Device Classification Name |
System, X-Ray, Tomography, Computed
|
510(k) Number |
K082816 |
Device Name |
GE BRIGHTSPEED DELIGHT CT SCANNER SYSTEM |
Applicant |
GE MEDICAL SYSTEMS, LLC |
3000 N GRANDVIEW BLVD. |
WAUKESHA,
WI
53188
|
|
Applicant Contact |
STEVEN KACHELMEYER |
Correspondent |
INTERTEK TESTING SERVICES |
2307 EAST AURORA ROAD |
UNIT B7 |
TWINSBURG,
OH
44087
|
|
Correspondent Contact |
JAMES W MONROE |
Regulation Number | 892.1750
|
Classification Product Code |
|
Date Received | 09/25/2008 |
Decision Date | 10/08/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|