Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound System— 510(k) K232988
Substantially EquivalentCanon Medical Systems Corporation
FDA 510(k) clearance K232988 for Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound System, Substantially Equivalent on 2023-11-21. 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.