Data / Medical devices / United States / Nview Medical

Nview Medical: FDA-registered device maker in Salt Lake City, UT, United States, 2 510(k) clearances

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

Nview Medical is registered with the FDA (registration 3016619943) in Salt Lake City, UT, United States. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 28, 2022. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3016619943
Address: 550 W 900 S Ste C, Salt Lake City, UT, United States, 84101
Owner or operator: nView medical (10083398)
Roles: Complaint file establishment, Manufacturer, Repackager or relabeler
First device listed: November 16, 2021
Registered through: 2026
Brand names listed: nView s1, nView s1 with nav option

Devices it lists

Device	Product code	Class	Role	Source
Image-Intensified Fluoroscopic X-Ray System, Mobile	OXO	2	Complaint file establishment, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Interventional Fluoroscopic X-Ray System	OWB	2	Complaint file establishment, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Orthopedic Stereotaxic Instrument	OLO	2	Complaint file establishment, Manufacturer, Repackager or relabeler	accessdata.fda.gov
System, X-Ray, Fluoroscopic, Image-Intensified	JAA	2	Complaint file establishment, Manufacturer, Repackager or relabeler	accessdata.fda.gov
System, X-Ray, Tomography, Computed	JAK	2	Complaint file establishment, Manufacturer, 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
December 28, 2022	K221344	nView s1 with nav option	OWB	Substantially Equivalent	Nview Medical	accessdata.fda.gov
October 29, 2021	K211064	nView s1 with nav option	OWB	Substantially Equivalent	Nview Medical	accessdata.fda.gov

Compare with other makers

Updated December 28, 2022. 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.