Device Classification Name |
System, Applicator, Radionuclide, Remote-Controlled
|
510(k) Number |
K912555 |
Device Name |
GAMMAMED 12IT HIGH DOSE RATE REMOTE AFTERLOADER |
Applicant |
RTS TECHNOLOGY, INC. |
35 FLAGSHIP DR. |
NORTH ANDOVER,
MA
01845
|
|
Applicant Contact |
MUNRO III |
Correspondent |
RTS TECHNOLOGY, INC. |
35 FLAGSHIP DR. |
NORTH ANDOVER,
MA
01845
|
|
Correspondent Contact |
MUNRO III |
Regulation Number | 892.5700
|
Classification Product Code |
|
Date Received | 06/11/1991 |
Decision Date | 08/02/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|