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D200 Advanced Computer Cardiac Analysis System

by Dextra Medical, Inc. 510(k)

Active United States

510(k) K863230

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK863230 Date25 Nov 1986ClearedStatusActive

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  • Withdrawn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
DXG
Device Class
Class II
Regulation
21 CFR Part 870.1435
Advisory Committee
Cardiovascular
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 D200 Advanced Computer Cardiac Analysis System is a pre-programmed, single-function diagnostic computer designed for cardiovascular applications. It processes and analyzes cardiac data to assist in clinical decision-making, leveraging automated algorithms for electrocardiogram interpretation and other cardiac assessments.

This device is intended for use in clinical settings, supplied as a reusable system with no specified sterility requirements. It operates in environments compatible with MRI safety standards for Class 2 devices, as classified under FDA regulation 870.1435. The system requires appropriate storage and maintenance to ensure accurate performance, and its regulatory clearance (FDA 510K, K863230) confirms compliance with U.S. medical device standards.

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