IPACS PRISM

K030751 · Realtimeimage, Inc. · LLZ · May 29, 2003 · Radiology

Device Facts

• Record ID: K030751
• Device Name: IPACS PRISM
• Applicant: Realtimeimage, Inc.
• Product Code: LLZ · Radiology
• Decision Date: May 29, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

iPACS Prism™ from RealTimeImage Inc. is a device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Typical users of this system are trained professionals, including but not limited to physicians, nurses, and technicians.

Device Story

iPACS Prism™ is a modular Picture Archiving and Communication System (PACS) designed for local and wide area network deployment. It receives digital medical images and data objects from various imaging sources; stores, communicates, and processes these objects; and displays them to users. Operated by trained professionals (physicians, nurses, technicians) in clinical environments, the system enables simultaneous access to patient information and images across a facility. The device does not contact the patient or control life-sustaining equipment; it serves as a tool for image management, with clinical interpretation performed by a physician who provides human intervention. The system facilitates efficient clinical workflows by centralizing image storage and distribution, potentially improving access to diagnostic information for patient care.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Medical image software for PACS environment; operates on standard computer hardware. Connectivity via local and wide area networks. Does not contact patient. No life-sustaining functions. Human-in-the-loop interpretation required. Hazard analysis performed.

Indications for Use

Indicated for trained professionals, including physicians, nurses, and technicians, to receive, store, communicate, process, and display medical images and data from various imaging sources across computer 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

• ISITE RADIOLOGY (K013630)

Submission Summary (Full Text)

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## 103 0751

# MAY 2 9 2003

Page 1

#### 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: March 2, 2003

Submitter's Information: 21 CFR 807.92(a)(1) RealTimeImage Inc. Zvi Eintracht, CEO 1111 Bayhill Dr. Suite 290 San Bruno, CA 94066

Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2) Trade Name: iPACS Prism™ bv RealTimeImage Inc. Common Name: Picture Archiving Communications System Device Classification: 892 2050 Name: System, Image Processing

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

SYSTEM, IMAGE PROCESSING, Device Classification Name RADIOLOGICAL

| Regulation Number | 892.2050 |
|-------------------|---------------------------------------------------------------|
| 510(k) Number | K013630 |
| Device Name | ISITE RADIOLOGY |
| Applicant | STENTOR, INC.<br>16303 PANORAMIC WAY<br>SAN LEANDRO, CA 94578 |
| Product Code | LLZ |
| Date Received | 11/05/2001 |
| Decision Date | 12/05/2001 |

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

iPACS Prism™ is a complete PACS solution designed to be Internet friendly for easy deployment over local area networks and/or wide area networks. The system is modular and will be offered under different brand names depending upon customer implementation and which system components of iPACS Prism are needed. iPACS™ handles various images and data objects in a Picture Archive and Communication System (PACS) environment. These objects can be images, requests, patients, examination etc. PACS transmits digital electronic images and generates reports over a high-speed network to centralized storage. After transmission, patient information and images are available throughout the facility to many users simultaneously.

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Image /page/1/Picture/0 description: The image shows a square filled with a dot pattern in the upper left corner. Below the square, the word "RealTime" is written in a stylized font. Underneath "RealTime", the word "image" is written in a smaller, dotted font, giving it a faded appearance.

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

iPACS Prism™ from RealTimeImage Inc. is a device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Typical users of this system are trained professionals, including but not limited to 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 iPACS Prism™ contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device. The system has been and 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 potential hazards have been classified as Minor.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle or bird-like symbol with three horizontal lines extending from its head, resembling feathers or wings.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 9 2003

Real Time Image Inc. c/o Mr. Carl Alletto OTech, Inc. 1100 Lakeview Blvd. DENTON TX 76208

Re: K030751

Trade/Device Name: iPACS Prism" Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: February 9, 2003 Received: March 10, 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 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 Cbrogdon

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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Image /page/4/Picture/0 description: The image shows a logo with a square pattern at the top left. Below the pattern, the words "RealTime" are printed in a stylized font. Underneath "RealTime", the word "Image" is printed in a similar font, completing the logo design.

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(Indications for Use Form)

Ko30751

510(k) Number:

Device Name:

iPACS Prism™ from Real Time Image Inc.

Indications for Use:

iPACS Prism™ from Real Time Image Inc. is a device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations.

Typical users of this system are trained professionals, including but not limited to 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 (Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

David R. Leggerson

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