LUMAGEM SCINTILLATION CAMERA— 510(k) K993813
Substantially EquivalentGamma Medica
FDA 510(k) clearance K993813 for LUMAGEM SCINTILLATION CAMERA, Substantially Equivalent on 2000-01-18. Applicant: Gamma Medica. Device class: 1.
Clearance details
- Applicant
- Gamma Medica
- 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
- Northridge, CA, US
Recent devices under product code IYX
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