Device Classification Name |
System, Planning, Radiation Therapy Treatment
|
510(k) Number |
K993675 |
Device Name |
PEREGRINE RADIATION THERAPY DOSE CALCULATION SYSTEM |
Applicant |
NOMOS CORP. |
2591 WEXFORD BAYNE RD. |
SUITE 400 |
SEWICKLEY,
PA
15143
|
|
Applicant Contact |
FRANCIS X DOBSCHA |
Correspondent |
NOMOS CORP. |
2591 WEXFORD BAYNE RD. |
SUITE 400 |
SEWICKLEY,
PA
15143
|
|
Correspondent Contact |
FRANCIS X DOBSCHA |
Regulation Number | 892.5050
|
Classification Product Code |
|
Date Received | 11/01/1999 |
Decision Date | 09/05/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|