FDA 510(k) Application Details - K212587

Device Classification Name	Camera, Scintillation (Gamma)   More FDA Info for this Device
510(K) Number	K212587
Device Name	Camera, Scintillation (Gamma)
Applicant	Radiopharmaceutical Imaging and Dosimetry, LLC 1800 Gough St. Baltimore, MD 21231 US Other 510(k) Applications for this Company
Contact	Nadine Bonds Other 510(k) Applications for this Contact
Regulation Number	892.1100   More FDA Info for this Regulation Number
Classification Product Code	IYX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/16/2021
Decision Date	02/22/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review