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K Number
K960421

Validate with FDA (Live)

Device Name
SINUSCAN 102/SINUSPRINT
Manufacturer
FERGUSON MEDICAL
Date Cleared
1997-04-16

(443 days)

Product Code
LWI
Regulation Number
892.1560
Type
Traditional
Panel
Radiology
Age Range
All
Reference & Predicate Devices
K874081
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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

Device Description

The Oriola Sinuscan 102/ Sinusprint is a pulsed ultrasound scanner. The Oriola Sinuscan 102/Sinusprint device functions by ultrasonic sending pulses of energy and receiving echoes from acoustic interfaces in the manner of an echo sounder. The reflected echoes are converted to an electric signal and concise on the LCD display and/or printed by the printer.

AI/ML Overview

This document is a 510(k) summary for the Oriola Sinuscan 102/Sinusprint device, a pulsed ultrasound scanner intended for the detection of frontal and maxillary sinusitis. It does not contain information about acceptance criteria, device performance, studies, ground truth establishment, or sample sizes.

Therefore, I cannot provide the requested information based on the provided text. The document focuses on the device's classification, proprietary name, substantial equivalence, description, intended use, and technological characteristics, as required for a 510(k) submission.

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Image /page/0/Picture/0 description: The image shows the logo for Ferguson Medical. The logo consists of a stylized, solid black shape on the left, resembling a medical device or a stylized letter. To the right of this shape is the text "FERGUSON" in bold, block letters, stacked above the word "MEDICAL", also in bold, block letters. The overall design is simple and professional, likely representing a medical organization or company.

APR 1 6 1997

1960421

20 December 1995

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

Proprietary name: Sinuscan 102/Sinusprint.

  • equivalence: Various ultrasound B. Substantial radiographic/CT devices. scanners and Enterscan ultrasound sinus device by Pie Data, K874081.
  • C. Device description: The Oriola Sinuscan 102/ Sinusprint is a pulsed ultrasound scanner.
  • The Oriola Sinuscan 102/Sinusprint D. Intended use: 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 ultrasonic sending pulses of energy and

3407 Bay Avenue ● Chico, California 95926 USA Phone: (916) 342-4133 ● FAX: (916) 343-4541

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receiving echoes from acoustic interfaces in receiving conon echo sounder. The reflected che manner of an con-electric signal and echoes are convercise on the LCD display and/or printed by the printer.

Submitted, FERGUSON MEDICAL FDA Establishment Registration Number 2937794

Frank Gery

Frank Ferguson Official Correspondent

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