Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart C — Cardiovascular Monitoring Devices](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices) → [21 CFR 870.2320](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2320) → DXR — Ballistocardiograph

# DXR · Ballistocardiograph

_Cardiovascular · 21 CFR 870.2320 · Class 2_

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

## Overview

- **Product Code:** DXR
- **Device Name:** Ballistocardiograph
- **Regulation:** [21 CFR 870.2320](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2320)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)
- **3rd-party reviewable:** yes

## Identification

A ballistocardiograph is a device, including a supporting structure on which the patient is placed, that moves in response to blood ejection from the heart. The device often provides a visual display.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (5 of 5)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K243566](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXR/K243566.md) | CardioTag™ | Cardiosense, Inc. | Jul 22, 2025 | SESE |
| [K160656](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXR/K160656.md) | CorSens | Corsens Medical , Ltd. | Nov 21, 2016 | SESE |
| [K081603](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXR/K081603.md) | DIGITAL BALLISTOCARDIOGRAPH, MODEL DGB 300 | Heartforce Medical, Inc. | Jul 24, 2009 | SESE |
| [K870442](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXR/K870442.md) | QUANTASCOPE | Vital Science Corp. | Aug 11, 1987 | SN |
| [K863508](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXR/K863508.md) | FRANTZ MEDICAL ELECTRODE | Frantz Medical Development, Ltd. | Feb 6, 1987 | SESE |

## Top Applicants

- Cardiosense, Inc. — 1 clearance
- Corsens Medical , Ltd. — 1 clearance
- Frantz Medical Development, Ltd. — 1 clearance
- Heartforce Medical, Inc. — 1 clearance
- Vital Science Corp. — 1 clearance

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

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