Data / Medical devices / Germany / Neoscan Solutions GMBH
Neoscan Solutions GMBH: FDA-registered device maker in Magdeburg Saxony-Anhalt, Germany, 1 510(k) clearance
Neoscan Solutions GMBH is registered with the FDA (registration 3033536331) in Magdeburg Saxony-Anhalt, Germany. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated July 22, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3033536331
- Address
- Joseph-von-Fraunhofer-Str. 6, Magdeburg Saxony-Anhalt, Germany, 39106
- Owner or operator
- Neoscan Solutions GmbH (10091656)
- Roles
- Complaint file establishment, Exporter to the US, Manufacturer
- First device listed
- October 22, 2024
- Registered through
- 2027
- Brand names listed
- neo315
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Nuclear Magnetic Resonance Imaging | LNH | 2 | Complaint file establishment, Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| July 22, 2024 | K231133 | neo315 | LNH | Substantially Equivalent | Neoscan Solution GmbH | accessdata.fda.gov |
Compare with other makers
Updated July 22, 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.