510(k) K190232 ยท LLZ System, Image Processing, Radiological
Synapse PACS
| Applicant | Fujifilm Corporation, Minato-Ku, Tokyo, JP |
| Decision | Substantially Equivalent, Mar 26, 2019 |
| Received | Feb 6, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190232
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 26, 2026 | FUJIFILM Healthcare Americas Corporation FUJIFILM Synapse PACS software v7.4.310; radiological image processing system Open, Classified |
LLZ | None listed |
| Mar 20, 2025 | FUJIFILM Healthcare Americas Corporation Synapse PACS Software Version 7.4.x; Software Versions: 7.4.000, 7.4.001, 7.4.010, 7.4.100, 7.4.110, 7.4.200. Open, Classified |
LLZ | None listed |
| Mar 7, 2024 | FUJIFILM Healthcare Americas Corporation Synapse PACS - Version 7.1.000 Open, Classified |
LLZ | None listed |
| Mar 7, 2024 | FUJIFILM Healthcare Americas Corporation Synapse PACS - Version 7.1.000US Open, Classified |
LLZ | None listed |
| Mar 7, 2024 | FUJIFILM Healthcare Americas Corporation Synapse PACS - Version 7.2.000 Open, Classified |
LLZ | None listed |
| Mar 7, 2024 | FUJIFILM Healthcare Americas Corporation Synapse PACS - Version 7.2.100 Open, Classified |
LLZ | None listed |
| Mar 7, 2024 | FUJIFILM Healthcare Americas Corporation Synapse PACS - Version 7.2.200 Open, Classified |
LLZ | None listed |
| Mar 7, 2024 | FUJIFILM Healthcare Americas Corporation Synapse PACS - Version 7.3.000 Open, Classified |
LLZ | None listed |
| Feb 21, 2024 | FUJIFILM Healthcare Americas Corporation Synapse Cardiology PACS V7.3.0, V7.2, V7.1, V7.0.
A web-based application as the primary user interface for the processing of medical images. Open, Classified |
LLZ | None listed |
| Dec 11, 2020 | Fujifilm Medical Systems U.S.A., Inc. FUJIFILM Synapse PACS Software: versions 7.0.0 and 7.0.1 - Product Usage: intended for use as a web based application on an off-the shelf PC which meets or exceeds minimum specifications and is netwo Terminated |
LLZ | None listed |
| Sep 11, 2020 | Fujifilm Medical Systems U.S.A., Inc. Synapse PACS Software Version 5.6.1 - Product Usage: intended for use as a web based application on an off-the shelf PC which meets or exceeds minimum specifications and is networked with a FUJIFILM S Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.