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510(k) K212587

3D-RD-S by Radiopharmaceutical Imaging and Dosimetry, LLC — Product Code IYX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 2023
Date Received
August 16, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Camera, Scintillation (Gamma)
Device Class
Class I
Regulation Number
892.1100
Review Panel
RA
Submission Type

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