VISIX IMAGING

K082623 · Televere Systems · LLZ · Feb 25, 2009 · Radiology

Device Facts

• Record ID: K082623
• Device Name: VISIX IMAGING
• Applicant: Televere Systems
• Product Code: LLZ · Radiology
• Decision Date: Feb 25, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

Visix Imaging is a clinical software application that receives images and data from various imaging sources (e.g., radiographic devices, digital video capture devices, and generic image devices such as scanners). Visix Imaging is intended to acquire, display, edit (e.g., resize, adjust contrast, annotate, etc.), review, store, print, and distribute images, plus store clinical notes in the form of annotations and measurements, using standard PC hardware. Visix Imaging is currently intended for dental use. It is not intended for mammography use.

Device Story

Visix Imaging is a clinical software application (PACS) operating on standard PC hardware; receives images/data from radiographic devices, digital video capture devices, and scanners via USB, parallel, S-video, or SCSI ports. Enables physicians to acquire, display, edit (resize, contrast adjustment, annotation), review, store, print, and distribute medical images; stores clinical notes as annotations and measurements. Used in dental clinical settings to manage patient imaging data; supports clinical decision-making by providing organized access to diagnostic images and measurements. Benefits include streamlined image management and documentation within a dental practice.

Clinical Evidence

Bench testing only. The device was demonstrated to perform as intended through functional verification of image management and processing capabilities.

Technological Characteristics

Software application for PACS; runs on standard PC-compatible hardware. Interfaces with imaging sources via USB, parallel, S-video, or SCSI ports. Provides image processing tools including resizing, contrast adjustment, and annotation. No specific algorithm architecture or hardware materials specified.

Indications for Use

Indicated for dental use in patients requiring image acquisition, display, editing, review, storage, printing, and distribution of medical images and clinical notes. Not indicated for mammography.

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

• TigerView Professional (K061035)
• EagleSoft ChairSide Software Application (K982422)
• TigerScan/TigerView (K955237)

Submission Summary (Full Text)

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1082623

Televere Systems Section 005_510(k) Summary 510(k) Premarket Notification

Visix Imaging Page 1 of 2

#### CONFIDENTIAL

### 510(k) SUMMARY

## FEB 2 5 2009

#### General Information

Submitted by:

Televere Systems 1611 Center Avenue Janesville, WI 53545

Phone: [phone] Fax: [phone]

Contact Person:

Barbara Deay 471 Stage Road Charlton, NY 12019

Phone: [phone] x128 408-762-2760 Fax: Email: [e-mail]

Date Prepared:

August 29, 2008

#### Device Name

Trade Name: Visix Imaging Common Name: Picture archiving and communications system Classification Name: System, Image Processing, Radiological, 21 CFR 892.2050

#### Predicate Device

| Manufacturer | Product Name | 510(k) No. |
|----------------------------------------------|---------------------------------------------|------------|
| Televere Systems | TigerView Professional | K061035 |
| EagleSoft | EagleSoft ChairSide Software<br>Application | K982422 |
| Tau Corp. (purchased by<br>Televere Systems) | TigerScan/TigerView | K955237 |

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Televere Systems Section 005_510(k) Summary Visix Imaging Page 2 of 2

#### CONFIDENTIAL

#### Device Description

Visix Imaging is an image management system that allows the physician to acquire, display, edit (e.g., resize, adjust contrast, etc.), review, store, print, and distribute medical images within a Picture Archiving and Communication System (PACS) environment. Visix Imaging runs on standard PC-compatible computers and is compatible with capture devices which attach to the computer using a USB port, parallel port, S-video port on a video capture card, or SCSI card.

#### Intended Use

Visix Imaging is a clinical software application that receives images and data from various imaging sources (e.g., radiographic devices, digital video capture devices, and generic image devices such as scanners). Visix Imaging is intended to acquire, display, edit (e.g., resize, adjust contrast, annotate, etc.), review, store, print, and distribute images, plus store clinical notes in the form of annotations and measurements, using standard PC hardware. Visix Imaging is currently intended for dental use. It is not intended for mammography use.

#### Technological Comparison

Visix Imaging, Tiger View Professional, Tiger View, and EagleSoft ChairSide are each software applications that have similar indications for use and overall function and perform in a similar manner with respect to image processing systems (i.e. PACS).

#### Testing

Visix Imaging has been demonstrated to perform as intended.

#### Conclusions

Visix Imaging is substantially equivalent to legally marketed Picture Archiving and Communications Systems.

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized human figure with three arms or extensions, representing health and human services. The overall design is simple and recognizable, conveying the department's role and purpose.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

· Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 5 2009

Televere Systems % Ms. Barbara Deay . Technical Support and Writing Televere Systems 471 Stage Road CHARLTON NY 12019

Re: K082623

Trade/Device Name: Visix Imaging Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 11, 2009 Received: January 14, 2009

#### Dear Ms. Deay:

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. Drue, 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 electronic 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 os 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.xxx |
|----------------|
| 21 CFR 884.xxx |
| 21 CFR 892.xxx |
| Other |

(Gastroenterology/Renal/Urology) [phone] (Obstetrics/Gynecology) [phone] (Radiology) [phone] [phone]

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry.suppot/index.html.

Sincerely yours,

Janine M. Morris

Janine M. Morris Acting 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) Premarket Notification Televere Systems Section 004 _Indications for Use Statement

Visix Imaqinq Page 1 of 1

# INDICATIONS FOR USE

510(k) Number (if known): K082623

Visix Imaging Device Name:

Sponsor Name: : Televere Systems

Indications for Use:

Visix Imaging is a clinical software application that receives images and data from various imaging sources (e.g., radiographic devices, digital video capture devices, and generic image devices such as scanners). Visix Imaging is intended to acquire, display, edit (e.g., resize, adjust contrast, annotate, etc.), review, store, print, and distribute images, plus store clinical notes in the form of annotations and measurements, using standard PC hardware. Visix Imaging is currently intended for dental use. It is not intended for mammography use.

Prescription Use X (21 CFR 801 Subpart D)

And/Or

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

Do Not Write Below This Line - Continue on Another Page if Needed Concurrence of CDRH, Office of Device Evaluation (ODE)

Tony Thien

(Division Sign-Off) Division of Reproductive. Abdominal and Radiologics' " ﮨﮯ-------510(k) Num. ..

August 29, 2008