Device Classification Name |
Interventional Fluoroscopic X-Ray System
|
510(k) Number |
K974355 |
Device Name |
INTERVENTIONAL MOBILE DIGITAL IMAGING SYSTEM (HEREIN CALLED IMDIS) |
Applicant |
GE DEC MEDICAL SYSTEMS |
384 WRIGHT BROTHERS DR. |
SALT LAKE CITY,
UT
84116
|
|
Applicant Contact |
TED L PARROT |
Correspondent |
GE DEC MEDICAL SYSTEMS |
384 WRIGHT BROTHERS DR. |
SALT LAKE CITY,
UT
84116
|
|
Correspondent Contact |
TED L PARROT |
Regulation Number | 892.1650
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 11/19/1997 |
Decision Date | 02/17/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|