K Number

Device Name

FACT Medical Imaging Sysytem

Manufacturer

Dexin Medical Imaging Technology Co., Ltd.

Date Cleared

2015-09-02

(258 days)

Product Code

LLZ

Regulation Number

892.2050

Intended Use

The FACT Medical Imaging System is a medical software application that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. The FACT Medical Imaging System is not meant for primary image interpretation in mammography. In addition, the FACT Medical Imaging System has the following indications: (1) Pulmonary Review and Analysis Application Pulmonary Review and Analysis application is an option that is intended for supporting physicians in the diagnosis and documentation of pulmonary tissue images (e.g., abnormalities) from pulmonary CT images. Three-Dimensional segmentation and isolation of sub-compartments, volumetric analysis, density evaluations, and reporting tools are combined with a dedicated workflow. The automated image registration facilitates the synchronous display and navigation of multiple datasets for viewing data and easy follow-up comparison. The summary report of findings helps the user to track findings and note changes, such as shape, size, or overtime. (2) Vessel Review and Analysis Application Vessel Review and Analysis application is an option intended for viewing the anatomy and pathology of a patient's coronary arteries. Physicians can select any artery to view the following anatomical references: the highlighted vessel in 3D, curved MPR vessel view, and straightened MPR view with cross sections of the vessel. Physicians can semi-automatically stenosis measurements, and maximum and minimum lumen diameters. In addition, physicians can also measure vessel dimensions along the centerline in curved MPR view and examine Hounsfield unit or signal intensity statistics.

Device Description

The FACT Medical Imaging System is self-contained, non-invasive medical image processing software. It can be marketed as software only, as well as packaged with standard off-the-shelf PC hardware. It can operate as a stand-alone workstation or in a distributed server-client configuration across a computer network. The FACT Medical Imaging System allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. This device addresses physicians' needs through various application options for pulmonary and vessel applications.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K071331, K120484, K083227

Reference Devices

K071331, K120484, K083227

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes standard image processing techniques like segmentation, volumetric analysis, density evaluations, and automated image registration. There is no mention of AI, ML, or related terms, nor are there descriptions of training or test sets typically associated with AI/ML development.

Therapeutic

No
The device is described as medical imaging software used for processing, review, and analysis of multi-dimensional digital images. Its intended use is to support diagnosis and documentation, not to provide therapy directly.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states that the Pulmonary Review and Analysis application is "intended for supporting physicians in the diagnosis and documentation of pulmonary tissue images". Similarly, the Vessel Review and Analysis application helps physicians examine "anatomy and pathology."

SaMD (Software as a Medical Device)

Yes

The device description explicitly states it "can be marketed as software only". While it can also be packaged with hardware, the option for software-only marketing and operation as a standalone workstation or in a distributed configuration supports its classification as a software-only medical device.

IVD (In Vitro Diagnostic)

Based on the provided information, the FACT Medical Imaging System is not an In Vitro Diagnostic (IVD).

Here's why:

IVDs analyze samples taken from the human body (like blood, urine, tissue). The FACT Medical Imaging System processes and analyzes images acquired from imaging devices (like CT scans).
The intended use and device description clearly state its function is image processing, review, and analysis. It works with digital images, not biological samples.
The anatomical sites mentioned (pulmonary tissue, coronary arteries) are the subjects of the imaging, not the source of a sample for analysis.

Therefore, the FACT Medical Imaging System falls under the category of medical imaging software, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

(1) Pulmonary Review and Analysis Application
Pulmonary Review and Analysis application is an option that is intended for supporting physicians in the diagnosis and documentation of pulmonary tissue images (e.g., abnormalities) from pulmonary CT images. Three-Dimensional segmentation and isolation of sub-compartments, volumetric analysis, density evaluations, and reporting tools are combined with a dedicated workflow.

The automated image registration facilitates the synchronous display and navigation of multiple datasets for viewing data and easy follow-up comparison. The summary report of findings helps the user to track findings and note changes, such as shape, size, or overtime.

(2) Vessel Review and Analysis Application
Vessel Review and Analysis application is an option intended for viewing the anatomy and pathology of a patient's coronary arteries.

Physicians can select any artery to view the following anatomical references: the highlighted vessel in 3D, curved MPR vessel view, and straightened MPR view with cross sections of the vessel. Physicians can semi-automatically stenosis measurements, and maximum and minimum lumen diameters. In addition, physicians can also measure vessel dimensions along the centerline in curved MPR view and examine Hounsfield unit or signal intensity statistics.

Product codes

LLZ

Device Description

The FACT Medical Imaging System allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. This device addresses physicians' needs through various application options for pulmonary and vessel applications.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

CT images

Anatomical Site

Pulmonary tissue, coronary arteries

Indicated Patient Age Range

No restriction

Intended User / Care Setting

trained professional-s

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)

Functional test, Functional regression test, Performance test, Portability test, Graphical user interface test, Usability test, Interoperability test, Measurement accuracy evaluation and validation: Accuracy of pulmonary segmentation and measurements, Accuracy of fissure seqmentation and measurements, Accuracy of airway segmentation and measurements, Accuracy of vessel segmentation and measurements.
Test results showed that all tests successfully passed.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K071331, K120484, K083227

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other and are connected by a flowing line.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 2, 2015

Dexin Medical Imaging Technology Co., Ltd. % Mr. Leon Lu Director of Ouality and Regulatory Affairs MEDevice Services. LLC 3500 South Dupont Highway DOVER DE 19901

Re: K143586

Trade/Device Name: FACT Medical Imaging System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 18, 2015 Received: August 4, 2015

Dear Mr. Lu:

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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael O'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K143586

Device Name

FACT Medical Imaging System

Indications for Use (Describe)

(1) Pulmonary Review and Analysis Application

Pulmonary Review and Analysis application is an option that is intended for supporting physicians in the diagnosis and documentation of pulmonary tissue images (e.g., abnormalities) from pulmonary CT images. Three-Dimensional segmentation and isolation of sub-compartments, volumetric analysis, density evaluations, and reporting tools are combined with a dedicated workflow.

(2) Vessel Review and Analysis Application

Vessel Review and Analysis application is an option intended for viewing the anatomy and pathology of a patient's coronary arteries.

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)

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510(k) Summary

Summary Prepared Date: 8/28/2015

Submission Sponsor (Manufacturer):

Dexin Medical Imaging Technology Co., Ltd. 227 Chongye Street, Weinan High-tech Zone, Weinan, Shaanxi, China 714000

Contact Person Name: Wanq, Yu Title: QA Manager

Submission Correspondent (Agent):

Mr. Anthony Hopkins Regulatory Affairs Specialist

Mr. Leon Lu Director of Quality and Regulatory Affairs

MEDevice Services, LLC 3500 South Dupont Highway Dover, Delaware 19901 USA Email: info@medeviceservices.com www.medeviceservices.com

MEDevice China, Ltd. 12F Weiya Building, No.29 Suzhou Street, Haidian District Beijing, China 100080 Email: info@medevicechina.com www.medevicechina.com

Trade/Device Name: FACT Medical Imaging System

Device Class: II Classification Name: Medical Image Processing Software Regulation Number: 21 CFR. 892.2050

Product Code: LLZ Review Panel: Radiology Predicate Device:

K071331 . Vital Images, Inc. Vitrea, version 4.0 Medical Image processing Software
K120484 . Mevis Medical Solutions Visia™ Oncology
K083227 . VIDA Diagnostics VIDA Pulmonary Workstation 2 (PW2)

Device Description:

Over the counter use: No Duration and type of contact: N/A Single use: No Sterile: No

Indication for Use:

The FACT Medical Imaging System is a medical software application that allows the processing, review, analysis, communication and media interchange of multidimensional digital images acquired from a variety of imaging devices. The FACT Medical Imaging System is not meant for primary image interpretation in mammography.

In addition. the FACT Medical Imaging System has the following indications:

(1) Pulmonary Review and Analysis Application

Pulmonary Review and Analysis application is an option that is intended for supporting physicians in the diagnosis and documentation of pulmonary tissue images (e.g., abnormalities) from pulmonary CT images. Three-Dimensional seqmentation and isolation of sub-compartments, volumetric analysis, density evaluations, and reporting tools are combined with a dedicated workflow.

(2) Vessel Review and Analysis Application

Vessel Review and Analysis application is an option intended for viewing the anatomy and pathology of a patient's coronary arteries.

Software Development:

The FACT Medical Imaging System was designed, developed, tested and validated according to written procedures. These procedures specify individuals within the orqanization responsible for developing and approving product specifications, coding and testing, validation testing and maintenance.

Comparison to Predicate Devices:

Indications For Use Statement
		Subject Device	Predicate
Device 1	Predicate Device
2	Predicate Device 4	Discussion
		FACT Medical
Imaging System	Vitrea, version
4.0	Visia™ Oncology	VIDA Pulmonary
Workstation 2 (PW2)	N/A
1	Acquiring images from a
variety of imaging devices	Same	Same	Same	Similar	Same
2	Processing, review,
analysis, communication
and media interchange of
multi-dimensional digital
images	Same	Same	Same	Similar	Same
3	To be used for supporting
physicians in the
diagnosis and
documentation of
pulmonary tissue images
(e.g., abnormalities) from
pulmonary CT images.	Same	None	Similar	Same	Same
4	To be used for viewing
the anatomy and
pathology of a patient's
coronary arteries	Same	Same	None	None	Same
			Standards Met
		Subject Device	Predicate
Device 1	Predicate Device
2	Predicate Device 4	Discussion
		FACT Medical
Imaging System	Vitrea, version
4.0	Visia™ Oncology	VIDA Pulmonary
Workstation 2 (PW2)	N/A
5	Conforms to the essential
requirements of the
DICOM standard for data
exchange (PS 3.3 - PS
3.12)	Same	Same	Same	Same	Same
			Design
		Subject Device	Predicate
Device 1	Predicate Device
2	Predicate Device 4	Discussion
		FACT Medical
Imaging System	Vitrea, version
4.0	Visia™ Oncology	VIDA Pulmonary
Workstation 2 (PW2)	N/A
6	Software device that
operates on off-the-shelf
hardware	Same	Same	Same	Same	Same
7	Device is a system
composed of multiple
components that work
stand-alone and in
concert	Same	Same	Same	Partial, stand-alone
only	Same
8	Web-based client	Same	None	None	None	N/A.
But this
web-based
feature has
been
included by
many
PACS, such
as K131424
(Product
name:
miPlatform
medical
imaging
suite,
Company
name:
Hinacom
						Software
and
Technology
Ltd. Co.).
This new
feature
						won't affect
the safety
and
effectivenes
s of the
						subject
device.
9	Operating System	Windows	Windows	Windows	Linux	Same
		Functions and Capabilities - General Functions
		Subject Device	Predicate
Device 1	Predicate Device
2	Predicate Device 4	Discussion
		FACT Medical
Imaging System	Vitrea, version
4.0	Visia™ Oncology	VIDA Pulmonary
Workstation 2 (PW2)	N/A
10	DICOM Image Import/
Export (Support DICOM
Storage, Query/Retrieve,
and Print)	Same	Same	Same	Partial, PW2 support
DICOM Image
Import	Same
11	Present a study list	Same	Same	Same	Same	Same
12	2D image reading
(Support image
annotation, measurement
and cine)	Same	Same	Same	Same	Same
13	Synchronized stacking	Same	Same	Same	None	Same
14	3D visualization (Support
MPR, MIP, volume
rendering)	Same	Same	Same	Same	Same
	Functions and Capabilities - Pulmonary Review and Analysis Application
		Subject Device	Predicate
Device 1	Predicate Device
2	Predicate Device 4	Discussion
		FACT Medical
Imaging System	Vitrea, version
4.0	Visia™ Oncology	VIDA Pulmonary
Workstation 2 (PW2)	N/A
15	Segmentation of left /
right lungs	Same	None	Same	Same	Same
16	Segmentation of
pulmonary fissures/ lobes	Same	None	None	Same	Same
17	Segmentation of
pulmonary airways tree	Same	None	Same	Same	Same
18	Segmentation of
pulmonary vessels	Same	None	Same	Same	Same
19	Segmentation of
suspicious nodules	Same	None	Same	None	Same
20	Export reports (including
key image and
measurement )	Same	Same	Same	Partial. Export
measure-ment only	Same
21	Automated image
registration of two
datasets for follow-up
comparison	Same	None	Same	None	Same
22	Virtual fly-through the
airways	Same	None	None	Same	Same
23	3D visualization of
pulmonary sub-
compartments	Same	None	Same	Same	Same
24	Volumetric analysis
(Support size, density,
volume)	Same	None	Same	Same	Same
25	airway lumen and wall
thickness measurements	Same	None	None	Same	Same
		Functions and Capabilities - Vessel Review and Analysis Application
		Subject Device	Predicate
Device 1	Predicate Device
2	Predicate Device 4	Discussion
26	Segmentation of coronary
vessels	Same	Same	None	None	Same
27	3D visualization of
coronary vessels	Same	Same	None	None	Same
28	Vessel centerline review	Same	Same	None	None	Same
29	Curved MPR vessel view	Same	Same	None	None	Same
30	Measurement of vessel
dimensions	Same	Same	None	None	Same
31	Measurement of stenosis	Same	Same	None	None	Same
32	Exporting reports	Same	Same	None	None	Same
Other Areas of Comparison
		Subject Device	Predicate
Device 1	Predicate Device
2	Predicate Device 4	Discussion
		FACT Medical
Imaging System	Vitrea, version
4.0	Visia™ Oncology	VIDA Pulmonary
Workstation 2 (PW2)	N/A
33	Target population	No restriction	Same	Same	Same	Same
34	Intended user	to be used by
trained
professional-s
only	Same	Same	Same	Same
35	Energy used and/or
delivered	Electric power
supply to
computer
hardware only	Same	Same	Same	Same
36	Materials	N/A	N/A	N/A	N/A	N/A
37	Biocompatibility	N/A	N/A	N/A	N/A	N/A
38	Compatibility with
environment and other
devices	Interoperation
with other
devices based
on consensus
standards on
data exchange
(DICOM)	Same	Same	No direct interface
with any CT or data
collection equipment	Same

Section5 510(k) Summary

The proposed FACT Medical Imaging System has similar intended use as the predicate devices, Vitrea Medical Image processing software (K071331), Visia™ Oncology (K120484), and VIDA Pulmonary Workstation 2 (PW2) (K083227).

The FACT Medical Imaging System is similar in overall design, principal of operation and configuration compared to the predicate devices. These devices are medical application software and they all provide 2D & 3D image visualization and manipulation tools for medical image analysis.

The FACT Medical Imaging System and its predicate device, Vitrea Medical Image processing software, both allow for the analysis, communication and media interchange of digital images acquired from a variety of acquisition devices, support the DICOM protocol for communication of images with other medical imaging devices, and support the workflows, UI, and functions for vessel analysis scope.

The FACT Medical Imaging System and its predicate devices, Visia™ Oncology and VIDA Pulmonary Workstation 2 (PW2) support the workflows, UI, and functions for pulmonary analysis scope.

No new issues of safety or effectiveness are introduced by using this proposed device. In summary, this proposed device is substantially equivalent to the predicate devices in the areas of technical characteristics, general function, application, and intended use. This device does not raise any new potential safety risks and is equivalent in performance to the predication devices.

Discussion of Non-Clinical Tests Performed:

The following non-clinical tests have been performed:

Functional test ●
Functional regression test ●
Performance test ●
Portability test ●
Graphical user interface test ●
Usability test ●
Interoperability test ●
Measurement accuracy evaluation and validation: ●
- Accuracy of pulmonary segmentation and measurements
- Accuracy of fissure seqmentation and measurements
- Accuracy of airway segmentation and measurements
- Accuracy of vessel segmentation and measurements

The FACT Medical Imaging System was tested successfully with reference to its Software Requirements Specification, as well as design verification and validation documents and Traceability Matrix document. Verification, validation, and testing activities established the performance, functionality, and reliability characteristics of this device, which is found to be safe and effective and substantially equivalent to the currently-cleared predication devices. Pass/Fail criteria were based on the requirements and intended use of the proposed device. Test results showed that all tests successfully passed.

Discussion of Clinical Tests Performed:

None

General Safety and Effectiveness Concerns:

The device labeling contains instructions for use and any necessary cautions and warnings, to provide for safe and effective use of the device. It is the user's responsibility to ensure that display quality, environmental lighting and other

possible distractions are consistent with the clinical environment. The hardware components specified are all 'off the shelf' computer components.

Conclusion:

The proposed device is as safe and effective as the predicate devices. The proposed device has the same intended uses and indications, similar technological characteristics, and principles of operation as its predicate device. The minor differences between the proposed device and its predicate devices raise no new issues of safety or effectiveness. Thus, the proposed device is considered to be substantially equivalent to its predicate devices.