DR 800 with DSA, DR 800— 510(k) K212145

Substantially Equivalent

Agfa N.V.

FDA 510(k) clearance K212145 for DR 800 with DSA, DR 800, Substantially Equivalent on 2021-08-31. Applicant: Agfa N.V..

Clearance details

Applicant: Agfa N.V.
Product code: Code JAA
Advisory panel: Radiology
Date received: 2021-07-09
Decision date: 2021-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mortsel, BE

Download summary PDF View on FDA.gov ↗

Adverse events under product code JAA

product code JAA

Other: 1
Total: 1

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.