← Product Code [MUA](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MUA) · P970026

# MYRIAD ULTRASOUND SYSTEMS LTD. SOUNDSCAN (P970026)

_Myriad Ultrasound Systems , Ltd. · MUA · May 29, 1998 · Radiology · APRL_

**Canonical URL:** https://fda.innolitics.com/submissions/RADIOLOGY/subpart-b%E2%80%94diagnostic-devices/MUA/P970026

## Device Facts

- **Applicant:** Myriad Ultrasound Systems , Ltd.
- **Product Code:** [MUA](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MUA.md)
- **Decision Date:** May 29, 1998
- **Decision:** APRL
- **Regulation:** 21 CFR 892.1180
- **Device Class:** Class 2
- **Review Panel:** Radiology

## Regulatory Identification

A bone sonometer is a device that transmits ultrasound energy into the human body to measure acoustic properties of bone that indicate overall bone health and fracture risk. The primary components of the device are a voltage generator, a transmitting transducer, a receiving transducer, and hardware and software for reception and processing of the received ultrasonic signal.

## Special Controls

*Classification.* Class II (special controls). The special control for this device is FDA's “Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Bone Sonometers.” See § 892.1(e) for the availability of this guidance document.

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**Source:** [https://fda.innolitics.com/submissions/RADIOLOGY/subpart-b%E2%80%94diagnostic-devices/MUA/P970026](https://fda.innolitics.com/submissions/RADIOLOGY/subpart-b%E2%80%94diagnostic-devices/MUA/P970026)

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