Device Classification Name |
accelerator, linear, medical
|
510(k) Number |
K123371 |
Device Name |
ALIGNRT PLUS |
Applicant |
VISION RT LIMITED |
Dove House |
Arcadia Avenue |
LONDON,
GB
N3 2JU
|
|
Applicant Contact |
NORMAN SMITH |
Correspondent |
VISION RT LIMITED |
Dove House |
Arcadia Avenue |
LONDON,
GB
N3 2JU
|
|
Correspondent Contact |
NORMAN SMITH |
Regulation Number | 892.5050
|
Classification Product Code |
|
Date Received | 11/01/2012 |
Decision Date | 01/08/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|