NCS · System, Imaging, Holography, Acoustic
Radiology · 21 CFR 892.1550 · Class 2
Overview
| Product Code | NCS |
|---|---|
| Device Name | System, Imaging, Holography, Acoustic |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Review Panel | Radiology |
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.
Classification Rationale
Class II.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K013886 | AVERA MODEL DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM) | Advanced Diagnostics, Inc. | May 10, 2002 | SESE |
| K013291 | ALTAIR MODEL, DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM) | Advanced Diagnostics, Inc. | Nov 14, 2001 | SESE |
| K001510 | OS-2000 OPTICAL SONOGRAPHY SYSTEM | Advanced Diagnostics, Inc. | Nov 30, 2000 | SESE |
Top Applicants
- Advanced Diagnostics, Inc. — 3 clearances
