K253473
- 510(k) number
- K253473
- Device name
- Synchrony
- Applicant
- Stereotaxis, Inc. MO · US
- Product code
- DQK — Computer, Diagnostic, Programmable
- Decision date
- 2026-04-01
- Date received
- 2025-10-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 3.1 MB · U.S. public domain
Also available from FDA: K253473.pdf
Official FDA record: K253473
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.