Device Classification Name |
Full Field Digital, System, X-Ray, Mammographic
|
510(k) Number |
K122510 |
Device Name |
ICRCO 3600M |
Applicant |
ICRCO INC. |
2580 WEST 237TH STREET |
TORRANCE,
CA
90505
|
|
Applicant Contact |
GREG WACHTLER |
Correspondent |
ICRCO INC. |
2580 WEST 237TH STREET |
TORRANCE,
CA
90505
|
|
Correspondent Contact |
GREG WACHTLER |
Regulation Number | 892.1715
|
Classification Product Code |
|
Date Received | 08/17/2012 |
Decision Date | 04/26/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|