K242240
- 510(k) number
- K242240
- Device name
- CaRi-Plaque
- Applicant
- Caristo Diagnostics , Ltd. GB
- Product code
- LLZ — System, Image Processing, Radiological
- Decision date
- 2025-02-20
- Date received
- 2024-07-30
- 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: K242240.pdf
Official FDA record: K242240
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.