Device Classification Name |
system, x-ray, tomography, computed
|
510(k) Number |
K884268 |
Device Name |
VOXELSCOPE(TM) |
Applicant |
DYNAMIC DIGITAL DISPLAYS, INC. |
3508 MARKET ST. SUITE 257 |
PHILADELPHIA,
PA
19104
|
|
Applicant Contact |
DAVID A TALTON |
Correspondent |
DYNAMIC DIGITAL DISPLAYS, INC. |
3508 MARKET ST. SUITE 257 |
PHILADELPHIA,
PA
19104
|
|
Correspondent Contact |
DAVID A TALTON |
Regulation Number | 892.1750
|
Classification Product Code |
|
Date Received | 10/11/1988 |
Decision Date | 12/20/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|