Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K171133
Device Classification Name
Accelerator, Linear, Medical
More FDA Info for this Device
510(K) Number
K171133
Device Name
Accelerator, Linear, Medical
Applicant
Qfix
440 Church Road
Avondale, PA 19311 US
Other 510(k) Applications for this Company
Contact
Alexandra Nicole Low
Other 510(k) Applications for this Contact
Regulation Number
892.5050
More FDA Info for this Regulation Number
Classification Product Code
IYE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/17/2017
Decision Date
07/11/2017
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