FDA 510(k) Application Details - K960043

Device Classification Name System, Image Processing, Radiological

  More FDA Info for this Device
510(K) Number K960043
Device Name System, Image Processing, Radiological
Applicant JAMIESON FILM CO.
HEALTH SCIENCES DIVISION
901 ELMGROVE ROAD
ROCHESTER, NY 14653-5741 US
Other 510(k) Applications for this Company
Contact BARRY KEYS
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 01/03/1996
Decision Date 03/27/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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