ISITE PACS, V 4. X

K063267 · Stentor Inc., A Philips Medical Systems Co. · LLZ · Nov 9, 2006 · Radiology

Device Facts

• Record ID: K063267
• Device Name: ISITE PACS, V 4. X
• Applicant: Stentor Inc., A Philips Medical Systems Co.
• Product Code: LLZ · Radiology
• Decision Date: Nov 9, 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

iSite PACS is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, communication and storage. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

Device Story

iSite PACS is a software-based image management system operating on general-purpose computing hardware. It acquires, stores, distributes, processes, and displays medical images (CT, MR, NM, US, XA, PET, DX, DR, RF, RT, MG, SC, VL) and associated data via DICOM. Used by physicians, nurses, and technicians in clinical environments to facilitate diagnostic review. Software performs digital image processing and measurements. Output is displayed on clinical workstations to support clinical decision-making and diagnostic interpretation. System supports integration with hospital and radiology information systems.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and effectiveness are supported by design, development, testing, and validation procedures consistent with standard software engineering practices for diagnostic radiological workstations.

Technological Characteristics

Software-based PACS running on off-the-shelf general-purpose computing hardware. Supports DICOM connectivity for image acquisition, storage, and display. Performs digital image processing and measurement functions. Designed for use with standard clinical display monitors (with specific requirements for mammography).

Indications for Use

Indicated for trained professionals (physicians, nurses, technicians) in clinical environments for acquisition, storage, distribution, processing, and display of medical images and data. Contraindicated for primary interpretation of lossy compressed mammographic images and digitized film screen images. Mammographic interpretation requires FDA-approved 5 Mpixel monitors.

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

• GE Centricity PACS (K043415)
• Kodak PACS (K060055)
• iSite PACS 3.3 (K042292)

Submission Summary (Full Text)

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K063267

510(k) SUMMARY

In accordance with the provisions of the Safe Medical Device Act of 1990, Stentor, Inc., a Philips Medical Systems Company is providing a summary of safety and effectiveness information regarding the iSite PACS software.

- 1.1 Company Identification Stentor, Inc., a Philips Medical Systems Company 5000 Marina Blvd, Suite 100 Brisbane, CA 94005
NOV - 9 2006

## Registration Number: 2954704

- 1.2 Contact Person Deana Wiseman Sr. Manager of Quality and Regulatory Telephone: [phone] Fax: [phone]
- 1.3 Preparation Date May 18, 2006

## Identification of Product and Classification 1.4 iSite PACS V. 4. X Device Trade Name: Classification Name: Picture Archiving and Communications System Classification Panel: Radiology 892.2050 CRF Section: Device Class: 11 LLZ Product Code:

- Substantial Equivalence 1.5 Manufacturer: General Electric Medical Systems Model: GE Centricity PACS 510(k) Number: K043415
Manufacturer: Eastman Kodak Company Model: Kodak PACS 510(k) Number: K060055

Manufacturer: Stentor, Inc. Model: iSite PACS 3.3 510(k) Number: K042292


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#### 1.6 Device Description and Intended Use

iSite PACS is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians.

The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, communication and storage.

iSite supports receiving, sending, printing, storing and displaying studies received from the following modality types via DICOM: CT, MR, NM, US, XA, PET, DX, DR, RF, RT, MG, SC, VL, as well as hospital/radiology information systems.

## 1.7 Software Development

Stentor certifies that the iSite software is designed, developed, tested and validated according to written procedures. These procedures identify individuals within the organization responsible for developing and approving product specifications, coding and testing, validation testing and field maintenance. The software developed for this product is used to provide diagnostic-quality images and associated information to the intended users.

#### 1.8 Safety and Effectiveness

# General Safety and Effectiveness Concerns:

The device labeling contains instructions for use and any necessary cautions and warnings, to provide for safe and effective use of the device. It is the user's responsibility to ensure that display quality, environmental lighting and other possible distractions are consistent with the clinical environment. The hardware components specified are all "off the shelf" computer components.

# Conclusion:

iSite is substantially equivalent in design and intended use to diagnostic radiological workstations, PACS and image management systems as substantiated in the feature comparison. Any differences between the iSite PACS software and the equivalent devices have no significant influence on safety or effectiveness. Therefore, iSite PACS raises no new issues of safety or effectiveness from its predicate devices.

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Image /page/2/Picture/1 description: The image shows a logo with a stylized human head composed of three curved lines. The lines are stacked vertically, with each line representing a different part of the head. To the left of the head is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES" in a circular arrangement.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Stentor, Inc., A Phillips Mcdical System Company % Ms. Laura Danielson Program Manager TÜV Product Service 1775 Old Highway 8 NEW BRIGHTON MN 55112-1891

NOV - 9 2006

Re: K063267

Trade/Device Name: iSite PACS v 4.x Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 25, 2006 Received: October 30, 2006

Dear Ms. Danielson:

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 is a circular logo or emblem. The text "1906 - 2006" is at the top of the circle. The letters "PA" are in the center of the circle in a bold, sans-serif font. Below the letters, the word "Centennial" is written in a cursive font. There are three stars below the word "Centennial". The entire design is surrounded by a dotted border.

Protecting and Promoting Public Health

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean I that FDA has made a determination that your device complies with other requirements of the Act that I Dri has made a and regulations administered by other Federal agencies. You must of any I coolar statutes and regirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI It I at 007), laooinig (21 OS) regulation (21 CFR Part 820); and if applicable, the electronic forul in the quality systems (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) I ins leter with anow you'ts ough finding of substantial equivalence of your device to a legally premaince notifications of cresults 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 n you don Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology | 240-276-0115 |
|----------------|---------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

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/cdrl/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

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

Enclosure

Page 2 -

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# Indications for Use

510(k) Number: Ko x 3267

Device Name: iSite PACS v 4.x

Indications for Use:

iSite PACS is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians.

The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, communication and storage.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations.

Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

Prescription Use × (Part 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)

Nancy Brogdon

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