FDA 510(k) Application Details - K093066

Device Classification Name

  More FDA Info for this Device
510(K) Number K093066
Device Name I5 DIGITAL X-RAY IMAGING SYSTEM, MODEL I5
Applicant INFIMED, INC.
55 Northern Blvd.
Suite 200
Great Neck, NY 11021 US
Other 510(k) Applications for this Company
Contact JIGAR SHAH
Other 510(k) Applications for this Contact
Regulation Number

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

  More FDA Info for this Product Code
Date Received 09/30/2009
Decision Date 03/16/2010
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