(50 days)
Not Found
No
The document does not mention AI, ML, or related terms like DNN, nor does it describe training or test sets typically associated with AI/ML development. The focus is on standard image viewing and processing functionalities.
No
The device is described as a software for viewing and post-processing medical images, not for providing therapy.
No
The device is described as a software for "viewing of images" and "review and post processing of diagnostic medical images and information," but it explicitly states that "Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretation," and for "primary diagnosis, post process DICOM 'for presentation' images must be used." This indicates that while it processes diagnostic images, it is not intended for primary diagnosis itself.
Yes
The device is explicitly described as a "software device" and its function is centered around viewing, processing, and managing medical images on standard hardware. While it requires hardware to run, the device itself is the software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "viewing of images acquired from CT, MR, CR, DR, US and other DICOM compliant medical imaging systems." This describes a medical imaging workstation used for reviewing and processing images generated by other diagnostic devices.
- Device Description: The description reinforces this by stating it "provides services for review and post processing of diagnostic medical images and information."
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of biological specimens.
The device is a medical imaging software used for interpreting images generated by other medical devices, which falls under a different regulatory category than IVDs.
N/A
Intended Use / 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.
Product codes
LLZ
Device Description
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR, CR, DR, US and other DICOM compliant medical imaging systems
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
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.(b)
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).
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Image /page/0/Picture/0 description: The image contains a handwritten string of characters. The string begins with the letters 'Ko' followed by the number '1'. After the number '1', there is a '3', '4', '7', and '0'. The characters are written in a simple, slightly uneven style, suggesting they were written quickly or without much attention to detail.
510(k) Summary of Safety and Effectiveness
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.
1
510(k) Summary of Safety and Effectiveness
Image /page/1/Picture/1 description: The image shows a close-up of some handwritten text. The text is somewhat blurry and difficult to read, but it appears to contain a combination of letters and numbers. The writing is in dark ink on a light background, and the overall impression is that of a quick note or sketch.
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".
2
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
3
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 (800) 638-2041 or (240) 276-3150
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
4
(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 | AND/OR | Over-The-Counter Use | ||
---|---|---|---|---|
(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 |
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--------------- | --------- |