K223234
- 510(k) number
- K223234
- Device name
- Delta4 Insight
- Applicant
- Scandidos AB SE
- Product code
- IYE — Accelerator, Linear, Medical
- Decision date
- 2024-01-16
- Date received
- 2022-10-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K223234.pdf
Official FDA record: K223234
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.