MEDICAL IMAGE MANAGEMENT DEVICES FOR VISION TOOLS

K063439 · Mtd, Inc. · LLZ · Jan 22, 2007 · Radiology

Device Facts

• Record ID: K063439
• Device Name: MEDICAL IMAGE MANAGEMENT DEVICES FOR VISION TOOLS
• Applicant: Mtd, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Jan 22, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Millennium Technology's Vision Tools is intended to be used as a complete medical imaging and information solution that helps users in the Radiology/Tele-Radiology fields. It is considered one of the most powerful radiology viewing stations for PACS systems. Vision Tools is software that enables the user to handle all patient data including images, cine loops, reports, voice notes and information through the medical imaging machines that are connected to the system. It can handle all types of modalities (CT, MRI, US, CR, ...) and has many processing tools and functions such as handling DICOM work lists, integrating with PACS, RIS, HIS, speech recognition systems, DICOM printing, CD publishing, etc. With Vision Tools 3Dview, high quality 3D volumes from CT, MRI and ultrasound can be created with volume rendering, MPR, MIP, color rendering, cut planes, volume rotation and much more. The large number of image processing tools, filters, annotations, measurements, windowing and display functions can be customized for viewing. Lossy compressed mammogrphic images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by the FDA,

Device Story

Millennium Technology Vision Tools is a PACS-integrated software workstation for radiology/tele-radiology. It ingests patient data, images, cine loops, reports, and voice notes from connected medical imaging modalities (CT, MRI, US, CR). The software provides tools for DICOM worklist management, RIS/HIS integration, speech recognition, DICOM printing, and CD publishing. The 3Dview module enables volume rendering, multi-planar reconstruction (MPR), maximum intensity projection (MIP), color rendering, and volume manipulation. Clinicians use the workstation to view, process, annotate, and measure images to support diagnostic decision-making. The system facilitates efficient clinical workflows by centralizing multi-modality data access.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based medical imaging and information solution. Supports DICOM standards for connectivity and interoperability with PACS, RIS, and HIS. Features include 3D volume rendering, MPR, MIP, and image processing filters. Operates as a viewing station for multi-modality data (CT, MRI, US, CR).

Indications for Use

Indicated for use by radiology and tele-radiology professionals as a medical imaging and information solution for viewing, processing, and managing patient data from modalities including CT, MRI, US, and CR. Contraindicated for primary interpretation of lossy compressed mammographic images and digitized film screen images.

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).

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Ms. Christine Nichols Official Correspondent MTD, Inc. 8 Crownview Court SPARTA NJ 07871

Re: K063439

Trade/Device Name: Millennium Technology Vision Tools Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 8, 2006 Received: November 16, 2006

Dear Ms. Nichols:

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.

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Protecting and Promoting Public Health

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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 fimited to: registration and fisting (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.

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.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

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 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/cdrl/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

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

510(k) Number (if known):

Device Name: Millennium Technology Vision Tools

Indications For Use:

Millennium Technology's Vision Tools is intended to be used as a complete medical imaging and information solution that helps users in the Radiology/Tele-Radiology fields. It is considered one of the most powerful radiology viewing stations for PACS systems. Vision Tools is software that enables the user to handle all patient data including images, cine loops, reports, voice notes and information through the medical imaging machines that are connected to the system. It can handle all types of modalities (CT, MRI, US, CR, ...) and has many processing tools and functions such as handling DICOM work lists, integrating with PACS, RIS, HIS, speech recognition systems, DICOM printing, CD publishing, etc.

With Vision Tools 3Dview, high quality 3D volumes from CT, MRI and ultrasound can be created with volume rendering, MPR, MIP, color rendering, cut planes, volume rotation and much more. The large number of image processing tools, filters, annotations, measurements, windowing and display functions can be customized for viewing. Lossy compressed mammogrphic images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by the FDA,

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)

David Ingram

(Division Sian-Off) Division of Reproductive. Abdominal, and