← Product Code [IYN](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN) · K033196

# SONOLINE ANTARES WITH CLARIFY VE (K033196)

_Siemens Medical Solutions USA, Inc. · IYN · Oct 16, 2003 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN/K033196

## Device Facts

- **Applicant:** Siemens Medical Solutions USA, Inc.
- **Product Code:** [IYN](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN.md)
- **Decision Date:** Oct 16, 2003
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1550
- **Device Class:** Class 2
- **Review Panel:** Radiology
- **Attributes:** 3rd-Party Reviewed

## Regulatory Identification

An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue 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/IYN/K033196](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN/K033196)

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