Data / Medical devices / United States / Philips Ultrasound LLC
Philips Ultrasound LLC: FDA-registered device maker in Cambridge, MA, United States, 61 510(k) clearances
Philips Ultrasound LLC is registered with the FDA (registration 3017894900) in Cambridge, MA, United States. It lists 8 device types. The FDA files 61 510(k) clearances under its listings, the newest dated December 22, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017894900
- Address
- 222 Jacobs Street, Cambridge, MA, United States, 02141
- Owner or operator
- Philips Medical Systems International BV (1217116)
- Roles
- Manufacturer, Specification developer
- First device listed
- November 19, 1992
- Registered through
- 2026
- Brand names listed
- 21221B (C1914C), 21223B (D5014V), 21228B (D1914V), 21321A (C3540), 21330A (S4), 21350A (S8), 21359A (L7535), 21360A (L5035) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Catheter, Ultrasound, Intravascular | OBJ | 2 | Specification developer | accessdata.fda.gov |
| System, Digital Image Communications, Radiological | LMD | 1 | Specification developer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Specification developer | accessdata.fda.gov |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| System, X-Ray, Tomography, Computed | JAK | 2 | Specification developer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 22, 2025 | K252557 | Lumify Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound, LLC | accessdata.fda.gov |
| May 15, 2025 | K242519 | Lumify Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound | accessdata.fda.gov |
| May 8, 2025 | K242670 | Lumify Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound | accessdata.fda.gov |
| April 24, 2024 | K240850 | EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems | IYN | Substantially Equivalent | Philips Ultrasound, LLC | accessdata.fda.gov |
| February 13, 2024 | K233788 | EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound, LLC | accessdata.fda.gov |
| November 30, 2023 | K233545 | EPIQ Series Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound, LLC | accessdata.fda.gov |
| October 26, 2023 | K232500 | Lumify Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound | accessdata.fda.gov |
| May 12, 2023 | K231190 | EPIQ Series Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound, LLC | accessdata.fda.gov |
| May 4, 2023 | K223771 | Lumify Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound | accessdata.fda.gov |
| January 18, 2023 | K223804 | PercuNav Image Fusion and Interventional Navigation System | JAK | Substantially Equivalent | Philips Ultrasound, LLC | accessdata.fda.gov |
| September 27, 2022 | K222648 | 5000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500 P, Ultrasound System 5500 W, Ultrasound System 5500 CV, Ultrasound System 5300 G, Ultrasound System 5300 P, Ultrasound System 5300 W) | IYN | Substantially Equivalent | Philips Ultrasound, LLC | accessdata.fda.gov |
| September 24, 2021 | K212777 | Collaboration Live | LLZ | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| September 24, 2021 | K212704 | Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Medical Systems | accessdata.fda.gov |
| September 8, 2021 | K211597 | EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Medical Systems | accessdata.fda.gov |
| February 23, 2021 | K203406 | Lumify Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| September 20, 2020 | K200603 | AAA Model | LLZ | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| September 15, 2020 | K201665 | Collaboration Live | LLZ | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| September 2, 2020 | K202216 | EPIQ Series Diagnostic Ultrasound Systems | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| August 17, 2020 | K201352 | 3D Auto LAA | LLZ | Substantially Equivalent | Philips Health Care | accessdata.fda.gov |
| June 3, 2020 | K200974 | QLAB Advanced Quantification Software | QIH | Substantially Equivalent | Philips Health Care | accessdata.fda.gov |
| May 14, 2020 | K201053 | PercuNav Image Fusion and Interventional Navigation | JAK | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| May 1, 2020 | K201012 | EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| March 6, 2020 | K200304 | EPIQ Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| February 18, 2020 | K200179 | Collaboration Live | LLZ | Substantially Equivalent | Philips Health Care | accessdata.fda.gov |
| December 20, 2019 | K191647 | QLAB Advanced Quantification Software | QIH | Substantially Equivalent | Philips Health Care | accessdata.fda.gov |
| September 6, 2019 | K192226 | Lumify Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Health Care | accessdata.fda.gov |
| June 18, 2019 | K190913 | QLAB Advanced Quantification Software 13 | LLZ | Substantially Equivalent | Philips Health Care | accessdata.fda.gov |
| November 9, 2018 | K182857 | 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 | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| October 23, 2018 | K182529 | Xperius Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| July 27, 2018 | K181485 | EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| June 7, 2018 | K181264 | QLAB Advanced Quantification Software | LLZ | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| October 4, 2017 | K172607 | Philips 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 | IYN | Substantially Equivalent | Philips Health Care | accessdata.fda.gov |
| May 30, 2017 | K171314 | QLAB Advanced Quantification Software | LLZ | Substantially Equivalent | Philips Health Care | accessdata.fda.gov |
| April 21, 2017 | K170716 | PercuNav Image Fusion and Interventional Navigation | JAK | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| January 10, 2017 | K163120 | EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50 Diagnostic Ultrasound System; Affiniti 70 Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| November 16, 2016 | K163020 | Xperius Ultrasound System | IYN | Substantially Equivalent | Philips Health Care | accessdata.fda.gov |
| October 3, 2016 | K162549 | Lumify Ultrasound System | IYN | Substantially Equivalent | Philips Health Care | accessdata.fda.gov |
| September 14, 2016 | K162329 | CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Health Care | accessdata.fda.gov |
| April 6, 2016 | K160807 | EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| December 16, 2015 | K153480 | ClearVue850 Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Health Care | accessdata.fda.gov |
| October 30, 2015 | K152899 | Philips Lumify Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Healthcare, Inc. | accessdata.fda.gov |
| July 2, 2014 | K141369 | VISIQ DIAGNOSTIC ULTRA SOUND SYSTEM | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| April 17, 2014 | K140808 | Q-STATION | LLZ | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| August 21, 2013 | K132304 | EPIQ DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| July 24, 2013 | K132087 | PERCUNAV SYSTEM | JAK | Substantially Equivalent | Philips Health Care | accessdata.fda.gov |
| June 18, 2013 | K130499 | IU22 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| December 21, 2012 | K123754 | CX50 3.0 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| February 17, 2012 | K120321 | CLEARVUE 350/550 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | Philips Health Care | accessdata.fda.gov |
| June 24, 2011 | K111513 | CX50 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| February 1, 2010 | K093563 | IU22 ULTRASOUND SYSTEM AND TRANSDUCERS | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| July 17, 2009 | K091804 | CX50 VERSION 2.0 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS | ITX | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| July 11, 2008 | K081802 | CX50 DIAGNOSTIC ULTRASOUND SYSTEM | ITX | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| June 24, 2008 | K081661 | HD15 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| December 14, 2006 | K063580 | SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | Medison Co., Ltd. | accessdata.fda.gov |
| August 18, 2006 | K062247 | HD11 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| January 6, 2005 | K043535 | HD11 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| October 4, 2004 | K042540 | PHILIPS IU22 ULTRASOUND SYSTEM | IYO | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| March 13, 2003 | K030455 | BORIS PLATFORM DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| January 7, 2002 | K014191 | M2540 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL M2540 | IYN | Substantially Equivalent | Philips Medical Systems | accessdata.fda.gov |
| June 18, 1999 | K991671 | HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM | IYO | Substantially Equivalent | Advanced Technology Laboratories, Inc. | accessdata.fda.gov |
| February 18, 1999 | K990339 | SONOS 5500 IMAGING SYSTEM M2424A VERSION B.O | IYN | Substantially Equivalent | Hewlett-Packard Co. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Imaging, Pulsed Doppler, Ultrasonic
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
- All makers of Transducer, Ultrasonic, Diagnostic
- All makers of System, Image Processing, Radiological
- All makers of System, X-Ray, Tomography, Computed
- All makers of Automated Radiological Image Processing Software
Updated December 22, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.