Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart B — Neurological Diagnostic Devices](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices) → [21 CFR 882.1240](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1240) → GXW — Echoencephalograph

# GXW · Echoencephalograph

_Neurology · 21 CFR 882.1240 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXW

## Overview

- **Product Code:** GXW
- **Device Name:** Echoencephalograph
- **Regulation:** [21 CFR 882.1240](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1240)
- **Device Class:** 2
- **Review Panel:** [Neurology](/submissions/NE)
- **3rd-party reviewable:** yes

## Identification

An echoencephalograph is an ultrasonic scanning device (including A-scan, B-scan, and doppler systems) that uses noninvasive transducers for measuring intracranial interfaces and blood flow velocity to and in the head.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (7 of 7)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K921863](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXW/K921863.md) | SONOS 500, 1000, 1500/SONOS OR ULTRASOUND IMAG SYS | Hewlett-Packard Co. | Sep 28, 1992 | SESE |
| [K903085](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXW/K903085.md) | SMS-712NA | Toshiba America Medical Systems, In.C | Oct 5, 1990 | SESE |
| [K853432](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXW/K853432.md) | 5.0 IOP & 7.5 IOP PROBES | Diasonics, Inc. | Feb 7, 1986 | SESE |
| [K833522](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXW/K833522.md) | NEURO SECTOR FIXATION DEVICE | Advanced Technology Laboratories, Inc. | May 25, 1984 | SESE |
| [K821736](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXW/K821736.md) | ECHO-PULSE KM555 | Rabar, Inc. | Dec 9, 1982 | SESE |
| [K770788](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXW/K770788.md) | ECHOENCEPHALOGRAPH, DIGITAL,DIGIECHO2000 | Storz Instrument Co. | May 6, 1977 | SESE |
| [K770575](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXW/K770575.md) | ECHOENCEPHALOGRAPH, DIGITAL, 1000 | Storz Instrument Co. | Apr 26, 1977 | SESE |

## Top Applicants

- Storz Instrument Co. — 2 clearances
- Advanced Technology Laboratories, Inc. — 1 clearance
- Diasonics, Inc. — 1 clearance
- Hewlett-Packard Co. — 1 clearance
- Rabar, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXW](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXW)

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