Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K071166
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K071166
Device Name
System, Image Processing, Radiological
Applicant
ELECTRONIC BUSINESS MACHINE CO., LTD. (EBM)
1600 KAPIOLANI BLVD.
SUITE 1300
HONOLULU, HI 96814 US
Other 510(k) Applications for this Company
Contact
ANDY YEW
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
04/26/2007
Decision Date
07/23/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact