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Simpleware Product Group, SYNOPSYS NORTHERN EUROPE
FDA Regulatory Profile
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2253-2021 | Class II | Simpleware ScanIP software. For transfer of imaging information from a medical scanner to an output | June 4, 2021 |
| Z-2254-2021 | Class II | Simpleware ScanIP medical software. For transfer of imaging information from a medical scanner to a | June 4, 2021 |