| Z-1299-2026 | Class II | FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3) | January 9, 2026 |
| Z-0044-2026 | Class II | FDR Visionary Suite, CH-200 Model/Version Numbers: (1) 566-16130-23, (2) 566-16130-31, (3) 566-1613 | September 15, 2025 |
| Z-2219-2025 | Class II | ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Dig | June 11, 2025 |
| Z-1407-2025 | Class II | Synapse PACS Software Version 7.4.x; Software Versions: 7.4.000, 7.4.001, 7.4.010, 7.4.100, 7.4.110, | February 11, 2025 |
| Z-1884-2024 | Class II | Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24 | April 11, 2024 |
| Z-1898-2024 | Class II | FDR Visionary Suite - Intended to generate digital or conventional radiographic images of the skull | April 11, 2024 |
| Z-1270-2024 | Class II | Synapse PACS - Version 7.2.000 | January 10, 2024 |
| Z-1273-2024 | Class II | Synapse PACS - Version 7.3.000 | January 10, 2024 |
| Z-1271-2024 | Class II | Synapse PACS - Version 7.2.100 | January 10, 2024 |
| Z-1272-2024 | Class II | Synapse PACS - Version 7.2.200 | January 10, 2024 |
| Z-1269-2024 | Class II | Synapse PACS - Version 7.1.000US | January 10, 2024 |
| Z-1268-2024 | Class II | Synapse PACS - Version 7.1.000 | January 10, 2024 |
| Z-1171-2024 | Class II | Synapse Cardiology PACS V7.3.0, V7.2, V7.1, V7.0. A web-based application as the primary user inte | January 3, 2024 |
| Z-1172-2024 | Class II | Synapse CV 6. with AR. A web-based application as the primary user interface for the processing o | January 3, 2024 |
| Z-3158-2024 | Class II | The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR D- | November 23, 2023 |
| Z-1470-2023 | Class II | FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended for use in general purpo | February 27, 2023 |
| Z-1748-2022 | Class II | SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C | July 12, 2022 |
| Z-1749-2022 | Class II | Surpria: Software Version V3.11, V3.22 | July 12, 2022 |
| Z-1750-2022 | Class II | Surpria 64: Software Version V3.11, V3.22 | July 12, 2022 |
| Z-0190-2022 | Class II | Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3 | October 14, 2021 |