Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K111098
Device Classification Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
More FDA Info for this Device
510(K) Number
K111098
Device Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Applicant
IMAGING DYNAMICS COMPANY LTD.
8870 RAVELLO CT
NAPLES, FL 34114 US
Other 510(k) Applications for this Company
Contact
DANIEL KAMM
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
04/20/2011
Decision Date
05/27/2011
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