Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Philips Ultrasound, Inc. · Predicate Candidate Screening
46 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
29 daysmedian FDA review time
140 days90th percentile
46clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K212777 | Collaboration Live | Philips Ultrasound, Inc. | 2021-09-24 | 23 | 0 |
| K203406 | Lumify Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2021-02-23 | 96 | 3 |
| K200603 | AAA Model | Philips Ultrasound, Inc. | 2020-09-20 | 195 | 0 |
| K201665 | Collaboration Live | Philips Ultrasound, Inc. | 2020-09-15 | 88 | 0 |
| K202216 | EPIQ Series Diagnostic Ultrasound Systems | Philips Ultrasound, Inc. | 2020-09-02 | 27 | 8 |
| K201053 | PercuNav Image Fusion and Interventional Navigation | Philips Ultrasound, Inc. | 2020-05-14 | 23 | 0 |
| K201012 | EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnosti | Philips Ultrasound, Inc. | 2020-05-01 | 14 | 3 |
| K200304 | EPIQ Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2020-03-06 | 29 | 2 |
| K182857 | EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultraso | Philips Ultrasound, Inc. | 2018-11-09 | 30 | 17 |
| K182529 | Xperius Ultrasound System | Philips Ultrasound, Inc. | 2018-10-23 | 39 | 0 |
| K181485 | EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti | Philips Ultrasound, Inc. | 2018-07-27 | 51 | 24 |
| K181264 | QLAB Advanced Quantification Software | Philips Ultrasound, Inc. | 2018-06-07 | 24 | 0 |
| K170716 | PercuNav Image Fusion and Interventional Navigation | Philips Ultrasound, Inc. | 2017-04-21 | 43 | 0 |
| K163120 | EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultra | Philips Ultrasound, Inc. | 2017-01-10 | 63 | 28 |
| K160807 | EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultras | Philips Ultrasound, Inc. | 2016-04-06 | 13 | 32 |
| K141369 | VISIQ DIAGNOSTIC ULTRA SOUND SYSTEM | Philips Ultrasound, Inc. | 2014-07-02 | 40 | 0 |
| K140808 | Q-STATION | Philips Ultrasound, Inc. | 2014-04-17 | 16 | 2 |
| K133833 | NUVIS DIAGNOSTIC ULTRASOUND SYSTEM | Philips Ultrasound, Inc. | 2014-01-17 | 31 | 3 |
| K132304 | EPIQ DIAGNOSTIC ULTRASOUND SYSTEM | Philips Ultrasound, Inc. | 2013-08-21 | 28 | 35 |
| K132165 | QLAB QUANTIFICATION SOFTWARE | Philips Ultrasound, Inc. | 2013-08-09 | 28 | 1 |
| K130499 | IU22 DIAGNOSTIC ULTRASOUND SYSTEM | Philips Ultrasound, Inc. | 2013-06-18 | 112 | 2 |
| K123754 | CX50 3.0 DIAGNOSTIC ULTRASOUND SYSTEM | Philips Ultrasound, Inc. | 2012-12-21 | 15 | 22 |
| K121223 | QLAB WITH FHN AND VPQ PLUG-IN | Philips Ultrasound, Inc. | 2012-05-15 | 22 | 0 |
| K111513 | CX50 DIAGNOSTIC ULTRASOUND SYSTEM | Philips Ultrasound, Inc. | 2011-06-24 | 23 | 10 |
| K110414 | QLAB 8.1 QUANTIFICATION SOFTWARE | Philips Ultrasound, Inc. | 2011-06-21 | 127 | 0 |
| K103815 | Q-STATION | Philips Ultrasound, Inc. | 2011-01-25 | 27 | 0 |
| K093563 | IU22 ULTRASOUND SYSTEM AND TRANSDUCERS | Philips Ultrasound, Inc. | 2010-02-01 | 75 | 2 |
| K091804 | CX50 VERSION 2.0 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCER | Philips Ultrasound, Inc. | 2009-07-17 | 29 | 7 |
| K081802 | CX50 DIAGNOSTIC ULTRASOUND SYSTEM | Philips Ultrasound, Inc. | 2008-07-11 | 15 | 4 |
| K081661 | HD15 DIAGNOSTIC ULTRASOUND SYSTEM | Philips Ultrasound, Inc. | 2008-06-24 | 11 | 25 |
| K070792 | QLAB QUANTIFICATION | Philips Ultrasound, Inc. | 2007-04-06 | 15 | 0 |
| K062247 | HD11 DIAGNOSTIC ULTRASOUND SYSTEM | Philips Ultrasound, Inc. | 2006-08-18 | 15 | 3 |
| K061396 | QLAB QUANTIFICATION SOFTWARE | Philips Ultrasound, Inc. | 2006-05-30 | 11 | 0 |
| K043535 | HD11 DIAGNOSTIC ULTRASOUND SYSTEM | Philips Ultrasound, Inc. | 2005-01-06 | 15 | 35 |
| K042540 | PHILIPS IU22 ULTRASOUND SYSTEM | Philips Ultrasound, Inc. | 2004-10-04 | 14 | 4 |
| K034003 | HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM | Philips Ultrasound, Inc. | 2004-01-08 | 15 | 4 |
| K030455 | BORIS PLATFORM DIAGNOSTIC ULTRASOUND SYSTEM | Philips Ultrasound, Inc. | 2003-03-13 | 30 | 29 |
| K023877 | Q LAB QUANTIFICATION SOFTWARE WITH STRAIN RATE QUANTIFICATIO | Philips Ultrasound, Inc. | 2002-12-23 | 32 | 0 |
| K022303 | PHILIPS M2424 DIAGNOSTIC ULTRASOUND SYSTEM &PHILIPS 21315 DI | Philips Ultrasound, Inc. | 2002-07-30 | 14 | 0 |
| K881028 | 7.5 MHZ ENDORECTAL PROBE | Philips Ultrasound, Inc. | 1988-04-27 | 48 | 0 |
| K873937 | SDR 3500 (PHILIPS PLATINUM +) | Philips Ultrasound, Inc. | 1988-03-23 | 177 | 0 |
| K872817 | 5 MHZ DOPPLER OUTRIGGER | Philips Ultrasound, Inc. | 1988-02-08 | 207 | 0 |
| K864980 | 3MHZ ANNULAR ARRAY | Philips Ultrasound, Inc. | 1987-05-11 | 140 | 0 |
| K870748 | 7.5 MHZ TRANSRECTAL (ENDORECTAL) PROBE | Philips Ultrasound, Inc. | 1987-04-10 | 44 | 0 |
| K870709 | 7.5 MHZ ENDOVAGINAL PROBE | Philips Ultrasound, Inc. | 1987-03-27 | 35 | 0 |
| K841048 | TRANSDUCER 4.OMHZ LA4011 | Philips Ultrasound, Inc. | 1985-01-25 | 319 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda