X-RAY, TOMOGRAPHY, COMPUTED, DENTAL— 510(k) K083917
Substantially EquivalentSuni Medical Imaging, Inc.
FDA 510(k) clearance K083917 for X-RAY, TOMOGRAPHY, COMPUTED, DENTAL, Substantially Equivalent on 2009-06-02. Applicant: Suni Medical Imaging, Inc.. Device class: 2.
Clearance details
- Applicant
- Suni Medical Imaging, Inc.
- Product code
- Code OAS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1750
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Jose, CA, US
Recent devices under product code OAS
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