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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Scintillation (Gamma)
510(k) Number K212587
Device Name 3D-RD-S
Applicant
Radiopharmaceutical Imaging and Dosimetry, LLC
1800 Gough St.
Baltimore,  MD  21231
Applicant Contact Nadine Bonds
Correspondent
Radiopharmaceutical Imaging and Dosimetry, LLC
1800 Gough St.
Baltimore,  MD  21231
Correspondent Contact Nadine Bonds
Regulation Number892.1100
Classification Product Code
IYX  
Date Received08/16/2021
Decision Date 02/22/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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