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 |