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Turner Imaging Systems, Inc.: FDA-registered device maker in Orem, UT, United States, 1 510(k) clearance

Name: Turner Imaging Systems, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Turner Imaging Systems, Inc. is registered with the FDA (registration 3013099020) in Orem, UT, United States. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 27, 2019. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3013099020
Address: 1119 S 1680 W, Orem, UT, United States, 84058
Owner or operator: Turner Imaging Systems (10061743)
Roles: Contract manufacturer, Manufacturer
First device listed: November 15, 2019
Registered through: 2026
Brand names listed: KyphoLift, Lumos 3DX, Smart-C

Devices it lists

Device	Product code	Class	Role	Source
Image-Intensified Fluoroscopic X-Ray System, Mobile	OXO	2	Manufacturer	accessdata.fda.gov
Platform, Force-Measuring	KHX	1	Contract manufacturer	accessdata.fda.gov
System, X-Ray, Fluoroscopic, Image-Intensified	JAA	2	Manufacturer	accessdata.fda.gov
Unit, X-Ray, Extraoral With Timer	EHD	2	Contract manufacturer	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
September 27, 2019	K190024	Smart-C	OXO	Substantially Equivalent	Turner Imaging Systems, Inc.	accessdata.fda.gov

Compare with other makers

Updated September 27, 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.