The following data is part of a premarket notification filed by Scandidos Ab with the FDA for Scandidos Delta4 Discover, Alternative Trade Name: Scandidos Delta4 Discover+.
| Device ID | K151426 |
| 510k Number | K151426 |
| Device Name: | ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+ |
| Classification | Accelerator, Linear, Medical |
| Applicant | SCANDIDOS AB DAG HAMMARSKJOLDS VAG 52A Uppsala, SE Se-75237 |
| Contact | Thomas Matzen |
| Correspondent | Thomas Matzen SCANDIDOS AB DAG HAMMARSKJOLDS VAG 52A Uppsala, SE Se-75237 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-28 |
| Decision Date | 2016-01-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17350005180079 | K151426 | 000 |
| 17350005180062 | K151426 | 000 |