Scandidos AB - FDA 510(k) Cleared Devices
Recent clearances: Delta4 Insight, Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW)
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Scandidos AB Radiology ✕
5 devices
Cleared
Jan 16, 2024
Delta4 Insight
Radiology
454d
Cleared
Apr 08, 2019
Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW)
Radiology
103d
Cleared
Jan 29, 2016
ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+
Radiology
246d
Cleared
Aug 19, 2015
ScandiDos Delta4 Phantom+
Radiology
107d
Cleared
Jan 12, 2006
DELTA4
Radiology
87d