Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K080770
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K080770
Device Name
System, Image Processing, Radiological
Applicant
CARDIOVASCULAR IMAGING TECHNOLOGIES, LLC
9755 RIDGE DR.
LENEXA, KS 66219 US
Other 510(k) Applications for this Company
Contact
MELANIE HASEK
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
03/18/2008
Decision Date
04/09/2008
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
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact