K231642
- 510(k) number
- K231642
- Device name
- Veuron-Brain-pAb3
- Applicant
- Heuron Co., Ltd. KR
- Product code
- LLZ — System, Image Processing, Radiological
- Decision date
- 2023-10-13
- Date received
- 2023-06-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K231642.pdf
Official FDA record: K231642
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.