GXW · Echoencephalograph
Neurology · 21 CFR 882.1240 · Class 2
Overview
| Product Code | GXW |
|---|---|
| Device Name | Echoencephalograph |
| Regulation | 21 CFR 882.1240 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| 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 | SONOS 500, 1000, 1500/SONOS OR ULTRASOUND IMAG SYS | Hewlett-Packard Co. | Sep 28, 1992 | SESE |
| K903085 | SMS-712NA | Toshiba America Medical Systems, In.C | Oct 5, 1990 | SESE |
| K853432 | 5.0 IOP & 7.5 IOP PROBES | Diasonics, Inc. | Feb 7, 1986 | SESE |
| K833522 | NEURO SECTOR FIXATION DEVICE | Advanced Technology Laboratories, Inc. | May 25, 1984 | SESE |
| K821736 | ECHO-PULSE KM555 | Rabar, Inc. | Dec 9, 1982 | SESE |
| K770788 | ECHOENCEPHALOGRAPH, DIGITAL,DIGIECHO2000 | Storz Instrument Co. | May 6, 1977 | SESE |
| K770575 | 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
