Data / Medical devices / United Kingdom / Cirdan Imaging Limited
Cirdan Imaging Limited: FDA-registered device maker in Lisburn Antrim and Newtownabbey, United Kingdom, 2 510(k) clearances
Cirdan Imaging Limited is registered with the FDA (registration 3010478247) in Lisburn Antrim and Newtownabbey, United Kingdom. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 22, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010478247
- Address
- Riverbank The Green, Lisburn Antrim and Newtownabbey, United Kingdom, BT27 5SR
- Owner or operator
- Cirdan Imaging Limited (10045054)
- Roles
- Manufacturer
- First device listed
- September 23, 2013
- Registered through
- 2026
- Brand names listed
- CoreLite, SolasOR, ULTRA, ULTRA TM
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Blood Establishment Computer Software And Accessories | MMH | 2 | Manufacturer | accessdata.fda.gov |
| Cabinet, X-Ray System | MWP | 2 | Manufacturer | accessdata.fda.gov |
| Digital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System | NVV | 1 | 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 |
|---|---|---|---|---|---|---|
| December 22, 2021 | K213691 | Solas OR | MWP | Substantially Equivalent | Cirdan Imaging, Ltd. | accessdata.fda.gov |
| December 13, 2019 | K193317 | CoreLite X-Ray Specimen Cabinet | MWP | Substantially Equivalent | Cirdan Imaging Limited | accessdata.fda.gov |
Compare with other makers
- All makers of Digital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System
- All makers of Blood Establishment Computer Software And Accessories
- All makers of Cabinet, X-Ray System
Updated December 22, 2021. 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.