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Multi-Dop L

by Dantec Medical, Inc. 510(k)

Active United States

510(k) K930458

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK930458 Date3 Feb 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  • Withdrawn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
IYN
Device Class
Class II
Regulation
21 CFR Part 892.1550
Advisory Committee
Radiology
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 Multi-Dop L is an ultrasound system. It is a Class II device manufactured by Dantec Medical, Inc.

The device is used in radiology. It has been cleared under FDA 510(k) with the k-number K930458. The device was cleared on February 3, 1995.

Other devices from Dantec Medical, Inc.

See all devices from Dantec Medical, Inc. →

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 Multi-Dop L used for?

    The Multi-Dop L is used in radiology, providing ultrasound capabilities for medical imaging and diagnosis.

  • Is the Multi-Dop L a single-use or reusable device?

    The device data does not specify whether the Multi-Dop L is single-use or reusable, but as an ultrasound system, it is likely designed for repeated use.

  • What is the regulatory status of the Multi-Dop L?

    The Multi-Dop L has been cleared under FDA 510(k) with the k-number K930458, indicating that it is substantially equivalent to a predicate device.