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Del Mar Avionics 8300 Sector Imager Sys

by Del Mar Avionics 510(k)

Active United States

510(k) K844896

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK844896 Date10 Jun 1985ClearedStatusActive

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  • Withdrawn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 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DXK
Device Class
Class II
Regulation
21 CFR Part 870.2330
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 Del Mar Avionics 8300 Sector Imager Sys is an echocardiograph, a medical device used for ultrasound imaging of the heart. It is classified under product code DXK and regulation number 870.2330, and is intended for cardiovascular imaging applications.

This device received FDA 510(k) clearance (K844896) on June 10, 1985, as a substantially equivalent device following a traditional review. It is a Class II medical device subject to special controls, manufactured by Del Mar Avionics in Irvine, California, and is supplied as a non-sterile, reusable system for use in clinical cardiovascular settings.

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Questions

AI-generated answers, 27 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 Del Mar Avionics 8300 Sector Imager Sys used for?

    It is an echocardiograph used for ultrasound imaging of the heart, intended for cardiovascular imaging applications in clinical settings.

  • Is the Del Mar Avionics 8300 Sector Imager Sys sterile or non-sterile, and is it single-use or reusable?

    The device is supplied as a non-sterile, reusable system, meaning it is not provided sterile and is designed for multiple uses after appropriate cleaning and disinfection between patients.

  • What regulatory pathway was used for the Del Mar Avionics 8300 Sector Imager Sys, and when was it cleared?

    It received FDA 510(k) clearance (K844896) on June 10, 1985, through a traditional review process as a substantially equivalent device.