Data / Medical devices / Sweden / Syntheticmr AB
Syntheticmr AB: FDA-registered device maker in Linkoping Ostergotland, Sweden, 8 510(k) clearances
Syntheticmr AB is registered with the FDA (registration 3014111222) in Linkoping Ostergotland, Sweden. It lists 2 device types. The FDA files 8 510(k) clearances under its listings, the newest dated December 6, 2024. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3014111222
- Address
- Storgatan 11, Linkoping Ostergotland, Sweden, SE-582 23
- Owner or operator
- SyntheticMR AB (10056087)
- Roles
- Manufacturer
- First device listed
- November 5, 2017
- Registered through
- 2026
- Brand names listed
- SyMRI
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
| System, Nuclear Magnetic Resonance Imaging | LNH | 2 | Manufacturer | 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 6, 2024 | K242524 | SyMRI | LNH | Substantially Equivalent | Syntheticmr AB (Publ.) | accessdata.fda.gov |
| March 26, 2024 | K233733 | SyMRI | LNH | Substantially Equivalent | Syntheticmr AB (Publ.) | accessdata.fda.gov |
| November 3, 2021 | K203372 | SyMRI | LNH | Substantially Equivalent | Syntheticmr AB | accessdata.fda.gov |
| July 28, 2020 | K201616 | SyMRI | LNH | Substantially Equivalent | Syntheticmr AB | accessdata.fda.gov |
| June 13, 2019 | K191036 | SyMRI | LNH | Substantially Equivalent | Syntheticmr AB | accessdata.fda.gov |
| June 12, 2018 | K181093 | SyMRI | LNH | Substantially Equivalent | Syntheticmr AB | accessdata.fda.gov |
| January 26, 2018 | K173558 | SyMRI | LNH | Substantially Equivalent | Syntheticmr AB | accessdata.fda.gov |
| August 29, 2017 | K162943 | SyMRI | LNH | Substantially Equivalent | Syntheticmr AB | accessdata.fda.gov |
Compare with other makers
- All makers of System, Nuclear Magnetic Resonance Imaging
- All makers of System, Image Processing, Radiological
Updated December 6, 2024. 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.