CARDIO VASCULAR INFORMATION ENHANCED WORKSTATION

K031638 · Electromed Imaging, Inc. · LLZ · Jul 21, 2003 · Radiology

Device Facts

• Record ID: K031638
• Device Name: CARDIO VASCULAR INFORMATION ENHANCED WORKSTATION
• Applicant: Electromed Imaging, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Jul 21, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The CVIEW™ is a high performance, digital, cardiac image viewer. The System supports DICOM 3.x and higher cardiac and angio images and displays them in their original dynamic mode. The CVIEW accepts images from DICOM 3.x CDs or can be configured to read DICOM 3 images from a DICOM Archive Server. The CVIEW allows immediate playback of images from any patient stored on the system and burning CDs in the DICOM part 10 - file format. It represents the next generation in network cardiac review systems. Features include 1024 viewing, security, report generation, multi-modality viewing, databasing as well as instant access to hundreds of cases on-line or thousands through the network.

Device Story

CVIEW is a digital cardiac image viewing workstation for cath, echo, and angio studies. Input: DICOM 3.x images from CDs or network archive servers. Operation: System provides 1024-resolution viewing, multi-modality display, and database management. Output: Visual display of dynamic cardiac images and DICOM Part 10 CD burning. Used in clinical settings by healthcare professionals for case review and report generation. Benefits: Provides immediate access to patient studies, facilitating efficient clinical decision-making and workflow in cardiac review environments.

Clinical Evidence

No clinical data provided; not required for this device type.

Technological Characteristics

Digital workstation for DICOM 3.x image viewing and management. Supports 1024-resolution display, multi-modality integration, and network connectivity. Features include report generation, database management, and DICOM Part 10 CD burning capability.

Indications for Use

Indicated for use as a digital cardiac image viewer for clinicians to review, manage, and report on cardiac and angio case studies. Supports DICOM 3.x 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

• ViewNT (K000474)
• Centricity PACS Plus (K023557)
• Video Plus System (K992666)
• Echocardiography System (K992259)
• Impax Workstation (K022292)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows a logo with the letter 'C' in a bold, curved font, with a circle above it. Below the 'C' is the text 'Electromed' in a bold font, with the word 'imaging' underneath in italics. The logo appears to be for a company called Electromed Imaging.

JUL 2 1 2003

# 510(k) SUMMARY

K 831638

### DATE PREPARED 1

May 21st, 2003

### CONTACT PERSON 2

Warren Baker President, Chief Executive Officer (Official Correspondent)

### DEVICE NAME 3

| Proprietary Name: | CARDIO VASCULAR INFORMATION ENHANCED WORKSTATION™<br>(CVIEW)™ |
|---------------------|---------------------------------------------------------------|
| Common Name: | DICOM Workstation |
| Radiology Panel: | 90LLZ - System, Image Processing |
| Classification Name | Picture Archiving and Communications Systems (PACS) |
| | 21CFR892.2050 |
| | (Federal Register / Vol. 63, No. 82 / April 29, 1998) |

### DEVICE DESCRIPTION AND INTENDED USE 4

Cardio Vascular Information Enhanced Workstation™ (CVIEW)™ is a viewing stations for Cath, Echo and Angio case studies, represent the next generation in network cardiac review systems. Features include 1024 viewing, security, report generation, multi-modality viewing, databasing as well as instant access to hundreds of cases on-line or thousands through the network.

C-510(k) Summary

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Image /page/1/Picture/0 description: The image shows a logo for "Electromed imaging". The logo consists of a stylized letter "C" inside of a circle. Above the letter "C" is a small dot. Below the circle are the words "Electromed" and "imaging" stacked on top of each other.

### SUBSTANTIAL EQUIVALENCE TO PREDICATE DEVICE(S) 5

## Substantially Equivalent (Predicate) Devices

| Product Tradename | Manufacturer | 510(k) Number |
|------------------------------------------------|----------------------------|----------------------|
| ViewNT | Electromed International | K000474 |
| Centricity PACS Plus | GE Medical Systems | K023557 |
| Video Plus System &<br>Echocardiography System | Camtronics Medical Systems | K992666 &<br>K992259 |
| Impax Workstation | AGFA Corporation | K022292 |

### SAFETY AND EFFECTIVENESS 6

The intended use and technological characteristic of the Cardio Vascular Information Enhanced Workstation (CVIEW)™ are similar or equivalent to the Predicate Device(s). Any differences between the CVIEW™and the Predicate Device(s) have no significant influence on the safety and/or effectiveness of the Device.

### CLINICAL PERFORMANCE DATA 7

Not required for determination of substantial equivalence for this type and class of device.

### CONCLUSION DRAWN FROM CLINICAL AND NONCLINICAL TEST DATA 8

Not required for determination of substantial equivalence for this type and class of device.

C-510(k) Summary

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Image /page/2/Picture/1 description: The image is a black and white logo. The logo consists of a circular border with text around the perimeter. Inside the circle is a stylized image of three birds in flight, overlapping each other. The text around the perimeter of the circle reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 1 2003

Mr. Warren Baker President, Chief Executive Officer Electromed Imaging 440 boul. Armand-Frappier, bureau 250, Laval (Québec) H7V 4B4 CANADA

Re: K031638

Trade/Device Name: Cardio Vascular Information Enhanced Workstation™ (CVIEWTM) Regulation Number: 21 CFR 892.1000 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: May 22, 2003 Received: June 4, 2003

Dear Mr. Baker:

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. Ilisting 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 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.

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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 the letter:

| 8xx. Ixxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, 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 may be obtained 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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Image /page/4/Picture/0 description: The image shows a logo with a stylized letter 'C' inside a black circle. Above the 'C' is a small, white, circular dot, possibly representing a light or highlight. Below the circle, the words 'Electromed' are printed in a bold, sans-serif font, with the word 'imaging' directly underneath in a smaller, italicized font. The overall design is simple and professional, likely representing a company in the medical imaging field.

## Indication for Use Statement

510(k) Number:(if known):

No 3 1638

Device Name:

Cardio Vascular Information Enhanced Workstation™ (CVIEW™M)

Indications for Use:

The CVIEW™ is a high performance, digital, cardiac image viewer. The System supports DICOM 3.x and higher cardiac and angio images and displays them in their original dynamic mode. The CVIEW accepts images from DICOM 3.x CDs or can be configured to read DICOM 3 images from a DICOM Archive Server. The CVIEW allows immediate playback of images from any patient stored on the system and burning CDs in the DICOM part 10 - file format.

It represents the next generation in network cardiac review systems. Features include 1024 viewing, security, report generation, multi-modality viewing, databasing as well as instant access to hundreds of cases on-line or thousands through the network.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Symm

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number *K031638*

Prescription Use

OR

Over-the-Counter Use

(per 21CFR801.109)

CVIEW-USE-STAT