K231852
- 510(k) number
- K231852
- Device name
- BinkieRT
- Applicant
- Papricalab KR
- Product code
- IYE — Accelerator, Linear, Medical
- Decision date
- 2023-11-15
- Date received
- 2023-06-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K231852.pdf
Official FDA record: K231852
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.