 |
| 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 |
| MI View&GO (K242300) | Siemens Medical Solutions USA, Inc. | 2024-08-30 |
| Overjet Charting Assist (K241684) | Overjet, Inc. | 2024-08-27 |
| NeuroQuant (K241098) | Cortechs Labs, Inc. | 2024-08-22 |
| qCT LN Quant (K240740) | Qure.Ai Technologies | 2024-08-16 |
| CoLumbo (K241211) | Smart Soft Healthcare | 2024-08-15 |
| OptimMRI (v2) (K242054) | Rebrain, Sas | 2024-08-12 |
| i2Contour (K233822) | Mrimath, LLC | 2024-08-08 |
| AI Platform 2.0 (AIP002) (K240953) | Exo Imaging | 2024-08-05 |
| RUS (K233457) | Hutom, Inc. | 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 |
| SMART Bun-Yo-Matic X-Ray (K240736) | Disior, Ltd. | 2024-07-02 |
| VEA Align; spineEOS (K240582) | Eos Imaging | 2024-06-25 |
| Medihub Prostate (K233196) | JLK, Inc. | 2024-06-21 |
| SMART Bun-Yo-Matic CT (K240642) | Disior, Ltd. | 2024-06-20 |
| SIS System (K241083) | Surgical Information Sciences, Inc. | 2024-06-14 |
| Relu Creator (K233925) | Relu BV | 2024-06-13 |
| EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100) (K234042) | Ever Fortune.Ai, Co., Ltd. | 2024-06-07 |
| Cardiac CT Function Software Application (K241038) | Circle Cardiovascular Imaging | 2024-06-07 |
| LVivo IQS (K240769) | Dia Imaging Analysis, Ltd. | 2024-05-24 |