SVIEW

K060840 · Mri Cardiac Services, Incorporated · LLZ · Apr 7, 2006 · Radiology

Device Facts

• Record ID: K060840
• Device Name: SVIEW
• Applicant: Mri Cardiac Services, Incorporated
• Product Code: LLZ · Radiology
• Decision Date: Apr 7, 2006
• 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

SView 1.0 is a medical image management device intended for viewing, manipulating and analyzing DICOM-compliant medical images acquired from MRI scanners and other DICOM -compliant imaging devices. SView™ 1.0 can be used for real-time image viewing, image manipulation, and analysis that aid a cardiologist or radiologist in their diagnosis. In addition, it facilitates the physician's reporting and reviewing of patient studies.

Device Story

SView 1.0 is a software tool for 2D viewing, manipulation, and analysis of DICOM-compliant medical images; inputs include MRI and other DICOM-compliant image data. Operated on a standard Windows PC, the device supports dual-monitor configurations for simultaneous image viewing and reporting. It provides real-time visualization and analysis capabilities to assist cardiologists and radiologists in clinical diagnosis and study reporting. The device does not perform image digitization and utilizes lossless compression. It is intended for use in clinical settings by healthcare professionals to facilitate diagnostic workflows and patient study management.

Clinical Evidence

Bench testing only. No clinical data was required as the device is a medical image management tool using lossless compression and no image digitizers. Extensive testing was performed by programmers, non-programmers, quality assurance staff, and potential customers.

Technological Characteristics

PC-based software; runs on standard Windows operating system; supports DICOM-compliant images; dual-monitor capability; lossless compression; no image digitizers; standalone medical image management device.

Indications for Use

Indicated for cardiologists and radiologists to view, manipulate, and analyze DICOM-compliant medical images from MRI and other imaging devices to aid in diagnosis, reporting, and review of patient studies.

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

• AccuView Diagnostic Imaging Workstation Software Package (K990241)

Submission Summary (Full Text)

{0}------------------------------------------------

## Ko60840 MRI Cardiac Services, Inc. 510(k) Summary

#### Submitter:

MRI Cardiac Services, Inc. 8 West Third Street, M9 Winston-Salem, NC 27101 336-831-1908 (v) 336-727-0919 (f)

7 2006 APR

Date Prepared:

June 1, 2004

#### Contact Person(s):

Scott Huber, President 336-831-1908 (v) 336-727-0919 (f)

Device Trade Name: SView™

#### Device Common Name:

PACS / Medical Image Management Device

#### Classification Name:

Class II - System, Image Processing

Product Code/Regulation Number:

LLZ/892.2050

#### Substantially Equivalent To:

AccuView Diagnostic Imaging Workstation Software Package (K990241) AccuImage Diagnostics Corporation 400 Oyster Point Boulevard, Suite 114 S. San Francisco, CA 94080

#### Device Description:

SView " 1.0 is a tool for 2D (two-dimensional) viewing and manipulation of DICOM compliant MR images and other DICOM-compliant images. The proposed device provides real-time image viewing, manipulation, analysis and reporting.

#### Indications for Use:

SView 1.0 is a medical image management device intended for viewing. manipulating and analyzing DICOM-compliant medical images acquired from MRI scanners and other DICOM -compliant imaging devices. SView™ 1.0 can be used for real-time image viewing, image manipulation, and analysis that aid a cardiologist or radiologist in their diagnosis. In addition, it facilitates the physician's reporting and

8 West Third Street, Suite M9 Winston-Salem, NC 27101 (t)336-831-1908 (f) 336-727-0919 (e) [e-mail]

{1}------------------------------------------------

# MRI Cardiac Services, Inc.

reviewing of patient studies.

#### Technological Comparison to Predicate Device:

The proposed and predicate medical image management devices are both devices that can be used for manipulation of DICOM-compliant MR images. The proposed and predicate device can be operated from a personal computer. SView™ 1.0 and a standard Windows operating system. SView is a subset of the AccuView Diagnostic Imaging Workstation features with an optional added monitor to allow a Cardiologist or Radiologist the convenience of using two monitors, one for image viewing and manipulation, and the other for reporting. SView™ 1.0 has substantially equivalent features and specifications versus the existing AccuView Diagnostic Imaging Workstation for those features and specifications the two devices have in common.

#### Laboratory and Clinical Testing

SView 1.0 is intended for use with existing MRI images for real-time image viewing, image manipulation, and analysis that aid a cardiologist or radiologist in their diagnosis. In addition it facilitates the physician's reporting and reviewing of patient studies. The SView™ medical image management device contains no image digitizers and uses only lossless compression. On this basis, MRI Cardiac Services, Inc. believes that clinical investigation is not necessary.

Extensive testing of the device will be performed by programmers, by nonprogrammers, quality assurance staff and by potential customers prior to commercial release.

#### Adverse Effects on Health:

The potential hazards are identified in the Hazard Analysis and are controlled by:

- Designing controls directed at the cause and/or
- Introducing protective measures and/or
- o Warning the Users

All identified hazards are mitigated to minor level of concern.

See Summary of Safety and Effectiveness on the following page.

#### Conclusions:

We conclude that the subject device, SView™ 1.0 is as safe and effective as the predicate device and posses no new questions of safety and effectiveness. SView 114 1.0 performs in accordance with its intended use as well as the AccuView Diagnostic Imaging device currently on the market. MRI Cardiac Services, Inc. considers features of the SView™ 1.0 to be substantially equivalent to the subset of features in common with the AccuView. Diagnostic Imaging device (510(k)990241.)

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes on its back, representing the three branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - U.S.A." is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MRI Cardiac Services, Inc. % Mr. Daniel W. Lehtonen Responsible Third Party Official Intertek Testing Services NA, Inc. 2307 East Aurora Rd., Unit B7 TWINSBURG OH 44087

Re: K060840 Trade/Device Name: SView™ Version 1.0 PACS Medical Image Management Device Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II

Product Code: LLZ Dated: March 27, 2006 Received: March 28, 2006

Dear Mr. Lehtonen:

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.

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 (2) CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

APR 7 2006

{3}------------------------------------------------

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/industrv/support/index.html.

Sincerely vours.

Nancy C. Brigdon

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

Enclosure

{4}------------------------------------------------

### Indications for Use

501(k) Number: _______________________________________________________________________________________________________________________________________________________________

Device Name: SView™ Version 1.0 PACS/Medical Image Management Device

Indications For Use:

SView 1.0 is a medical image management device intended for viewing, manipulating and analyzing DICOM-compliant medical images acquired from MRI scanners and other DICOM -compliant imaging devices. SView™ 1.0 can be used for real-time image viewing, manipulation and analysis that aid a cardiologist or radiologist in their diagnosis. In addition, it facilitates the physician's reporting and reviewing of patient studies.

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

Over- The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Ingram

(Division Sign-Off) Division of Reproductive. Ab and Radiological Devices 510(k) Number

Page 1 of 1