Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart B — Cardiovascular Diagnostic Devices](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices) → [21 CFR 870.1435](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1435) → DXG — Computer, Diagnostic, Pre-Programmed, Single-Function

# DXG · Computer, Diagnostic, Pre-Programmed, Single-Function

_Cardiovascular · 21 CFR 870.1435 · Class 2_

**Canonical URL:** https://fda.innolitics.com/productcode/DXG

## Overview

- **Product Code:** DXG
- **Device Name:** Computer, Diagnostic, Pre-Programmed, Single-Function
- **Regulation:** [21 CFR 870.1435](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1435)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)
- **3rd-party reviewable:** yes

## Identification

A single-function, preprogrammed diagnostic computer is a hard-wired computer that calculates a specific physiological or blood-flow parameter based on information obtained from one or more electrodes, transducers, or measuring devices.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (20 of 177)

Showing 20 most recent of 177 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K253092](/device/K253092.md) | Argos Infinity (Rev. 1.0) | Retia Medical Systems, Inc. | Feb 13, 2026 | SESE |
| [K251275](/device/K251275.md) | VitalStream ART Connect; VitalStream-Hemo | Caretaker Medical | Sep 26, 2025 | SESE |
| [K232048](/device/K232048.md) | Cogent™ Hemodynamic Monitoring System; Cogent™ HMS | Icu Medical | Dec 20, 2023 | SESE |
| [K212529](/device/K212529.md) | Hypotension Decision Assist Model HDA-OR2 | Directed Systems, Ltd. | Nov 23, 2021 | SESE |
| [K192169](/device/K192169.md) | PulsioFlex Monitoring System with ProAQT Sensor | Pulsion Medical Systems SE | Apr 30, 2020 | SESE |
| [K193179](/device/K193179.md) | EV1000 Clinical Platform | Edwards Lifesciences, LLC | Dec 17, 2019 | SESE |
| [K190955](/device/K190955.md) | Hypotension Decision Assist | Directed Systems, Ltd. | Nov 27, 2019 | SESE |
| [K181372](/device/K181372.md) | Argos | Retia Medical, LLC | Dec 13, 2018 | SESE |
| [K172259](/device/K172259.md) | PulsioFlex Monitoring System | Pulsion Medical Systems SE | Jan 18, 2018 | SESE |
| [K163334](/device/K163334.md) | LiDCOunity v2 Hemodynamic Monitor | Lidco, Ltd. | Jun 5, 2017 | SESE |
| [K152935](/device/K152935.md) | LiDCOunity Monitor | Lidco, Ltd. | Mar 17, 2016 | SESE |
| [K134051](/device/K134051.md) | TRANSONIC ELSA SYSTEM | Transonic Systems, Inc. | Jan 29, 2015 | SESE |
| [K134035](/device/K134035.md) | TRANSONIC HCM 103 SYSTEM | Transonic Systems, Inc. | Sep 17, 2014 | SESE |
| [K140017](/device/K140017.md) | TRANSONIC HCM 102 SYSTEM | Transonic Systems, Inc. | Sep 16, 2014 | SESE |
| [K132892](/device/K132892.md) | TEBCO-W | Bomed, Inc. | Aug 1, 2014 | SESE |
| [K131892](/device/K131892.md) | EV1000 CLINICAL PLATFORM | Edwards Lifesciences, LLC | May 22, 2014 | SESE |
| [K131588](/device/K131588.md) | VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR; VIGILEO APCO/OXIMETRY MONITOR | Edwards Lifesciences, LLC | May 22, 2014 | SESE |
| [K132528](/device/K132528.md) | E-PICCO CONTINUOUS CARDIAC OUTPUT MODULE AND ACCESSORIES | GE Healthcare Finland Oy | Jan 16, 2014 | SESE |
| [K122400](/device/K122400.md) | CARDIOX FLOW DETECTION SYSTEM | Cardiox Corp. | Nov 5, 2013 | SESE |
| [K131048](/device/K131048.md) | LIDCO CNAP MODULE | Lidco, Ltd. | Aug 28, 2013 | SESE |

## Top Applicants

- Edwards Lifesciences, LLC — 10 clearances
- Lidco, Ltd. — 7 clearances
- Hewlett-Packard Co. — 6 clearances
- Transonic Systems, Inc. — 5 clearances
- Abbott Laboratories — 4 clearances

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**Source:** [https://fda.innolitics.com/productcode/DXG](https://fda.innolitics.com/productcode/DXG)

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