Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System
FDA 510(k) clearance K233195 · decided 2024-01-24
Clearance details
- K-number
- K233195
- Device name
- Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System
- Applicant
- Canon Medical Systems Corporation
- Decision
- Substantially Equivalent
- Date received
- 2023-09-28
- Decision date
- 2024-01-24
- Days to decision
- 118 days
- Clearance type
- Traditional
- Product code
- IYN
- Device class
- 2
- Regulation number
- 892.1550
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Otawara-Shi, JP
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.