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VS3-Ir

by Medtronic 2 variants

510(k) K183453

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 NumberK183453 Date4 Mar 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  • Withdrawn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
OWN
Device class
Class II
Regulation
21 CFR Part 876.1500
Advisory committee
Gastroenterology, Urology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The VS3-IR is a confocal optical imaging system designed for high-resolution visualization of tissue surfaces. It employs laser-based confocal microscopy to provide real-time, magnified images of mucosal and cellular structures, enabling precise diagnostic assessment in endoscopic procedures. This technology supports the identification of abnormalities such as dysplasia or early neoplastic changes in gastrointestinal and urological tissues.

The device is intended for use in clinical settings, including gastroenterology and urology, and is supplied as a reusable medical instrument. It requires proper sterilization between uses and must be handled in accordance with manufacturer guidelines to ensure safety and functionality. The VS3-IR is classified as a Class II device under FDA regulations and holds a 510(k) clearance (K183453) for substantial equivalence. No specific MRI safety information is provided in the available data.

Other devices from Medtronic, Inc.

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Questions

AI-generated answers, 1 Oct 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 VS3-IR confocal optical imaging system used for?

    The VS3-IR is designed for high-resolution visualization of tissue surfaces, enabling precise diagnostic assessment in endoscopic procedures. It helps identify abnormalities such as dysplasia or early neoplastic changes in gastrointestinal and urological tissues through real-time, magnified images.

  • How is the VS3-IR supplied and what are its sterilization requirements?

    The VS3-IR is supplied as a reusable medical instrument that requires proper sterilization between uses. It must be handled in accordance with manufacturer guidelines to ensure safety and functionality. The device is classified as a Class II device under FDA regulations.

  • What regulatory approvals does the VS3-IR have?

    The VS3-IR holds a 510(k) clearance (K183453) for substantial equivalence. It is classified as a Class II device under FDA regulations and is intended for use in gastroenterology and urology clinical settings.

  • What are the specifications of the VS3-IR system?

    The VS3-IR is a confocal optical imaging system that employs laser-based confocal microscopy to provide real-time, magnified images of mucosal and cellular structures. It is manufactured by Medtronic and has product code OWN with registration number 9614683.