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).
Cleared Devices (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
- Toshiba America Medical Systems, In.C — 1 clearance
- Rabar, Inc. — 1 clearance
- Hewlett-Packard Co. — 1 clearance
- Diasonics, Inc. — 1 clearance
