TELEMIS-MEDICAL SOLUTION

K032157 · Telemis S.A. · LLZ · Sep 24, 2003 · Radiology

Device Facts

• Record ID: K032157
• Device Name: TELEMIS-MEDICAL SOLUTION
• Applicant: Telemis S.A.
• Product Code: LLZ · Radiology
• Decision Date: Sep 24, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Telemis-Medical solution is a software package intended for the acquisition, management, distribution and display of medical images within the healthcare system. It can be marketed as software only, as well as packaged with standard PC hardware. It was developed with the Java® technology that allows the software to run on every operating system implementing a Java Virtual Machine Environment (f.i. Windows, MacOS, Unix). It communications using the standard TCP/IP network protocol.

Device Story

Telemis-Medical is a PACS software suite for digital medical image management. Inputs include DICOM 3.0 and other image formats acquired from medical devices. The system performs image acquisition, storage, archiving, distribution, review, and analysis. Components include TM-AutoAcquisition (data ingestion), TM-Worklist (patient validation), TM-Server (management/security), and various reception modules (TM-Reception, TM-ReceptionHE, TM-Reception Lite, TM-Home) for user review and processing. TM-Link integrates with Electronic Patient Records; TM-Publisher exports studies via CD-ROM, paper, or email. Used in clinical environments by healthcare professionals to review images and support clinical decision-making. Operates on standard PC hardware via Java Virtual Machine across Windows, MacOS, or Unix platforms using TCP/IP protocols. Benefits include centralized access, efficient distribution, and enhanced review capabilities for medical imaging studies.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based PACS; Java-based architecture running on Java Virtual Machine (Windows, MacOS, Unix). Connectivity via TCP/IP. Supports DICOM 3.0. Image compression includes lossless or lossy (wavelet or JPEG). Deployment as software-only or bundled with standard PC hardware.

Indications for Use

Indicated for the acquisition, management, distribution, and display of medical images within a healthcare system. No specific patient population, age, or gender restrictions are defined.

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

• iSite Radiology (K013630)

Submission Summary (Full Text)

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Ko3 2/5 7

SEP 2 4 2003

# 510(k) SUMMARY

#### Company Identification:

Telemis S.A. Avenue du Grand Cortil, 34 B-1348 Louvain-la-Neuve Belgium Phone: [phone] Fax: [phone]

#### Official Correspondent:

Eric Thibau. European Certification Partners, Inc. 7560 Lindbergh Drive Gaithersburg, MD 20879 FAX: [phone] [phone] Tel:

### Date Summary Prepared:

September 1, 2002

#### Name of the Device:

| Trade Name: | Telemis-Medical |
|----------------------|--------------------------------------------|
| Common name: | PACS |
| Classification name: | Picture Archiving and Communication System |

## Predicate Device:

| Name of the device: | iSite Radiology |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) Number: | K013630 |
| Company: | Stentor, Inc.<br>385 Oyster Point Blvd., Suite 8B<br>Establishment Registration #2954704<br>Tel: [phone]<br>Fax: [phone] |

#### Device Description:

The Telemis-Medical Solution is a Medical Image Management software package designed to perform required functions for the import, storage, archive, distribution, review, analysis of digital medical images in DICOM 3.0 and other formats. The Telemis Medical Solution consists of the TM-AutoAcquisition. TM-Worklist. TM-Server. TM-Reception, TM-ReceptionHE, TM-Reception Lite, TM-Home, TM-Link and TM-Publisher.

TM-AutoAcquisition acquires image studies from medical devices, converts them into secure multimedia documents and sends them to the TM-Server. The TM-Worklist is used by the TM-AutoAcquisition to validate patient information. The TM-Server manages documents and security permissions. The TM-Reception allows

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authenticated users to retrieve, manage, review and process their image documents. The TM-ReceptionHE is an enhanced TM-Reception that provides users with extra image processing features. The TM-Reception Lite allows users to manage and review local image documents. The TM-Home delivers TM-Reception's features for personal use. The TM-Link provides transparent integration between Telemis-Medical and Electronic Patient Record system. The TM-Publisher makes image study summary available on CD-ROM, paper or e-mail.

#### Intended Use:

The Telemis-Medical solution is a software package intended for the acquisition, management, distribution and display of medical images within the healthcare system. It can be marketed as software only, as well as packaged with standard PC hardware. It was developed with the Java® technology that allows the software to run on every operating system implementing a Java Virtual Machine Environment (f.i. Windows, MacOS, Unix). It communications using the standard TCP/IP network protocol.

## Technological comparison to Predicate Device:

The Telemis-Medical solution is substantially equivalent to the Stentor, Inc. iSite Radiology (K013630) system, in that it receives DICOM images, converts them to lossless or lossy (wavelet or jpeq) format, store, transmit and displays them. The intended use and technological characteristics of the Telemis-Medical solution are virtually identical to the Stentor iSite system. Any differences between the Telemis-Medical solution and the equivalent devices have no significant influence on safety or effectiveness.

#### Conclusion:

It is our conclusion that there is no software component in the Telemis-Medical solution or hardware component that would be used in conjunction with the Telemis-Medical solution that we know of, whose failure or latent design flaw would be expected to result in death or injury to a patient. Thus, the "Level of Concern" of the Telemis Medical Solution product is "minor".

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Thomas J. Bouchard Official Correspondent Telemis-Medical S.A. 7560 Lindberg Drive

GAITHERSBURG MD 20879

Re: K032157

SEP 2 4 2003

Trade/Device Name: Telemis-Medical Solution Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: May 20, 2003 Received: July 14, 2003

Dear Mr. Bouchard:

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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K032157

of Page

# 510(k) Number (if known):

Device Name: Telemis-Medical

Indications For Use:

The Telemis-Medical solution is a software package intended for the acquisition, management, distribution and display of medical images within the healthcare system.

It can be marketed as software only, as well as packaged with standard PC hardware. It was developed with the Java® technology that allows the software to run on every operating system implementing a Java Virtual Machine Environment (f.i. Windows, MacOS, Unix). It communications using the standard TCP/IP network protocol.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

*Prescription Use* ✓

(Optional Format 3-10-98)

David M. Sezmm

(Division Sign-Off) Division of Reproductive. and Radiological Devic 510(k) Number