FDA 510(k) Application Details - K183541

Device Classification Name	System, X-Ray, Stationary   More FDA Info for this Device
510(K) Number	K183541
Device Name	System, X-Ray, Stationary
Applicant	Prognosys Medical Systems Private Limited No. 249, Ground Floor, Front Building, 4th Main Road, Chamrajpet Bangalore 560018 IN Other 510(k) Applications for this Company
Contact	V. Krishna Prasad Other 510(k) Applications for this Contact
Regulation Number	892.1680   More FDA Info for this Regulation Number
Classification Product Code	KPR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/20/2018
Decision Date	01/24/2019
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