FDA 510(k) Applications Submitted by Katherine Y. Choi
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K230540 |
02/27/2023 |
Patient Specific Planning SolutionÖ 3D Bone Models |
Biomet Manufacturing Corp. |
| K110202 |
01/24/2011 |
FUJIFILM DIAGNOSTIC ULTRASOUND SYSTEM FAZONE CB |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
| K111243 |
05/03/2011 |
FUJINON ULTRASONIC PROCESSOR |
FUJINON INC. |
| K121499 |
05/21/2012 |
FUJIFILM TOMOSYNTHESIS OPTION FOR FDR ACSELERATE STATIONARY X-RAY SYSTEM |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
| K111548 |
06/03/2011 |
WIRELESS/WIRED FDR D-EVO FLAT PANCEL DETECTOR SYSTEM MODEL DR-ID600 W/DR-ID611SE |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
| K201672 |
06/19/2020 |
Signia Stapler (with new software) |
Covidien |
| K141765 |
07/01/2014 |
FDR D-EVO FLAT PANEL DETECTOR SYSTEM |
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. |
| K142003 |
07/23/2014 |
FDR D-EVO II FLAT PANEL DETECTOR SYSTEM |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
| K152138 |
07/31/2015 |
FDR D-EVO GL Flat Panel Detector System |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
| K132509 |
08/12/2013 |
FDR D-EVO FLAT PANEL DETECTOR SYSTEM |
FUJIFILM MEDICAL SYSTEMS USA, INC. |
| K103596 |
12/08/2010 |
WIRELESS/WIRED FDR D-EVO FLAT PANEL DETECTOR |
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. |
| K170348 |
02/03/2017 |
Signia Four-Bay Smart Charger (to be used with Signia Stapler) |
Covidien |
| K161347 |
05/16/2016 |
Signia sterilization tray |
COVIDIEN |
| K221629 |
06/06/2022 |
Tri-StapleÖ 2.0 Black Circular Reloads (for use with SigniaÖ Circular Adapters) |
Covidien |
| K182475 |
09/10/2018 |
Signia Circular Adapters (for use with Signia Staplers), Tri-Staple 2.0 Circular Reloads (for use with Signia Circular Adapters) |
Covidien |
| K153464 |
12/01/2015 |
FDR D-EVO flat Panel Detector System |
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. |
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