Device Classification Name |
device, spot-film
|
510(k) Number |
K111304 |
Device Name |
OPTIMA XR120 |
Applicant |
GE MEDICAL SYSTEMS, LLC |
3000 N GRANDVIEW BLVD. |
WAUKESHA,
WI
53188
|
|
Applicant Contact |
NIDHI CHAUDHARY |
Correspondent |
GE MEDICAL SYSTEMS, LLC |
3000 N GRANDVIEW BLVD. |
WAUKESHA,
WI
53188
|
|
Correspondent Contact |
NIDHI CHAUDHARY |
Regulation Number | 892.1670
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/09/2011 |
Decision Date | 07/19/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|