FDA 510(k) Application Details - K030347

Device Classification Name System, Image Processing, Radiological

  More FDA Info for this Device
510(K) Number K030347
Device Name System, Image Processing, Radiological
Applicant EIZO NANAO CORPORATION
319 AKENO, OBATA-CHO
WATARAI-GUN, MIE-KEN 519-05 JP
Other 510(k) Applications for this Company
Contact AKIRA WAKAYAMA
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 02/03/2003
Decision Date 05/02/2003
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