Scandidos AB
Scandidos AB appears in FDA public data with 0 recalls, 5 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent FDA inspection ended on Jul 12, 2018 (Voluntary Action Indicated (VAI)). Its most recent 510(k) clearance was granted on Jan 16, 2024.
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Summary
- Total Recalls
- 0
- 510(k) Clearances
- 5
- Inspections
- 1
- Compliance Actions
- 0
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jul 12, 2018 | Uppsala, Sweden | Devices | Voluntary Action Indicated (VAI) | 3005596716 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K223234 | Delta4 Insight | Jan 16, 2024 |
| K183606 | Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW) | Apr 8, 2019 |
| K151426 | ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+ | Jan 29, 2016 |
| K151180 | ScandiDos Delta4 Phantom+ | Aug 19, 2015 |
| K052920 | DELTA4 | Jan 12, 2006 |