FDA 510(k) Application Details - K163687

Device Classification Name	Camera, Scintillation (Gamma)   More FDA Info for this Device
510(K) Number	K163687
Device Name	Camera, Scintillation (Gamma)
Applicant	Hermes Medical Solutions AB Skeppsbron 44 Stockholm 11130 SE Other 510(k) Applications for this Company
Contact	Joakim Arwidson 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	12/28/2016
Decision Date	07/19/2017
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