Device Classification Name |
Solid State X-Ray Imager (Flat Panel/Digital Imager)
|
510(k) Number |
K052938 |
Device Name |
CR-PRO |
Applicant |
ERADLINK, INC. |
22750 HAWTHORNE BLVD. |
TORRANCE,
CA
90505 -3664
|
|
Applicant Contact |
ALBERT KOUBA |
Correspondent |
INTERTEK TESTING SERVICES |
70 CODMAN HILL RD. |
BOXBOROUGH,
MA
01719
|
|
Correspondent Contact |
DANIEL W LEHTONEN |
Regulation Number | 892.1680
|
Classification Product Code |
|
Date Received | 10/20/2005 |
Decision Date | 11/17/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|