PHYSICIAN'S DESKTOP REVIEW

K021669 · Adac Laboratories · LLZ · Jun 5, 2002 · Radiology

Device Facts

• Record ID: K021669
• Device Name: PHYSICIAN'S DESKTOP REVIEW
• Applicant: Adac Laboratories
• Product Code: LLZ · Radiology
• Decision Date: Jun 5, 2002
• 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

Physician's Desktop Review is a medical image display workstation that provides software applications used for review and interpretation of medical images/data. The results obtained may be used as a tool in interpretation of data derived from any medical imaging procedures. The Physician's Desktop Review system should only be operated by qualified healthcare professionals (e.g., radiologists, cardiologists, oncologists, or general nuclear medicine physicians) trained in the use of medical imaging equipment.

Device Story

Physician's Desktop Review (PDT) is a Windows-based workstation for medical image display and interpretation. It integrates image and information data into a desktop environment, allowing clinicians to review, interpret, and report results remotely. The system includes a connectivity package to download image data to the physician's location, reducing travel time and improving result turnaround. Operated by trained healthcare professionals in office environments, the device serves as a tool to assist in the interpretation of data from various medical imaging procedures, facilitating clinical decision-making through improved access to diagnostic information.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological comparison and system performance characteristics similar to predicate devices.

Technological Characteristics

Windows-based workstation; software applications for image display, review, and interpretation; connectivity package for remote data download; system utilities for data storage. No specific hardware materials or energy sources defined beyond standard workstation components.

Indications for Use

Indicated for use by qualified healthcare professionals (radiologists, cardiologists, oncologists, nuclear medicine physicians) for the review and interpretation of medical images and data derived from medical imaging procedures.

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

• Pegasys Ultra™ (K993946)
• Pegasys InTouch (WebView™) (K974474)

Submission Summary (Full Text)

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| ADAC Laboratories | | | | K02 1669 | |
|----------------------------|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|----------|--|
| Physician's Desktop Review | | CONFIDENTIAL | 510(k) Premarket Notification<br>Section B. Administrative Information | | |
| | JUN 5 2002 | | ADMINISTRATIVE INFORMATION | | |
| I. | 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS | | | | |
| A. | Submitted By: | ADAC Laboratories A Philips Medical<br>Systems Company<br>540 Alder Drive<br>Milpitas, California 95035 | | | |
| | | Tel: | [phone] | | |
| | | Fax: | [phone] | | |
| | Contact Person: | Coleen Coleman<br>At address above | | | |
| B. | Device Trade Name: | Physician's Desktop Review | | | |
| | Common Name: | Picture Archive and Communication<br>Systems (PACS) | | | |
| | Classification Name: | Image Processing System | | | |
| C. | Predicate Device(s): | | | | |
| | Manufacturer | Product Name | 510(k) No. | | |
| | ADAC Laboratories | Pegasys Ultra™ | K993946 | | |
| | ADAC Laboratories | Pegasys InTouch (WebView™) | K974474 | | |
| D. | Device Description: | Physician's Desktop Review (PDT) is a Windows®-based physician<br>workstation. The product's design and features improve physician<br>workflow by integrating image and information into his/her desktop<br>environment. The comprehensive tools and features provided with this<br>product allow the physician to review, interpret, and report results and not<br>have to leave the office environment. The connectivity package allows the<br>physician to download image data to his/her location reducing the time for<br>travel and improving turn-around time for patient results. | | | |
| E. | Indications for Use: | Physician's Desktop Review is a medical image display workstation that<br>provides software applications used for review and interpretation of | | | |

provides software applications used for review and interpretation of medical images/data. The results obtained may be used as a tool in interpretation of data derived from any medical imaging procedures. The Physician's Desktop Review system should only be operated by qualified

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healthcare professionals (e.g., radiologists, cardiologists, oncologists, or general nuclear medicine physicians) trained in the use of medical imaging equipment.

- F. Technological Comparison:
The Physician's Desktop Review, Pegasys Ultra™ (K993946), and Pegasys InTouch (WebView™) (K974474) have similar indications for use and overall function and perform in a similar manner with respect to, display, review applications, data storage, and system utilities.

## II. CONCLUSION

Physician's Desktop Review is substantially equivalent to the predicate devices the Pegasys Ultra™ (K993946) and InTouch (Webview™ K974474) based on similar intended use, technological comparison, and system performance.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, with three lines above them. The logo is presented in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 5 2002

ADAC Laboratories % Ms. Elizabeth Drew Reviewer Underwriters Laboratories, Inc. 1655 Scott Boulevard SANTA CLARA CA 95050-4169 Re: K021669

Trade/Device Name: Physician's Desktop Review Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system

Regulatory Class: II Product Code: 90 LLZ Dated: May 17, 2002 Received: May 21, 2002

Dear Ms. Drew:

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 (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 (OS) 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 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:

| 8xx.1xxx | [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" (21 CFR Part 807.97). 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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## INDICATIONS FOR USE STATEMENT

510(k) Number (if known): Ko 2 166 9 - ------

Device Name: Physician's Desktop Review

Sponsor Name: ADAC Laboratories A Philips Medical Systems Company

Indications for Use:

Physician's Desktop Review is a medical image display workstation that provides software applications used for review and interpretation of medical images/data. The results obtained may be used as a tool in interpretation of data derived from any medical imaging procedures. The Physician's Desktop Review system should only be operated by qualified healthcare professionals (e.g., radiologists, cardiologists, oncologists, or general nuclear medicine physicians) trained in the use of medical imaging equipment.

Do Not Write Below This Line - Continue on Another Page if Needed

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
Over-The-Counter Use

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K021669