APAX PACS SYSTEM

K032760 · Tis, Inc. · LLZ · Sep 17, 2003 · Radiology

Device Facts

• Record ID: K032760
• Device Name: APAX PACS SYSTEM
• Applicant: Tis, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Sep 17, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Intended Use

The APAX™ PACS is intended to be used by authorized staff to perform medical image management, communications, storage, archiving and review. Images and data can be stored, transmitted (communicated), processed at the workstation, physician's desktop or other clinical application and distributed across networks or the world wide web. Typical users are trained professionals, including not limited to physicians, nurses, and technicians.

Device Story

APAX™ PACS is a software system for acquisition, capture, viewing, archiving, and transmission of medical images. Inputs include DICOM images from modalities (MRI, CT, CR) and non-DICOM images (ultrasound via capture, X-ray film via scanning). System allows image selection, processing, and filming. Used by trained professionals (physicians, nurses, technicians) at workstations or clinical desktops. Output consists of displayed or filmed images for physician interpretation to support clinical diagnosis. Distributed across networks or web.

Clinical Evidence

Bench testing only.

Technological Characteristics

General purpose software for medical image management. Supports DICOM and non-DICOM image formats. Connectivity via network or web. Operates on workstations or clinical desktops.

Indications for Use

Indicated for use by authorized staff (physicians, nurses, technicians) for medical image management, communication, storage, archiving, and review of multi-modality diagnostic 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

• Mediface PACS™ System (K010259)

Submission Summary (Full Text)

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K032760

## SEP 1 7 2003

000024

## 510(k) Summary

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

#### 1. Company and Correspondent making the submission:

Name - TIS, Inc.. Address - Suite 602, KWTC, 159-1, Samsung-Dong, Kangnam-Ku, Seoul, 135-729, Korea Telephone — [phone] – [phone] Fax – Mr. Sung Ho Byun Contact Internet – http://www.tis21.com

### 2. Device :

Proprietary Name - - APAX™ - Picture archiving and communication system Common Name Classification Name - Picture archiving and communication system

#### 3. Predicate Device :

Mediface Co., Ltd. Mediface PACS™ System K010259

#### 4. Classifications Names & Citations :

21CFR 820.2050, LLZ, Picture archiving and communication system, Class2 Guidance document for the preparation of premarket notifications [510(k)'s].

- 5. Description :
The APAX™ PACS system is a general purpose software designed for acquisition/ capture/ view/ archival and transmission of medical images. This device allows easy capturing, selection, review, processing and filming of multi-modality DICOM images from a variety of diagnosis imaging systems such as MRI, CT, CR, etc., and of non-DICOM images from Ultrasound (by capturing) and X-ray Film (by scanning). When interpreted by a trained

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physician, filmed images may be used as a basis for a diagnosis. The PACS system

The APAX™ PACS is intended to be used by authorized staff to perform medical image management, communications, storage, archiving and review. Images and data can be stored, transmitted (communicated), processed at the workstation, physician's desktop or other clinical application and distributed across networks or the world wide web. Typical users are trained professionals, including not limited to physicians, nurses, and technicians.

- 6. Indication for use :
The APAX™ PACS is intended to be used by authorized staff to perform medical image management, communications, storage, archiving and review. Images and data can be stored, transmitted (communicated), processed at the workstation, physician's desktop or other clinical application and distributed across networks or the world wide web. Typical users are trained professionals, including not limited to physicians, nurses, and technicians.

- 7. Comparison with predicate device :
TIS, Inc., believes that the APAX™ PACS System is substantially equivalent to the Mediface PACS™ System.

- 8. Conclusions :
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification TIS, Inc.. concludes that APAX™ is safe and effective and substantially equivalent to predicate devices as described herein.

- 10. TIS, Inc.. will update and include in this summary any other information deemed seasonably necessary by the FDA.
### END

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Image /page/2/Picture/1 description: The image shows a black and white logo. The logo features a stylized bird in flight, composed of three curved lines that represent the bird's body and wings. The bird is oriented to the right. To the left of the bird, there is a semi-circular arrangement of small dots, which may represent a globe or a partial border. The overall design is simple and abstract.

Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

SEP 1 7 2003

TIS, Inc. % Mr. Marc M. Mouser Office Coordinator Underwriters Laboratories, Inc. 2600 N.W. Lake Road CAMAS WA 98607-8542

#### Re: K032760

Trade/Device Name: APAX™ PACS System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communication system Regulatory Class: II Product Code: 90 LLZ Dated: July 25, 2003 Received: September 5, 2003

Dear Mr. Mouser:

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 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); 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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of 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 the letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

# 510(k) Number (if known): Ko 3 2760

Device Name: APAX™PACS System

Indications for Use:

The Device is intended to be used by authorized staff to perform medical image management, communications, storage, archiving and review. Images and data can be stored, transmitted (communicated), processed at the workstation, physician's desktop or other clinical application and distributed across networks or the world wide web. Typical users are trained professionals, including not limited to physicians, nurses, and technicians.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

or

Over-The-Counter Use

(Per 21 CFR 801.109)

David R. Leggrm

, i

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Dev 510(k) Number __

(Optional Format 3-10-98)