Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K180522
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K180522
Device Name
System, Image Processing, Radiological
Applicant
IGI Technologies
387 Technology Dr. #311OD
College Park, MD 20742 US
Other 510(k) Applications for this Company
Contact
Will Plishker
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
02/27/2018
Decision Date
08/16/2018
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