Who is the manufacturer of OS-2000 OPTICAL SONOGRAPHY SYSTEM?

Advanced Diagnostics, Inc. submitted the Traditional clearance for OS-2000 OPTICAL SONOGRAPHY SYSTEM (K001510).

What is the FDA product code for OS-2000 OPTICAL SONOGRAPHY SYSTEM?

NCS. It is classified under 21 CFR 892.1550 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for OS-2000 OPTICAL SONOGRAPHY SYSTEM?

510(k) clearance (submission type: Traditional).

OS-2000 OPTICAL SONOGRAPHY SYSTEM

K001510 · Advanced Diagnostics, Inc. · NCS · Nov 30, 2000 · Radiology

Device Facts

Record ID	K001510
Device Name	OS-2000 OPTICAL SONOGRAPHY SYSTEM
Applicant	Advanced Diagnostics, Inc.
Product Code	NCS · Radiology
Decision Date	Nov 30, 2000
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1550
Device Class	Class 2

Regulatory Classification

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.