FDA product code GXX: Block, Test, Ultrasonic Scanner Calibration
GXX is the FDA product code for block, test, ultrasonic scanner calibration. It is a Class I device, regulated under 21 CFR 882.1925 and reviewed by the Neurology panel. FDA has cleared 3 510(k) submissions under GXX, from 3 different applicants. The average 510(k) review took 102 days (median 92).
Classification
| Field | Value |
|---|---|
| Device name | Block, Test, Ultrasonic Scanner Calibration |
| Device class | Class I |
| Regulation | 21 CFR 882.1925 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GXX clearance
Top GXX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Radiation Measurements, Inc. | 1 | 1989-09-05 |
| Technicare Corp. | 1 | 1985-01-23 |
| Echo Ultrasound | 1 | 1985-01-23 |
Most recent GXX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K893216 | Radiation Measurements, Inc. | RMI ULTRASOUND DOPPLER PHANTOM SYSTEM | 1989-09-05 | 131 |
| K844247 | Technicare Corp. | ULTRASONIC SCANNER CALIBRATION & TEST PHANTOMS | 1985-01-23 | 83 |
| K844120 | Echo Ultrasound | ULTRASONIC SCANNER CALIBRATION & TEST OBJECTS | 1985-01-23 | 92 |
Recalls for GXX devices
openFDA lists no recalls for product code GXX.
Frequently asked questions
What is FDA product code GXX?
GXX is the FDA product code for block, test, ultrasonic scanner calibration. It is a Class I device, regulated under 21 CFR 882.1925 and reviewed by the Neurology panel.
What device class is GXX?
Class I, regulation 21 CFR 882.1925. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GXX?
Across 3 cleared submissions the average was 102 days from receipt to decision (median 92).
Which companies have the most GXX clearances?
Radiation Measurements, Inc. (1); Technicare Corp. (1); Echo Ultrasound (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GXX
- Run a recall and safety report across every GXX manufacturer
- Watch product code GXX for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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