Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K121293
Device Classification Name
System, X-Ray, Fluoroscopic, Image-Intensified
More FDA Info for this Device
510(K) Number
K121293
Device Name
System, X-Ray, Fluoroscopic, Image-Intensified
Applicant
OMEGA MEDICAL IMAGING, LLC
675 HICKMAN CIRCLE
SANFORD, FL 32771 US
Other 510(k) Applications for this Company
Contact
BRIAN J FLEMING
Other 510(k) Applications for this Contact
Regulation Number
892.1650
More FDA Info for this Regulation Number
Classification Product Code
JAA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/30/2012
Decision Date
07/26/2012
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