SCANDIA-45 GAMMA CAMERA SYSTEM— 510(k) K101391
Substantially EquivalentScandia Corporation
FDA 510(k) clearance K101391 for SCANDIA-45 GAMMA CAMERA SYSTEM, Substantially Equivalent on 2010-08-04. Applicant: Scandia Corporation. Device class: 1.
Clearance details
- Applicant
- Scandia Corporation
- Product code
- Code IYX
- Device class
- Class 1
- Regulation
- 21 CFR 892.1100
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Urbandale, IA, US
Recent devices under product code IYX
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