Device Classification Name |
System, Radiation Therapy, Charged-Particle, Medical
More FDA Info for this Device |
510(K) Number |
K134052 |
Device Name |
System, Radiation Therapy, Charged-Particle, Medical |
Applicant |
ProTom International, Inc.
555 13TH ST. NW
WASHINGTON, DC 20001 US
Other 510(k) Applications for this Company
|
Contact |
JOHN J SMITH, MD, JD
Other 510(k) Applications for this Contact |
Regulation Number |
892.5050
More FDA Info for this Regulation Number |
Classification Product Code |
LHN
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
12/31/2013 |
Decision Date |
03/14/2014 |
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 |
|