Device Classification Name |
Solid State X-Ray Imager (Flat Panel/Digital Imager)
|
510(k) Number |
K982661 |
Device Name |
CDR - PAN MODEL 4700 |
Applicant |
SCHICK TECHNOLOGIES, INC. |
3100 47TH AVE. |
LONG ISLAND,
NY
11101
|
|
Applicant Contact |
ENRICO RENZI |
Correspondent |
SCHICK TECHNOLOGIES, INC. |
3100 47TH AVE. |
LONG ISLAND,
NY
11101
|
|
Correspondent Contact |
ENRICO RENZI |
Regulation Number | 892.1680
|
Classification Product Code |
|
Date Received | 07/30/1998 |
Decision Date | 12/11/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|