Who is the manufacturer of AMCAD-UT DETECTION MODEL 2.0?

Lin & Associates, LLC filed the 510(k) submission for AMCAD-UT DETECTION MODEL 2.0 (K122536).

What is the FDA product code for AMCAD-UT DETECTION MODEL 2.0?

LLZ. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for AMCAD-UT DETECTION MODEL 2.0?

510(k) clearance (submission type: Traditional).

Does AMCAD-UT DETECTION MODEL 2.0 use AI or machine learning?

Yes. AMCAD-UT DETECTION MODEL 2.0 (K122536) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

What are the predicate devices for AMCAD-UT DETECTION MODEL 2.0?

Q LAB Software (K021966); B-CAD System, Version 1.0 (K050846); ColonCAD API (K083423).

Who can help prepare an FDA 510(k) submission like AMCAD-UT DETECTION MODEL 2.0?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like AMCAD-UT DETECTION MODEL 2.0 get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

AMCAD-UT DETECTION MODEL 2.0

K122536 · Lin & Associates, LLC · LLZ · Oct 3, 2013 · Radiology

Device Facts

Record ID	K122536
Device Name	AMCAD-UT DETECTION MODEL 2.0
Applicant	Lin & Associates, LLC
Product Code	LLZ · Radiology
Decision Date	Oct 3, 2013
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device

Intended Use

AmCAD-UT® Detection 2.0 is a Windows-based computer-assisted detection (CADe) device intended to assist the medical professionals in analyzing thyroid ultrasound images of user-selected regions of interest (ROI). 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 Philips HDI5000 images of discrete thyroid nodules larger than 1cm, for which a biopsy has been recommended. The device performance has been validated on images collected from Philips HDI5000 with a 5-12MHz multi-frequency probe.

Device Story

AmCAD-UT® Detection 2.0 is a Windows-based CADe software application for clinical review stations. It processes DICOM/JPEG/Bitmap thyroid ultrasound images. Physician selects ROI; software performs statistical pattern recognition and quantification of sonographic characteristics (hyperechoic foci, echo-pattern, echo-texture, anechoic areas). Output includes quantified data, visualizations, and automated reports (PDF or print). Used by physicians as a 'second detector' after initial image review to assist in interpretation and clinical judgment. Benefits include enhanced analysis of thyroid nodule characteristics.

Clinical Evidence

Clinical evidence includes standalone performance testing (detection accuracy, reproducibility, algorithm stability) and a clinical Multi-Reader Multi-Case (MRMC) study. Results demonstrated that physician use of the device significantly enhanced the ability to analyze sonographic characteristics and improved clinical judgment effectiveness.

Technological Characteristics

Windows-based software; standalone PC or review station deployment. Inputs: DICOM/JPEG/Bitmap ultrasound images. Processing: Statistical pattern recognition and quantification. Outputs: Annotated images, quantified sonographic characteristics, automated reports. Connectivity: DICOM-compliant, intranet/web server integration.

Indications for Use

Indicated for medical professionals analyzing thyroid ultrasound images of discrete thyroid nodules >1cm in patients for whom biopsy is recommended. Intended for use on images from Philips HDI5000 with 5-12MHz multi-frequency probe.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

Q LAB Software (K021966)
B-CAD System, Version 1.0 (K050846)
ColonCAD API (K083423)

Related Devices

K180006 — AmCAD-UT Detection 2.2 · Amcad Biomed Corporation · Aug 31, 2018
K203555 — AmCAD-UT · Amcad Biomed Corporation · Sep 8, 2021
K203502 — MEDO-Thyroid · Medo DX Pte. , Ltd. · Apr 23, 2021
K240697 — See-Mode Augmented Reporting Tool, Thyroid (SMART-T) · See-Mode Technologies Pte, Ltd. · Sep 9, 2024
K242130 — Koios DS · Koios Medical, Inc. · Nov 15, 2024

Submission Summary (Full Text)

{0}------------------------------------------------ K122536 Page 1 of 11 # 510(k) Summary of Safety and Effectiveness This 510(k) summary of safety and effectiveness information is submitted as part of the Premarket Notification in compliance with requirements of CFR Part 807, Subpart E and Section 807.92 # 5.1 Identification of Submitter: | Submitter: | AmCad BioMed Corporation | |---------------|-------------------------------------------------------------| | Address: | FL.5-2, NO.167, Fu Hsing N. RD., Taipei 105, Taiwan, R.O.C. | | Phone: | 886-2-2713-6227 | | Fax: | 886-2-2514-0245 | | Contact: | Jack Yang | | Title: | Vice President | | Phone: | 886-2-2713-6227 ext.358 | | Fax: | 886-2-2514-0245 | | Email: | jack.yang@amcad.com.tw | | Manufacturer: | AmCad BioMed Corporation | | US Agent and Contact: | Chiu S. Lin, Ph.D. Lin & Associates, LLC | |-----------------------|-------------------------------------------------| | Address: | 9223 Cambridge Manor Court Potomac, MD 20854 | | Phone: | (O) 301-591-3895 | | E-mail: | cslin@lin-associates.com | Date prepared: August 17, 2012 # 5.2 Identification of Product AmCAD-UT® Detection 2.0 Device Trade Name: Common and Usual Name: Computer-Assisted Detection (CAD) Device Device Classification Name: Picture Archiving and Communications System {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo and contact information for AmCad BioMed Corporation. The logo features a stylized image of an elephant. Below the logo is the company name in both Chinese and English. The address is listed as FL.5, NO.167, Fu Hsing N. RD., Taipei 105, Taiwan, ROC, and the telephone number is +886-2-27136227, while the fax number is +886-2-25140245. Regulation Number: 21 CFR 892.205 Classification Product Code: 90 LLZ Classification: Class II Classification Panel: Radiology Devices Manufacturer: AmCad BioMed Corporation ### 5.3 Predicate Device This subject software medical device is substantially equivalent to the devices listed below: | Model: | Q LAB Software | |----------------|----------------------------------| | Manufacturer: | Philips Medical System Company | | 510(k) Number: | K021966, cleared on July 2, 2002 | Model: B-CAD System, Version 1.0 Manufacturer: Medipattem Corporation K050846, cleared on May 26, 2005 510(k) Number: Model: ColonCAD API Manufacturer: Medicsight PLC 510(k) Number: K083423, cleared on May 17, 2011 ### 5.4 Device Description AmCAD-UT® Detection 2.0 is a Windows-based computer-assisted detection (CADe) software application device designed to assist medical professionals in analyzing thyroid ultrasound images of user selected regions of interest (ROI). The device uses statistical pattern recognition and quantification methods to perform analytical function of images. For thyroid ultrasound, these pattern recognition and quantification methods are used by a medical professional to analyze DICOM/JPEG/Bitmap compliant thyroid ultrasound images. {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo and contact information for AmCad BioMed Corporation. The logo features a stylized image of an elephant. Below the logo is the company name in both Chinese and English. The address is listed as FL.S, NO.167, Fu Hsing N. RD., Taipei 105, Taiwan, ROC, and the telephone number is +886-2-27136227, while the fax number is +886-2-25140245. The software application consists of proprietary software developed by AmCad BioMed Corporation. The software is a Windows-based that may be installed on a standalone PC or review station. AmCAD-UT® Detection 2.0 user interface is designed to follow typical clinical workflow patterns to process, review, and analyze digital images. After the initial review of thyroid ultrasound images by the physician, he/she can use AmCAD-UT® Detection 2.0 to analyze the thyroid images for further interpretation. The physician selects an ROI (Region of Interest) to define the initial boundary of the ROI. Once the ROI is confirmed, the physician may process the image for detection and quantification of sonographic characteristics (i.e., hyperechoic foci, echo-pattern, echo-texture, and anechoic areas) by AmCAD-UT® Detection 2.0. The device provides more detailed information with quantification and visualization of the sonographic characteristics of thyroid nodule that may assist physician in his/her complete interpretation. The software application also automatically generates reports given the user preference inputs (e.g., the nodule size, nodule location and shape, and the presence or absence of the sonographic characteristics) annotated during the image analysis process. A report form has been designed by AmCad to be consistent with the conventional clinical thyroid report form. An output of the report may be viewed and sent to paper printers or saved on the standalone PC or review station as PDF file. ## 5.5 Indications for Use AmCAD-UT® Detection 2.0 is a Windows-based computer-assisted detection (CADe) device intended to assist the medical professionals in analyzing thyroid ultrasound images of user-selected regions of interest (ROI). 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 Philips HDI5000 images of discrete thyroid nodules larger than 1cm, for which a biopsy has been recommended. The device performance has been validated on images collected from Philips HDI5000 with a 5-12MHz multi-frequency probe. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo and contact information for AmCad BioMed Corporation. The logo features a stylized elephant-like figure with the letters 'C' and 'A' incorporated into its design. Below the logo is the company name in both Chinese and English, followed by the address: FL.5, NO.167, Fu Hsing N. RD., Taipei 105, Taiwan, ROC. The telephone number is +886-2-27136227 and the fax number is +886-2-25140245. # 5.6 Comparison with Predicate Devices AmCAD-UT® Detection 2.0 is substantially equivalent to Q LAB Software with a general intended use for viewing and quantifying ultrasound image data. AmCAD-UT® Detection 2.0 is also substantially equivalent to B-CAD, version 1.0 and ColonCAD API as being Computer-Assisted Detection software device to assist the physicians in clinical practice. The standalone and clinical reader performance assessment of AmCAD-UT® Detection 2.0 are substantially equivalent to the standalone performance assessment and clinical MRMC reader study of ColonCAD API. Minor technological characteristics differences do not raise any new questions of safety and effectiveness. Thus, AmCAD-UT® Detection 2.0 is substantially equivalent to the Q LAB Software generally intended for viewing and quantifying ultrasound image data and substantially equivalent to the B-CAD System and ColonCAD API as the Computer-Assisted Detection device intended to assist the physicians in clinical practice. The comparison table between our device and the predicate devices is provided below: | | AmCAD-UT® Detection 2.0 | B-CAD System Version 1.0 | ColonCAD API | Q LAB Software | |-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------| | Manufacturer | AmCad BioMed Corp. | Medipattem Corp. | Medicsight PLC | Philips Medical System Company | | 510(k) Number | K122536 | K050846 | K083423 | K021966 | | Device Common Name | Computer-Assisted Detection (CADe) | Same | Same | Picture Archiving and Communications Systems Workstation | | Regulation Number | 21 CFR 892.2050 - Class II | Same | Same | Same | | Regulation Name | Picture archiving and communications system | Same | Same | Same | | Product Code | LLZ | LLZ | NWE | LLZ | | | AmCAD-UT® Detection 2.0 | B-CAD System Version 1.0 | ColonCAD API | Q LAB Software | | Intended Use | AmCAD-UT® Detection 2.0 is intended to assist the medical professionals in analyzing thyroid ultrasound images of user-selected regions of interest (ROI). 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 B-CAD System provides viewing and post-acquisition image analysis of user-selected regions of interest on breast ultrasound images. | The Medicsight ColonCAD API is intended to be used on patients referred for a CT colonography (CTC) examination, as an overlay tool to prompt the radiologist to colonic findings that have been identified by the device. The CAD can assist radiologists after they have made an initial review of all the colonography. image data, supporting their evaluation ( | | | AmCAD-UT® | B-CAD System | ColonCAD API | Q LAB Software | | | Detection 2.0 | Version 1.0 | | | | | The device is | software | | | | | intended for use | automatically | | | | | on Philips HDI5000 | generates reports | | | | | images of discrete | from user inputs | | | | | thyroid nodules | annotated during | | | | | larger than 1cm, | the image | | | | | for which a biopsy | analysis process. | | | | | has been | An output may be | | | | | recommended. | viewed and sent | | | | | The device | to standard film | | | | | performance has | or paper printers | | | | | been validated on | or sent | | | | | images collected | electronically to | | | | | from Philips | an intranet web | | | | | HD15000 with a | server or other | | | | | 5-12MHz | DICOM device. | | | | | multi-frequency | The software may | | | | | probe. | retrieve archived | | | | | | reports from a | | | | | | web server or | | | | | | other DICOM | | | | | | device. | | | | | | B-CAD includes | | | | | | the option to add | | | | | | annotations | | | | | | based on the | | | | | | ACR-BI-RADS® | | | | | | Breast Imaging | | | | | | Atlas. In addition, | | | | | | the report form | | | | | | has been | | | | | | designed to | | | | | | support | | | | | | compliance with | | | | | | the ACR-BI-RADS® Ultrasound Lexicon Classification Form. | | | | | | When interpreted | | | | | | by a skilled | | | | | | physician, this | | | | | | device provides | | | | | | information that | | | | | | may be useful in | | | | | | screening and | | | | | | diagnosis. Patient | | | | | | management | | | | | | decisions should | | | | | | not be made | | | | | | | | | | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo of Anke BioMedical Co., Ltd. The logo consists of a circled "C" symbol followed by the company name in traditional Chinese characters. The characters are arranged horizontally, with "Anke" followed by "BioMedical" and then "Co., Ltd." J AmCad BioMed Corporation . {5}------------------------------------------------ Image /page/5/Picture/0 description: The image contains the logo and name of a company. The logo is a stylized letter C. Next to the logo is the company name in Chinese characters, which translates to "Anke Sheng Medical Co., Ltd." Below the Chinese name is the company name in English, "AmCad BioMed Corporation." FLS, NO.167, Fo Hsing N. RD., Taipei 105, Taiwan, ROC FL.S, NO.167, Fo Hsing N. RD., Taipei 105, Taiwan, ROC Tel: +886-2-27136227 Fax: +886-2-25140245 {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Anke Bio Co., Ltd. The logo consists of a stylized letter "C" with a small circle inside, followed by the company name in traditional Chinese characters. The text reads "安克生醫股份有限公司", which translates to Anke Bio Co., Ltd. FL.5, NO.167, Fu Hsing N. RD., Taipei 105, Taiwan, ROC FL.5, NO.167, Fu Hsing N. RD., Taipei 105, Taiwan, ROC Tel: +886-2-27136227 - Fax: +886-2-25140245 | | AmCAD-UT® Detection 2.0 | B-CAD System Version 1.0 | ColonCAD API | Q LAB Software | |----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Functional Capability of Image Processing | AmCAD-UT®. Detection 2.0 analyzes the user-selected regions of interest (ROI) of thyroid ultrasound image for the detection and quantification of sonographic characteristics (hyperechoic foci, echo-pattern, echo-texture and anechoic areas). The device further provides detailed information with visualization of sonographic characteristics of thyroid nodules. | B-CAD System Version 1.0 solely on the results of B-CAD analysis. The ultrasound images displayed on B-CAD must not be used for primary diagnostic interpretation. B-CAD automatically segments and classifies shape and orientation characteristics of user-selected regions of interest (ROI) of breast ultrasound images. | The device highlights the potential polyps (of the colon) in 2D and 3 D image views. The results are displayed in the form of "CAD marks" on or near the potential polyps | The Q LAB software provide…