AMCAD BIOMED CORPORATION

Address:5F., No.167, Fu Hsing N. Rd., Taipei 105, Taiwan, R.O.C.,Taipei,TW

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Image Processing, Radiological (LLZ) (1)

Premarket Exempt

No Yes

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AmCAD UO - 04719875623103 Catalog Number : UO-0102

Device Description : AmCAD UO is a PC based, self contained, non invasive image analysis software app AmCAD UO is a PC based, self contained, non invasive image analysis software application for reviewing the pharyngeal/upper airway ultrasonic image acquired from an FDA cleared ultrasound system. The software is designed to support visualization and quantification of the airway sonographic characteristics. The software also provides tools for manual or interactive selection of Region of Interest to allow for analysis of the airway in terms of its size, position and enhancement pattern. This analysis provides information for physician’s evaluation and monitoring of the airway state.

Device Class : 2

Duns Number: 656738726

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

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