RATIONAL IMAGING PACS

K031473 · Intuitive Imaging Informatics, LLC · LLZ · Oct 30, 2003 · Radiology

Device Facts

• Record ID: K031473
• Device Name: RATIONAL IMAGING PACS
• Applicant: Intuitive Imaging Informatics, LLC
• Product Code: LLZ · Radiology
• Decision Date: Oct 30, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Rational Imaging PACS is intended to be used in a Radiological Laboratory or Doctors office to allow the medical professionals to retrieve and review exam images at various rotations and options, add patient identification and compress the image using industry accepted techniques. Lossy and lossless compressed images are encapsulated in DICOM v3.0 format, which then may be transmitted via various communication protocols to other sites or archived by a PACS host.

Device Story

Rational Imaging PACS is a software suite for medical imaging management. It acquires images and demographic data from various modalities (CT, MRI, NM, DR, US, Angio, film digitizers); processes, displays, and archives them; and enables transmission to remote sites. Operated by physicians or medical professionals in radiological labs or doctors' offices. Features include image manipulation, lossy/lossless compression, Multi-planar Reconstruction (MPR), Anatomic Triangulation (AT), and 3D display. Output is viewed by radiologists for clinical review and decision-making. System operates on commercially available hardware; supports DICOM v3.0 standard for interoperability.

Clinical Evidence

No clinical data. Safety and effectiveness are supported by a risk management plan, software development and validation processes, and conformance to industry standards.

Technological Characteristics

Software-based PACS; operates on commercially available hardware. Supports DICOM v3.0. Features include image compression (lossy/lossless), Multi-planar Reconstruction (MPR), Anatomic Triangulation (AT), and 3D display. Connectivity via standard communication protocols for remote retrieval and archiving.

Indications for Use

Indicated for use by physicians or medical professionals to acquire, display, process, review, store, archive, and print medical images and demographic data from institutional modalities including CT, MRI, NM, DR, US, nuclear medicine, Angio, and secondary capture devices (e.g., film digitizers). Includes optional Multi-planar Reconstruction (MPR), Anatomic Triangulation (AT), and 3D display.

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

• MediSurf (K971347)

Submission Summary (Full Text)

{0}------------------------------------------------

OCT 3 0 2003

510(k) Summary of Safety and Effectiveness

K 031473

## Submitted by

Intuitive Imaging Informatics, LLC 30 Hackamore Lane Suite 4 Bell Canyon, CA 91307-1061

> 818-347-8919 (phn) 818-347-8909 (fax)

29 April 2003

{1}------------------------------------------------

K031473

Per Title 21 CFR 807 . 92, the following is the 510(k) Summary for the Rational Imaging PACS manufactured and marketed by Intuitive Imaging Informatics, LLC under the trade-name

#### SUBMITTER: (1)

Intuitive Imaging Informatics, LLC 30 Hackamore Lane Suite 4 Bell Canyon, CA 91307-1061

818-347-8919 (phone) 818-347-8909 (fax)

CONTACT:

Donald Mundt Manager, Regulatory Affairs Intuitive Imaging Informatics, LLC 30 Hackamore Lane Suite 4 Bell Canyon, CA 91307-1061

818-347-8919 (phone) 818-347-8909 (fax)

29 April 2003 SUBMISSION DATE:

#### (2) DEVICE NAME:

Rational Imaging PACS TRADE NAME:

- CLASSIFICATION NAME: (per regulation 21 CFR 892.2030) (Class II device) Picture Archiving and Communication System
PRODUCT CODE: LLZ

#### PREDICATE DEVICE: (3)

Intuitive Imaging Informatics claims Substantial Equivalence to the following device:

| Manufacturer | Trade Name | 510(k) Number | Decision Date |
|----------------------|------------|---------------|---------------|
| Algotec Systems Ltd. | MediSurf | K971347 | 07-03-1997 |

#### DEVICE DESCRIPTION: (4)

Rational Imaging PACS is designed for use by a physician or other medical professionals in the acquisition of medical images and demographic detail from all institutional imaging modalities, including CT, CR, MRI, NM, DR, US, Angio, nuclear medicine, and secondary capture devices

{2}------------------------------------------------

# 1214 +

such as film digitizers or other imaging sources. The acquired medical images and demographic information may be displayed, processed, reviewed, sent to and retrieved by radiologists at remote sites, stored, archived or printed. Multi-planar Reconstruction (MPR). Anatomic Triangulation (AT) and 3D display are optionally available.

#### (5) INTENDED USE OF DEVICE

The Rational Imaging PACS is intended to be used in a Radiological Laboratory or Doctors office to allow the medical professionals to retrieve and review exam images at various rotations and options, add patient identification and compress the image using industry accepted techniques. Lossy and lossless compressed images are encapsulated in DICOM v3.0 format, which then may be transmitted via various communication protocols to other sites or archived by a PACS host.

#### SUBSTANTIAL EQUIVALENCE TO PREDICATE DEVICE (6)

The proposed Rational Imaging PACS, with MPR, AT options, and the predicate device MediSurf are both software suites that process DICOM compliant images and provide a standard set of features pertaining to image processing, archiving and networking. The image manipulation tools and storage techniques are essentially comparable. Workstations are technologically the same with some differences in media type for archival storage. Compression algorithms are different but accomplish the same results. Both products operate on commercially available equipment and are available as either a hardware/software package or software only.

## (7) SAFETY

The potential hazards are identified and controlled by a risk management plan. The plan consists of a risk management summary, a software development and validation process, a software verification plan and conformance to Federal Regulations and Industry Standards.

## (8) CONCLUSION

The Rational Imaging PACS DICOM compliant imaging system acquires, processes, archives and distributes images over the Internet utilizing similar techniques and functions as the predicate device MediSurf.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines extending from its head, resembling feathers or wings. The bird is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 3 0 2003

Mr. Donald Mundt Manager, Regulatory Affairs Intuitive Imaging Informatics, LLC 30 Hackamore Lane, Suite 4 BELL CANYON CA 91307-1061

Re: K031473

Trade/Device Name: Rational Imaging PACS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communication system

Regulatory Class: II Product Code: 90 LLZ Dated: September 2, 2003 Received: September 4, 2003

Dear Mr. Mundt:

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 adultcration.

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.

{4}------------------------------------------------

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

{5}------------------------------------------------

510(k) Number (if known): _ KO31473

Device Name: Rational Imaging PACS

## Indications for Use

Rational Imaging PACS is intended for use by a physician or other medical professionals in the acquisition of medical images and demographic detail from all institutional imaging modalities, including CT, MRI, NM, DR, US, nuclear medicine, Angio and secondary capture devices such as film digitizers or other imaging sources. The acquired medical images and demographic information may be displayed, processed, reviewed optionally utilizing Multi-planar Reconstruction (MPR), Anatomic Triangulation (AT) and 3D display, sent to and retrieved by radiologists at remote sites, stored, archived or printed.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Symm

(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number_

Prescription Use (Per 21 CFR 801.109) (Optional Format 1-2-96) OR

Over-the-Counter Use

47