FDA.reportPublic FDA data

Philips Ultrasound LLC

Matched from indexed company URL: Philips Ultrasound

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
25185862518586Philips Ultrasound LLC1N2026-01-011 Echo Dr Reedsville PA US 17084
30192163019216Philips Ultrasound LLC1Y2026-01-0122100 Bothell Everett Hwy BOTHELL WA US 98021
30178949003017894900Philips Ultrasound LLC1N2026-01-01222 Jacobs Street Cambridge MA US 02141

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
12271177303896K991671HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEMIYO1999-06-18
3006281177303896K991671HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEMIYO1999-06-18
12271326600785K990339SONOS 5500 IMAGING SYSTEM M2424A VERSION B.OIYN1999-02-18
3006281326600785K990339SONOS 5500 IMAGING SYSTEM M2424A VERSION B.OIYN1999-02-18
12271685485643K944048ULTRASOUND 77030 IMAGING SYSTEMIYN1995-03-01
12271561022621K253595EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemIYN2026-03-27
12421561022621K253595EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemIYN2026-03-27
12271916306450K252557Lumify Diagnostic Ultrasound SystemIYN2025-12-22
12421916306450K252557Lumify Diagnostic Ultrasound SystemIYN2025-12-22
3006281916306450K252557Lumify Diagnostic Ultrasound SystemIYN2025-12-22
12271326358187K251651EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemIYN2025-10-09
12421326358187K251651EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemIYN2025-10-09
12271290736422K251455EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemIYN2025-07-24
12421290736422K251455EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemIYN2025-07-24
12272073419848K251110EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsIYN2025-05-09
12422073419848K251110EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsIYN2025-05-09
12271095885118K250886EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsIYN2025-06-18
12421095885118K250886EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsIYN2025-06-18
12271183559055K250177EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemIYN2025-04-10
12421183559055K250177EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemIYN2025-04-10
12271734786918K250030Flash Ultrasound System 5100 Point of CareIYN2025-04-28
12271733822071K243794EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemIYN2025-02-06
12421733822071K243794EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemIYN2025-02-06
12271973406234K243793EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemIYN2025-05-21
12421973406234K243793EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemIYN2025-05-21
12271725203696K243331LVivo SeamlessQIH2025-03-06
12271476223281K242800The 5000 Compact Series Ultrasound SystemsIYN2024-11-15
12421476223281K242800The 5000 Compact Series Ultrasound SystemsIYN2024-11-15
12271002933266K242670Lumify Diagnostic Ultrasound SystemIYN2025-05-08
12421002933266K242670Lumify Diagnostic Ultrasound SystemIYN2025-05-08
3006281002933266K242670Lumify Diagnostic Ultrasound SystemIYN2025-05-08
12272023505101K242519Lumify Diagnostic Ultrasound SystemIYN2025-05-15
12422023505101K242519Lumify Diagnostic Ultrasound SystemIYN2025-05-15
3006282023505101K242519Lumify Diagnostic Ultrasound SystemIYN2025-05-15
12271110401506K242020EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemIYN2024-12-12
12421110401506K242020EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemIYN2024-12-12
12271380672905K241659Ultrasound Workspace (UWS 6.0)QIH2025-02-10
12271284232681K240980EPIQ Series Diagnostic Ultrasound SystemIYN2024-10-07
12272018424886K240850EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsIYN2024-04-24
3006282018424886K240850EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsIYN2024-04-24
12271481221983K233788EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemIYN2024-02-13
3006281481221983K233788EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemIYN2024-02-13
12271963741387K233545EPIQ Series Diagnostic Ultrasound SystemIYN2023-11-30
12421963741387K233545EPIQ Series Diagnostic Ultrasound SystemIYN2023-11-30
3006281963741387K233545EPIQ Series Diagnostic Ultrasound SystemIYN2023-11-30
12271139344084K232500Lumify Diagnostic Ultrasound SystemIYN2023-10-26
12421139344084K232500Lumify Diagnostic Ultrasound SystemIYN2023-10-26
3006281139344084K232500Lumify Diagnostic Ultrasound SystemIYN2023-10-26
12271465817488K231190EPIQ Series Diagnostic Ultrasound SystemIYN2023-05-12
3006281465817488K231190EPIQ Series Diagnostic Ultrasound SystemIYN2023-05-12
12271001162419K223804PercuNav Image Fusion and Interventional Navigation SystemJAK2023-01-18
3006281001162419K223804PercuNav Image Fusion and Interventional Navigation SystemJAK2023-01-18
12271062981624K223771Lumify Diagnostic Ultrasound SystemIYN2023-05-04
12421062981624K223771Lumify Diagnostic Ultrasound SystemIYN2023-05-04
3006281062981624K223771Lumify Diagnostic Ultrasound SystemIYN2023-05-04
12271729933378K2226485000 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)IYN2022-09-27
3006281729933378K2226485000 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)IYN2022-09-27
12271177659823K213544TOMTEC-ARENAQIH2022-01-06
12271314722734K212777Collaboration LiveLLZ2021-09-24
3006281314722734K212777Collaboration LiveLLZ2021-09-24
12271458250520K212704Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound SystemIYN2021-09-24
3006281458250520K212704Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound SystemIYN2021-09-24
12271344587417K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemIYN2021-09-08
12421344587417K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemIYN2021-09-08
3006281344587417K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemIYN2021-09-08
12271112735061K203406Lumify Diagnostic Ultrasound SystemIYN2021-02-23
12421112735061K203406Lumify Diagnostic Ultrasound SystemIYN2021-02-23
3006281112735061K203406Lumify Diagnostic Ultrasound SystemIYN2021-02-23
12271856288179K202216EPIQ Series Diagnostic Ultrasound SystemsIYN2020-09-02
12421856288179K202216EPIQ Series Diagnostic Ultrasound SystemsIYN2020-09-02
3006281856288179K202216EPIQ Series Diagnostic Ultrasound SystemsIYN2020-09-02
12271356270618K201665Collaboration LiveLLZ2020-09-15
3006281356270618K201665Collaboration LiveLLZ2020-09-15
12271181615785K201632TOMTEC-ARENALLZ2020-08-14
12271281850111K2013523D Auto LAALLZ2020-08-17
3006281281850111K2013523D Auto LAALLZ2020-08-17
12271738063504K201053PercuNav Image Fusion and Interventional NavigationJAK2020-05-14
3006281738063504K201053PercuNav Image Fusion and Interventional NavigationJAK2020-05-14
12271591389388K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound SystemIYN2020-05-01
12421591389388K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound SystemIYN2020-05-01
3006281591389388K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound SystemIYN2020-05-01
12271988380984K200974QLAB Advanced Quantification SoftwareQIH2020-06-03
3006281988380984K200974QLAB Advanced Quantification SoftwareQIH2020-06-03
12272001696745K200603AAA ModelLLZ2020-09-20
3006282001696745K200603AAA ModelLLZ2020-09-20
12271138288257K200304EPIQ Diagnostic Ultrasound SystemIYN2020-03-06
3006281138288257K200304EPIQ Diagnostic Ultrasound SystemIYN2020-03-06
12271193374191K200179Collaboration LiveLLZ2020-02-18
3006281193374191K200179Collaboration LiveLLZ2020-02-18
12271207277983K192226Lumify Diagnostic Ultrasound SystemIYN2019-09-06
12421207277983K192226Lumify Diagnostic Ultrasound SystemIYN2019-09-06
3006281207277983K192226Lumify Diagnostic Ultrasound SystemIYN2019-09-06
12271701408985K191647QLAB Advanced Quantification SoftwareQIH2019-12-20
3006281701408985K191647QLAB Advanced Quantification SoftwareQIH2019-12-20
12272000658651K190913QLAB Advanced Quantification Software 13LLZ2019-06-18
3006282000658651K190913QLAB Advanced Quantification Software 13LLZ2019-06-18
12271987703575K182857EPIQ 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 SystemIYN2018-11-09
12421987703575K182857EPIQ 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 SystemIYN2018-11-09
3006281987703575K182857EPIQ 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 SystemIYN2018-11-09
12271876290552K182529
12421876290552K182529
3006281876290552K182529
12271000785157K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound SystemIYN2018-07-27
12421000785157K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound SystemIYN2018-07-27
3006281000785157K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound SystemIYN2018-07-27
12271049533428K181264QLAB Advanced Quantification SoftwareLLZ2018-06-07
3006281049533428K181264QLAB Advanced Quantification SoftwareLLZ2018-06-07
12271992450528K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound SystemIYN2017-10-04
12421992450528K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound SystemIYN2017-10-04
3006281992450528K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound SystemIYN2017-10-04
12271496891241K172056InnoSight Diagnostic Ultrasound SystemIYO2017-12-13
12271330096492K171314QLAB Advanced Quantification SoftwareLLZ2017-05-30
3006281330096492K171314QLAB Advanced Quantification SoftwareLLZ2017-05-30
12271734113842K170716PercuNav Image Fusion and Interventional NavigationJAK2017-04-21
3006281734113842K170716PercuNav Image Fusion and Interventional NavigationJAK2017-04-21
12271219284102K163120EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50 Diagnostic Ultrasound System; Affiniti 70 Diagnostic Ultrasound SystemIYN2017-01-10
12421219284102K163120EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50 Diagnostic Ultrasound System; Affiniti 70 Diagnostic Ultrasound SystemIYN2017-01-10
3006281219284102K163120EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50 Diagnostic Ultrasound System; Affiniti 70 Diagnostic Ultrasound SystemIYN2017-01-10
12271590997478K163020Xperius Ultrasound SystemIYN2016-11-16
12421590997478K163020Xperius Ultrasound SystemIYN2016-11-16

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IYN1442026-03-27
LLZ212021-09-24
JAK82023-01-18
QIH72025-03-06
ITX72009-07-17
IYO62017-12-13

PMN#

59 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next