Data / Medical devices / Hungary / MEDISO Ltd..
MEDISO Ltd..: FDA-registered device maker in Budapest, Hungary, 1 510(k) clearance
MEDISO Ltd.. is registered with the FDA (registration 3003757027) in Budapest, Hungary. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated March 29, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003757027
- Address
- Laborc 3, Budapest, Hungary, 1037
- Owner or operator
- Mediso Ltd. (10044998)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- January 18, 2025
- Registered through
- 2026
- Brand names listed
- InterView FUSION, InterView XP
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| March 29, 2023 | K221984 | InterView XP; InterView FUSION | LLZ | Substantially Equivalent | Mediso Medical Imaging Systems, Lttd. | accessdata.fda.gov |
Compare with other makers
Updated March 29, 2023. 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.