FDA 510(k) Application Details - K230221

Device Classification Name	Camera, Scintillation (Gamma)   More FDA Info for this Device
510(K) Number	K230221
Device Name	Camera, Scintillation (Gamma)
Applicant	Versant Medical Physics and Radiation Safety 119 N. Church Street Kalamazoo, MI 49007 US Other 510(k) Applications for this Company
Contact	Darrell R. Fisher 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	01/26/2023
Decision Date	08/28/2023
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