Data / Medical devices / United Kingdom / Blackford Analysis Ltd
Blackford Analysis Ltd: FDA-registered device maker in EDINBURGH Midlothian, United Kingdom, 1 510(k) clearance
Blackford Analysis Ltd is registered with the FDA (registration 3011713193) in EDINBURGH Midlothian, United Kingdom. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 19, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011713193
- Address
- 160 Causewayside, EDINBURGH Midlothian, United Kingdom, EH9 1PR
- Owner or operator
- Blackford Analysis (10049370)
- Roles
- Manufacturer
- First device listed
- May 19, 2015
- Registered through
- 2026
- Brand names listed
- Blackford Accept Reject Tool, Blackford Analysis Registration Product Family, Blackford Platform & Blackford Smart Localizer, Blackford Product Family
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Digital Image Communications, Radiological | LMD | 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 |
|---|---|---|---|---|---|---|
| March 19, 2015 | K142337 | Blackford Analysis Registration Product Family | LLZ | Substantially Equivalent | Blackford Analysis, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Digital Image Communications, Radiological
- All makers of System, Image Processing, Radiological
Updated March 19, 2015. 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.