Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A— 510(k) K182223
Substantially EquivalentCanon Medical Systems, USA
FDA 510(k) clearance K182223 for Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A, Substantially Equivalent on 2018-09-14. Applicant: Canon Medical Systems, USA.
Clearance details
- Applicant
- Canon Medical Systems, USA
- Product code
- Code JAK
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Otawara-Shi, JP
Adverse events under product code JAK
product code JAK- Death
- 27
- Injury
- 571
- Malfunction
- 779
- Total
- 1,377
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.