K242062
- 510(k) number
- K242062
- Device name
- 1CMR Pro
- Applicant
- Mycardium AI Limited GB
- Product code
- LLZ — System, Image Processing, Radiological
- Decision date
- 2024-11-15
- Date received
- 2024-07-15
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K242062.pdf
Official FDA record: K242062
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.