Data / Medical devices / Sweden / Exini Diagnostics AB
Exini Diagnostics AB: FDA-registered device maker in LUND Skane, Sweden, 2 510(k) clearances
Exini Diagnostics AB is registered with the FDA (registration 3010146120) in LUND Skane, Sweden. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated April 29, 2022. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3010146120
- Address
- Ideon Science Park Scheelevagen 27, LUND Skane, Sweden, SE-223 70
- Owner or operator
- EXINI Diagnostics AB (10042079)
- Roles
- Manufacturer
- First device listed
- October 4, 2019
- Registered through
- 2027
- Brand names listed
- EXINI Bone, aBSI, aPROMISE
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 |
|---|---|---|---|---|---|---|
| April 29, 2022 | K220590 | aPROMISE X | LLZ | Substantially Equivalent | Exini Diagnostics AB | accessdata.fda.gov |
| August 5, 2019 | K191262 | aBSI | LLZ | Substantially Equivalent | Exini Diagnostics AB | accessdata.fda.gov |
Compare with other makers
Updated April 29, 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.