| Device Classification Name |
system, x-ray, angiographic
|
|---|
| 510(K) Number |
K122457 |
|---|
| Models |
INNOVA 2121-IQ, INNOVA 3131-IQ,
INNOVA 4100-IQ, INNOVA3100-IQ, INNOVA 2100-IQ,
INNOVA IGS 540, INNOVA IGS 530, INNOVA IGS 520,
INNOVA IGS 620, INNOVS IGS 630, DISCOVERY IGS 730,
OPTIMA CL320I, OPTIMA CL323I
|
| Device Name |
GE INNOVA/INNOVA IGS/DISCOVERY IGS/OPTIMA ANGIOGRAPHIC, FLUOSCOPIC X-RAY SYSTEMS WITH CATHLAB FRONTIERS SOLUTIONS |
|---|
| Applicant |
| GE HEALTHCARE |
| 283, rue de la miniere |
|
buc,
|
|
| Contact |
malca |
| Regulation Number | 892.1600
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 08/13/2012 |
|---|
| Decision Date | 01/02/2013 |
|---|
| Decision |
substantially equivalent (SE) |
|---|
| Classification Advisory Committee |
Radiology
|
|---|
| Review Advisory Committee |
Radiology
|
|---|
| summary |
summary
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
