TIGERVIEW PROFESSIONAL

K061035 · Televere Systems · LLZ · Jun 5, 2006 · Radiology

Device Facts

• Record ID: K061035
• Device Name: TIGERVIEW PROFESSIONAL
• Applicant: Televere Systems
• Product Code: LLZ · Radiology
• Decision Date: Jun 5, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

TigerView Professional 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). In addition, TigerView Professional enables the storage of clinical notes, audio recordings, and clinical exam data. It is intended to acquire, display, edit (e.g., resize, adjust contrast, crop, annotate, etc.), review, store, print, and distribute images using standard PC hardware.

Device Story

TigerView Professional is a PACS software application running on standard PC hardware; receives images/data from radiographic, digital video, and scanner sources; enables storage of clinical notes, audio, and exam data. Physician/clinician uses software to acquire, display, edit (resize, contrast, crop, annotate), review, print, and distribute medical images. Device facilitates clinical workflow by centralizing image management and documentation; supports clinical decision-making through improved access to diagnostic images and patient records.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Software-based PACS application; runs on standard PC-compatible hardware; interfaces with imaging sources via Network Adaptor, USB, PCI, parallel port, memory card, S-video, or SCSI. Performs image processing (resize, contrast, crop, annotation).

Indications for Use

Indicated for clinical use as a software application to receive, store, and manage medical images and clinical data from various imaging sources, including radiographic, digital video, and scanner devices, for review and distribution by healthcare professionals.

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

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

Submission Summary (Full Text)

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Kob/035

Televere Systems TigerView Professional Section 5.0, 510(k) Summary 510(k) Premarket Notification

.

Page 1 of 2

## 510(k) SUMMARY

## General Information

# JUN - 5 2006

| Submitted by: | Televere Systems |
|-----------------|------------------------------------|
| | 16275 South Monterey Road, Suite K |
| | Morgan Hill, CA 95037 |
| | Phone: [phone] |
| | Fax: [phone] |
| Contact Person: | Mr. Randell Quaal |
| | 16275 South Monterey Road, Suite K |
| | Morgan Hill, CA 95037 |
| | Phone: [phone] |
| | Fax: [phone] |
| | Email: [e-mail] |
| Date Prepared: | April 14, 2006 |

### Device Name

| Trade Name: | TigerView Professional |
|----------------------|------------------------------------------------------------|
| Common Name: | Picture archiving and communications system |
| Classification Name: | System, Image Processing, Radiological,<br>21 CFR 892.2050 |

#### Predicate Device

| Manufacturer | Product Name | 510(k) No. |
|----------------------------|---------------------------------------------|------------|
| EagleSoft, A Patterson Co. | EagleSoft ChairSide Software<br>Application | K982422 |
| Tau Corp. | TigerScan/TigerView | K955237 |

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#### Device Description

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

#### Intended Use

TigerView Professional 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). In addition, TigerView Professional enables the storage of clinical notes, audio recordings, and clinical exam data.

It is intended to acquire, display, edit (e.g., resize, adjust contrast, crop, annotate, etc.), review, store, print, and distribute images using standard PC hardware.

#### Technological Comparison

TigerView Professional, TigerScan/TigerView, 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

TigerView Professional has been demonstrated to perform as intended.

#### Conclusions

Tiger View Professional is substantially equivalent to legally marketed Image Processing Systems (i.e. PACS).

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JUN - 5 2006

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Televere Systems % Ms. Melissa Mahall Director, Regulatory Affairs Bio-Reg Associates, Inc. 6304 Belmont Circle, Bldg 2 MOUNT AIRY MD 21771

Re: K061035

Trade/Device Name: TigerView Professional Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 14, 2006 Received: April 14, 2006

Dear Ms. Mahall:

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.

Image /page/2/Picture/10 description: The image shows a circular logo with the text "1906-2006 FDA Centennial" in bold letters. The logo is surrounded by text that reads "Dedicated to the science of sound nutrition". The logo appears to be a commemorative emblem for the FDA's centennial anniversary.

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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 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/industry/support/index.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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## INDICATIONS FOR USE

Kol 1035 510(k) Number (if known):

7

TigerView Professional

Sponsor Name:

Televere Systems

Indications for Use:

Device Name:

TigerView Professional 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). In addition, TigerView Professional enables the storage of clinical notes, audio recordings, and clinical exam data.

It is intended to acquire, display, edit (e.g., resize, adjust contrast, crop, annotate, etc.), review, store, print, and distribute images using standard PC hardware.

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)

David A. Leggion

n of Reproductive. Abdomina adiological Devic