UNIPACS WORKSTATION

K023476 · Universal Pacs, Inc. · LLZ · Jan 7, 2003 · Radiology

Device Facts

• Record ID: K023476
• Device Name: UNIPACS WORKSTATION
• Applicant: Universal Pacs, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Jan 7, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

UniPACS Workstation software is intended to be used as a fully-functional, PCbased PACS software application, to review, interpret, manipulate, network, print and visualize medical multi-modality image data in DICOM format. When interpreted by a trained physician, reviewed images can be used as an element for diagnosis.

Device Story

UniPACS Workstation is a Windows-based software application functioning as a standalone Picture Archiving and Communications System (PACS). It operates on standard off-the-shelf PC hardware. The system ingests medical image data in DICOM format; provides tools for physician review, interpretation, manipulation, printing, and visualization. Networking capabilities allow exchange of image data with DICOM or FTP-compatible servers via TCP/IP. A web component enables remote review and reporting via web-browser interface. Used by physicians, nurses, and technicians in clinical settings. Output assists physicians in clinical decision-making and diagnosis. Device does not contact patients or control life-sustaining equipment.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Windows-based software application; runs on standard off-the-shelf PC hardware; supports DICOM and FTP networking protocols; TCP/IP connectivity; web-browser interface for remote access.

Indications for Use

Indicated for trained professionals (physicians, nurses, technicians) to review, interpret, manipulate, network, print, and visualize multi-modality medical images in DICOM format for diagnostic support.

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

• eFilm Workstation (K012211)

Reference Devices

• eFilm Workstation (K020995)

Submission Summary (Full Text)

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Ko2 3476

JAN 0 7 2003

# B. Administrative Information

### 1. 510(k) Summary of Safety and Effectiveness

### Date Prepared

October 8, 2002

#### Submitter's Information

Universal PACS, Inc. 127 Albert Hart Drive Baton Rouge, LA 70803 Phone: [phone]

## Contact Person

John M. Tyler, CEO, Universal PACS, Inc. Phone: [phone] [phone] Email: [e-mail]

#### Device

Trade Name: UniPACS Workstation Picture Archiving and Communications System Common Name: PACS (per 21 CFR 892.2050), LLZ, Class II Classification Name:

### Substantially Equivalent To

eFilm Workstation (k012211, see also k020995)) eFilm Medical Inc. 500 University Ave, Suite 300 Toronto, Ontario Canada M5G 1V7 www.efilm.ca

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#### Device Description

The UniPACS Workstation is a Windows-based software application acting as stand alone Picture Archiving and Communications System (PACS). It may be marketed as software only, as well as packaged with standard "off-the-shelf" PC hardware.

The comprehensive set of tools provided in this software allows the physician to review, interpret, manipulate, print and visualize medical image data stored in DICOM format. The networking component of the product allows the physician to exchange image data with any other DICOM-compatible or FTP-compatible server over a standard TCP/IP network. The web component of the product displays workstation images in the web-browser interface, for remote review and reporting.

The device does not contain the patient, nor does it control any life sustaining devices.

#### Indications for Use

UniPACS Workstation software is intended to be used as a fully-functional, PCbased PACS, to review, interpret, manipulate, network, print and visualize medical multi-modality image data in DICOM format. When interpreted by a trained physician, reviewed images can be used as an element for diagnosis.

Typical users of this system are trained professionals, including but not limited to physicians, nurses and technicians.

#### Technological Comparison to Predicate Device

The proposed (UniPACS) and predicate (eFilm) devices are both software programs that can be used for manipulation of DICOM-compliant images on PC hardware. The proposed and predicate software can be operated from a personal computer, and provide a standard set of features with respect to image processing, storage and networking. The detailed feature comparison between the UniPACS Workstation and the eFilm Workstation demonstrates that, except a few minor, unimportant differences, the UniPACS Workstation provides the users with functionality, equivalent to that of the eFilm Workstation predicate device. This is a strong proof that the UniPACS and eFilm PACS Workstations are substantially equivalent.

#### Conclusion

Universal PACS Inc. considers the UniPACS Workstation to be substantially equivalent to the eFilm Workstation (k012211) device. The 510(k) Premarket Notification for the UniPACS Workstation contains adequate information and data to enable FDA-CDRH to determine substantial equivalence to the predicate device.

The UniPACS Workstation PACS software will be manufactured in accordance with the voluntary standards and development techniques listed in the submission. The software does not result in any new potential safety risks and performs as stated in its intended use.

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 0 7 2003

Mr. John M. Tyler CEO Universal PACS, Inc. 127 Albert Hart Drive BATON ROUGE LA 70803 Re: K023476

Trade/Device Name: UniPACS Workstation Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communication system Regulatory Class: II

Product Code: 90 LLZ Dated: October 8, 2002 Received: October 16, 2002

Dear Mr. Tyler:

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 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 this 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" (21 CFR Part 807.97). 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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2. FDA Statement of Indications for Use

Kaz 3476 510(k) Number (if known)

Device Name: UniPACS Workstation

#### Indications for Use:

UniPACS Workstation software is intended to be used as a fully-functional, PCbased PACS software application, to review, interpret, manipulate, network, print and visualize medical multi-modality image data in DICOM format. When interpreted by a trained physician, reviewed images can be used as an element for diagnosis.

Typical users of this system are trained professionals, including but not limited to physicians, nurses and technicians.

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#### Concurrence of CDRH, Office of Device Evaluation (ODE)

-OR-

Prescription Use . (Per 21 CFR 801.109) Over-The-Counter Use

Daniel A. Searson

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K023476