Device Classification Name |
System, X-Ray, Angiographic
|
510(k) Number |
K920705 |
Device Name |
POLYTRON DIGITAL IMAGING SYSTEM |
Applicant |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
186 WOOD AVENUE SOUTH |
ISELIN,
NJ
08830
|
|
Applicant Contact |
LINDA JALBERT |
Correspondent |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
186 WOOD AVENUE SOUTH |
ISELIN,
NJ
08830
|
|
Correspondent Contact |
LINDA JALBERT |
Regulation Number | 892.1600
|
Classification Product Code |
|
Date Received | 02/18/1992 |
Decision Date | 04/27/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|