DDRCRUZE (DIGITAL MOBILE DIAGNOSTIC X-RAY SYSTEM)— 510(k) K131314

Name: FDA 510(k) clearance K131314
Creator: U.S. Food and Drug Administration
Published: 2013-06-25

Substantially Equivalent

Swissray Medical AG

FDA 510(k) clearance K131314 for DDRCRUZE (DIGITAL MOBILE DIAGNOSTIC X-RAY SYSTEM), Substantially Equivalent on 2013-06-25. Applicant: Swissray Medical AG. Device class: 2.

Clearance details

Applicant: Swissray Medical AG
Product code: Code MQB
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2013-05-07
Decision date: 2013-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hochdorf, CH

Download summary PDF View on FDA.gov ↗

Recent devices under product code MQB

view all

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 Medical AG

view all

K123005 — DDRVERSA MOTION2012-12-07
K110828 — DDRELEMENT2011-08-23
K052943 — DDRFORMULA AND DDRFORMULA PLUS2005-12-15

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