FDA 510(k) Application Details - K023008

Device Classification Name System, X-Ray, Stationary

  More FDA Info for this Device
510(K) Number K023008
Device Name System, X-Ray, Stationary
Applicant QUANTUM MEDICAL IMAGING, LLC.
2905 VETERANS MEMORIAL HIGHWAY
RONKONKOMA, NY 11779 US
Other 510(k) Applications for this Company
Contact MARK CAMIRAND
Other 510(k) Applications for this Contact
Regulation Number 892.1680

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

  More FDA Info for this Product Code
Date Received 09/09/2002
Decision Date 11/13/2002
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