← Product Code [JOP](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/JOP) · K843130

# SCANHEAD 2.25MHZ ADDED TO ULTRAMARK 4 (K843130)

_Advanced Technology Laboratories, Inc. · JOP · Dec 6, 1984 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/JOP/K843130

## Device Facts

- **Applicant:** Advanced Technology Laboratories, Inc.
- **Product Code:** [JOP](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/JOP.md)
- **Decision Date:** Dec 6, 1984
- **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/K843130](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/JOP/K843130)

**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