AYCAN WORKSTATION OSIRIX

K063470 · Aycan Digitalsysteme GmbH · LLZ · Jan 5, 2007 · Radiology

Device Facts

• Record ID: K063470
• Device Name: AYCAN WORKSTATION OSIRIX
• Applicant: Aycan Digitalsysteme GmbH
• Product Code: LLZ · Radiology
• Decision Date: Jan 5, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

aycan Workstation OsiriX is a software device intended for viewing of images acquired from CT, MR, CR, DR, US and other DICOM compliant medical imaging systems when installed on suitable commercial standard hardware. Images and data can be captured, stored, communicated, processed, and displayed within the system and or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretation. For primary diagnosis, post process DICOM "for presentation" images must be used. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images. It is the User's responsibility to ensure monitor quality, ambient light conditions, and image compression ratios are consistent with clinical application.

Device Story

Software-based PACS workstation; runs on Apple Mac OSX; processes DICOM-compliant medical images (CT, MR, CR, DR, US). Enables capture, storage, communication, processing, and display of multidimensional/multimodality images across networks. Operated by clinicians in clinical settings; provides high-performance review, navigation, and post-processing tools. Physician interprets displayed images; device does not contact patient or control life-sustaining equipment. Output supports clinical decision-making by facilitating diagnostic review. Benefits include efficient image management and visualization.

Clinical Evidence

Bench testing only. Verification and validation activities performed per risk analysis; system passed all testing criteria. No clinical data presented.

Technological Characteristics

Software-based PACS; runs on Apple Mac OSX hardware. Conforms to DICOM 3.0 standards for image communication. Provides multidimensional/multimodality image processing and review. No patient contact. Hazard analysis classified as 'Minor' level of concern.

Indications for Use

Indicated for viewing medical images (CT, MR, CR, DR, US) from DICOM-compliant systems. Intended for use by clinicians for image review and post-processing. Contraindicated for primary diagnosis using lossy compressed mammographic images or digitized film screen images.

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

• IQ-SYSTEM PACS SYSTEM (K062488)

Submission Summary (Full Text)

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# 510(k) Summary of Safety and Effectiveness

K063470

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

Date Prepared:

November 8, 2000

JAN - 5 2007

Submitter's Information: 21 CFR 807.92(a)(1) Mr. Stephan Lange aycan Digitalsysteme GmbH Innere Aumuehlstrasse 5 97076 Wurerzburg, Germanv

Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2)

| Trade Name: | aycan Workstation OsiriX |
|----------------------|-----------------------------------------|
| Common Name: | Picture Archiving Communications System |
| Classification Name: | system, image processing, radiological |
| Product code: | LLZ |

#### Predicate Device: 21 CFR 807. 92(a)(3)

FDA has classified the predicate device (K062488) as Class II, CFR 892.2050, LLZ. It is our understanding that aycan Workstation OsiriX device falls under the same classification as the predicate device. Predicate device details are as follows:

| Device Classification Name | system, image processing, radiological |
|-----------------------------|----------------------------------------|
| 510(k) Number | K062488 |
| Regulation Number | 892.2050 |
| Device Name | IQ-SYSTEM PACS SYSTEM |
| Applicant | IMAGE INFORMATION SYSTEMS, LTD. |
| Classification Product Code | LLZ |
| Decision Date | 09/19/2006 |

Classification Advisory Committee Radiology

# Device Description: 21 CFR 807 92(a)(4)

The aycan Workstation OsiriX provides services for review and post processing of diagnostic medical images and information. It conforms to the DICOM 3.0 standard to allow the sharing of medical information with other digital imaging systems. aycan workstation OsiriX runs on Apple Mac OSX systems and provides high performance review, navigation and post processing functionality for multidimensional and multimodality images.

## Indications for Use: 21 CFR 807 92(a)(5)

aycan Workstation OsiriX is a software device intended for viewing of images acquired from CT, MR, CR, DR, US and other DICOM compliant medical imaging systems when installed on suitable commercial standard hardware.

Images and data can be captured, stored, communicated, processed, and displayed within the system and or across computer networks at distributed locations.

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# 510(k) Summary of Safety and Effectiveness

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Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretation. For primary diagnosis, post process DICOM "for presentation" images must be used. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images. Shirty

It is the User's responsibility to ensure monitor quality, ambient light conditions, and image compression ratios are consistent with clinical application.

Technological Characteristics: 21 CFR 807 92(a)(6)

aycan Workstation OsiriX is a software device that handles and manipulates digital medical images.

The device does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human intervention interarets images and information being displayed and printed

#### Testing:

As required by the risk analysis, designated individuals performed all verification and validation activities and results demonstrated that the predetermined acceptance citerial were met. The system passed all testing criteria.

### Conclusion: 21 CFR 807 92(b)(1)

The 510(k) Pre-Market Notification for aycan Workstation OsiriX contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.

The submission contains the results of a hazard analysis and the "Level of Concern" for potential hazards has been classified as "Minor".

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Acyan Digitalsystemc GmbH % Mr. Carl Alletto Consultant OTech, Inc. 1600 Manchester Way CORINTH TX 76210

Re: K063470

Trade/Device Name: aycan Workstation OsiriX Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 13, 2006 Received: November 21, 2006

Dear Mr. Alletto:

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.

JAN 0 5 2007

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/8 description: The image is a black and white circular logo. The logo contains the letters "FDA" in a stylized font, with the text "Centennial" underneath. Above the letters "FDA" are the numbers "1906-2006". Below the word "Centennial" are three stars. The logo is surrounded by a dotted circle.

Protecting and Promoting Public Health

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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.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

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#### (Indications for Use Form)

# 510(k) Number: K063470

Device Name: aycan Workstation OsiriX

Indications for Use:

aycan Workstation OsiriX is a software device intended for viewing of images acquired from CT, MR, CR, DR, US and other DICOM compliant medical imaging systems when installed on suitable commercial standard hardware.

Images and data can be captured, stored, communicated, processed, and displayed within the system and or across computer networks at distributed locations.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretation. For primary diagnosis, post process DICOM "for presentation" images must be used. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images.

It is the User's responsibility to ensure monitor quality, ambient light conditions, and image compression ratios are consistent with clinical application.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <div> <span style="text-decoration: underline;"></span> </div> | AND/OR | Over-The-Counter Use | <div> <span style="text-decoration: underline;"></span> </div> |
|-----------------------------|----------------------------------------------------------------|------------------------|----------------------|----------------------------------------------------------------|
| (Part 21 CFR 801 Subpart D) | | (21 CFR 807 Subpart C) | | |

David A. Byman
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices

| 510(k) Number | K063470 |
|---------------|---------|
|---------------|---------|