K252164
- 510(k) number
- K252164
- Device name
- NorthStar Mapping System
- Applicant
- Imricor Medical Systems MN · US
- Product code
- DQK — Computer, Diagnostic, Programmable
- Decision date
- 2026-01-28
- Date received
- 2025-07-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K252164.pdf
Official FDA record: K252164
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.