K242188
- 510(k) number
- K242188
- Device name
- ClearRead CT CAC
- Applicant
- Riverain Technologies, Inc. OH · US
- Product code
- JAK — System, X-Ray, Tomography, Computed
- Decision date
- 2024-12-03
- Date received
- 2024-07-25
- 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: K242188.pdf
Official FDA record: K242188
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.