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Multi-Dop X

by Dantec Medical, Inc. 510(k)

Active United States

510(k) K931801

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK931801 Date14 Jun 1995ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
IYO
Device Class
Class II
Regulation
21 CFR Part 892.1560
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 Multi-Dop X is a Doppler ultrasound system designed for vascular imaging and blood flow assessment. It employs Doppler technology to measure and visualize blood flow velocity, direction, and spectral analysis, aiding in the evaluation of circulatory conditions and vascular health.

This device is intended for use in radiology settings and has received FDA 510(k) clearance under the product code IYO. Supplied as a reusable medical instrument, it requires proper maintenance and calibration. The Multi-Dop X was cleared as substantially equivalent to a predicate device in 1995 and remains subject to regulatory oversight under the applicable FDA guidelines for ultrasound systems.

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