Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016619943

FEI Number

3016619943

Entity Name

NVIEW MEDICAL

City/State/Country

Salt Lake City, UT, US

Establishment Address

550 W 900 S Ste C, Salt Lake City, UT 84101, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

nView medical (Owner Number: 10083398)

Owner / Operator Contact Address

2681 E Parleys Way, STE 107, Salt Lake City, UT 84109, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K221344

PMA Number

N/A

All Registered Proprietary Names

nView s1 with nav option nView s1 nView s1 with nav option

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2021-11-16
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2021-11-16
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2021-11-16
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2021-11-16
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2021-11-16
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2022-12-30
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2022-12-30
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2022-12-30
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2022-12-30
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2022-12-30

Official Correspondent

Lisa Last

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

nView medical

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K260601	Blue Belt Technologies, Inc.	REAL INTELLIGENCE CORI	2026-03-26
K863853	Superior Medical Products	EAZY COVERS	1987-03-06
K953974	Medivision Medical Imaging, Ltd.	CAMVISION 1000	1996-09-09
K024012	Ge Oec Medical Systems	OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM	2003-03-20
K970608	Guidant Cardiac and Vascular Surgery	EVT MARKER BOARD	1997-04-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0041-2024	Blue Belt Technologies, Inc	2	Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299
Z-0001-2007	GE OEC Medical Systems, Inc	2	GE 4 inch Anterior Cervical Post, GE Part Number 1006385 or 1006385-NAV, GE Healthcare OEC Medical Systems (an accessory used with the InstaTrak 3500 plus and 9800 C-Arm Navigation systems)
Z-0001-2009	Philips Medical Systems North America Co. Phillips	2	NeuViz Dual Multi-Slice Computed Tomography (CT) Scanner System (software). Whole body x-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system software is an interactive program used for x-ray scan control, image reconstruction, and image archive/evaluation. It is intended to produce cross-section images of head and body by computer reconstruction of x-ray transmission data taken at different angles. The function of Time Scan is intended to use in contrast scan include single phase and multi-phase scan, that is according to different density of contrast in vessels or organs between different phase to get necessary information to support doctor's diagnosis.
Z-0004-2010	Ge Healthcare	2	GE OEC 9900 Elite ESP To produce mobile fluoroscopic images of human anatomy.
Z-0005-2010	Ge Healthcare	2	GE OEC 9900 Elite GSP Fluoroscopes To produce mobile fluoroscopic images of human anatomy.

Similar Registrations

Registration Number	Establishment Name	Location
3002743211	NORTHERN DIGITAL, INC.	WATERLOO Ontario, CA
3016050940	Olive Branch Distribution Center	Olive Branch, MS, US
3020983478	ORTHOKEY ITALIA SRL	Firenze, IT
3014725904	Medtronic Medical Costa Rica S.R.L.	Coyol Alajuela, CR
3018405359	A7 INTEGRATION	Granby Quebec, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016619943. Last updated year: 2026. Please use registration number 3016619943 when referencing this establishment in official correspondence.