K233731
- 510(k) number
- K233731
- Device name
- CardIQ Suite
- Applicant
- GE Medical Systems SCS FR
- Product code
- JAK — System, X-Ray, Tomography, Computed
- Decision date
- 2024-08-01
- Date received
- 2023-11-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K233731.pdf
Official FDA record: K233731
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.