FDA 510(k) Application Details - K081262

Device Classification Name System, Image Processing, Radiological

  More FDA Info for this Device
510(K) Number K081262
Device Name System, Image Processing, Radiological
Applicant INVIVO CORPORATION
N27 W23676 PAUL RD.
PEWAUKEE, WI 53072 US
Other 510(k) Applications for this Company
Contact THEODORE J REISKER
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 05/05/2008
Decision Date 06/17/2008
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 Y
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact