LWI · Ultrasound, Sinus
Radiology · 21 CFR 892.1560 · Class 2
Overview
| Product Code | LWI |
|---|---|
| Device Name | Ultrasound, Sinus |
| Regulation | 21 CFR 892.1560 |
| Device Class | Class 2 |
| Review Panel | Radiology |
Identification
An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Classification Rationale
Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Special Controls
*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K960421 | SINUSCAN 102/SINUSPRINT | Ferguson Medical | Apr 16, 1997 | SESE |
| K960044 | ULTRAMAX/MODEL NUMBER A1 | Entlab OY | Aug 2, 1996 | SESE |
| K960241 | CPR GENERAL SURGERY TRAY | Custom Pack Reliability | Mar 22, 1996 | SESE |
| K874081 | ENTERSCAN | Pie Data Medical BV | Dec 31, 1987 | SESE |
Top Applicants
- Custom Pack Reliability — 1 clearance
- Entlab OY — 1 clearance
- Ferguson Medical — 1 clearance
- Pie Data Medical BV — 1 clearance
