FDA 510(k) Applications Submitted by PHILIPS ULTRASOUND, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K081661 |
06/13/2008 |
HD15 DIAGNOSTIC ULTRASOUND SYSTEM |
PHILIPS ULTRASOUND, INC. |
| K123754 |
12/06/2012 |
CX50 3.0 DIAGNOSTIC ULTRASOUND SYSTEM |
PHILIPS ULTRASOUND, INC. |
| K201665 |
06/19/2020 |
Collaboration Live |
Philips Ultrasound, Inc. |
| K202216 |
08/06/2020 |
EPIQ Series Diagnostic Ultrasound Systems |
Philips Ultrasound, Inc. |
| K203406 |
11/19/2020 |
Lumify Diagnostic Ultrasound System |
Philips Ultrasound, Inc. |
| K212777 |
09/01/2021 |
Collaboration Live |
Philips Ultrasound, Inc. |
| K201012 |
04/17/2020 |
EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System |
Philips Ultrasound, Inc. |
| K182529 |
09/14/2018 |
Xperius Ultrasound System |
Philips Ultrasound, Inc. |
| K130499 |
02/26/2013 |
IU22 DIAGNOSTIC ULTRASOUND SYSTEM |
PHILIPS ULTRASOUND, INC. |
| K132304 |
07/24/2013 |
EPIQ DIAGNOSTIC ULTRASOUND SYSTEM |
PHILIPS ULTRASOUND, INC. |
| K181485 |
06/06/2018 |
EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound System |
Philips Ultrasound, Inc. |
| K182857 |
10/10/2018 |
EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System |
Philips Ultrasound, Inc. |
| K200304 |
02/06/2020 |
EPIQ Diagnostic Ultrasound System |
Philips Ultrasound, Inc. |
| K030455 |
02/11/2003 |
BORIS PLATFORM DIAGNOSTIC ULTRASOUND SYSTEM |
PHILIPS ULTRASOUND, INC. |
| K070792 |
03/22/2007 |
QLAB QUANTIFICATION |
PHILIPS ULTRASOUND, INC. |
| K061396 |
05/19/2006 |
QLAB QUANTIFICATION SOFTWARE |
PHILIPS ULTRASOUND, INC. |
| K042540 |
09/20/2004 |
PHILIPS IU22 ULTRASOUND SYSTEM |
PHILIPS ULTRASOUND, INC. |
| K023877 |
11/21/2002 |
Q LAB QUANTIFICATION SOFTWARE WITH STRAIN RATE QUANTIFICATION PLUG-IN |
PHILIPS ULTRASOUND, INC. |
| K034003 |
12/24/2003 |
HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM |
PHILIPS ULTRASOUND, INC. |
| K133833 |
12/17/2013 |
NUVIS DIAGNOSTIC ULTRASOUND SYSTEM |
PHILIPS ULTRASOUND, INC. |
| K110414 |
02/14/2011 |
QLAB 8.1 QUANTIFICATION SOFTWARE |
PHILIPS ULTRASOUND, INC. |
| K093563 |
11/18/2009 |
IU22 ULTRASOUND SYSTEM AND TRANSDUCERS |
PHILIPS ULTRASOUND, INC. |
| K103815 |
12/29/2010 |
Q-STATION |
PHILIPS ULTRASOUND, INC. |
| K022303 |
07/16/2002 |
PHILIPS M2424 DIAGNOSTIC ULTRASOUND SYSTEM &PHILIPS 21315 DIAGNOSTIC ULTRASOUND TRANSDUCER |
PHILIPS ULTRASOUND, INC. |
| K160807 |
03/24/2016 |
EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System |
PHILIPS ULTRASOUND, INC. |
| K163120 |
11/08/2016 |
EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50 Diagnostic Ultrasound System; Affiniti 70 Diagnostic Ultrasound System |
Philips Ultrasound, Inc. |
| K140808 |
04/01/2014 |
Q-STATION |
PHILIPS ULTRASOUND, INC. |
| K121223 |
04/23/2012 |
QLAB WITH FHN AND VPQ PLUG-IN |
PHILIPS ULTRASOUND, INC. |
| K111513 |
06/01/2011 |
CX50 DIAGNOSTIC ULTRASOUND SYSTEM |
PHILIPS ULTRASOUND, INC. |
| K132165 |
07/12/2013 |
QLAB QUANTIFICATION SOFTWARE |
PHILIPS ULTRASOUND, INC. |
| K091804 |
06/18/2009 |
CX50 VERSION 2.0 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS |
PHILIPS ULTRASOUND, INC. |
| K081802 |
06/26/2008 |
CX50 DIAGNOSTIC ULTRASOUND SYSTEM |
PHILIPS ULTRASOUND, INC. |
| K141369 |
05/23/2014 |
VISIQ DIAGNOSTIC ULTRA SOUND SYSTEM |
PHILIPS ULTRASOUND, INC. |
| K062247 |
08/03/2006 |
HD11 DIAGNOSTIC ULTRASOUND SYSTEM |
PHILIPS ULTRASOUND, INC. |
| K043535 |
12/22/2004 |
HD11 DIAGNOSTIC ULTRASOUND SYSTEM |
PHILIPS ULTRASOUND, INC. |
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