(270 days)
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.
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 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. The generated information by AmCAD-UO software device must not be used alone for primary diagnostic interpretation.
Here's a breakdown of the acceptance criteria and study information for AmCAD-UO based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Accuracy of ROI identification and quantification of airspace characteristics | Verified using phantom images under allowable parameter settings. |
| Correlation between AmCAD-UO measurements and MRI measurements (for airway width) | Significant correlation observed; a larger airway width measured by one method was also observed larger by the other. |
| Ability to visualize and quantify airway in terms of size, position, and enhancement pattern | Demonstrated through the study. |
| Software meets all functional and specifications for its indication for use | Confirmed through software unit test, software integration test, and software system test. |
| No direct safety or health risk caused by, or related to, the use of the device | Stated to be confirmed by risk assessment and safety/effectiveness documentation. |
2. Sample size used for the test set and the data provenance:
- Sample Size: "very limited sample size of human subjects." (Specific number not provided)
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The comparison was performed against MRI measurements, implying real human subject data, not synthetic or phantom data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not provided in the document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- A MRMC comparative effectiveness study was not mentioned in the document. The study described focused on the device's performance against MRI measurements, not on human reader improvement with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance evaluation was done. The study "validated the performance of the AmCAD-UO for its intended use" by comparing its measurements against MRI. The device's output "must not be used alone for primary diagnostic interpretation," implying it's an analysis tool, but its performance was assessed independently as a measurement tool.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Magnetic Resonance Imaging (MRI) measurements were used as a comparative "ground truth" or reference standard for airway width.
8. The sample size for the training set:
- The document does not specify the sample size for the training set. It only mentions that the software's design is "Based on Statistical Pattern Recognition and Quantification method of airway."
9. How the ground truth for the training set was established:
- The document does not provide details on how the ground truth for the training set was established. It describes the software's methodology as "Statistical Pattern Recognition and Quantification method of airway," which implies a training process, but the specifics of ground truth generation for that training are not mentioned.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 28, 2018
AmCad BioMed Corporation % Chiu Lin President Lin & Associates, LLC 5614 Johnson Ave BETHESDA, MD 20817
Re: K180867
Trade/Device Name: AmCAD-UO Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: LLZ Dated: November 23, 2018 Received: November 28, 2018
Dear Chiu Lin:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
{1}------------------------------------------------
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Hole 2. Nils
for Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K180867
Device Name AmCAD-UO
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the logo and contact information for AmCad BioMed Corporation. The logo features a stylized blue "A" with a "C" inside. Below the logo is the company name in both Chinese and English. The address is listed as FL.3, NO.167, Fu Hsing N. RD., Taipei 105, Taiwan, ROC, and the telephone number is +886-2-27136227, while the fax number is +886-2-27152181.
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.3, NO.167, Fu Hsing N. RD., Taipei 105, Taiwan, R.O.C. |
| Phone: | 886-2-2713-6227 |
| Fax: | 886-2-2715-2181 |
| Contact: | Jack Yang |
| Title: | Vice President |
| Phone: | 886-2-2713-6227 ext.2358 |
| Fax: | 886-2-2715-2181 |
| Email: | jack.yang@amcad.com.tw |
| Manufacturer: | AmCad BioMed Corporation |
| US Agent and Contact: | Chiu S. Lin, Ph.D.Lin & Associates, LLC |
| Address: | 5614 Johnson AvenueBethesda, MD 20817 |
| Phone: | (301) 591-3895 |
| E-mail: | cslin@lin-associates.com |
| Date prepared: | March 28, 2018 |
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the logo and contact information for AmCad BioMed Corporation. The logo features a stylized blue "A" with a white "C" inside. Below the logo is the company name in both Chinese and English. The contact information includes the address: FL.3, NO.167, Fu Hsing N. RD., Taipei 105, Taiwan, ROC, as well as the telephone number: +886-2-27136227 and fax number: +886-2-27152181.
5.2 Identification of Product
| Device Trade Name: | AmCAD-UO |
|---|---|
| Version number: | 1.0 |
| Model number: | UO-0102 |
| Common and Usual Name: | Picture Archiving and Communications System |
| Device Classification Name: | Picture Archiving and Communications System |
| Regulation Number: | 21 CFR 892.2050 |
| Classification Product Code: | LLZ |
| Classification: | Class II |
| Classification Panel: | Radiology |
| Manufacturer: | AmCad BioMed Corporation |
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the logo and contact information for AmCad BioMed Corporation. The logo features a stylized blue "C" shape. The text includes the company name in both Chinese and English, followed by the address: FL.3, NO.167, Fu Hsing N. RD., Taipei 105, Taiwan, ROC. The telephone number is +886-2-27136227 and the fax number is +886-2-27152181.
5.3 Predicate Device
This subject software medical device is substantially equivalent to the devices listed below:
Primary Predicate Device Model: IQQA-Body Imaging Software Manufacturer: EDDA Technology, Inc. 510(k) Number: K141745
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the logo and contact information for AmCad BioMed Corporation. The logo features a stylized blue "A" with a "C" inside. Below the logo is the company name in both Chinese and English. The address is listed as FL.3, NO.167, Fu Hsing N. RD., Taipei 105, Taiwan, ROC, and the telephone number is +886-2-27136227, while the fax number is +886-2-27152181.
5.4 Device Description
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 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. The generated information by AmCAD-UO software device must not be used alone for primary diagnostic interpretation.
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the logo and contact information for AmCad BioMed Corporation. The logo features a stylized blue "C" inside a square shape. Below the logo is the company name in both Chinese and English, followed by the address: FL.3, NO.167, Fu Hsing N. RD., Taipei 105, Taiwan, ROC. The telephone number is +886-2-27136227 and the fax number is +886-2-27152181.
5.5 Indications for Use
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.
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image shows the logo and contact information for AmCad BioMed Corporation. The logo features a stylized blue "A" with a circle inside. Below the logo is the company name in both Chinese and English. The contact information includes the address: FL.3, NO.167, Fu Hsing N. RD., Taipei 105, Taiwan, ROC, as well as the telephone number: +886-2-27136227 and fax number: +886-2-27152181.
5.6 Comparison with Predicate Devices
The proposed device has different technological characteristics in software design and input images used for analysis, as compared to the predicate device. AmCAD-UO provides the function to review the pharyngeal/upper airway ultrasonic images and analyze the airway characterizes (i.e. size, position and enhancement pattern) based on the statistical pattern recognition and quantification methods. While, the predicate device, IQQA-Body Imaging Software, provides regional volumetric analysis for vascular/ductal/airway structure derived from CT and MR images. Although AmCAD-UO has the above described differences in technological characteristics, as compared to the predicate devices, it does not raise new types of safety or effectiveness questions.
This software, AmCAD-UO is substantially equivalent to the predicate device as described in table 5.6.1.
| Device | Proposed Device | Predicate Device |
|---|---|---|
| AmCAD-UO | IQQA-Body Imaging Software | |
| Manufacturer | AmCad BioMed Corp. | EDDA Technology, Inc. |
| 510(k) Number | K180867 | K141745 |
| Device Common Name | Picture archiving andcommunications system | Same |
| Regulation Number | 21 CFR 892.2050 - Class II | Same |
| Regulation Name | Picture archiving andcommunications system | Same |
| Product Code | LLZ | Same |
| Indications for Use | AmCAD-UO is a PC-based,self-contained, non-invasive imageanalysis software application forreviewing the pharyngeal/upperairway ultrasonic image acquiredfrom an FDA-cleared ultrasoundsystem. The software is designed tosupport visualization and | IQQA-BodyImaging Software is aPC-based, self-contained,non-invasive image analysis softwareapplication for reviewing bodyimaging studies (including thoracic,abdominal, and pelvic) derived fromCT and MR scanners. Combiningimage viewing, processing andreporting tools, the software isdesigned to support the visualization, |
| Device | Proposed Device | Predicate Device |
| AmCAD-UO | IQQA-Body Imaging Software | |
| quantification of the airwaysonographic characteristics. Thesoftware also provides tools formanual or interactive selection ofRegion of Interest to allow foranalysis of the airway in terms of itssize, position and enhancementpattern. This analysis providesinformation for physician's evaluationand monitoring of the airway state. | evaluation and reporting of bodyimaging studies andphysician-identified lesions.The software supports a workflowbased on automated imageregistration for viewing and analyzingmultiphase and multiple time-pointvolume datasets. It includes tools forinteractive segmentation and labelingof organ segments andvascular/ductal/airway structures.The software provides functionalitiesfor manual or interactivesegmentation of physician-identifiedlesions, interactive definition ofvirtual resection plane and virtualneedle path, and allows for regionalvolumetric analysis of such lesions interms of size, position, margin, andenhancement pattern, providinginformation for physician's evaluationand treatment planning, monitoring,and follow-up.The software is designed for use bytrained professionals, includingphysicians and technicians. Imagesource: DICOM. | |
| Functional Capability | The software is designed to supportvisualization and quantification of theairway sonographic characteristics.The software also provides tools formanual or interactive selection ofRegion of Interest to allow foranalysis of the airway in terms of itssize, position and enhancementpattern. This analysis providesinformation for physician's evaluationand monitoring of the airway state. | Combining image viewing, processingand reporting tools, the software isdesigned to support the visualization,evaluation and reporting of bodyimaging studies andphysician-identified lesions.The software supports a workflowbased on automated imageregistration for viewing and analyzingmultiphase and multiple time-pointvolume datasets. It includes tools forinteractive segmentation and labelingof organ segments and |
Table 5.6.1 - The substantial equivalence comparison table
{9}------------------------------------------------
Image /page/9/Picture/4 description: The image shows the logo and contact information for AmCad BioMed Corporation. The logo features a blue stylized "A" with a "C" inside. Below the logo is the company name in both Chinese and English. The address is listed as FL.3, NO.167, Fu Hsing N. RD., Taipei 105, Taiwan, ROC, and the telephone number is +886-2-27136227, while the fax number is +886-2-27152181.
Tel: +886-2-27136227 Fax: +886-2-27152181
{10}------------------------------------------------
| © 安克生醫股份有限公司 | |
|---|---|
| -------------- | -- |
AmCad BioMed Corporation
Tel: +886-2-27136227 Fax: +886-2-2715218
| Device | Proposed Device | Predicate Device |
|---|---|---|
| AmCAD-UO | IQQA-Body Imaging Software | |
| vascular/ductal/airway structures.The software provides functionalitiesfor manual or interactivesegmentation of physician-identifiedlesions, interactive definition ofvirtual resection plane and virtualneedle path, and allows for regionalvolumetric analysis of such lesions interms of size, position, margin, andenhancement pattern, providinginformation for physician's evaluationand treatment planning, monitoring,and follow-up.The software is designed for use bytrained professionals, includingphysicians and technicians. Imagesource: DICOM. | ||
| Input (format) | B-mode dynamic ultrasound image | Digital CT and MR Image data |
| Output (format) | The software can provide analysisinformation of the airway in terms ofits size, position and enhancementpattern to physicians in evaluatingand monitoring the airway state. | The software provides functionalitiesfor manual or interactivesegmentation of physician-identifiedlesions, interactive definition ofvirtual resection plane and virtualneedle path, and allows for regionalvolumetric analysis ofphysician-identified lesions or organsegments and vascular/ductal/airwaystructures in terms of size, position,margin, and enhancement pattern,providing information for physician'sevaluation and treatment planning, |
| Device | Proposed Device | Predicate Device |
| AmCAD-UO | IQQA-Body Imaging Software | |
| Example | Image: AmCAD-UO | Image: IQQA-Body Imaging Software |
| Tools provided by thedevice | The software also provides tools formanual or interactive selection ofRegion of Interest to allow foranalysis of the airway in terms of itssize, position and enhancementpattern with ultrasound images. | The software also provides tools forinteractive segmentation and labelingof organ segments andvascular/ductal/airway structureswith CT/MR images. |
| Software Design | Based on Statistical PatternRecognition and Quantificationmethod of airway. | Based on regional volumetric analysisof such lesions and organs |
| Operating System | Standard PC operating system | Same |
{11}------------------------------------------------
Image /page/11/Picture/0 description: The image contains the logo of Anke BioMedical Co., Ltd. The logo consists of a blue circular shape with a white "C" inside, followed by the company's name in traditional Chinese characters. The text reads "安克生醫股份有限公司", which translates to "Anke BioMedical Co., Ltd."
Tel: +886-2-27136227 Fax: +886-2-27152181
{12}------------------------------------------------
Image /page/12/Picture/0 description: The image displays the logo and contact information for AmCad BioMed Corporation. The logo features a stylized blue "A" with a "C" inside. Below the logo is the company name in both Chinese and English. The address is listed as FL.3, NO.167, Fu Hsing N. RD., Taipei 105, Taiwan, ROC, and the telephone number is +886-2-27136227, while the fax number is +886-2-27152181.
5.7 Performance Standards
No performance standards for PACS systems or components have been issued under the authority of Section 514.
5.8 General Safety and Effectiveness Concerns
Software development for the AmCAD-UO follows documented processes for software design, verification and validation testing. A risk assessment has been completed to identify potential design hazards that could cause an error or injurv based on the use of the quantification results. Appropriate steps have been taken to control all identified risks for this type of image viewing and quantification device. The device labeling contains operating instructions for use and necessary warnings and notes to provide the safe and effective use of the AmCAD-UO.
5.9 Summary of Performance Data to Support Substantial Equivalence
AmCad BioMed Corporation has conducted the software verification testing and performance validation testing to evaluate the safety and effectiveness of AmCAD-UO and to validate the performance of the AmCAD-UO for its intended use. The software verification testing, including software unit test, software integration test, and software system test, was performed to ensure that AmCAD-UO meets all functional and specifications for its indication for use. Phantom images were created to verify the accuracy of the region of interest (ROI) identification and the quantification of the airspace characteristics by the software under allowable ranges of parameter settings. AmCAD-UO performance was also validated through clinical assessment with a very limited sample size of human subjects. Comparison was performed against MRI measurements. It was found that the two measurement methods exhibit a significant correlation, i.e., a larger airway width measured in one method should be also observed larger in the other method. However, we are not able to conclude from the study, due to the small sample size and the systematic difference between the two imaging modalities, that the two measurement methods fully agree with each other.
{13}------------------------------------------------
Image /page/13/Picture/0 description: The image shows the logo and contact information for AmCad BioMed Corporation. The logo features a stylized blue "C" shape. Below the logo is the company name in both Chinese and English. The address is listed as FL.3, NO.167, Fu Hsing N. RD., Taipei 105, Taiwan, ROC, and the telephone number is +886-2-27136227, while the fax number is +886-2-27152181.
AmCAD-UO 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. The results demonstrated that AmCAD-UO can be used to visualize and quantify the airway in terms of its size, position and enhancement pattern. The analyzed images displayed on AmCAD-UO must not be used alone for primary diagnostic interpretation.
{14}------------------------------------------------
Image /page/14/Picture/0 description: The image shows the logo and contact information for AmCad BioMed Corporation. The logo features a stylized blue "A" with a "C" inside. Below the logo is the company name in both Chinese and English. The address is listed as FL.3, NO.167, Fu Hsing N. RD., Taipei 105, Taiwan, ROC, and the telephone number is +886-2-27136227, while the fax number is +886-2-27152181.
5.10 Conclusions
The software development for AmCAD-UO followed documented processes for software design, verification testing, and validation testing. A risk assessment has been completed to identify potential design hazards that could cause an error or injury based on the use of the quantification results. Appropriate steps have been taken to control all identified risks for the device. There is no known direct safety or health risk caused by, or related to, the use of the device. The safety and effectiveness of the device has been described in the verification and validation document.
The data presented in this 510(k) application demonstrates that the proposed device, AmCAD-UO, is as safe and effective as the predicate device. The intended use of AmCAD-UO is similar to the predicate device. The technological differences do not raise any new questions regarding the safety and effectiveness of the device. Thus, AmCAD-UO is substantially equivalent to the predicate device as a software device intended to view and analyze airway structures of ultrasound image. Both devices are classified as Picture Archiving and Communication Systems, 21 CFR 892.2050.
§ 892.2050 Medical image management and processing system.
(a)
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.(b)
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).