MIRAGE, RELEASE 5.5

K043441 · Segami Corporation · KPS · Jan 13, 2005 · Radiology

Device Facts

• Record ID: K043441
• Device Name: MIRAGE, RELEASE 5.5
• Applicant: Segami Corporation
• Product Code: KPS · Radiology
• Decision Date: Jan 13, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1200
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Mirage Release 5.5 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 Release 5.5 is a software system for scintigraphy camera data management. It ingests raw output data from scintigraphy cameras; processes, reviews, and archives diagnostic images. The system transforms input data into traditional 2D formats, pseudo 3D renderings, and animated sequences to visualize organ kinetics. Used in clinical settings by healthcare professionals (physicians, technologists) to assist in diagnostic interpretation. Output is displayed on workstations for clinical review, aiding in the assessment of organ function and pathology.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based system for medical image processing and archiving. Functions as an emission computed tomography system and PACS. Supports 2D, pseudo 3D, and animated sequence rendering of scintigraphy 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

An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines representing the serpent wrapped around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the caduceus.

JAN 1 3 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Philippe A. Briandet, Ph.D. President Segami Corporation 8325 Guilford Road, Suite B COLUMBIA MD 21046-2818

Re: K043441 Trade/Device Name: Mirage Release 5.5 Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II -- --Product Code: 90 KPS and LLZ Dated: December 12, 2004 Received: December 14, 2004

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, labeline, 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 (0S) regulation (21 CFR Part 820); and if applicable, the clectronic 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 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/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

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510(k) Number (if known): K043441

Device Name: Mirage Release 5.5

## Indications for Use:

The Mirage Release 5.5 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**
Use
(Per 21 CFR 801.109)
✓

OR

## Over-The-Counter

(Optional Format 1-2-96)

-' Jancy C. Srigdon

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