SINUSCAN 102/SINUSPRINT

K960421 · Ferguson Medical · LWI · Apr 16, 1997 · Radiology

Device Facts

• Record ID: K960421
• Device Name: SINUSCAN 102/SINUSPRINT
• Applicant: Ferguson Medical
• Product Code: LWI · Radiology
• Decision Date: Apr 16, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

Intended Use

The Oriola Sinuscan 102/Sinusprint device is intended for use in the ultrasound detection of frontal and maxillary sinusitis.

Device Story

Pulsed ultrasound scanner; operates as echo sounder. Sends ultrasonic energy pulses; receives echoes from acoustic interfaces. Converts reflected echoes to electric signals. Displays results as graph on LCD; optional printout via integrated printer. Used in clinical settings by healthcare providers to detect sinusitis. Output assists in clinical assessment of sinus inflammation; aids diagnostic decision-making.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Pulsed ultrasound scanner; echo sounder principle. LCD display; integrated printer. Standalone device.

Indications for Use

Indicated for patients requiring detection of frontal and maxillary sinusitis.

Regulatory Classification

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.

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.

Predicate Devices

• Enterscan ultrasound sinus device (K874081)

Submission Summary (Full Text)

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K960421

# FERGUSON MEDICAL

APR 16 1997

20 December 1995

## 510(k) SUMMARY

The 510(k) summary information required by 21 CFR 807.92 is as follows:

A. Classification name: Ultrasonic pulsed imaging system, or sinus ultrasound device.

Common/usual name: Ultrasonic sinusitis detector, ultrasound sinus monitor, and others.

Proprietary name: Sinuscan 102/Sinusprint.

B. Substantial equivalence: Various ultrasound scanners and radiographic/CT devices. Enterscan ultrasound sinus device by Pie Data, K874081.

C. Device description: The Oriola Sinuscan 102/Sinusprint is a pulsed ultrasound scanner.

D. Intended use: The Oriola Sinuscan 102/Sinusprint device is intended for use in the ultrasound detection of frontal and maxillary sinusitis.

E. Technological Characteristics: The Oriola Sinuscan 102/Sinusprint device functions by sending pulses of ultrasonic energy and

3407 Bay Avenue • Chico, California 95926 USA

Phone: [phone] • FAX: [phone]

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receiving echoes from acoustic interfaces in the manner of an echo sounder. The reflected echoes are converted to an electric signal and presented as a graph on the LCD display and/or printed by the printer.

Submitted,
FERGUSON MEDICAL
FDA Establishment Registration Number 2937794

Frank Ferguson
Official Correspondent