← Product Code [JOP](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/JOP) · K870726

# RT5000 ECHOCARDIOGRAPHY #H4100C/CE (K870726)

_General Electric Co. · JOP · Oct 20, 1987 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/JOP/K870726

## Device Facts

- **Applicant:** General Electric Co.
- **Product Code:** [JOP](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/JOP.md)
- **Decision Date:** Oct 20, 1987
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.2880
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

An ultrasonic transducer is a device applied to the skin to transmit and receive ultrasonic energy that is used in conjunction with an echocardiograph to provide imaging of cardiovascular structures. This device includes phased arrays and two-dimensional scanning transducers.

---

**Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/JOP/K870726](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/JOP/K870726)

**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