FDA 510(k) Applications Submitted by JYH-SHYAN LIN
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K160108 |
01/19/2016 |
Synapse PACS |
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. |
| K130383 |
02/14/2013 |
SYNAPSE 3D CARDIAC TOOLS |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
| K120636 |
03/01/2012 |
SYNAPSE 3D CARDIAC TOOLS |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
| K120637 |
03/01/2012 |
SYNAPSE 3D BRAIN PERFUSION |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
| K130542 |
03/01/2013 |
SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
| K120648 |
03/02/2012 |
SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
| K120679 |
03/06/2012 |
SYNAPSE 3D NODULE ANALYSIS |
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. |
| K171463 |
05/18/2017 |
ASPIRE Bellus II |
FUJIFILM Medical Systems U.S.A., Inc. |
| K141514 |
06/09/2014 |
SYNAPSE 3D TENSOR ANALYSIS |
FUJIFILM MEIDCAL SYSTEMS U.S.A..,INC. |
| K151859 |
07/08/2015 |
Synapse Cardiovascular |
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. |
| K132188 |
07/15/2013 |
MAMMOGRAPHY VIEWER SMV658 |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
| K162287 |
08/15/2016 |
Synapse 3D Perfusion Analysis |
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. |
| K112439 |
08/24/2011 |
SYNAPSE WORKSTATION SOFTWARE VERSION 3.3.0 |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
| K142521 |
09/08/2014 |
Synapse 3D Liver and Kidney Analysis |
FUJIFILM MEIDCAL SYSTEMS U.S.A.,INC. |
| K173132 |
09/29/2017 |
ASPIRE Cristalle |
Fujifilm Medical Systems U.S.A., Inc. |
| K123566 |
11/20/2012 |
SYNAPSE 3D COLON ANALYSIS |
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. |
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