Device Classification Name |
System, Tomography, Computed, Emission
|
510(k) Number |
K952674 |
Device Name |
TRANSACT: ATTENUATION CORRECTION SYSTEM FOR THE APEX CARDIAL GAMMA CAMERA |
Applicant |
ELSCINT, INC. |
505 MAIN ST. |
SUITE 300 |
HACKENSACK,
NJ
07601
|
|
Applicant Contact |
KATHLEEN MURRAY |
Correspondent |
ELSCINT, INC. |
505 MAIN ST. |
SUITE 300 |
HACKENSACK,
NJ
07601
|
|
Correspondent Contact |
KATHLEEN MURRAY |
Regulation Number | 892.1200
|
Classification Product Code |
|
Date Received | 06/12/1995 |
Decision Date | 09/26/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|