K243333
- 510(k) number
- K243333
- Device name
- rTOP
- Applicant
- Roclub GmbH DE
- Product code
- LLZ — System, Image Processing, Radiological
- Decision date
- 2025-02-04
- Date received
- 2024-10-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K243333.pdf
Official FDA record: K243333
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.