R650 QDASM COLLIMATOR— 510(k) K093572
Substantially EquivalentOmega Medical Imaging, Inc.
FDA 510(k) clearance K093572 for R650 QDASM COLLIMATOR, Substantially Equivalent on 2010-02-03. Applicant: Omega Medical Imaging, Inc.. Device class: 2.
Clearance details
- Applicant
- Omega Medical Imaging, Inc.
- Product code
- Code IZW
- Device class
- Class 2
- Regulation
- 21 CFR 892.1610
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sanford, FL, US
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