INTELEPACS

K032533 · Intelerad Medical Systems, Inc. · LLZ · Oct 16, 2003 · Radiology

Device Facts

• Record ID: K032533
• Device Name: INTELEPACS
• Applicant: Intelerad Medical Systems, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Oct 16, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

IntelePACS™ is a device that receives digital images and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, R/F units, computer & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be communicated, processed, manipulated, enhanced, stored, and displayed within the system and or across computer networks at distributed locations. Typical users of this system are trained professionals, physicians, nurses, and technicians.

Device Story

IntelePACS™ is a software-based Picture Archiving and Communications System (PACS). It ingests digital medical images and data from various sources, including CT, MR, ultrasound, R/F units, and radiographic devices; utilizes DICOM image gateways or film digitizers for non-DICOM sources. The system provides tools for image storage, distribution, enhancement, manipulation, and networking across distributed clinical locations. Operated by physicians, nurses, and technicians in clinical environments, the system displays images on workstations for interpretation by trained professionals. The device does not contact patients or control life-sustaining equipment; it serves as a diagnostic aid where human intervention is required for image interpretation. Benefits include centralized access to medical imaging data, facilitating efficient clinical workflows and decision-making.

Clinical Evidence

No clinical data. Bench testing only. The submission includes a hazard analysis and confirms the device is manufactured in accordance with voluntary standards.

Technological Characteristics

Medical image software for use with standard computer hardware in a PACS environment. Supports DICOM standards for image acquisition and transmission. Connectivity via network. Software hazard level classified as minor. No patient-contacting components.

Indications for Use

Indicated for use by trained professionals, physicians, nurses, and technicians to receive, communicate, process, manipulate, enhance, store, and display digital medical images and data from various imaging sources (CT, MR, ultrasound, R/F, radiographic, etc.) across distributed networks.

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

• PACSPLUS (K023460)

Submission Summary (Full Text)

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Ko 3 2533

## OCT 1 6 2003

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

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

Date Prepared: June 29, 2003

Submitter's Information: 21 CFR 807.92(a)(1)

Intelerad Medical Systems Inc. Richard Rubin, Executive Vice President, R&D 460 Ste-Catherine West, Suite 210 Montreal, QC Canada H3B 1A7 Tel: [phone] Fax: [phone]

Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2)

| Trade Name: | IntelePACS™ |
|------------------------|-----------------------------------------|
| Common Name: | Picture Archiving Communications System |
| Device Classification: | 892.2050 |
| Name: | System, Image Processing |

Predicate Device: 21 CFR 807. 92(a)(3)

| Device Classification<br>Name | SYSTEM, IMAGE PROCESSING, RADIOLOGICAL |
|--------------------------------------|----------------------------------------|
| Requlation Number | 892.2050 |
| 510(k) Number | K023460 |
| Device Name | PACSPLUS |
| Applicant | MEDICAL STANDARD CO., LTD. |
| Product Code | LLZ |
| Date Received | 10/15/2002 |
| Decision Date | 01/09/2003 |
| Decision | SUBSTANTIALLY EQUIVALENT (SE) |
| Classification Advisory<br>Committee | Radiology |
| Review Advisory<br>Committee | Radiology |

Device Description: 21 CFR 807 92(a)(4)

IntelePACS™ is comprised of software modules that provide image capture, storage, distribution, enhancement, manipulation, and networking of medical images at distributed locations. In cases where DICOM images are not directly available to

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IntelePACS™, the system can acquire medical images using a DICOM image gateway, which generates DICOM-type files. For example, film digitizers obtain images from original film and convert them to meet DICOM standards and stored. Stored files are transmitted using a network and can be viewed or manipulated from imaging workstation.

Indications for Use: 21 CFR 807 92(a)(5)

IntelePACS™ is a device that receives digital images and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, R/F units, computer & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be communicated, processed, manipulated, enhanced, stored, and displayed within the system and or across computer networks at distributed locations.

Typical users of this system are trained professionals, physicians, nurses, and technicians.

Technological Characteristics: 21 CFR 807 92(a)(6)

The device is medical device image software that is used with computer hardware in a picture archiving and communications system user environment. The device 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.

Conclusion: 21 CFR 807 92(b)(1)

The 510(k) Pre-Market Notification for IntelePACS™ contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.

IntelePACS™ system will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey. The submission contains the results of a hazard analysis and the "Level of Concern for potential hazards has been classified as "minor".

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Image /page/2/Picture/1 description: The image shows a logo with a stylized bird figure. The bird is composed of three curved lines that suggest movement or flight. The logo is encircled by text that reads 'DEPARTMENT OF HEALTH & HUMAN SERVICES'.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# OCT 1 6 2003

Intelerad Medical Systems, Inc. % Mr. Carl Alletto 1100 Lakewood Blvd. DENTON TX 76208

Re: K032533

Trade/Device Name: IntelePACSTM Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: June 29, 2003 Received: August 15, 2003

Dear Mr. Alletto:

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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### (Indications for Use Form)

510(k) Number: Ko3 2533

Device Name:

IntelePACS™ from Intelerad Medical Systems Inc.

Indications for Use:

IntelePACS™ is a device that receives digital images and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, R/F units, computer & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be communicated, processed, manipulated, enhanced, stored, and displayed within the system and or across computer networks at distributed locations.

Typical users of this system are trained professionals, physicians, nurses, and technicians.

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

NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Nancy C. Brogdon

and Radiological Devices 510(k) Numb