K241713
- 510(k) number
- K241713
- Device name
- HiRise (1040-230)
- Applicant
- Curvebeam, LLC PA · US
- Product code
- JAK — System, X-Ray, Tomography, Computed
- Decision date
- 2024-07-12
- Date received
- 2024-06-14
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K241713.pdf
Official FDA record: K241713
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.