FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System
K Number: K253597
·
Decision Jan 20, 2026
Classifications
1
FEI Numbers
220
Registration Numbers
220
Same Product Code
1171
Applicant Total
97
Review Days
63
Basic Information
- Device Name
- Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System
- K Number
- K253597
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1550
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Canon Medical Systems Corporation
- Date Received
- November 18, 2025
- Decision Date
- January 20, 2026
- Product Code
- IYN
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | FDA class 2 | Radiology |
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FDA 510(k)
FDA Class 2
·Radiology
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