Device Classification Name |
accelerator, linear, medical
|
510(k) Number |
K942346 |
Device Name |
IMAGERT |
Applicant |
IMPAC MEDICAL SYSTEMS, INC. |
209 HAMILTON AVE. |
PALO ALTO,
CA
94301
|
|
Applicant Contact |
JOSEPH K JACHNOWSKI |
Correspondent |
IMPAC MEDICAL SYSTEMS, INC. |
209 HAMILTON AVE. |
PALO ALTO,
CA
94301
|
|
Correspondent Contact |
JOSEPH K JACHNOWSKI |
Regulation Number | 892.5050
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/16/1994 |
Decision Date | 05/15/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|