FDA 510(k) Application Details - K983392

Device Classification Name System, Image Processing, Radiological

  More FDA Info for this Device
510(K) Number K983392
Device Name System, Image Processing, Radiological
Applicant DATA RAY
12300 PECOS ST.
WESTMINSTER, CO 80234 US
Other 510(k) Applications for this Company
Contact GREG ROBERTS
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 09/25/1998
Decision Date 12/15/1998
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