IMAGESVR PACS

K082808 · Jaguar Technology Limited · LLZ · Jan 9, 2009 · Radiology

Device Facts

• Record ID: K082808
• Device Name: IMAGESVR PACS
• Applicant: Jaguar Technology Limited
• Product Code: LLZ · Radiology
• Decision Date: Jan 9, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The ImageSVR PACS is intended for the manipulation, management, and display of medical images. It can manage and display images from different modalities and interfaces and can distribute those images to various workstation, image storage and printing devices using DICOM or similar standards. Typical users of this system are trained medical professionals, including physicians, nurses, technicians and computer system professionals. To support the diagnostic interpretation of mammography studies, ImageSVR PACS will display the full fidelity DICOM image in a non-compressed format. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5Mpixel resolution and meets other technical specifications reviewed and accepted by FDA. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretation.

Device Story

ImageSVR PACS is a client-server software system for archiving, retrieving, and displaying medical images. It ingests images from various modalities via DICOM or similar standards; manages storage; and distributes images to workstations and printing devices. Used in clinical settings by physicians, nurses, and technicians. The system displays images for diagnostic interpretation; for mammography, it requires non-compressed, full-fidelity DICOM images and FDA-approved 5Mpixel monitors. It does not contact patients or control life-sustaining equipment; clinical decisions rely on human interpretation of displayed data.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Software server application; client-server architecture. Supports DICOM and similar standards for image distribution. Does not contact patients. Requires 5Mpixel resolution monitors for mammography interpretation. Software validation performed.

Indications for Use

Indicated for use by trained medical professionals (physicians, nurses, technicians) for manipulation, management, and display of medical images from various modalities. Supports diagnostic interpretation of mammography studies using non-compressed, full-fidelity DICOM images on FDA-approved 5Mpixel monitors. Contraindicated for primary diagnosis or interpretation of lossy compressed mammographic images or digitized film screen images.

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

• Taiwan Electronics Data Processing Corporation Smart PACS (K022710)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Jaguar Technology. The logo consists of the letters 'JTF' stacked on top of each other in a stylized, blocky font. Below the logo, the words 'jaguar technology' are written in a smaller, sans-serif font.

#### Limited Technology Jaguar

19F-7, No.378, Sec. 1, Wunsin Rd., Nantun District, Taichung City 408, Taiwan R.O.C.

tel:[phone] fax:[phone] www.jaguartech.com.tw

| | 2. ADMINISTRATIVE INFORMATION | K082808 |
|--------------------------|-------------------------------------------------------------------------|--------------|
| | 2.1 510(k) Summary of Safety and Effectiveness | JAN - 9 2009 |
| | (Per 21 CFR 807.92) | |
| | General Information Establishment | |
| Manufacturer: | Jaguar Technology Limited | |
| Address: | 19F-7, No.378, Sec.1, Wusin Rd., Nantun District, Taichung City, 40862, | |
| Taiwan, ROC | | |
| Owner Number: | 10026627 | |
| Contact Person: | Dr. Jen, Ke-Min E-mail: [e-mail] | |
| (official correspondent) | 886-3-5208829 (Tel); 886-3-5209783 (Fax) | |
| Address: | No.58, Fu Chiun Street, Hsin Chu City, 30067, Taiwan, ROC | |
| Date Prepared: | September 20, 2008 | |
| | Device Information | |
| Proprietary Name: | ImageSVR ^TM PACS | |
| Classification Name: | SYSTEM, IMAGE PROCESSING, RADIOLOGICAL, | |
| | Class II | |
| Regulation Number: | 892.2050 | |
| Product Code: | LLZ | |
| | Safety and Effectiveness Information | |

Safety and Effectiveness Information

### ● Predicate Device:

Claim of Substantial Equivalence (SE) is made to Taiwan Electronics Data Processing Corporation Smart PACS (K022710)

#### . Device Description:

The ImageSVR PACS is a suite of applications designed and produced by Jaguar Technology Ltd. It is a client-server based software system manages archiving, retrieving and displaying medical images. The server side application is ImageSVR PACS SERVER. And client side is ImageSVR PACS CLIENT.

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Technology Limited laquar

9F-7, No.37B, Sec. 2, Wunsin Rd., Nantun District, Taichung-City 408, Taiwan R.O.C.

tel:[phone] fax:[phone] www.jaquartech.com.tw

### Intended Use: .

laguar technology

The ImageSVR PACS is intended for the manipulation, management, and display of medical images. It can manage and display images from different modalities and interfaces and can distribute those images to various workstation, image storage and printing devices using DICOM or similar standards. Typical users of this system are trained medical professionals, including physicians, nurses, technicians and computer system professionals.

To support the diagnostic interpretation of mammography studies, ImageSVR PACS in a non-compressed the full fidelity DICOM image will display format. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5Mpixel resolution and meets other technical specifications reviewed and accepted by FDA. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretation.

### Technological Characteristics

The ImageSVR PACS is a software server application and does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed.

### Substantial Equivalence (SE)

A claim of substantial equivalence is made to Smart PACS (K022710). Both of them have the same working principle and technologies. - The differences are due to the feature design aspects, not relating to the safety or effectiveness aspects. Besides, the submission contains the results of software validation that the risks and the potential hazards have been classified Minor. Thus they are substantially equivalent.

te-Din-Ten

Dr. Jen, Ke-Min official correspondent for Jaguar Technology Limited

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or other bird. The symbol is composed of three curved lines that suggest the wings and body of the bird.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JAN - 9 2009

Jaguar Technology Limited % Dr. Jen. Ke-Min Official Correspondent ROC Chinese-European Industrial Research Society No. 58. Fu Chiun Street Hsin Chu City, TW-HSQ 30067 CHINA (Taiwan)

Re: K082808

Trade/Device Name: Jaguar Technology Limited ImageSVR PACS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 20, 2008 Received: December 29, 2008

Dear Dr. Jen, Ke-Min:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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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; 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding os substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please . contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | [phone] |
|----------------|----------------------------------|----------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | [phone] |
| 21 CFR 892.xxx | (Radiology) | [phone] |
| Other | | [phone] |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry.suppot/index.html.

Sincerely yours,

Janine M. Morris

anine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Image /page/4/Picture/0 description: The image shows the logo for Jaguar Technology. The logo consists of the letters 'JT' stacked on top of each other in a stylized font. Below the logo, the words 'jaguar technology' are written in a simple, sans-serif font. The logo is black and white.

#### Limited Jaguar Technology

19F-7, No.378, Sec. 1, Wunsin Rd., Nantun District, Taichung City 408, Taiwan R.O.C.

tel:[phone] fax:[phone] www.jaguartech.com.tw

# - Indications for Use

K082808 510(k) Number:

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.

.

Device Name: Jaguar Technology Limited

ImageSVR PACS

Indications for Use:

- · The ImageSVR PACS is intended for the manipulation, management, and display of medical images. It can manage and display images from different modalities and interfaces and can distribute those images to various workstation, image storage and printing devices using DICOM or similar standards.
Typical users of this system are trained medical professionals, including physicians, nurses, technicians and computer system professionals.

- To support the diagnostic interpretation of mammography studies, ImageSVR PACS will display the full fidelity DICOM image in a non-compressed format. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5Mpixel resolution and meets other technical specifications reviewed and accepted by FDA. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretation.
Prescription Use V

. AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K082808

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