IMAGECAST PACS

K052618 · Idx Systems Corp. · LLZ · Nov 17, 2005 · Radiology

Device Facts

• Record ID: K052618
• Device Name: IMAGECAST PACS
• Applicant: Idx Systems Corp.
• Product Code: LLZ · Radiology
• Decision Date: Nov 17, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Imagecast™ 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 used with general purpose computing hardware to acquire, transmit, process and store images and data throughout a clinical environment. Data and images are acquired through DICOM compliant imaging devices and modalities. 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 the FDA.

Device Story

Imagecast™ PACS is an image management system for clinical environments; operated by physicians, nurses, and technicians. It acquires, transmits, processes, and stores medical images and data from DICOM-compliant modalities. The system replaces iSite PACS worklist software with Imagecast™ Worklist software to optimize clinician workflows, including organizing, finding, reading, sharing, and reporting. It runs on general-purpose computing hardware. Clinicians use the system to view images for diagnostic purposes, facilitating clinical decision-making. It benefits patients by streamlining image access and management for healthcare providers.

Clinical Evidence

Bench testing only. Verification and validation activities were performed to confirm the device meets design and performance specifications and user needs.

Technological Characteristics

PACS software for image management; utilizes general-purpose computing hardware; DICOM-compliant connectivity; supports high-resolution (≥5 Mpixel) monitors for mammography; software-based workflow management.

Indications for Use

Indicated for trained professionals (physicians, nurses, medical technicians) to acquire, transmit, process, and store medical images/data in clinical environments. Contraindicated for primary interpretation of lossy compressed mammographic images or digitized film screen images; mammography 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

• iSite PACS System (K042292)

Submission Summary (Full Text)

{0}------------------------------------------------

# NOV 1 7 2005

# 510(k) Summary for the IDX Systems Corporation Imagecast™ PACS

#### 1. SUBMITTER/HOLDER

K052618

IDX Systems Corporation 40 IDX Drive P.O. Box 1070 Burlington, VT 05402

Contact Person: Dan McKibben Telephone: [phone]

Date Prepared: September 6, 2005

#### 2. DEVICE NAME

Proprietary Name: Imagecast™ PACS Common/Usual Name: PACS Picture archiving and communication system Classification Name:

#### PREDICATE DEVICE 3.

iSite PACS System, K042292, Stentor, Inc.

#### 4. DEVICE DESCRIPTION

The Imagecast™ PACS is a modification of the iSite PACS that replaces the iSite worklist software with the Imagecast™ Worklist software. The Imagecast™ PACS is designed to optimize the clinician's workflow, and targets activities fundamental to their work: organizing, finding, reading, sharing and reporting. The Imagecast™ PACS trade name is also currently in use by IDX to resell the iSite PACS product.

#### ડ. INTENDED USE

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

{1}------------------------------------------------

technicians. The system is used with general purpose computing hardware to acquire, transmit, process and store images and data throughout a clinical environment. Data and images are acquired through DICOM compliant imaging devices and modalities.

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 the FDA.

### TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

The Imagecast™ PACS is substantially equivalent to the iSite PACS in intended use, indications for use, technological characteristics and operational characteristics.

#### 7. PERFORMANCE TESTING

Prospectively defined verification and validation activities for the Imagecast™ PACS assure that the Imagecast™ PACS is substantially equivalent to the cleared iSite PACS and meets design and performance specifications as well as user needs when operated according to the operating instructions.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized depiction of an eagle or bird-like figure, composed of three curved lines that suggest wings or feathers. The logo is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" arranged in a circular fashion.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Dan McKibben Executive Quality Management Representative IDX IMAGECAST DIVISION 40 IDX Drive PO Box 1070 BURLINGTON VT 05402

# Re .: K052618

Trade/Device Name: Imagecast PCS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system. Regulatory Class: II Product Code: LLZ Dated: November 8, 2005 Received: November 9, 2005

Dear Mr. McKibben:

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 (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.

NOV 1 7 2005

{3}------------------------------------------------

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter natification. The FDA finding of substantial equivalence of your device to a legally premated 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 If you don't specifice 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 Alloy, production other general information on your responsibilities under the Act from the 601:37): " For may overnin sturers, 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

{4}------------------------------------------------

## Indications for Use

510(k) Number (if known):

KOSZ618

Imagecast™ PACS Device Name:

Indications For Use:

Imagecast™ 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 used with general purpose computing hardware to acquire, transmit, process and store images and data throughout a clinical environment. Data and images are acquired through DICOM compliant imaging devices and modalities.

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 the FDA.

X Prescription Use (Part 21 CFR 801 Subpart D)

Image /page/4/Picture/8 description: The image shows the text "AND/OR" with a line drawn through the word "AND". The text is in a simple, sans-serif font and is horizontally aligned. The slash between the words "AND" and "OR" is clearly visible. The line through "AND" suggests a negation or cancellation of that option.

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel R. Syverson

Page 4-1