Siemens Healthineers Ltd.

FDA Device Registration & Listing · SEONGNAM-SI Gyeonggi, KR · Registration 3002619337

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3002619337
FEI Number
3002619337
Entity Name
Siemens Healthineers Ltd.
City/State/Country
SEONGNAM-SI Gyeonggi, KR
Establishment Address
6 & 7 FI., Bundang First Tower, 55, Bundang-ro, Bundang-gu, SEONGNAM-SI Gyeonggi 13591, KR
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
SIEMENS MEDICAL SOLUTIONS USA, INC. (Owner Number: 9002915)
Owner / Operator Contact Address
40 Liberty Boulevard, Malvern, PA 19355, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K253457
PMA Number
N/A

All Registered Proprietary Names

ACUSON Juniper Diagnostic Ultrasound System ACUSON Juniper Select Diagnostic Ultrasound System ACUSON Redwood Ultrasound System ACUSON NX3 Elite Diagnostic Ultrasound System ACUSON NX3 Diagnostic Ultrasound System ACUSON SC2000 Diagnostic Ultrasound System ACUSON Origin ICE Diagnostic Ultrasound System ACUSON Origin Diagnostic Ultrasound System ACUSON Sequoia Diagnostic Ultrasound System ACUSON Sequoia Select Diagnostic Ultrasound System ACUSON Maple Diagnostic Ultrasound System ACUSON Maple Select Diagnostic Ultrasound System ACUSON P500 Ultrasound System ACUSON P500 ICE Ultrasound System ACUSON NX2 Diagnostic Ultrasound System ACUSON NX2 Elite Diagnostic Ultrasound System ACUSON Juniper Select Diagnostic Ultrasound System ACUSON Juniper Diagnostic Ultrasound System ACUSON Maple Diagnostic Ultrasound System ACUSON Maple Select Diagnostic Ultrasound System ACUSON Juniper Diagnostic Ultrasound System ACUSON Origin ICE Diagnostic Ultrasound System ACUSON Sequoia Diagnostic Ultrasound System ACUSON Origin Diagnostic Ultrasound System ACUSON Sequoia Select Diagnostic Ultrasound System ACUSON Juniper Diagnostic Ultrasound System ACUSON Juniper Select Diagnostic Ultrasound System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OIJ Biopsy Needle Guide Kit Radiology Class 2 892.1560 2023-03-01
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2023-03-01
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2023-03-01
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2023-03-01
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2021-05-26
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2021-05-26
OIJ Biopsy Needle Guide Kit Radiology Class 2 892.1560 2021-05-26
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2021-05-26
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2019-10-24
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2019-10-24
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2019-10-24
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2024-06-13
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2024-06-13
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2024-06-13
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2024-06-13
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2024-06-13
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2024-07-23
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2024-07-23
OIJ Biopsy Needle Guide Kit Radiology Class 2 892.1560 2024-07-23
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2024-07-23
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2024-07-23
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2024-07-23
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2023-09-28
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2023-09-28
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2023-09-28
OIJ Biopsy Needle Guide Kit Radiology Class 2 892.1560 2023-09-28
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2024-06-13
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2024-06-13
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2024-06-13
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2024-06-13
OIJ Biopsy Needle Guide Kit Radiology Class 2 892.1560 2024-06-13
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2018-02-02
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2018-02-02
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2018-02-02
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2022-08-22
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2022-08-22
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2022-08-22
OIJ Biopsy Needle Guide Kit Radiology Class 2 892.1560 2022-08-22
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2025-11-21
OIJ Biopsy Needle Guide Kit Radiology Class 2 892.1560 2025-11-21
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2025-11-21
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2025-11-21
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2020-05-27
OIJ Biopsy Needle Guide Kit Radiology Class 2 892.1560 2020-05-27
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2020-05-27
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2020-05-27
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2024-11-20
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2024-11-20
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2024-11-20
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2024-11-20
OIJ Biopsy Needle Guide Kit Radiology Class 2 892.1560 2024-11-20
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2024-11-20
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2025-11-20
OIJ Biopsy Needle Guide Kit Radiology Class 2 892.1560 2025-11-20
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2025-11-20
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2025-11-20

Official Correspondent

No official correspondent registered.

US Agent Details

Zhengbin Xu Business: Siemens Medical Solutions USA, Inc. Email: zhengbin.xu@siemens-healthineers.com Phone: (425) 2418272

Related Public Records

Same Entity

SIEMENS MEDICAL SOLUTIONS USA, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
1836549 SIEMENS MEDICAL SOLUTIONS USA, INC. ANN ARBOR, MI, US
3012127758 Siemens Healthcare Limited Oakville Ontario, CA
2531814 Siemens Medical Solutions USA, Inc. Plymouth Meeting, PA, US
1034973 SIEMENS MEDICAL SOLUTIONS USA, INC. KNOXVILLE, TN, US
3014745562 Siemens Healthcare s.r.o. Kosice-Barca Kosicky, SK

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K951723 GE Medical Systems GE B510 TRANSDUCER 1995-11-14
K903562 Diasonics, Inc. CW DOPPLER 2.25 MHZ PROBE 1992-03-02
K945318 Tetra Corp. TETRAD MODEL 6F, END-VIEWING, ENDOCAVITY PROBE, 4.5/8.5 MHZ, CA 1995-05-05
K231666 FUJIFILM Healthcare Americas Corporation Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) 2023-12-13
K191007 Supersonic Imagine Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems 2019-10-25

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0009-2022 DJO, LLC 2
GEL CONDUCTOR, Description/REF: 5 LITER W/DISP/4238, 24-8.5OZ BOTTLES/4248, 5 LITER/4266, distributed by DJO, LLC / DJO FRANCE in the following kits, Part/Description: 2073/ INTELECT RPW 120V, 2073-BR/ INTELECT RPW 120V BRAZIL, 2074/ INTELECT RPW 230 V, 2082/ INTELECT RPW 100 V, 2760/ INTELECT LEGEND XT COMBOUS STD, 2791/ INTELECT LEGEND XT COMBO US STD W/CART, 2782-10/ INTELECT TRANSPORT US STD, 2782-2/ INTELECT TRANSPORT US STD, 2843/ INTELECT VET 4CH COMBO PKG, 2845K/ KIT INTELECT VET 4CH COMBO PKG, 2863/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 5CM, 2863-10/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 10CM APPL, 2863-2/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 2CM APPL, 2864/ SENIOR SOLUTIONS 4CH COMBO PKG US STD, 2761/ VECTRA GENISYS 2CH COMBO PKG US STD 5CM APPL, 2792/ VECTRA GENISYS 2CH COMBO US STD W/CART, 2761-10/ VECTRA GENISYS 2CH COMBO PKG US STD 10CM APPL, 2761-2/ VECTRA GENISYS 2CH COMBO PKG US STD 2CM APPL, 2762CC/ INT ADV 2CH COLOR COMBO INT'L 5CM APPL, 2762CC-10/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 10CM APPL, 2762CC-2/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 2CM APPL, 2788/ LEGEND XT 4CH COMBO PKG US STD 5CM APPL, 2795/ INTELECT XT 4CH COMBO US STD 5CM APPL W/CART, 2788-10/ LEGEND XT 4CH COMBO PKG US STD 10CM APPL, 2795-10/ INTELECT XT4CH COMBO US STD 10CM APPL, 2788-2/ LEGEND XT 4CH COMBO PKG US STD 2CM APPL, 2795-2/ INTELECT XT 4CH COMBO US STD 2CM APPL, 2789/ VECTRA GENISYS 4CH COMBO PKG US 5CM APPL, 2796/ VECTRA GENISYS 4CH COMBO US STD W/CART, 2796K/ KIT VECTRA GENISYS 4CH COMBO P, 2789-10/ VECTRA GENISYS 4CH COMBO PKG US STD 10CM APPL, 2796-10/ VECTRA GENISYS 4CH COMBO US US STD 10CM APPL, 2789-2/ VECTRA GENISYS 4CH COMBO PKG US STD 2CM APPL, 2796-2/ VECTRA GENISYS 4CH COMBO US STD 2CM APPL, 2738/ INTELECT TRANSPORT COMBO PKG US STD, 8250KP/ KIT TRITON DTS PROMO, 6001/ INTELECT NEO, 2738-10/ INTELECT TRANSPORT COMBO PKG US STD, 2738-2/ INTELECT TRANSPORT COMBO PKG US STD, 2772MC/ INT ADVANCED COMBO MONOCHROMEINT'L STD, 2776/ INTELECT MOBILE INT'L STD 5CM APPL, 27800/ ULTRASOUND ON CART, 2776-BR/ INTELECT MOBILE INTL STD 5CM APPL BRAZIL, 2776-10/ INT MOBIL INT'L STD 10CM APPL, 2776-2/ INT MOBILE INT'L STD 2CM APPL, 2778/ INTELECT MOBILE COMBO INT'L STD 5CM APPL, 2778-10/ INTELECT MOBILE COMBO INT'L STD 10CM APPL, 2778-2/ INTELECT MOBILE COMBO INT'L STD 2CM APPL, 2752CC/ INT ADV 2CH COLOR COMBO INT'L STD, 2756/ INTELECT VET 2CH COMBO PKG INT'L STD, 2844K/ KIT INTELECT VET 2CH COMBO PKG, 2782/ INTELECT TRANSPORT US STD, 2895K/ KIT CART ADAPT BL W/CT/SPEC US, 2872/ VECTRA GEN 2C COMBO W/O EMG PK US STD, 2876/ VECTR GEN 2C COMBO W/O EMG US STD W/CART, 2874/ VECTRA GEN 4C COMBO W/O EMG PK US STD, 2878/ VECTR GEN 4C COMBO W/O EM US STD W/CART, 7550/ INT LEGEND COMBO 4C US STD, INT001/ INTELECT LEGEND ULTRASOUND US STD, INTC B/ INT CB PKGD US STD, 39-0701/ DIRECT SUPPLY PANACEA VECTRA 2-CHNL ULTRASOUND/ESTIM COMBO, 39-0702/ DIRECT SUPPLY PANACEA VECTRA 4-CHNL ULTRASOUND/ESTIM COMBO, 13-4248/ GEL CONDUCTOR 24-8.5OZ BOTTLES, 15-1200/ INTELECT MOBILE 2 ULTRASOUND INTL SET EU PLUG, 15-1201/ INTELECT MOBILE 2 ULTRASOUND INTL SET ALL PLUGS, 15-1204/ INTELECT MOBILE 2 COMBO INTL SET EU PLUG, 15-1205/ INTELECT MOBILE 2 COMBO INTL SET ALL PLUGS, 2173KIT/ INTELECT RPW 2 120V INTERNATIONAL KIT US PLUG, 2174KIT/ INTELECT RPW 2 230V KIT EU PLUG, 2175KIT/ INTELECT RPW 2 100V KIT JPN PLUG, 2176KIT/ INTELECT RPW 2 120V USA KIT, 12-2756-1/ INTELECT VET 2CH COMBO PKG INTL STD, 2756K/ KIT INTELECT VET 2CH COMBO PKGUS STD, 70002/ NEO MODULE ULTRASOUND
Z-0010-2022 DJO, LLC 2
Ultra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossage Lotion 1-gallon bottle, REF: 4210, located in the following DJO, LLC / DJO FRANCE kits:
Z-0029-2022 Aesthetics Systems Usa Inc 2
Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue.
Z-0038-2026 ImaCor Inc. 2
ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH.
Z-0189-2022 FujiFilm Healthcare Americas Corporation 2
Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002619337. Last updated year: 2026. Please use registration number 3002619337 when referencing this establishment in official correspondence.
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