AXIS Image Management System— 510(k) K171098
Substantially EquivalentSonomed, Inc.
FDA 510(k) clearance K171098 for AXIS Image Management System, Substantially Equivalent on 2017-05-02. Applicant: Sonomed, Inc.. Device class: 2.
Clearance details
- Applicant
- Sonomed, Inc.
- Product code
- Code NFJ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- New Hyde Park, NY, US
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