FDA 510(k) Application Details - K990359

Device Classification Name Solid State X-Ray Imager (Flat Panel/Digital Imager)

  More FDA Info for this Device
510(K) Number K990359
Device Name Solid State X-Ray Imager (Flat Panel/Digital Imager)
Applicant KONICA CORP.
THE CHRYSLER BUILDING
405 LEXINGTON AVENUE
NEW YORK, NY 10174 US
Other 510(k) Applications for this Company
Contact RUSSELL D MUNVES
Other 510(k) Applications for this Contact
Regulation Number 892.1650

  More FDA Info for this Regulation Number
Classification Product Code MQB
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 02/05/1999
Decision Date 08/17/1999
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