Scandidos AB

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
5
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K223234Delta4 InsightJanuary 16, 2024
K183606Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW)April 8, 2019
K151426ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+January 29, 2016
K151180ScandiDos Delta4 Phantom+August 19, 2015
K052920DELTA4January 12, 2006