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Visaris D.O.O.: FDA-registered device maker in Zemun Beograd, Serbia, 2 510(k) clearances

Name: Visaris D.O.O. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Visaris D.O.O. is registered with the FDA (registration 3012569470) in Zemun Beograd, Serbia. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 30, 2016. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3012569470
Address: Batajnicki drum 10. deo 1B, Zemun Beograd, Serbia, 11080
Owner or operator: Visaris d.o.o. (10051372)
Roles: Manufacturer, Repackager or relabeler
First device listed: March 8, 2016
Registered through: 2027
Brand names listed: Avanse, Avanse DR, LuminX DR Retrofit, LuminX FMTS, LuminX Overhead, LuminX Overhead Auto, LuminX Straight Arm, LuminX U-Arm Auto and more

Devices it lists

Device	Product code	Class	Role	Source
System, Image Processing, Radiological	LLZ	2	Manufacturer	accessdata.fda.gov
System, X-Ray, Stationary	KPR	2	Manufacturer	accessdata.fda.gov
Table, Radiographic, Non-Tilting, Powered	IZZ	2	Repackager or relabeler	accessdata.fda.gov
Table, Radiographic, Stationary Top	IXQ	2	Manufacturer	accessdata.fda.gov
Tube Mount, X-Ray, Diagnostic	IYB	1	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 8, 2015	K150725	Visaris Avanse	KPR	Substantially Equivalent	Visaris D.O.O. Belgrade	accessdata.fda.gov

Recalls

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

Initiated	Event	Class	Status	Product	Reason	Source
April 5, 2018	79848	Class II	Terminated	Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.2 The Vision systems are intended for use in all areas of diagnostic radiography imaging and specifically at secondary and tertiary levels of medic	A failure of the tube arm suspension is possible while the tube arm height is being adjusted. During tube height adjustment there is a small probability of failure of both the primary and redundant holding mechanisms, causing uncontrollable descent of the tube arm and a potential risk of injury to the patient.	accessdata.fda.gov

Compare with other makers

Updated March 30, 2016. 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.