Device Classification Name |
accelerator, linear, medical
|
510(k) Number |
K962335 |
Device Name |
MLC FIT |
Applicant |
IMPAC MEDICAL SYSTEMS, INC. |
215 CASTRO ST. |
MOUNTAIN VIEW,
CA
94041 -1203
|
|
Applicant Contact |
JOSEPH K JACHINOWSKI |
Correspondent |
IMPAC MEDICAL SYSTEMS, INC. |
215 CASTRO ST. |
MOUNTAIN VIEW,
CA
94041 -1203
|
|
Correspondent Contact |
JOSEPH K JACHINOWSKI |
Regulation Number | 892.5050
|
Classification Product Code |
|
Date Received | 06/17/1996 |
Decision Date | 02/06/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|