BRAIN VIEWRX VIEWER, VERSION 1.0

K052467 · Kyron Clinical Imaging, Inc. · LLZ · Dec 20, 2005 · Radiology

Device Facts

• Record ID: K052467
• Device Name: BRAIN VIEWRX VIEWER, VERSION 1.0
• Applicant: Kyron Clinical Imaging, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Dec 20, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

BrainViewRx™ provides visualization of functional and physiologic brain imaging data. The software package provides both analysis and viewing capabilities that promote the integration of physiologic and functional imaging data sets, including blood oxygen level dependent (BOLD) fMRI, magnetic resonance spectroscopy (MRS), and MR diffusion including diffusion tensor imaging (DT). The integration of these data, when interpreted by a trained physician, yields information that may assist in the diagnosis of brain pathology and the planning and monitoring of medical treatments.

Device Story

BrainViewRx is image processing software for personal computers; enables visualization and manipulation of clinical imagery. Inputs include anatomical, physiologic, and functional brain imaging data (BOLD fMRI, MRS, MR diffusion/DTI). Software aligns disparate data sets; provides display and analysis tools for integrated viewing. Used by physicians in clinical settings to interpret integrated imagery; output assists in diagnosing brain pathology and planning/monitoring medical treatments. Benefits include improved clinical decision-making through integrated visualization of complex functional and physiologic data.

Clinical Evidence

No clinical data. Bench testing only; software verification and validation conducted to confirm proper function of device features.

Technological Characteristics

Image processing software for PC platform. Functions include multi-modality image registration, visualization, and analysis of BOLD fMRI, MRS, and MR diffusion/DTI data. Standalone software package.

Indications for Use

Indicated for use by trained physicians to visualize, integrate, and analyze functional and physiologic brain imaging data (BOLD fMRI, MRS, MR diffusion/DTI) to assist in the diagnosis of brain pathology and the planning and monitoring of medical treatments.

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

• Fusion 7D Multi-modality registration workstation software (K020546)
• Eloquence Integrated Functional Imaging System (K023130)
• Syngo® Multimodality Workstation (K010938)

Submission Summary (Full Text)

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DEC 2 0 2005

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# 5 510(k) Summary

K052467 - Kyron™ Clinical Imaging BrainViewRxTM Viewer

#### 1. Contact Information

Contact Person Submitter Michael Schmainda, CEO Kyron Clinical Imaging, Inc. 2433 N. Mayfair Rd., Suite 103 Phone [phone] Wauwatosa, WI 53226 Fax [phone]

Date Summary Prepared: November 10, 2005

#### 2. Device Name and Classification

The proprietary name of the device to be introduced into interstate commerce is the BrainViewRx software package. It is image processing software running on a personal computer platform, and is classified under regulatory product code 90 LLZ (regulation # 892.2050), "Picture archiving and communications systems" as a class II medical device.

## 3. Identification of Legally Marketed Equivalent Predicate Devices

| Predicate System | Manufacturer | Reg. Data |
|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|----------------------------------------------------------|
| Fusion 7D<br>Multi-modality registration<br>workstation software | Mirada Solutions Ltd.<br>Oxford Centre for Innov.<br>Mill Street, Oxford OX2 OJX<br>United Kingdom | K020546<br>SE 10/11/2002<br>Product code LLZ<br>Class II |
| Eloquence Integrated<br>Functional Imaging<br>System | MRI Devices Corp.<br>1515 Paramount Dr.<br>Waukesha, WI 53186 | K023130<br>SE 10/11/2002<br>Product code LNH<br>Class II |
| Syngo® Multimodality<br>Workstation | Siemens Medical Systems<br>186 Wood Ave. South<br>Iselin, NJ 08830 | K010938<br>SE 6/26/2001<br>Product code LLZ<br>Class II |

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K052467

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## Description of Device 4.

BrainViewRx is an image processing software package for the visualization and manipulation of clinical imagery of multiple kinds. It brings sets of anatomical, physiologic and/or functional imagery into alignment and provides a variety of display and analysis options for utilizing the imagery relationships.

## Statement of Intended Use 5.

Brain ViewRx ™ provides visualization of functional and physiologic brain imaging data. The software package provides both analysis and viewing capabilities that promote the integration of physiologic and functional imaging data sets, including blood oxygen level dependent (BOLD) fMRI and magnetic resonance spectroscopy (MRS). The integration of these data, when interpreted by a trained physician, yields information that may assist in the diagnosis of brain pathology and the planning and monitoring of medical treatments.

# Predicate Device Comparison of Technological Characteristics 6.

The BrainViewRx Viewer image display capabilities are substantially equivalent to the Mirada Solutions Fusion 7D software package, and the image processing software provided with the MRI Devices Eloquence workstation. The selection of imagery displayed by BrainViewRx is substantially equivalent to Siemens syngo software. BrainViewRx provides similar capabilities for processing and integrated display of clinical imagery from a variety of sources.

# 7. Performance Study

FDA has not established special controls or performance standards for this device. Software verification and validation was conducted to confirm proper function of the device's features.

## 8. Safety information

No new safety hazards are introduced by the use of the BrainViewRx software package in comparison to the software of the predicate devices.

rev. 12/2005

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Public Health Service

MAY 1 7 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

James L. Reuss, Ph.D. Chief Technology Officer Kyron Clinical Imaging, Inc. 2457 N. Mayfair Rd., Suite 202 WAUWATOSA WI 53226

Re: K052467

Trade/Device Name: BrainViewRx™ Viewer Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 24, 2006 Received: April 28, 2006

Dear Dr. Reuss:

This letter corrects our substantially equivalent letter of December 20, 2005.

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 (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 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

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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 continue 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 [phone]. 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/cdrh/dsma/dsmamain.html

Sincerely yours.

Nancyc brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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# Indications For Use 4

510(k) Number (if known): K052467 (corrected)

Kyron™ Clinical Imaging, Inc. - BrainViewRxTM Viewer Device Name:

# INDICATIONS FOR USE:

BrainViewRxTM provides visualization of functional and physiologic brain imaging data. The software package provides both analysis and viewing capabilities that promote the integration of physiologic and functional imaging data sets, including blood oxygen level dependent (BOLD) fMRI, magnetic resonance spectroscopy (MRS), and MR diffusion including diffusion tensor imaging (DT). The integration of these data, when interpreted by a trained physician, yields information that may assist in the diagnosis of brain pathology and the planning and monitoring of medical treatments.

Prescription Use X (Per 21 CFR 801 Subpart D) OR

Over-the-Counter Use (Per 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 Buxton

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

4-1