(443 days)
Not Found
No
The description focuses on basic ultrasound technology and signal processing, with no mention of AI, ML, or advanced image analysis techniques typically associated with these technologies.
No.
The device is used for detection/diagnosis of sinusitis, not for treatment.
Yes
The device is described as an "ultrasound detection" device for "frontal and maxillary sinusitis," which clearly indicates its purpose is to identify a medical condition.
No
The device description explicitly states it is a "pulsed ultrasound scanner" and functions by "ultrasonic sending pulses of energy and receiving echoes," which are hardware functions. It also mentions an "LCD display and/or printed by the printer," indicating hardware components.
Based on the provided information, the Oriola Sinuscan 102/Sinusprint device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is the "ultrasound detection of frontal and maxillary sinusitis." This involves using ultrasound technology to image and assess the sinuses within the body.
- Device Description: The description clearly states it's a "pulsed ultrasound scanner" that sends and receives ultrasonic pulses to detect echoes from acoustic interfaces. This is a description of an in-vivo imaging device, not a device that analyzes samples taken from the body (which is the core of IVD).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
Therefore, the Oriola Sinuscan 102/Sinusprint is an in-vivo diagnostic imaging device, specifically an ultrasound scanner for sinus assessment.
N/A
Intended Use / Indications for Use
The Oriola Sinuscan 102/Sinusprint device is intended for use in the ultrasound detection of frontal and maxillary sinusitis.
Product codes
Not Found
Device Description
The Oriola Sinuscan 102/ Sinusprint is a pulsed ultrasound scanner.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
Anatomical Site
frontal and maxillary sinusitis
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
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.(b)
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.
0
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
ﺴﺘﺸﻔﺖ ﺍﻟﻤﺴﺘﺸﻔﻴﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ
ﺳﺘﺎﻥ
一
ﺴﻴﺮ ﺍﻟ
ﺳﺖ
ﺳﺴ
ﺴﺴﺮ
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
1
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