GXW
7 FDA 510(k) clearances · Product code
164 daysmedian time to decision
249 days90th percentile
7clearances measured
FDA profile
- Official device name
- Echoencephalograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.1240
- Medical specialty
- Neurology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| SONOS 500, 1000, 1500/SONOS OR ULTRASOUND IMAG SYS (K921863) | Hewlett-Packard Co. | 1992-09-28 |
| SMS-712NA (K903085) | Toshiba America Medical Systems, In.C | 1990-10-05 |
| 5.0 IOP & 7.5 IOP PROBES (K853432) | Diasonics, Inc. | 1986-02-07 |
| NEURO SECTOR FIXATION DEVICE (K833522) | Advanced Technology Laboratories, Inc. | 1984-05-25 |
| ECHO-PULSE KM555 (K821736) | Rabar, Inc. | 1982-12-09 |
| ECHOENCEPHALOGRAPH, DIGITAL,DIGIECHO2000 (K770788) | Storz Instrument Co. | 1977-05-06 |
| ECHOENCEPHALOGRAPH, DIGITAL, 1000 (K770575) | Storz Instrument Co. | 1977-04-26 |
Track GXW automatically
Every clearance here is in the API, with alerts when new ones post.