FIATLUX VISUALIZE

K082041 · Fiatlux Imaging, Inc. · LLZ · Aug 1, 2008 · Radiology

Device Facts

• Record ID: K082041
• Device Name: FIATLUX VISUALIZE
• Applicant: Fiatlux Imaging, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Aug 1, 2008
• 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

FiatLux Visualize™ is a medical diagnosis software application that allows physicians, radiologists, medical technicians, nurses, and other trained medical professionals to select, review and analyze DICOM images acquired from CT and MR devices. It provides a suite of tools for 2D/3D reconstruction based on the input image dataset. FiatLux Visualize software must be installed on a suitable commercial computer platform. It is the user's responsibility to ensure the monitor quality and ambient light conditions are consistent with the clinical applications. Mammographic and compressed images are not supported for viewing.

Device Story

FiatLux Visualize™ is a software application for multidimensional visualization of CT and MR medical images. It accepts DICOM images via removable media or Windows networking. The software provides tools for 2D/3D reconstruction, image display, and analysis. Used in clinical settings by radiologists, physicians, and medical technicians; the device requires installation on a commercial computer platform. The healthcare provider interacts with the software to manipulate and analyze images to visualize anatomy and pathology. The output assists in clinical decision-making by providing enhanced visualization of diagnostic data. The device does not contact the patient or control life-sustaining equipment; interpretation remains the responsibility of the clinician.

Clinical Evidence

No clinical data. Bench testing only; software verification and validation testing performed.

Technological Characteristics

Software-only device for commercial computer platforms. Supports DICOM standard for image input. Provides 2D/3D reconstruction and visualization tools. No patient contact. Interpretation performed by human clinician.

Indications for Use

Indicated for physicians, radiologists, medical technicians, and nurses to select, review, and analyze DICOM CT and MR images. Not for viewing mammographic or compressed 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).

Predicate Devices

• avcan Workstation OsiriX (K063470)
• BarcoView Voxar 3D (K060505)

Submission Summary (Full Text)

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K08204)

# 5. 510(k) Summary of Safety and Effectiveness

This summary of safety and effectiveness is being submitted in accordance with 21CFR Part 807, Subpart E, Section 807.92.

Submitter's name and contact information

Quentin Dewolf, President and Chief Technology Officer FiatLux Imaging, Inc. 8430 - 154th Ave NE Redmond, WA 98052 Telephone: [phone] Fax: [phone] E-mail: [e-mail]

AUG - 1 2008

Date prepared 30 June 2008

Trade Name, Common Name and Classification Trade Name: FiatLux Visualize™ Common Name: Image Processing System, Radiology Classification: Picture Archiving and Communications System, Class II

### Substantially Equivalent Devices

FiatLux Imaging believes that FiatLux Visualize™ is substantially equivalent to other commercially available products, specifically:

- avcan Workstation OsiriX (K063470) .
- . BarcoView Voxar 3D (K060505)

### Device Description

FiatLux Visualize™ is a medical device software application that provides multidimensional visualization of CT and MR medical images. FiatLux Visualize allows the user to select and retrieve a patient series, display and view the images and data, interactively manipulate the images to visualize anatomy and pathology, and analyze the images using a set of tools. It reads DICOM CT and MR images transferred using removable media or Microsoft Windows networking.

### Intended Use:

FiatLux Visualize™ is a medical diagnosis software application that allows physicians, radiologists, medical technicians, nurses, and other trained medical professionals to select, review and analyze DICOM images acquired from CT and MR devices. It provides a suite of tools for 2D/3D reconstruction based on the input image dataset.

FiatLux Visualize software must be installed on a suitable commercial computer platform. It is the user's responsibility to ensure the monitor quality and ambient

510(k) Premarket Notification FiatLux Visualize™

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light conditions are consistent with the clinical applications. Mammographic and compressed images are not supported for viewing.

## Substantially Equivalent Device Comparison

FiatLux Visualize™ and its substantially equivalent, commercially available devices allow for the media interchange and analysis of digital images acquired from CT and MR imaging devices. All devices support the DICOM protocol for reading images from the medical device data source.

### Software

Software development for the FiatLux Visualize™ software follows documented processes for software design, verification and validation testing. A risk assessment has been completed to identify potential design hazards that could cause an error or injury based on the use of the quantification results. Appropriate steps have been taken to control all identified risks for this type of medical device.

## Technological Characteristics

FiatLux Visualize™ is software that is used with computer hardware to read, render and analyze diagnostic medical images in a user environment. The device does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human intervention, interprets images and information being displayed.

### Conclusions

The FiatLux Visualize™ software has similar intended uses as the substantially equivalent devices and has very similar technological characteristics to those devices. Minor technological differences do not raise any new questions regarding safety or effectiveness of the device. Thus, FiatLux Visualize™ is substantially equivalent to the commercially available devices.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FaitLux Imaging, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

AUG - 1 2008

Re: K082041

Trade/Device Name: FiatLux Visualize™M Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 17, 2008 Received: July 18, 2008

#### Dear Mr. Job:

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 (PMA), 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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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 ed econic 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliarry proge 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Beportio (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may copyrin 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/cdrb/industry/support/index.html .

Sincerely vours.

Nancy 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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4. Indications for Use

510(k) Number (if known): K082041

Device Name: FiatLux Visualize TM

Indications for Use:

FiatLux Visualize™ is a medical diagnosis software application that allows physicians, radiologists, medical technicians, nurses, and other trained medical professionals to select, review and analyze DICOM images acquired from CT and MR devices. It provides a suite of tools for 2D/3D reconstruction based on the input image dataset.

FiatLux Visualize™ software must be installed on a suitable commercial computer platform. It is the user's responsibility to ensure the monitor quality and ambient light conditions are consistent with the clinical applications. Mammographic and compressed images are not supported for viewing.

Prescription Use X (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Lom M. Mhy
(Division Sign-Off)

Division of Reproductive, Abdominal an Radiological Devices 510(k) Number

> 510(k) Premarket Notification FiatLux Visualize TM