Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K080553
Device Classification Name
System, X-Ray, Stationary
More FDA Info for this Device
510(K) Number
K080553
Device Name
System, X-Ray, Stationary
Applicant
VIEWORKS CO., LTD.
340 SHADY GROVE ROAD
FLINTVILLE, TN 37335 US
Other 510(k) Applications for this Company
Contact
CHARLIE MACK
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
02/28/2008
Decision Date
04/16/2008
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