Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart B — Neurological Diagnostic Devices](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices) → [21 CFR 882.1925](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1925) → GXX — Block, Test, Ultrasonic Scanner Calibration

# GXX · Block, Test, Ultrasonic Scanner Calibration

_Neurology · 21 CFR 882.1925 · Class 1_

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

## Overview

- **Product Code:** GXX
- **Device Name:** Block, Test, Ultrasonic Scanner Calibration
- **Regulation:** [21 CFR 882.1925](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1925)
- **Device Class:** 1
- **Review Panel:** [Neurology](/submissions/NE)

## Identification

An ultrasonic scanner calibration test block is a block of material with known properties used to calibrate ultrasonic scanning devices (e.g., the echoencephalograph).

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K893216](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXX/K893216.md) | RMI ULTRASOUND DOPPLER PHANTOM SYSTEM | Radiation Measurements, Inc. | Sep 5, 1989 | SESE |
| [K844247](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXX/K844247.md) | ULTRASONIC SCANNER CALIBRATION & TEST PHANTOMS | Technicare Corp. | Jan 23, 1985 | SESE |
| [K844120](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXX/K844120.md) | ULTRASONIC SCANNER CALIBRATION & TEST OBJECTS | Echo Ultrasound | Jan 23, 1985 | SESE |

## Top Applicants

- Echo Ultrasound — 1 clearance
- Radiation Measurements, Inc. — 1 clearance
- Technicare Corp. — 1 clearance

---

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

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com