Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1— 510(k) K202364
Substantially EquivalentCanon Medical Systems Corporation
FDA 510(k) clearance K202364 for Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1, Substantially Equivalent on 2020-10-15. Applicant: Canon Medical Systems Corporation.
Clearance details
- Applicant
- Canon Medical Systems Corporation
- Product code
- Code IYN
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Otawara-Shi, JP
Adverse events under product code IYN
product code IYN- Death
- 25
- Injury
- 163
- Malfunction
- 1,538
- Other
- 4
- Total
- 1,730
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.