Device Classification Name |
Solid State X-Ray Imager (Flat Panel/Digital Imager)
|
510(k) Number |
K062376 |
Device Name |
DIRECT DIGITAL RADIOGRAPHY CCD IMAGING SENSOR, NAOMI |
Applicant |
RF SYSTEMS LAB. |
110 E. GRANADA BLVD. |
SUITE 208 |
ORMOND BEACH,
FL
32164
|
|
Applicant Contact |
CLAUDE D BERTHOIN |
Correspondent |
RF SYSTEMS LAB. |
110 E. GRANADA BLVD. |
SUITE 208 |
ORMOND BEACH,
FL
32164
|
|
Correspondent Contact |
CLAUDE D BERTHOIN |
Regulation Number | 892.1680
|
Classification Product Code |
|
Date Received | 08/15/2006 |
Decision Date | 10/27/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|