SCENIUM 1.1— 510(k) K061545

Substantially Equivalent

Siemens Molecular Imaging, Ltd.

FDA 510(k) clearance K061545 for SCENIUM 1.1, Substantially Equivalent on 2006-06-30. Applicant: Siemens Molecular Imaging, Ltd.. Device class: 2.

Clearance details

Applicant: Siemens Molecular Imaging, Ltd.
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 2006-06-05
Decision date: 2006-06-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Hoffman Estates, IL, US

Download summary PDF View on FDA.gov ↗

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