Device Classification Name |
Solid State X-Ray Imager (Flat Panel/Digital Imager)
|
510(k) Number |
K024147 |
Device Name |
PAXSCAN 4030 MEDICAL DIGITAL IMAGING SYSTEM |
Applicant |
VARIAN MEDICAL SYSTEMS, INC. |
3100 HANSEN WAY |
PALO ALTO,
CA
94304
|
|
Applicant Contact |
LINDA S NASH |
Correspondent |
VARIAN MEDICAL SYSTEMS, INC. |
3100 HANSEN WAY |
PALO ALTO,
CA
94304
|
|
Correspondent Contact |
LINDA S NASH |
Regulation Number | 892.1680
|
Classification Product Code |
|
Date Received | 12/16/2002 |
Decision Date | 02/12/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|