IMAGEQUBE PACS

K051037 · Intuitive Imaging Informatics, LLC · LLZ · Jun 28, 2005 · Radiology

Device Facts

• Record ID: K051037
• Device Name: IMAGEQUBE PACS
• Applicant: Intuitive Imaging Informatics, LLC
• Product Code: LLZ · Radiology
• Decision Date: Jun 28, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Intended Use

The ImageQube 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.

Device Story

ImageQube is a PACS software suite for medical imaging. It acquires images and demographic data from institutional modalities (CT, MRI, NM, DR, US, Angio, film digitizers). It enables display, processing, review, storage, archiving, and printing of images. Optional features include Multi-planar Reconstruction (MPR), Anatomic Triangulation (AT), and 3D display. Used by radiologists and medical professionals in clinical settings, including remote sites via Internet/Intranet. It integrates with HL7-compliant RIS and supports DICOM/IHE standards. The system facilitates clinical decision-making by providing image review and manipulation tools, measurement tools, and individual user templates. It benefits patients by enabling efficient image distribution and remote radiologist access.

Clinical Evidence

No clinical data. Substantial equivalence is based on technological characteristics, software verification, and validation processes.

Technological Characteristics

Software-based PACS; DICOM and IHE compliant; supports HL7 integration. Features include MPR, AT, and 3D display. Uses Lurawave compression. Operates on commercially available hardware. Software development and validation follow a risk management plan.

Indications for Use

Indicated for physicians and medical professionals for acquisition, storage, distribution, and primary interpretation of medical images from CT, MRI, NM, DR, US, Angio, and secondary capture devices. Contraindicated for primary imaging diagnosis in mammography.

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

• Amicas Light Beam Workstation (K022970)

Submission Summary (Full Text)

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# JUN 2 8 2005

## 510(k) Summary of Safety and Effectiveness

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

| (1) | SUBMITTER: | Intuitive Imaging Informatics, LLC<br>30 Hackamore Lane Suite 4<br>Bell Canyon, CA 91307-1061<br><br>818-347-8919 (phone)<br>818-347-8909 (fax) |
|-----|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | CONTACT: | Donald Mundt<br>Manager, Regulatory Affairs<br>Intuitive Imaging Informatics, LLC<br>30 Hackamore Lane Suite 4<br>Bell Canyon, CA 91307-1061<br><br>818-347-8919 (phone)<br>818-347-8909 (fax) |
| | SUBMISSION DATE: | 15 January 2005 |
| (2) | DEVICE NAME: | |
| | TRADE NAME: | ImageQube |
| | COMMON NAME: | Image Processing system |
| | CLASSIFICATION NAME: | (per regulation 21 CFR 892.2050) (Class II device)<br>Picture Archiving and Communication System (PACS) |
| | PRODUCT CODE: | LLZ |

#### (3) PREDICATE DEVICE:

Intuitive Imaging Informatics claims Substantial Equivalence to the following device:

| Manufacturer | Trade Name | 510(k) Number | Decision Date |
|--------------|----------------------------------|---------------|---------------|
| Amicas Inc. | Amicas Light Beam<br>Workstation | K022970 | 11-22-02 |

#### (4) DEVICE DESCRIPTION:

ImageQube 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 such as film

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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.

#### (ર) INTENDED USE OF DEVICE

The ImageQube 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.

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

The proposed ImageQube, with MPR, AT options, and the predicate device Light Beam 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.

| Feature | I3<br>ImageQube | Amicas<br>Light Beam<br>Workstation |
|-----------------------------------------------------------------------------------|-----------------|-------------------------------------|
| Multimedia Enterprise Distribution of images and data via<br>Internet or Intranet | Y | Y |
| Automatically receive DICOM images from any Imaging<br>Acquisition Device | Y | Y |
| Inter-vendor communication | | |
| Receive RIS from HL7 compliant systems | Y | Y |
| DICOM | Y | Y |
| IHE | Y | Y |
| Image Server API | IQViewer | LightView |
| Secure Web Based Administration | Y | Y |
| Maximum Intensity Projection (MIP) | N | Y |
| Cross Sectional Viewing | Y | Y |
| Plain Film Studies | Y | Y |
| Individual User Templates | Y | Y |
| Image review and manipulation tools | Y | Y |
| Image Measurement tools | Y | Y |
| Transmission | Lurawave® | JPEG2000 |

(7) SAFETY

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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 ImageQube DICOM compliant imaging system acquires, processes, archives and distributes images over the Internet utilizing similar techniques and functions as the predicate device Amicas Light Beam Workstation.

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Intuitive Imaging Informatics, LLC % Mr. Morten Simon Christensen Staff Engineer & FDA Office Coordinator Medical Device Services Underwriters Laboratories, Inc. 1655 Scott Boulevard SANTA CLARA CA 95050-4169

Re: K051037 Trade/Device Name: Intuitive Imaging Informatics ImageQube Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 14, 2005 Received: June 15, 2005

Dear Mr. Christensen:

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 (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 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.

JUN 2 8 2005

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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 this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.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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510(k) Number (if known): _ K051037_

Device Name: Intuitive Imaging Informatics ImageQube

### Indications for Use

ImageQube 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 ImageQube Web system is designed for acquisition, storage, and distribution of all modalities. Device is also designed for primary interpretation of all modalities except manmography. Device is not to be used for primary imaging diagnosis in mammography and will be conspicuously labeled as such during display of mammography images. The acquired medical images and demographic information may be displayed, processed, reviewed optionally utilizing Rational Imaging PACS Multi-planar Reconstruction (MPR), Anatomic Triangulation (AT) and 3D display, sent to and retrieved by radiologists at remote sites, stored, archived or printed.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Brogdon

(Division Stan-Off), Division of Reproductive, Abe and Radiological Devices 510(k) Number