UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program— 510(k) K250328
Substantially EquivalentCanon Medical Systems Corporation
FDA 510(k) clearance K250328 for UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program, Substantially Equivalent on 2025-04-30. Applicant: Canon Medical Systems Corporation. Device class: 2.
Clearance details
- Applicant
- Canon Medical Systems Corporation
- Product code
- Code QIH
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Otawara-Shi, JP
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Data sourced from openFDA. This site is unofficial and independent of the FDA.