Data / Medical devices / System, Image Processing, Radiological / Sweden
FDA-registered makers of System, Image Processing, Radiological in Sweden: 7 establishments
7 establishments in Sweden are registered with the FDA to make System, Image Processing, Radiological (product code LLZ). 6 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- System, Image Processing, Radiological
- Product code
- LLZ
- Country
- Sweden
Makers of System, Image Processing, Radiological in Sweden
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Elekta Solutions AB | Stockholm, Sweden | Exporter to the US, Manufacturer | 13 | October 8, 2025 | 0 | 0 | 0 | api.fda.gov |
| Nobel Biocare AB | GOTEBORG Vastra Gotaland, Sweden | Specification developer | 7 | December 8, 2023 | 0 | 0 | 0 | api.fda.gov |
| Medviso AB | Lund Skane, Sweden | Manufacturer | 3 | May 6, 2022 | 0 | 0 | 0 | api.fda.gov |
| Exini Diagnostics AB | LUND Skane, Sweden | Manufacturer | 2 | April 29, 2022 | 0 | 0 | 0 | api.fda.gov |
| Sectra AB | LINKOPING Ostergotland, Sweden | Manufacturer | 2 | June 12, 2008 | 0 | 0 | 0 | api.fda.gov |
| Hermes Medical Solutions, AB | Stockholm, Sweden | Complaint file establishment, Manufacturer | 1 | October 17, 2019 | 0 | 0 | 0 | api.fda.gov |
| Syntheticmr AB | Linkoping Ostergotland, Sweden | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.