← Product Code [JAF](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAF) · K944196

# IMWXDOP IR (K944196)

_Imex Medical Systems, Inc. · JAF · May 12, 1995 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAF/K944196

## Device Facts

- **Applicant:** Imex Medical Systems, Inc.
- **Product Code:** [JAF](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAF.md)
- **Decision Date:** May 12, 1995
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1540
- **Device Class:** Class 2
- **Review Panel:** Radiology

## Regulatory Identification

A nonfetal ultrasonic monitor is a device that projects a continuous high-frequency sound wave into body tissue other than a fetus to determine frequency changes (doppler shift) in the reflected wave and is intended for use in the investigation of nonfetal blood flow and other nonfetal body tissues in motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAF/K944196](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAF/K944196)

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