CENTARISONE RIS/PACS

K063037 · Centarisone, LLC · LLZ · Oct 18, 2006 · Radiology

Device Facts

• Record ID: K063037
• Device Name: CENTARISONE RIS/PACS
• Applicant: Centarisone, LLC
• Product Code: LLZ · Radiology
• Decision Date: Oct 18, 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

CentarisOne™ RIS/PACS is intended for use by a physicians and other medical staff as a full service DICOM and IHE compliant RIS/PACS solution for the storage, distribution and display of medical images from various imaging sources such as CT, MRI, NM, PT, DR, CR, US, XA scanners and secondary capture devices (film digitizers, etc.). This device may be used to archive mammography images (MG) but is not intended for primary diagnostic viewing of mammography images by this device.

Device Story

CentarisOne RIS/PACS is a DICOM and IHE-compliant software system for small to mid-sized imaging centers. It integrates radiology information system (RIS) patient data with picture archiving and communication system (PACS) image management. The system stores, distributes, and displays medical images from various modalities (CT, MRI, NM, PT, DR, CR, US, XA). Physicians and medical staff use the system to access patient information and images, facilitating clinical workflow. The device does not perform primary diagnostic viewing for mammography. It operates as a software solution within a clinical environment to support image management and clinical decision-making.

Clinical Evidence

Bench testing only. The device was tested in non-clinical and clinical locations to verify safety and effectiveness. A risk and hazards analysis was performed, with the level of concern classified as minor.

Technological Characteristics

Software-based RIS/PACS solution. DICOM and IHE compliant. Does not contact patients; does not control life-sustaining equipment. Operates as a networked system for image storage and display. Software developed under written procedures and quality controls.

Indications for Use

Indicated for use by physicians and medical staff for storage, distribution, and display of medical images from CT, MRI, NM, PT, DR, CR, US, XA, and secondary capture devices. Includes mammography image archiving, excluding primary diagnostic viewing of 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

• IMAGEQUBE PACS (K051037)

Submission Summary (Full Text)

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K063037

#### 510(k) Summary

# OCT 1 8 2006

Per Title 21 CFR 807.92, and in accordance with the provisions of the SMDA 1990. CentarisOne, LLC is providing a summary of the safety and effectiveness information regarding the CentarisOne RIS/PACS system.

#### Date Prepared

August 26, 2006

#### Submitters Information:

CentarisOne, LLC 11925 Wilshire Blvd., Suite 301 Los Angeles, Ca. 90025 Establishment Registration: REGISTRATION NUMBER Contact: Scott Shannon, Product Director [phone] ext. 114 (phone) [phone] (fax)

#### Device Name:

| Proprietary Name: | CentarisOne™ RIS/PACS |
|------------------------|------------------------------------------------------|
| Common Name: | Picture Archiving and Communication System<br>(PACS) |
| Product Code: | LLZ |
| Device Classification: | Class II - 892.2050 |
| Classification Name: | System, Image Processing, Radiological |

#### Predicate Device:

| | The CentarisOne™ RIS/PACS system is substantially equivalent to the |
|-----------------------------|---------------------------------------------------------------------|
| Manufacturer: | Intuitive Imaging Informatics, LLC |
| Device: | IMAGEQUBE PACS |
| 510(k) Number: | K051037 |
| Decision Date: | 06/28/2005 |
| Decision: | Substantially Equivalent |
| Product Code: | LLZ |
| Device Classification Name: | System, Image Processing, Radiological |
| Device Classification: | Class II - 892.2050 |

#### Device Description:

The CentarisOne™ RIS/PACS is a comprehensive DICOM and IHE compliant radiology software based solution for small to mid-sized imaging centers. The RIS maintains control over all patient related information. The product integrates the imaging aspect with the front office details of the imaging center. It provides all users of the system with more information about the activities of a patient. This all leads to a smoother workflow and better patient care. The PACS component manages the image storage and image display to end-users while

| September 5, 2006 |
|--------------------|
| 510k-100-00001-001 |

CentarisOne™ 510(k) Submission

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tightly integrated into the radiology information system (RIS) to provide users with more patient information resulting in a tighter work-flow.

# Indications for Use:

CentarisOne™ RIS/PACS is intended for use by a physicians and other medical staff as a full service DICOM and IHE compliant RIS/PACS solution for the storage, distribution and display of medical images from various imaging sources such as CT, MRI, NM, PT, DR, CR, US, XA scanners and secondary capture devices (film digitizers, etc.). This device may be used to archive mammography images (MG) but is not intended for primary diagnostic viewing of mammography images by this device.

# Substantial Equivalence to Predicate Device:

There are no significant differences between CentarisOne RIS/PACS and IMAGEQUBE PACS device. Both devices provide a comparable set of features for image storage, communication and display. Both devices support standard DICOM protocol for communication of images with other medical imaging devices.

# Technology Characteristics:

The device does not come in contact with the patient and does not control any life sustaining devices. The PACS device only stores and displays DICOM images to physicians and other professional clinical staff. The application software is designed, developed and tested using written procedures and quality controls.

# Safety:

The device has been tested in non-clinical and clinical locations and proven to be safe and effective. The device contains instructions for use and warnings or cautions to provide for the safe and effective use of the device.

A risk and hazards analysis for the device is included with the 510(k) submission and the "Level of Concern" for potential hazards has been classified as "minor".

# Conclusion:

The CentarisOne™ RIS/PACS product acquires, processes, archives and distributes images utilizing similar techniques functions and techniques as the predicate device IMAGEQUBE PACS.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure, represented by three curved lines that suggest the head and body.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

# OCT 1 8 2006

CentarisOne, LLC c/o Morten Simon Christensen Staff Engineer & FDA Office Coordinator Medical Device Services Underwriters Laboratories, Inc. 455 East Trimble Road SAN JOSE CA 95131

Re: K063037

, , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , Trade/Device Name: CentarisOne" RIS/PACS Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications system " Regulatory Class: II Product Code: LLZ Dated: October 2, 2006 Received: October 3, 2006

Dear Mr. Christensen:

We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave rotened your becation on the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce ass butted in are 1976, the enactment date of the Medical Device Amendments, or to devices that prov to thay Boy 1770, and cordance with the provisions of the Federal Food, Drug, and Cosmetic Ital (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 therefore, mainter 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 tryour do roo is election (oo arch additional controls. Existing major regulations affecting your Apploraly, it they of secret to east 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 for the FDA Centennial, celebrating 1906-2006. The letters "FDA" are prominently displayed in a bold, stylized font in the center of the logo. Below the letters, the word "Centennial" is written in a cursive font. The logo is surrounded by a dotted circle with text that reads "U.S. Department of Health & Human Services".

cting and Promoting Public Health

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Page 2 -

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.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/cdrlv/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

510(k) Number (if known): _ K 6 6 3 6 3 7

Device Name: CentarisOne RIS/PACS

Indications for Use:

CentarisOne™ RIS/PACS is intended for use by a physicians and other medical staff as a full service DICOM and IHE compliant RIS/PACS solution for the storage, distribution and display of medical images from various imaging sources such as CT, MRI, NM, PT, DR, CR, US, XA scanners and secondary capture devices (film digitizers, etc.). This device may be used to archive mammography images (MG) but is not intended for primary diagnostic viewing of mammography images by this device.

Prescription Use 1 (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel A. Segerson

of Reproductive. A

CentarisOne™ 510(k) Submission