Celesteion, PCA-9000A/3, V6.5— 510(k) K181646
Substantially EquivalentCanon Medical Systems Corporation
FDA 510(k) clearance K181646 for Celesteion, PCA-9000A/3, V6.5, Substantially Equivalent on 2018-11-16. Applicant: Canon Medical Systems Corporation.
Clearance details
- Applicant
- Canon Medical Systems Corporation
- 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.