FDA 510(k) Application Details - K191262

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K191262
Device Name	System, Image Processing, Radiological
Applicant	EXINI Diagnostics AB Ideon Science Park, Scheelevagen 27 Lund se-223 70 SE Other 510(k) Applications for this Company
Contact	Aseem Anand Other 510(k) Applications for this Contact
Regulation Number	892.2050   More FDA Info for this Regulation Number
Classification Product Code	LLZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/10/2019
Decision Date	08/05/2019
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