FDA 510(k) Applications Submitted by HELEN PENG
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K170752 |
03/13/2017 |
OEC Elite |
OEC Medical Systems, Inc. |
| K110834 |
03/25/2011 |
AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION |
GE HEALTHCARE |
| K131576 |
05/31/2013 |
OPTIMA CT660 |
GE MEDICAL SYSTEMS, LLC |
| K161574 |
06/07/2016 |
Discovery MI |
GE Medical Systems, L.L.C. |
| K121827 |
06/21/2012 |
GSI VIEWER WITH VUE OPTION |
GE MEDICAL SYSTEMS SCS |
| K122164 |
07/20/2012 |
MR VESSELLQ XPRESS |
GE MEDICAL SYSTEMS SCS |
| K132410 |
08/02/2013 |
DISCOVERY CT 590 RT, OPTIMA CT 580, OPTIMA CT 580 RT, OPTIMA CT 580 W |
GE MEDICAL SYSTEMS, LLC |
| K163213 |
11/16/2016 |
Revolution CT |
GE Medical Systems, L.L.C. |
| K123596 |
11/21/2012 |
OPTIMA CT520 |
GE HANGWEI MEDICAL SYSTEMS CO., LTD. |
| K133705 |
12/03/2013 |
REVOLUTION CT |
GE MEDICAL SYSTEMS, LLC |
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