Adora DRFi (04550010)— 510(k) K242948

Substantially Equivalent

Nrt X-Ray A/S

FDA 510(k) clearance K242948 for Adora DRFi (04550010), Substantially Equivalent on 2024-12-23. Applicant: Nrt X-Ray A/S.

Clearance details

Applicant: Nrt X-Ray A/S
Product code: Code JAA
Advisory panel: Radiology
Date received: 2024-09-25
Decision date: 2024-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hasselager, DK

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.