Device Classification Name |
System, Planning, Radiation Therapy Treatment
|
510(k) Number |
K090893 |
Device Name |
TIGRT TPS |
Applicant |
LINATECH, LLC |
1294 KIFER ROAD |
# 705 |
SUNNYVALE,
CA
94086
|
|
Applicant Contact |
JONATHAN YAO |
Correspondent |
LINATECH, LLC |
1294 KIFER ROAD |
# 705 |
SUNNYVALE,
CA
94086
|
|
Correspondent Contact |
JONATHAN YAO |
Regulation Number | 892.5050
|
Classification Product Code |
|
Date Received | 03/31/2009 |
Decision Date | 07/15/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|