Synapse PACS
FDA 510(k) clearance K190232 · decided 2019-03-26
Clearance details
- K-number
- K190232
- Device name
- Synapse PACS
- Applicant
- Fujifilm Corporation
- Decision
- Substantially Equivalent
- Date received
- 2019-02-06
- Decision date
- 2019-03-26
- Days to decision
- 48 days
- Clearance type
- Traditional
- Product code
- LLZ
- Device class
- 2
- Regulation number
- 892.2050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Minato-Ku, Tokyo, JP
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Synapse PACS Software Version 7.4.x; Software Versions: 7.4.000, 7.4.001, 7.4.010, 7.4.100 recall (Z-1407-2025) | FUJIFILM Healthcare Americas Corporation | 2025-03-20 |
| Synapse PACS - Version 7.1.000 recall (Z-1268-2024) | FUJIFILM Healthcare Americas Corporation | 2024-03-07 |
| Synapse PACS - Version 7.1.000US recall (Z-1269-2024) | FUJIFILM Healthcare Americas Corporation | 2024-03-07 |
| Synapse PACS - Version 7.2.000 recall (Z-1270-2024) | FUJIFILM Healthcare Americas Corporation | 2024-03-07 |
| Synapse PACS - Version 7.2.100 recall (Z-1271-2024) | FUJIFILM Healthcare Americas Corporation | 2024-03-07 |
| Synapse PACS - Version 7.2.200 recall (Z-1272-2024) | FUJIFILM Healthcare Americas Corporation | 2024-03-07 |
| Synapse PACS - Version 7.3.000 recall (Z-1273-2024) | FUJIFILM Healthcare Americas Corporation | 2024-03-07 |
| Synapse Cardiology PACS V7.3.0, V7.2, V7.1, V7.0. A web-based application as the primary u recall (Z-1171-2024) | FUJIFILM Healthcare Americas Corporation | 2024-02-21 |