K233693
- 510(k) number
- K233693
- Device name
- Nio Color 8MP (MDNC-8132)
- Applicant
- Barco N.V. BE
- Product code
- PGY — Display, Diagnostic Radiology
- Decision date
- 2023-12-11
- Date received
- 2023-11-17
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K233693.pdf
Official FDA record: K233693
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.