FDA 510(k) Application Details - K983447

Device Classification Name	Device, Digital Image Storage, Radiological   More FDA Info for this Device
510(K) Number	K983447
Device Name	Device, Digital Image Storage, Radiological
Applicant	SECTRA-IMTEC AB 6741 GRANT LN. PLANO, TX 75024 US Other 510(k) Applications for this Company
Contact	HERMAN OOSTERWIJK Other 510(k) Applications for this Contact
Regulation Number	892.2010   More FDA Info for this Regulation Number
Classification Product Code	LMB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/1998
Decision Date	10/29/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review