Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K070079
Device Classification Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
More FDA Info for this Device
510(K) Number
K070079
Device Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Applicant
IMAGING DYNAMICS COMPANY LTD.
2340 PEGASUS WAY, NE
SUITE 151
CALGARY T2E 8M5 CA
Other 510(k) Applications for this Company
Contact
SHIRANTHAN SAMARAPPULI
Other 510(k) Applications for this Contact
Regulation Number
892.1650
More FDA Info for this Regulation Number
Classification Product Code
MQB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/09/2007
Decision Date
01/31/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact