DICOM 3.0 SOFTWARE VERSION 2.0

K973239 · Adac Laboratories · LMD · Nov 26, 1997 · Radiology

Device Facts

• Record ID: K973239
• Device Name: DICOM 3.0 SOFTWARE VERSION 2.0
• Applicant: Adac Laboratories
• Product Code: LMD · Radiology
• Decision Date: Nov 26, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2020
• Device Class: Class 1
• Attributes: Software as a Medical Device

Intended Use

DICOM 3.0 Software Version 2.0 is intended to provide communication and data interchange between multi-modality medical imaging devices, while maintaining the integrity of the image data.

Device Story

DICOM 3.0 Software Version 2.0 is a connectivity software package designed to enable interoperability between ADAC Pegasys systems and other medical imaging devices. It functions by converting medical images (NM, CT, MRI, Ultrasound) from the DICOM 3.0 standard format into the proprietary Pegasys image format and vice-versa. The software supports three primary operations: image data transfer between ADAC systems, data output to DICOM-compatible printers, and image data exchange between ADAC and non-ADAC systems. It operates over standard network infrastructures, including LAN, WAN, and the Internet. By enabling seamless data interchange, the software allows healthcare providers to access and print multi-modality images across different systems, supporting clinical workflows and diagnostic continuity.

Clinical Evidence

Bench testing only. Testing verified software functionality against specifications, specifically focusing on the integrity of image data during import, export, and printing operations. All tests passed with results matching expected outcomes.

Technological Characteristics

Software-based connectivity package compliant with ACR-NEMA DICOM 3.0 standards. Operates via LAN, WAN, or Internet. Facilitates format conversion between DICOM 3.0 and ADAC Pegasys image formats. No hardware components; standalone software application.

Indications for Use

Indicated for use in clinical environments to facilitate communication and data interchange between multi-modality medical imaging devices (NM, CT, MRI, Ultrasound) while maintaining image data integrity.

Regulatory Classification

Identification

A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, and interfaces. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions. This does not include electronic transfer of medical image software functions.

Predicate Devices

• Cemax Vipstation
• AVP PACSPRO 640

Submission Summary (Full Text)

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# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS DATA NOV 2 6 1997

#### I. General Information

K973239

| A. Submitted By: | ADAC Laboratories<br>540 Alder Drive<br>Milpitas, CA 95035<br>Tel: [phone]<br>Fax: [phone] |
|-----------------------|----------------------------------------------------------------------------------------------------------|
| Contact Person: | Dennis Henkelman at address above |
| B. Device Trade Name: | DICOM 3.0 Software Version 2.0 |
| Common Name: | Gamma Camera System |
| Classification Name: | Digital Image Communication System |
| C. Predicate Device: | Cemax Vipstation<br>AVP PACSPRO 640 |

#### Device Description: D.

DICOM 3.0 Software Version 2.0 is a connectivity package software developed according to the ACR-NEMA standard for Digital Imaging and Communication in Medicine (DICOM 3.0). This software converts medical images, such as NM, CT, MRI, or Ultrasound, that are in DICOM 3.0 specified format into Pegasys image format and vice-versa to enable data communication between ADAC Pegasys systems and other medical imaging devices.

Three major operations can be performed with DICOM 3.0 Software Version 2.0 - image data transfer between ADAC systems, data output to DICOM compatible printers, and transfer of image data between ADAC and non-ADAC systems.

- E. Indications for Use:
DICOM 3.0 Software Version 2.0 is intended to provide communication and data interchange between multi-modality medical imaging devices, while maintaining the integrity of the image data.

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#### Technological Comparison: F.

DICOM 3.0 Software Version 2.0 and the communication/data interchange portions of the predicate devices have the same indications for use. The operating principles of DICOM 3.0 Software Version 2.0 and the predicate devices are based on ACR-NEMA standard for Digital Imaging and Communication in Medicine (DICOM 3.0), as described in the device description. Communication media, such as, Local Area Network (LAN), Wide Area Network (WAN), and Internet are used to send or receive image data.

#### II. Testing

Testing was conducted to demonstrate that the software functioned as per its specifications. Import and Export functions were comprehensively tested to ensure that image integrity was maintained. The Print functions were also tested. All tests passed with the actual results matching the expected results.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized lines.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Re:

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 26 1997

Dennis W. Henkelman Director, Regulatory Affairs and Quality Assurance ADAC Laboratories 540 Alder Drive Milpitas, CA 95035

K973239 DICOM 3.0 Software Version 2.0 Dated: August 22, 1997 Received: August 28, 1997 Regulatory class: Unclassified Procode: 90 LMD

Dear Mr. Henkelman:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, subject to the general controls provisions of 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 III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your 5100k) 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours

W. Lillian Yin, Ph.D.

Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K Y 1 32 3 7

DICOM 3.0 Software Version 2.0 Device Name:

ADAC Laboratories Sponsor Name:

## Indications for Use

DICOM 3.0 Software Version 2.0 is intended to provide communication and data interchange between multi-modality medical imaging devices, while maintaining the integrity of the image data.

## Do Not Write Below This Line - Continue on Another Page if Needed

Concurrence of CDRH, Office of Device Evaluation (ODE)

David li. de yarm

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

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