Data / Medical devices / United Kingdom / Mirada Medical Limited
Mirada Medical Limited: FDA-registered device maker in Oxford (UK) Oxfordshire, United Kingdom, 4 510(k) clearances
Mirada Medical Limited is registered with the FDA (registration 3007697958) in Oxford (UK) Oxfordshire, United Kingdom. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated April 15, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007697958
- Address
- New Barclay House 234 Botley Road, Oxford (UK) Oxfordshire, United Kingdom, OX2 0HP
- Owner or operator
- Mirada Medical Limited (10028869)
- Roles
- Manufacturer
- First device listed
- November 23, 2011
- Registered through
- 2026
- Brand names listed
- Aline Ablation Intelligence, DBx, RTx, Simplicit90Y, XD, XD4
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Medical Device Data System | OUG | 1 | Manufacturer | accessdata.fda.gov |
| 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 15, 2022 | K220779 | XD | LLZ | Substantially Equivalent | Mirada Medical, Ltd. | accessdata.fda.gov |
| September 11, 2020 | K202297 | Aline Ablation Intelligence | LLZ | Substantially Equivalent | Mirada Medical, Ltd. | accessdata.fda.gov |
| December 6, 2018 | K182016 | Simplicit90Y | LLZ | Substantially Equivalent | Mirada Medical, Ltd. | accessdata.fda.gov |
| March 20, 2013 | K130393 | MIRADA RTX | LLZ | Substantially Equivalent | Mirada Medical, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated April 15, 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.