Blackford Analysis Registration Product Family— 510(k) K142337

Substantially Equivalent

Blackford Analysis, Ltd.

FDA 510(k) clearance K142337 for Blackford Analysis Registration Product Family, Substantially Equivalent on 2015-03-19. Applicant: Blackford Analysis, Ltd..

Clearance details

Applicant: Blackford Analysis, Ltd.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2014-08-21
Decision date: 2015-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Edinburgh, Midlothian, GB

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Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.