Launch operations
Vendor outreach kit
Use this page with the generated CSV to run the Week 5 claim-profile campaign. The first pass targets one recent, exact-version profile per vendor.
Cold email template
Hi Spectrum Dynamics Medical, Ltd. team, I am building Radiology AI Directory, a U.S.-focused buyer directory for FDA-cleared radiology AI tools. We created a source-linked draft profile for the FDA-cleared version of TruSPECT Processing Station (K253532). The profile is meant to help radiology chairs, PACS admins, and imaging informatics teams verify practical shortlist details: - exact FDA file number and decision date - modality and use case fit - workflow, deployment, and RIS/PACS details - public evidence, pricing category, and correction sources Would you be open to reviewing the draft profile for factual corrections? Profile: /tools/truspect-processing-station-k253532/ Correction form: https://tally.so/r/0QZoey If you want the enhanced founding vendor profile, sponsor inquiries are here: https://tally.so/r/jaJGPa Best,
First 50
Vendor correction targets
| Vendor | Product | FDA file | Decision | Profile |
|---|---|---|---|---|
| Spectrum Dynamics Medical, Ltd. | TruSPECT Processing Station | K253532 | 2025-12-30 | Open |
| Ge Medical Systems, LLC | AIR Recon DL | K252379 | 2025-12-23 | Open |
| Bioticsai, Inc. | BioticsAI | K250959 | 2025-12-22 | Open |
| Peek Health, S.A. | PeekMed web | K252856 | 2025-12-22 | Open |
| Philips Ultrasound, LLC | Lumify Diagnostic Ultrasound System | K252557 | 2025-12-22 | Open |
| Siemens Healthcare GmbH | MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise | K252838 | 2025-12-19 | Open |
| TOPIA MEDTECH LIMITED | Alzevita | K252670 | 2025-12-19 | Open |
| Crescom Co., Ltd. | MediAI-BA | K250914 | 2025-12-18 | Open |
| Ultrasight , Ltd. | PVAD IQ Software | K252235 | 2025-12-18 | Open |
| Neosoma, Inc. | Neosoma Brain Mets | K252922 | 2025-12-17 | Open |
| Intuitive Surgical, Inc. | IRISeg | K251763 | 2025-12-16 | Open |
| Medcognetics, Inc. | CogNet AI-MT+ | K252482 | 2025-12-11 | Open |
| Brightheart | Fetal EchoScan (v1.2) | K252294 | 2025-12-08 | Open |
| Manteia Technologies Co., Ltd. | ARTAssistant | K250780 | 2025-12-05 | Open |
| Coreline Soft Co.,Ltd | AVIEW Lung Nodule CAD | K251203 | 2025-12-03 | Open |
| Mighty Oak Medical | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | K252103 | 2025-12-02 | Open |
| Canon Medical Systems Corporation | Cartesion Prime (PCD-1000A/3) V10.21 | K251370 | 2025-12-01 | Open |
| Canon Medical Informatics, Inc. | CT VScore+ | K252217 | 2025-11-28 | Open |
| Ge Hualun Medical Systems Co. , Ltd. | OEC One CFD | K253269 | 2025-11-26 | Open |
| Esaote, S.P.A. | 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30) | K253310 | 2025-11-25 | Open |
| Mlhealth 360 | Scaida BrainCT-ICH (v1.0) | K250694 | 2025-11-25 | Open |
| A2z Radiology Ai, Inc. | a2z-Unified-Triage | K252366 | 2025-11-24 | Open |
| Ge Medical Systems Ultrasound and Primary Care Diagnostics | Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 | K252328 | 2025-11-24 | Open |
| Siemens Shenzhen Magnetic Resonance , Ltd. | MAGNETOM Free.Max; MAGNETOM Free.Star | K251822 | 2025-11-20 | Open |
| Nobel Biocare C/O Medicim NV | DTX Studio Assist | K252086 | 2025-11-17 | Open |
| Eos Imaging | AutoDensity | K251078 | 2025-11-14 | Open |
| Pearl, Inc. | Second Opinion® Panoramic | K250525 | 2025-11-14 | Open |
| Bench7, Inc. | SugarBug (1.x) | K250264 | 2025-11-07 | Open |
| Aidoc Medical , Ltd. | BriefCase-Triage | K253265 | 2025-11-06 | Open |
| Pie Medical Imaging BV | 3mensio Workstation | K250330 | 2025-11-03 | Open |
| ViTAA Medical Solutions, Inc. | AiORTA - Plan | K250337 | 2025-10-30 | Open |
| Circle Cardiovascular Imaging, Inc. | cvi42 Coronary Plaque Software Application | K251027 | 2025-10-27 | Open |
| Siemens Healthineers AG | Syngo Carbon Clinicals (VA41) | K251059 | 2025-10-24 | Open |
| Avatar Medical | brAIn™ Shoulder Positioning | K252665 | 2025-10-20 | Open |
| Spectrawave, Inc. | X1-FFR | K251355 | 2025-10-17 | Open |
| X9, Inc. | X9 Ultrasound System | K251673 | 2025-10-17 | Open |
| Metamorphosis GmbH | AIAS Cephalon | K252214 | 2025-10-07 | Open |
| Deep Breathe, Inc. | BlineSlide | K252007 | 2025-10-06 | Open |
| Bunkerhill Health | Bunkerhill MAC | K250662 | 2025-10-03 | Open |
| Thirona BV | LungQ 4 | K250766 | 2025-10-02 | Open |
| Disior Ltd | SMART PCFD | K250023 | 2025-09-29 | Open |
| Ligence, UAB | Ligence Heart | K252105 | 2025-09-26 | Open |
| Shanghai United Imaging Healthcare Co., Ltd. | uMR 680 | K252371 | 2025-09-25 | Open |
| AIRS Medical Inc. | SwiftSight-Brain | K251483 | 2025-09-23 | Open |
| iSchemaView, Inc. | Rapid Aortic Measurements | K251987 | 2025-09-23 | Open |
| Axial Medical Printing Limited | Axial3D Insight | K250369 | 2025-09-18 | Open |
| Fujifilm Corporation | ECHELON Synergy | K251386 | 2025-09-17 | Open |
| Beijing Infervision Healthcare Medical Technology Co., Ltd. | InferOperate Suite | K250237 | 2025-09-15 | Open |
| Diagnoly | FETOLY | K251368 | 2025-09-12 | Open |
| Angiowave Imaging, Inc. | AngioWaveNet | K244002 | 2025-09-10 | Open |