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| Product | Model | Company | Device type |
|---|---|---|---|
| Aperio iQC DX SoftwareLeica Biosystems Imaging, IncLaboratory instrument/analyser application software IVD | 23iQCDXUS | Leica Biosystems Imaging, Inc | Laboratory instrument/analyser application software IVD |
| ArteraAI ProstateArtera Inc.Cancer risk assessment interpretive software IVD | 1.x.x | Artera Inc. | Cancer risk assessment interpretive software IVD |
| BeaconShenzhen Beacon Display Technology Co., Ltd.Pathology information system | PA27 | Shenzhen Beacon Display Technology Co., Ltd. | Pathology information system |
| Clinisys CoPathPlusCliniSys, IncPathology information system application software | 8.0.3 | CliniSys, Inc | Pathology information system application software |
| DIGITAL DIAGNOSTICS SYSTEMHologic, Inc.Laboratory instrument/analyser application software IVD | ASSEMBLY, REVIEW STATION COMPUTER | Hologic, Inc. | Laboratory instrument/analyser application software IVD |
| DIGITAL DIAGNOSTICS SYSTEMHologic, Inc.Microscope slide digital imaging scanner IVD | DIGITAL CYTOLOGY IMAGER | Hologic, Inc. | Microscope slide digital imaging scanner IVD |
| EUROPattern ClassifierEUROIMMUN Medizinische Labordiagnostika AGLaboratory instrument/analyser application software IVD | YG 0071-0101 | EUROIMMUN Medizinische Labordiagnostika AG | Laboratory instrument/analyser application software IVD |
| INFINITT DPSINFINITT Healthcare Co.,Ltd.Histology/cytology/microbiology image-analysis interpretive software IVD | INFINITT DPS | INFINITT Healthcare Co.,Ltd. | Histology/cytology/microbiology image-analysis interpretive software IVD |
| JelloXJelloX Biotech Inc.Pathology information system | 1.2.1 | JelloX Biotech Inc. | Pathology information system |
| Philips IntelliSite Pathology SolutionPhilips Medical Systems Nederland B.V.Microscope slide digital imaging scanner IVD | 5.1 | Philips Medical Systems Nederland B.V. | Microscope slide digital imaging scanner IVD |
| Sectra Digital Pathology ModuleSectra ABPathology information system | 2.3 | Sectra AB | Pathology information system |
| ThinPrep Imaging SystemHologic, Inc.Laboratory instrument/analyser application software IVD | ThinPrep Imaging System Imaging Station | Hologic, Inc. | Laboratory instrument/analyser application software IVD |