← Product Code [NCS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/NCS) · K001510

# OS-2000 OPTICAL SONOGRAPHY SYSTEM (K001510)

_Advanced Diagnostics, Inc. · NCS · Nov 30, 2000 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/NCS/K001510

## Device Facts

- **Applicant:** Advanced Diagnostics, Inc.
- **Product Code:** [NCS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/NCS.md)
- **Decision Date:** Nov 30, 2000
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1550
- **Device Class:** Class 2
- **Review Panel:** Radiology

## 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/NCS/K001510](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/NCS/K001510)

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