Data / Medical devices / Switzerland / SWISSRAY Medical, AG

SWISSRAY Medical, AG: FDA-registered device maker in HOCHDORF Luzern, Switzerland, 4 510(k) clearances

Name: SWISSRAY Medical, AG FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

SWISSRAY Medical, AG is registered with the FDA (registration 9614430) in HOCHDORF Luzern, Switzerland. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated March 30, 2016. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 9614430
FEI number: 3002143662
Address: Turbistrasse 25-27, HOCHDORF Luzern, Switzerland, CH 6280
Owner or operator: Swissray Medical AG (9003721)
Roles: Complaint file establishment, Repackager or relabeler
First device listed: March 25, 2008
Registered through: 2026
Brand names listed: ddRCruze, ddRCruze Plus, ddRElement, ddRFormula, ddRFormula Plus, ddrAura (TM) Series

Devices it lists

Device	Product code	Class	Role	Source
Solid State X-Ray Imager (Flat Panel/Digital Imager)	MQB	2	Complaint file establishment	accessdata.fda.gov
System, X-Ray, Mobile	IZL	2	Complaint file establishment	accessdata.fda.gov
System, X-Ray, Stationary	KPR	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
March 30, 2016	K160620	Visaris Vision® (Vision C, Vision U. Vision V, Vision X)	KPR	Substantially Equivalent	Visaris D.O.O. Belgrade	accessdata.fda.gov
June 25, 2013	K131314	DDRCRUZE (DIGITAL MOBILE DIAGNOSTIC X-RAY SYSTEM)	MQB	Substantially Equivalent	Swissray Medical AG	accessdata.fda.gov
August 23, 2011	K110828	DDRELEMENT	KPR	Substantially Equivalent	Swissray Medical AG	accessdata.fda.gov
December 15, 2005	K052943	DDRFORMULA AND DDRFORMULA PLUS	KPR	Substantially Equivalent	Swissray Medical AG	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
November 14, 2018	81749	Class II	Terminated	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 wit	A component of the device was recalled by a supplier. In rare cases of inadequate maintenance or very high clinical workload, the first steel wire rope of the lifting column, which is designed to take the load, can break without triggering the safety lock. This can lead to overloading of the safety cable, which is not designed to permanently carry the load o	accessdata.fda.gov

Compare with other makers

Updated January 8, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.