Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System— 510(k) K252074
Substantially EquivalentCanon Medical Systems Corporation
FDA 510(k) clearance K252074 for Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System, Substantially Equivalent on 2025-10-31. 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.