AMCAD BIOMED CORPORATION

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

Want to know more about this Organization? Request more information now!


Filters
Device Class
Product Code
Premarket Exempt
Clear
- Catalog Number : UT-0222

Device Description : AmCAD UT Detection is a Windows computer aided detection device intended to assi AmCAD UT Detection is a Windows computer aided detection device intended to assist the medical professionals in analyzing thyroid ultrasound images, acquired from FDA cleared ultrasound systems, with user selected regions of interest. After the initial review of the ultrasound images by the physicians, the device further provides detailed information with quantification and visualization of sonographic characteristics of thyroid nodules. The device is intended for use on ultrasound images of discrete thyroid nodules larger than 1cm, for which a biopsy recommendation is required.

Device Class :

Duns Number: 656738726

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

- Catalog Number : UT-0222-D

Device Description : AmCAD UT Detection is a Windows computer aided detection device intended to assi AmCAD UT Detection is a Windows computer aided detection device intended to assist the medical professionals in analyzing thyroid ultrasound images, acquired from FDA cleared ultrasound systems, with user selected regions of interest. After the initial review of the ultrasound images by the physicians, the device further provides detailed information with quantification and visualization of sonographic characteristics of thyroid nodules. The device is intended for use on ultrasound images of discrete thyroid nodules larger than 1cm, for which a biopsy recommendation is required.

Device Class : 2

Duns Number: 656738726

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

- Catalog Number : UT-0222-500

Device Description : AmCAD UT Detection is a Windows computer aided detection device intended to assi AmCAD UT Detection is a Windows computer aided detection device intended to assist the medical professionals in analyzing thyroid ultrasound images, acquired from FDA cleared ultrasound systems, with user selected regions of interest. After the initial review of the ultrasound images by the physicians, the device further provides detailed information with quantification and visualization of sonographic characteristics of thyroid nodules. The device is intended for use on ultrasound images of discrete thyroid nodules larger than 1cm, for which a biopsy recommendation is required.

Device Class : 2

Duns Number: 656738726

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

- Catalog Number : UT-0222-1Y

Device Description : AmCAD UT Detection is a Windows computer aided detection device intended to assi AmCAD UT Detection is a Windows computer aided detection device intended to assist the medical professionals in analyzing thyroid ultrasound images, acquired from FDA cleared ultrasound systems, with user selected regions of interest. After the initial review of the ultrasound images by the physicians, the device further provides detailed information with quantification and visualization of sonographic characteristics of thyroid nodules. The device is intended for use on ultrasound images of discrete thyroid nodules larger than 1cm, for which a biopsy recommendation is required.

Device Class : 2

Duns Number: 656738726

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

- Catalog Number : UT-0222-1000

Device Description : AmCAD UT Detection is a Windows computer aided detection device intended to assi AmCAD UT Detection is a Windows computer aided detection device intended to assist the medical professionals in analyzing thyroid ultrasound images, acquired from FDA cleared ultrasound systems, with user selected regions of interest. After the initial review of the ultrasound images by the physicians, the device further provides detailed information with quantification and visualization of sonographic characteristics of thyroid nodules. The device is intended for use on ultrasound images of discrete thyroid nodules larger than 1cm, for which a biopsy recommendation is required.

Device Class : 2

Duns Number: 656738726

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

- Catalog Number : UT-0222-50

Device Description : AmCAD UT Detection is a Windows computer aided detection device intended to assi AmCAD UT Detection is a Windows computer aided detection device intended to assist the medical professionals in analyzing thyroid ultrasound images, acquired from FDA cleared ultrasound systems, with user selected regions of interest. After the initial review of the ultrasound images by the physicians, the device further provides detailed information with quantification and visualization of sonographic characteristics of thyroid nodules. The device is intended for use on ultrasound images of discrete thyroid nodules larger than 1cm, for which a biopsy recommendation is required.

Device Class : 2

Duns Number: 656738726

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

- Catalog Number : UT-0222-KOL

Device Description : AmCAD UT Detection is a Windows computer aided detection device intended to assi AmCAD UT Detection is a Windows computer aided detection device intended to assist the medical professionals in analyzing thyroid ultrasound images, acquired from FDA cleared ultrasound systems, with user selected regions of interest. After the initial review of the ultrasound images by the physicians, the device further provides detailed information with quantification and visualization of sonographic characteristics of thyroid nodules. The device is intended for use on ultrasound images of discrete thyroid nodules larger than 1cm, for which a biopsy recommendation is required.

Device Class : 2

Duns Number: 656738726

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

- Catalog Number : UT-0222-1P

Device Description : AmCAD UT Detection is a Windows computer aided detection device intended to assi AmCAD UT Detection is a Windows computer aided detection device intended to assist the medical professionals in analyzing thyroid ultrasound images, acquired from FDA cleared ultrasound systems, with user selected regions of interest. After the initial review of the ultrasound images by the physicians, the device further provides detailed information with quantification and visualization of sonographic characteristics of thyroid nodules. The device is intended for use on ultrasound images of discrete thyroid nodules larger than 1cm, for which a biopsy recommendation is required.

Device Class : 2

Duns Number: 656738726

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

- Catalog Number : UT-0222-1Q

Device Description : AmCAD UT Detection is a Windows computer aided detection device intended to assi AmCAD UT Detection is a Windows computer aided detection device intended to assist the medical professionals in analyzing thyroid ultrasound images, acquired from FDA cleared ultrasound systems, with user selected regions of interest. After the initial review of the ultrasound images by the physicians, the device further provides detailed information with quantification and visualization of sonographic characteristics of thyroid nodules. The device is intended for use on ultrasound images of discrete thyroid nodules larger than 1cm, for which a biopsy recommendation is required.

Device Class : 2

Duns Number: 656738726

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

Device Description : Head & Neck Laser Alignment Tool is an apparatus for assisting pharyngeal/upper Head & Neck Laser Alignment Tool is an apparatus for assisting pharyngeal/upper airway general purposed ultrasound scan. The apparatus can align the position of head and the general purposed ultrasound probe for automatic multiple-angle ultrasound scan.

Device Class : 1

Duns Number: 656738726

Premarket Exempt : Yes

Product Code : IWE

Prescription Use : Yes

Device Count : 1