FDA 510(k) Application Details - K961753

Device Classification Name	System, Digital Image Communications, Radiological   More FDA Info for this Device
510(K) Number	K961753
Device Name	System, Digital Image Communications, Radiological
Applicant	IMAGELABS, INC. 19A CROSBY DR., SUITE 300 BEDFORD, MA 01730 US Other 510(k) Applications for this Company
Contact	LISA BERGEN Other 510(k) Applications for this Contact
Regulation Number	892.2020   More FDA Info for this Regulation Number
Classification Product Code	LMD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/06/1996
Decision Date	07/25/1996
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