Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard image processing and viewing functions without mentioning AI, ML, or related concepts like deep learning, neural networks, or algorithms that learn from data.

Therapeutic

No.
The device is described as an "image processing system" intended to assist physicians in "diagnosis or treatment planning" by viewing, manipulating, communicating, and storing medical images. It does not perform any direct therapeutic action on a patient.

Diagnostic

Yes

The device is explicitly stated as being "intended to assist the physician in diagnosis or treatment planning," which falls under the definition of a diagnostic device. While it processes images and is not for primary mammography diagnosis, its purpose is to aid in the diagnostic process for other modalities.

SaMD (Software as a Medical Device)

Yes

The device description explicitly states it is a "set of software solutions" and describes its functions in terms of software operations on DICOM images. There is no mention of accompanying hardware components that are part of the regulated device.

IVD (In Vitro Diagnostic)

Based on the provided text, the Anythink device is not an IVD (In Vitro Diagnostic).

Here's why:

Definition of IVD: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue taken from the human body to detect diseases, conditions, or infections.
Anythink's Function: The Anythink is described as a "medical image processing system" that works with "multi-modality DICOM images." It focuses on viewing, manipulation, communication, and storage of these images.
No Mention of Biological Samples: The description does not mention the analysis of any biological samples (blood, urine, tissue, etc.). Its input is medical images.

Therefore, the Anythink falls under the category of medical imaging software or a picture archiving and communication system (PACS) component, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Anythink is a medical image processing system, which offers comprehensive solutions to viewing, manipulation, communication and storage of multi-modality DICOM images and data on exchange media.

The Anythink® is a universal imaging platform, and supports different modalities, but it is not intended for the displaying of digital mammography images for diagnosis in the U.S.

Product codes

LLZ

Device Description

The Anythink® is based on Windows XP, providing a set of software solutions with flexible configurations in accordance with different medical imaging missions and demands. The system accepts multi-modality DICOM images and allows for view, post-processing, and communication. This product is not intended for use with or for the primary diagnostic interpretation of mammography images in the U.S.

Due to specific customer requirements and the clinical focus, the Anythink® consists of two parts: Basic Functions and Optional Functions.

Basic functions are mandatory, allowing view, easy manipulation, storage and communication of DICOM formatted images, except in the case of mammography images. Management of patient information is also included.

Optional Functions are a set of professional image processing functions, designed for specific modalities. Depending on the precise requirement, customers can select the appropriate function(s) from the optional functions, under the precondition of installing Basic Functions.

The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices. The Anythink® is intended to assist the physician in diagnosis or treatment planning.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

multi-modality DICOM images
Specifically mentions CT or MRI image, XA coronary artery projection image, XA heart projection image, CTA image.

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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)

Not Found

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

Not Found

Predicate Device(s)

K072728

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

0

K131299
Page 1 of 11

510K Summary of safety and effectiveness

MAY 2 2 2013

This summary of 510(K) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.92

1. GENERAL INFORMATION

Establishment:	Beijing Crealife Technology Co., Ltd.
Address:	Room 519, Huitong Office Building
B20 Fuxing Road, Haidian District
Beijing, China 100036
Registration Number:	3006104453
Contact Person:	Weihua Zhou
Management Representative
Telephone:(0086)1088288713-6200
Fax: (0086)1088112709
Mobile :(0086)1013683004936

Date of Preparation of Summary: Jan. 16, 2013

Device Name:
·Trade Name:	Anythink® / Anythink PACS Workstation
Classification:	Picture Archiving and Communication System
Classification Panel:	Radiology
CRF Section:	21 CFR§892.2050
·Device Class:	Class II
·Product Code:	LLZ

1

SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING THE 2. SUBSTANTIAL EQUIVALENCE DETERMINATION

·Intended Use:

The Anythink is a medical image processing system, which offers comprehensive solutions to viewing, manipulation, communication and storage of multi-modality DICOM images and data on exchange media.

.

The Anythink® is a universal imaging platform, and supports different modalities, but it is not intended for the displaying of digital mammography images for diagnosis in the U.S.

· Device Description

The Anythink® is based on Windows XP, providing a set of software solutions with flexible configurations in accordance with different medical imaging missions and demands. The system accepts multi-modality DICOM images and allows for view, post-processing, and communication. This product is not intended for use with or for the primary diagnostic interpretation of mammography images in the U.S.

Due to specific customer requirements and the clinical focus, the Anythink® consists of two parts: Basic Functions and Optional Functions.

Basic functions are mandatory, allowing view, easy manipulation, storage and communication of DICOM formatted images, except in the case of mammography images. Management of patient information is also included.

Optional Functions are a set of professional image processing functions, designed for specific modalities. Depending on the precise requirement, customers can select the appropriate function(s) from the optional functions, under the precondition of installing Basic Functions.

The clinician retains the ultimate responsibility for making the pertinent diagnosis

2

based on their standard practices. The Anythink® is intended to assist the physician in diagnosis or treatment planning.

. .

· Technological characteristics

The Anythink® will be marketed as a software solution for the end user (with recommended hardware requirements). It will be installed by Crealife's service engineers. The Anythink® described supports DICOM formatted images, and the system is based on the Windows XP operating system.

· General Safety and effectiveness concerns

The Anythink® software is specified, validated and tested under a registered ISO13485 and 21 CFR Part820 compliant Quality System.

The device labeling contains instructions for use and any necessary cautions and warnings, to provide for safe and effective use of the device.

Risk Management is ensured via a Risk Analysis, which is used to identify potential hazards. These potential hazards are controlled via software development, verification and validation testing.

· Substantial Equivalence

The Anythink®, addressed in this premarket notification, is substantially equivalent to the following commercially available devices:

510K Number	Trade or Model Name	Manufacturer
K072728	Syngo Multimodality Workplace	Siemens AG Medical
Solutions

3

Function	Anythink	Description	Function
Hardware
requirement	CPU: Dual-core 2.8G
Hard disk: 250G
Memory: 4 GB
Monitor Driver: 19 inch LCD
The resolution is no less than 1280*1024
Video card: Nvidia serial video card, 1G video memory	Hardware
requirement	Type: FSC Celsius R640
Processor: 2 x 3.0 GHz Intel Xeon Dual core
RAM: 4 GB (upgradable to 12 GB)
System disk: 73 GB
Hard disk for image data: 147 GB
DVD writer: DVD-R, CD-R
DVD reader: DVD-ROM, CD-ROM
Floppy disk: 3,5", 1,4 MB
Graphics card: OpenGL graphics
Network: 2 x Gigabit Ethernet LAN on board
Monitors: Flat-screen color monitor, high end 19" and/or Flat screen monochrome monitor, high end
	CD Drive: DVD-RW
Input Device: Keyboard/Mouse
100M/1000M network card
Operating
system	Microsoft Windows XP		Operating
system	Windows XP	Offers consistent access to patient and exam data from all applications.
Patient
information
management	Provides creating new, editing and deleting patient information and other management functions, inquires and ranks patient information using key words; provides disk backup function and burns data to DICOM, AVI or MPEG format.		Archiving
and
Networking	DICOM Media Storage for data exchange on CD and DVD media.	Applicable for medical images from DICOM compliant sources, except digital mammography.

Technological characteristics comparison of the Anythink and predicate devices

.

4

| Function | Anythink
Description | Function | SIEMENS Syngo-Multimodality Workplace
Description |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Image
Browsing | Supports adjusting windows width/level by
hotkeys, presetting tools or manually;
single/multiple window display, switching images
within one series as well as among different series.
Image switching between various patients is also
available. | syngo
Viewing | Offers comprehensive functions for 2D processing
and image evaluation.

Multimodality display with a wide range of intuitive
tools.

Display and arrange the images in the way best
suited to the diagnostic task. |
| Image
Manipulation | Applicable for medical images from DICOM
compliant sources, except digital mammography,
can apply to image adjustment of different human
tissue, body position, to meet the requirements of
reading images.

Provides converting positive-negative image,
local/overall zoom, dying scheme, image flip
(vertical/horizontal), image rotate (+/- 90 degree);
image edge enhancement/ smoothing, image
measurement and annotation. | | Review, process and evaluate the results and prepare
them for supporting physician's diagnosis.

Send the images to syngo Filming, store them, or
send them to other locations in the hospital: |
| Image
Transmit | Applicable for medical images from DICOM
compliant sources, except digital mammography.
Supports image transformation between the system
and other DICOM devices and can input images
from disk to system; | Archiving
and
Networking | syngo offers DICOM functions such as receiving
and sending digital examinations and local data
exchange to media like CD-R or DVD as well as
connecting the syngo MultiModality Workplace to
the radiological network.. |

:

.

5

Function	Anythink	Description	Function	SIEMENS Syngo-Multimodality Workplace	Description
Image Storage	Provides six image/series storage function, allows saving current image to temporary area/clipboard/file/database, saving current image sequence as video file or back to database.
Applicable for medical images from DICOM compliant sources, except digital mammography.			DICOM Storage for data transfer and archiving to connected network nodes
DICOM Storage Commitment to confirm successful storage at destination
DICOM Query & Retrieve to search and access patient data on connected DICOM nodes
DICOM Print for documentation of images on DICOM-capable laser cameras and network printers
	/		3D
Basic	Processes volume datasets from various modalities as MIP, MPR, or SSD reformats, quickly and easily in routine use.
3D reconstruction (3D View)	Multiplanar Reconstruction MPR: Applicable for CT or MRI image, used for the 3D displaying of various tissue;
Max/Min Intensity projection MIP: Applicable for CT or MRI image, mainly used for 3D displaying of bone, angiosteosis and other high density tissue;
Shaded surface Display: Applicable for CT or MRI image, used for 3D display of bone, lung and other tissues;
Volume Rendering: Applicable for CT or MRI image, used for 3D display of various tissue;
Virtual Endoscopy: Applicable for CT or MRI image, used for 3D display internal wall of vessel and cavity		syngo
VRT	Displays CT, MR, NM, and conventional angiography volume datasets with excellent quality to the finest detail and provides advanced editing and provides advanced editing, including bone removal.
Volume Rendering Technique: 3D visualization of volume data.
Multi-modality application for CT, MR and 3D-XA data. Provides virtual endoluminal views of hollow structures
			Syngo Fly Through
	Anythink		SIEMENS Syngo-Multimodality Workplace
Function	Description	Function	Description
Edit 3D: Applicable for observing, selecting, measuring and annotating of 3D images	XA heart and coronary artery analysis	Quantitative Coronary artery analysis(QCA): Applicable for XA coronary artery projection image, mainly used for vessel stenosis analysis, calculating stenosis rate and other relevant parameters; Functional implementation method: defined analyze-needed vessel, segmentalize vessel outline, calculate reference vessel outline, calculate stenosis analysis parameter, carry on multiple stenosis analysis; this implementation process applies Live-wire algorithm. The function is under the precondition of installing Basic Functions.	syngo Angio (DSA)	syngo Angio (DSA)	Shifts DSA image processing of native and subtracted angiography series to the syngo MultiModality Workplace - the imaging system is freed immediately for the next acquisition.
			syngo QCA		Provides quantitative coronary vessel analysis, optimized for small vessels like coronary arteries.
Function	Anythink	Description	SIEMENS Syngo-Multimodality Workplace	Function	Description
	Left Ventricular functional Analysis(LVA):

Applicable for XA heart projection image, mainly
used for the analysis of the cardiac ejection
functional and wall motion; | Function implementation method: select
end-diastolic image, define the left ventricular
outline of end-diastolic; select end-systole image,
define the left ventricular outline of end-systole;
input patient's height, weight; calculate ejection
fraction and other heart functional parameters;
select wall movement analysis method (radial line
method, center line method) | • syngo LVA

Provides left ventricle analysis including e. g.
ejection fraction calculation and wall motion
analysis. | | |
| | | The function is under the precondition of installing
Basic Functions. | • syngo LVA biplane

Provides left ventricle analysis for simultaneous
biplane acquisitions. | | |
| | | | • syngo QVA

Provides quantitative vessel analysis for abdominal
and peripheral vessels. | | |
| Anythink | Description | Function | SIEMENS Syngo-Multimodality Workplace | Description | |
| Applicable for CT image, mainly used for analyzing coronary artery; | Implementation method: extracting and adjusting coronary artery tree in the CTA image, define single coronary artery vessel and vessel analysis in the 3D image. This function applies QCA calculation method. | syngo Circulation | syngo Circulation | Offers comprehensive cardiac and chest pain evaluation with integrated reporting in a single application. | |
| | The function is under the precondition of installing both Basic Functions and 3D View. | | • syngo Circulation QCA with Plaque Analysis | | |
| | | | | Allows fast coronary tree segmentation, accurate stenosis quantification, stent planning and plaque analysis. | |
| | | | • syngo Circulation LVA | | |
| | | | | Enables complete ventricular function evaluation in multiphase cardiac datasets. | |
| Applicable for CT image, an assistant tool to obtain the endoluminal view of the colon derived for the purpose to detect colonic lesions. It provides functionality for extracting colon image, endoluminal display of the colon, and marking suspected lesions.) | Implementation method: 3D panoramic view, unfolding colon and endoscope of extracting colon, analysis colon, display colon in the CTC image. Apply the VR+SSD. | syngo Colonography | syngo Colonography | Locates and evaluates colon polyps using non-invasive, real-time virtual 3D endoluminal viewing for CT datasets. | |
| | The function is under the precondition of installing | | | • syngo Colonography Polyp Enhanced Viewing (PEV) Supports as automated second reader tool the visualization of lesions. | |
| | | | | • syngo Colonography Unfolding Allows the user to unfold the colon for easier polyp visualization and navigation. | |

:

6

:

4-8

. .

.

7

:

.

. .

and the comments of the comments of

:

8

.

9

	Description	Function	Description
Anythink	Creates 3D models of coronary vessel segments with two projection images, providing image analysis and stent indications of 3D angiostenosis.	syngo IC3D	SIEMENS Syngo-Multimodality Workplace
Creates 3D models of coronary vessel segments for highly accurate quantification of lesions - stent size and length quantification with as few as two projection images.
	Applicable for XA projection image, mainly used for 3D quantitative analysis of vessel.	syngo IC3D
	Implementation method: select two vessel projection image of which the angle is between 60 and 120 degree, separately define perfusion vessel's stenosis information, stenosis vessel 3D display, stenosis parameter calculation, virtual stent display;
	This function is under the precondition of installing Basic Functions

IT-t

10

Page 11 of 11
K131299

Crealife, Beijing

· Conclusion as to Substantial Equivalence

The Anythink®, described in this premarket notification has the same intended use and similar technical characteristics as the device listed above.

In summary, the Anythink® does not introduce new indications for use, nor does the use of the device result in any new potential safety risks. The Anythink® is substantially equivalent to and performs as well as the predicate device.

11

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/11/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

May 22, 2013

Beijing Crealife Technology Co., Ltd. % Mr. Ned Devine Senior Staff Engineer Underwriters Laboratories, Inc. 333 Pfingsten Road NORTHBROOK IL 60062

Re: K131299

Trade/Device Name: Anythink PACS Workstation Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 16, 2013 Received: May 07, 2013

Dear Mr. Devine:

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. Ilisting 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.

12

Page 2 - Mr. Ned Devine

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

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm.

Sincerely yours,

Michael D. O'Hara for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

13

Indications for Use Form

K131299 510(k) Number (if known):

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The Anythink is a medical image processing system, which offers comprehensive solutions to viewing, manipulation, communication and storage of multi-modality DICOM images and data on exchange media.

The Anythink® is a universal imaging platform, and supports different modalities, but it is not intended for the displaying of digital mammography images for diagnosis in the U.S.

Prescription Use AND/OR Over-the-Counter Use --------(Part 21 CFR 801 Subpart D) .(21 CFR 801 Subpart C)

(Please do not write below this line - continue on another page if needed)

Concurrence of the CDRH, Office of In Vitro Diagnostics and Radiological

Health (OIR)

Machiel D. D'Hara

(Division Sign-Off)

Office of In Vitro Diagnostics and Radiological Health

K131299 ·

510(k) Number

Page 1 of 1