K231855
- 510(k) number
- K231855
- Device name
- QOCA® image Smart RT Contouring System
- Applicant
- Quanta Computer, Inc. TW
- Product code
- QKB — Radiological Image Processing Software For Radiation
- Decision date
- 2024-02-13
- Date received
- 2023-06-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K231855.pdf
Official FDA record: K231855
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.