MIRAGE CEDARS OPTION

K070683 · Segami Corporation · LLZ · Apr 12, 2007 · Radiology

Device Facts

• Record ID: K070683
• Device Name: MIRAGE CEDARS OPTION
• Applicant: Segami Corporation
• Product Code: LLZ · Radiology
• Decision Date: Apr 12, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Mirage system is indicated for the acquisition, processing, review and archiving of scintigraphy camera output data and related diagnostic images. It is capable of processing and displaying the acquired information in traditional formats, as well as in pseudo three-dimensional renderings, and in various forms of animated sequences, showing kinetic attributes of the imaged organs.

Device Story

Mirage Cedars Option is a software-based system for scintigraphy data management. It accepts raw output from scintigraphy cameras; processes data to generate diagnostic images; creates pseudo three-dimensional renderings and animated sequences to visualize organ kinetics. Used in clinical settings by healthcare professionals to review and archive patient imaging studies. Output assists clinicians in diagnostic assessment of organ function and structure. Benefits include enhanced visualization of kinetic data and streamlined image archiving.

Clinical Evidence

No clinical data provided; device relies on established technological characteristics for image processing and archiving.

Technological Characteristics

Software-based system for scintigraphy data processing and display. Functions as a Picture Archiving and Communications System (PACS). Supports 2D, pseudo 3D, and animated sequence rendering of kinetic organ data.

Indications for Use

Indicated for the acquisition, processing, review, and archiving of scintigraphy camera data and diagnostic images for clinical diagnostic purposes.

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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Image /page/0/Picture/0 description: The image shows a circular logo with text around the perimeter and a symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The symbol in the center appears to be a stylized eagle or bird-like figure composed of three curved lines.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

# APR 1 2 2007

Philippe Briandet, Ph.D. President Segami Corporation 8325 Guilford Road, Suite B COLUMBIA MD 21046

Re: K070683

Trade/Device Name: Mirage Cedars Option Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 9, 2007 Received: March 13, 2007

#### Dear Dr. Briandet:

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.

Image /page/0/Picture/10 description: The image is a black and white circular logo. The logo contains the text "1906-2006" at the top, followed by the letters "FDA" in a bold, stylized font. Below the letters, the word "Centennial" is written in a cursive font. Three stars are located at the bottom of the logo.

Protesting 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 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.

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.litml.

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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SPECIAL 510(k) Mirage Cedars Option

070683 510(k) Number (if known):_

Device Name: Mirage Cedars Option .

# Indications for Use:

The Mirage system is indicated for the acquisition, processing, review and archiving of scintigraphy camera output data and related diagnostic images. It is capable of processing and displaying the acquired information in traditional formats, as well as in pseudo three-dimensional renderings, and in various forms of animated sequences, showing kinetic attributes of the imaged organs.

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

(Division Sign-Off) Division of Reproxime :: sodominal, and Radiological Device

**§10(k) Number** K07106

OR

Over-The-Counter Use

(Optional Format 1-2-96)

Appendix II-2