Adora DRFi (04550010)— 510(k) K242948

Name: FDA 510(k) clearance K242948
Creator: U.S. Food and Drug Administration
Published: 2024-12-23

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. Device class: 2.

Clearance details

Applicant: Nrt X-Ray A/S
Product code: Code JAA
Device class: Class 2
Regulation: 21 CFR 892.1650
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 ↗

Recent devices under product code JAA

view all

K253103 — Nexus DRF Digital X-ray Imaging System2026-05-29
K251650 — Insight Enhanced DRF (EN-1002-01)2025-09-16
K242488 — Soteria E-View2025-01-06
K233380 — TRIDENT Mobile Fluoroscopy System2024-06-26
K233945 — ProxiDiagnost N90 / Precision CRF (706110, 706400)2024-01-11

More clearances from Nrt X-Ray A/S

view all

K173631 — Intelli-C2018-07-11

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.