DX-D FULL LEG FULL SPINE— 510(k) K122119

Substantially Equivalent

Afga Healthcare N.V.

FDA 510(k) clearance K122119 for DX-D FULL LEG FULL SPINE, Substantially Equivalent on 2012-09-13. Applicant: Afga Healthcare N.V..

Clearance details

Applicant: Afga Healthcare N.V.
Product code: Code KPR
Advisory panel: Radiology
Date received: 2012-07-17
Decision date: 2012-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brevard, NC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KPR

product code KPR

Other: 6
Total: 6

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.