DDRCOMBI TRAUMA— 510(k) K050718

Substantially Equivalent

Swissray International, Inc.

FDA 510(k) clearance K050718 for DDRCOMBI TRAUMA, Substantially Equivalent on 2005-05-26. Applicant: Swissray International, Inc.. Device class: 2.

Clearance details

Applicant: Swissray International, Inc.
Product code: Code MQB
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2005-03-21
Decision date: 2005-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elizabeth, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MQB

K253800 — 0909FCE, 0909FCE-HS2026-07-31
K260820 — VIVIX-S 4386W (FXRD-4386WA)2026-06-18
K252996 — Universal 1417PI2026-06-12
K252911 — Lux HD 2530 detector (Lux HD 2530)2025-10-09
K250211 — Yushan X-Ray Flat Panel Detector2025-07-22

More clearances from Swissray International, Inc.

K070678 — DDRCOMPACT, DDRCOMPACT PLUS AND DDRCOMPACT CHEST2007-05-02
K973710 — DIGITAL ADD ON MULTI SYSTEM1997-12-18

Recalls naming K050718

K-number listed on FDA's recall record

Z-0697-2019 — ddRCombi Plus FP, Model Number 8.2000.0070.0 (US Version), 8.2000.0060.0 (Europe Version) The ddRCombi Plus FP is a fully digital, multifunctional X-ray system that allows the direct digitization of X-ray information without use of cassettes or other media. It can perform all applications in orthopedics and trauma as well as pulmonary imaging.Class II·Terminated·Swissray Medical AG·20181114

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K050718.

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