Device Classification Name |
interventional fluoroscopic x-ray system
|
510(k) Number |
K181403 |
Device Name |
Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR |
Applicant |
GE Healthcare |
283 Rue de la Miniere |
Buc,
FR
78530
|
|
Applicant Contact |
Michel Genuer |
Correspondent |
GE Healthcare |
283 Rue de la Miniere |
Buc,
FR
78530
|
|
Correspondent Contact |
Michel Genuer |
Regulation Number | 892.1650
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 05/29/2018 |
Decision Date | 11/02/2018 |
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
|
|
|