The following data is part of a premarket notification filed by Scandidos Ab with the FDA for Delta4 Phantom+ Mr (pmma), Delta4 Phantom+ Mr (pw).
| Device ID | K183606 |
| 510k Number | K183606 |
| Device Name: | Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW) |
| Classification | Accelerator, Linear, Medical |
| Applicant | ScandiDos AB Dag Hammarskjölds Väg 52A Uppsala, SE 752 37 |
| Contact | Thomas Matzen |
| Correspondent | Thomas Matzen ScandiDos AB Dag Hammarskjölds Väg 52A Uppsala, SE 752 37 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-26 |
| Decision Date | 2019-04-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17350005180086 | K183606 | 000 |
| 17350005180048 | K183606 | 000 |