Data / Medical devices / Sweden / Medviso AB
Medviso AB: FDA-registered device maker in Lund Skane, Sweden, 3 510(k) clearances
Medviso AB is registered with the FDA (registration 3008962159) in Lund Skane, Sweden. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated May 6, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008962159
- Address
- Griffelvagen 3, Lund Skane, Sweden, 224 67
- Owner or operator
- Medviso AB (10035478)
- Roles
- Manufacturer
- First device listed
- March 1, 2011
- Registered through
- 2026
- Brand names listed
- SEGMENT CMR, Segment, Segment 3DPrint
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | 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 |
|---|---|---|---|---|---|---|
| May 6, 2022 | K211966 | Segment 3DPrint | LLZ | Substantially Equivalent | Medviso AB | accessdata.fda.gov |
| April 5, 2017 | K163076 | Segment CMR | LLZ | Substantially Equivalent | Medviso AB | accessdata.fda.gov |
| May 12, 2009 | K090833 | SEGMENT | LLZ | Substantially Equivalent | Medviso | accessdata.fda.gov |
Compare with other makers
Updated May 6, 2022. 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.