FDA 510(k) Application Details - K002144

Device Classification Name System, Image Processing, Radiological

  More FDA Info for this Device
510(K) Number K002144
Device Name System, Image Processing, Radiological
Applicant ADVANCED TECHNOLOGY LABORATORIES, INC.
22100 BOTHELL EVERETT HWY.
P.O. BOX 3003
BOTHELL, WA 98041-3003 US
Other 510(k) Applications for this Company
Contact TERRENCE J SWEENEY
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 07/17/2000
Decision Date 09/28/2000
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



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact