Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart C — Cardiovascular Monitoring Devices](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices) → [21 CFR 870.2400](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2400) → DYC — Vectorcardiograph

# DYC · Vectorcardiograph

_Cardiovascular · 21 CFR 870.2400 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DYC

## Overview

- **Product Code:** DYC
- **Device Name:** Vectorcardiograph
- **Regulation:** [21 CFR 870.2400](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2400)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)
- **3rd-party reviewable:** yes

## Identification

A vectorcardiograph is a device used to process the electrical signal transmitted through electrocardiograph electrodes and to produce a visual display of the magnitude and direction of the electrical signal produced by the heart.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K023414](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DYC/K023414.md) | MIDA ALGORITHM REV. B | Ortivus AB | Dec 5, 2003 | SESE |
| [K896396](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DYC/K896396.md) | MIDA SYSTEM, MODELS 1000/1100 | Medical Graphics Corp. | Jan 18, 1990 | SESE |
| [K823934](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DYC/K823934.md) | CARIEL F12 | Odam | Dec 16, 1983 | SESE |
| [K810529](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DYC/K810529.md) | DIRECT WRITING VECTORCARDIOGRAPH | Elmed, Inc. | Apr 23, 1981 | SESE |

## Top Applicants

- Elmed, Inc. — 1 clearance
- Medical Graphics Corp. — 1 clearance
- Odam — 1 clearance
- Ortivus AB — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DYC](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DYC)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com
