Device Classification Name |
Interventional Fluoroscopic X-Ray System
|
510(k) Number |
K936180 |
Device Name |
TC+ SYSTEM (TILTING C-ARM SYSTEM) |
Applicant |
GE MEDICAL SYSTEMS |
3000 N GRANDVIEW BLVD. |
W-709 |
WAUKESHA,
WI
53188
|
|
Correspondent |
GE MEDICAL SYSTEMS |
3000 N GRANDVIEW BLVD. |
W-709 |
WAUKESHA,
WI
53188
|
|
Regulation Number | 892.1650
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/27/1993 |
Decision Date | 03/16/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|