# Scandidos AB

- Location (FDA's records): Uppsala, SE
- FDA decisions: 5 (2006–2024): 5 510(k) clearances
- Product codes: IYE (5)
- 510(k) review time since 2016: median 246 days, against 97 for FDA's reviews in the same codes and years (0 of 3 faster)
- Predicates its devices cite: 5 (1 its own); citations of its devices by later devices: 2 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Wellhofer Dosimetrie: 1 (https://510kreport.com/company/wellhofer-dosimetrie)
- Radialogica, LLC: 1 (https://510kreport.com/company/radialogica)
- Ptw-New York Corp.: 1 (https://510kreport.com/company/ptw-new-york)
- Scanditronix Wellhofer GmbH: 1 (https://510kreport.com/company/scanditronix-wellhofer)

## Firms that cite its devices most
- Rtsafe, Inc.: 1 (https://510kreport.com/company/rtsafe)

## Its most-cited devices
- K052920: DELTA4 (2006), cited by 1
- K151426: ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+ (2016), cited by 1

## Recent decisions
- K223234: Delta4 Insight (Jan 16, 2024)
- K183606: Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW) (Apr 8, 2019)
- K151426: ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+ (Jan 29, 2016)
- K151180: ScandiDos Delta4 Phantom+ (Aug 19, 2015)
- K052920: DELTA4 (Jan 12, 2006)

Source page: https://510kreport.com/company/scandidos