Data / Medical devices / Israel / Elsmed Ltd.
Elsmed Ltd.: FDA-registered device maker in Petah Tikva Central, Israel, 1 510(k) clearance
Elsmed Ltd. is registered with the FDA (registration 3008447096) in Petah Tikva Central, Israel. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 10, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008447096
- Address
- 20 Hamagshimim Street Kiryat Matalon, Petah Tikva Central, Israel, 49250
- Owner or operator
- Elsmed Ltd. (10034154)
- Roles
- Exporter to the US
- First device listed
- February 17, 2022
- Registered through
- 2026
- Brand names listed
- Achieva, Ingenia, Intera
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Nuclear Magnetic Resonance Imaging | LNH | 2 | Exporter to the US | accessdata.fda.gov |
| System, Nuclear Magnetic Resonance Spectroscopic | LNI | 2 | Exporter to the US | 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 |
|---|---|---|---|---|---|---|
| April 10, 2020 | K193215 | Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR Systems | LNH | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Nuclear Magnetic Resonance Imaging
- All makers of System, Nuclear Magnetic Resonance Spectroscopic
Updated April 10, 2020. 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.