Skip to content

nView system 1

by Nview Medical, Inc.

510(k) K190064

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK190064 Date8 Jul 2019ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
OWB
Device Class
Class II
Regulation
21 CFR Part 892.1650
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The nView system 1 is an interventional fluoroscopic X-ray system used for medical imaging procedures. It is designed to provide real-time X-ray images during interventional procedures, allowing healthcare professionals to visualize internal structures and guide medical instruments.

The system is manufactured by Nview Medical, Inc. and is a Class II medical device. It is not specified as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions is provided. The device received FDA 510(k) clearance with K number K190064 on July 8, 2019, under product code OWB for radiology procedures.

Other devices from Nview Medical

Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the nView system 1 used for?

    The nView system 1 is an interventional fluoroscopic X-ray system designed to provide real-time X-ray images during medical procedures. It helps healthcare professionals visualize internal structures and guide medical instruments during interventional procedures.

  • Is the nView system 1 single-use or reusable?

    The device data does not specify whether the nView system 1 is single-use or reusable. This information would need to be obtained directly from the manufacturer or product documentation.

  • What regulatory approvals does the nView system 1 have?

    The nView system 1 received FDA 510(k) clearance with K number K190064 on July 8, 2019. It is classified as a Class II medical device under product code OWB for radiology procedures.

  • What are the specifications of the nView system 1?

    The nView system 1 is an interventional fluoroscopic X-ray system manufactured by Nview Medical, Inc. It is designed for real-time imaging during procedures, but specific technical measurements or detailed specifications are not provided in the device data.