K253733
- 510(k) number
- K253733
- Device name
- STAR Apollo Mapping System
- Applicant
- Rhythm AI, Ltd. GB
- Product code
- DQK — Computer, Diagnostic, Programmable
- Decision date
- 2025-12-19
- Date received
- 2025-11-24
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K253733.pdf
Official FDA record: K253733
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.