Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System— 510(k) K233195
Substantially EquivalentCanon Medical Systems Corporation
FDA 510(k) clearance K233195 for Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System, Substantially Equivalent on 2024-01-24. Applicant: Canon Medical Systems Corporation. Device class: 2.
Clearance details
- Applicant
- Canon Medical Systems Corporation
- Product code
- Product code IYN
- Device class
- Class 2
- Regulation
- 21 CFR 892.1550
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Otawara-Shi, JP
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More clearances from Canon Medical Systems Corporation
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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.