ELSMED LTD.

FDA Device Registration & Listing · Petah Tikva Central, IL · Registration 3008447096

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
3008447096
FEI Number
3008447096
Entity Name
ELSMED LTD.
City/State/Country
Petah Tikva Central, IL
Establishment Address
20 Hamagshimim Street, Kiryat Matalon, Petah Tikva Central 49250, IL
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
Elsmed Ltd. (Owner Number: 10034154)
Owner / Operator Contact Address
20 Hamagshimim Street, Kiryat Matalon, Petah Tikva, IL-NOTA 49250, IL
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K193215
PMA Number
N/A

All Registered Proprietary Names

Achieva Intera Ingenia

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2022-02-17
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2022-02-17

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Elsmed Ltd.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K033504 General Electric Co. GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM 2003-11-25
K013636 GE Medical Systems SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY 2002-01-24
K250443 Siemens Healthcare GmbH MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile 2025-06-16
K151015 Hitachi Medical Systems America, Inc. ECHELON Oval V 5.0 MRI System 2015-07-29
K910715 Philips Medical Systems (Cleveland), Inc. VISTA HPQ SYSTEM 1991-06-07

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0459-2023 Philips North America Llc 2
Philips Ingenia Elition S MR System, Model Numbers 781357, 782106, 782137
Z-0460-2023 Philips North America Llc 2
Philips Ingenia Elition X MR System, Model Numbers 781358, 782107, 782119, 782136
Z-0461-2023 Philips North America Llc 2
Philips SmartPath to Ingenia Elition X MR System, Model Numbers 782118, 782132, 782144
Z-0462-2023 Philips North America Llc 2
Philips MR 7700 System, Model Number 782120
Z-0463-2023 Philips North America Llc 2
Philips Upgrade to MR 7700 System, Model Number 782130

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008447096. Last updated year: 2026. Please use registration number 3008447096 when referencing this establishment in official correspondence.
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