KODAK CARDIOLOGY DIGITAL ARCHIVE & REVIEW SYSTEM

K960043 · Jamieson Film Co. · LLZ · Mar 27, 1996 · Radiology

Device Facts

• Record ID: K960043
• Device Name: KODAK CARDIOLOGY DIGITAL ARCHIVE & REVIEW SYSTEM
• Applicant: Jamieson Film Co.
• Product Code: LLZ · Radiology
• Decision Date: Mar 27, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Device Story

The Kodak Cardiology Digital Archive and Review System is a Picture Archiving and Communication System (PACS) designed for the management, storage, and review of cardiology-related medical images. It functions as a digital repository, allowing clinicians to access, display, and analyze diagnostic images within a clinical environment. By facilitating the digital archiving of cardiology studies, the system enables healthcare providers to retrieve patient data efficiently, supporting clinical decision-making and diagnostic workflows. The system is intended for use by medical professionals to manage cardiology imaging data, potentially improving the speed and accessibility of patient information compared to traditional film-based systems.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

PACS (Picture Archiving and Communications System); digital image storage and review architecture; software-based system for medical image management.

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).

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993

Eastman Kodak Company
Health Imaging Division
% Mr. Berry Keys
Jamieson Film Co.
901 Elmgrove Road
ROCHESTER NY 14653

MAY - 7 2012

Re: K960043
Trade/Device Name: Kodak Cardiology Digital Archive and Review System
Regulation Number: 21 CFR 892.2050
Regulation Name: Picture archiving and communications system
Regulatory Class: II
Product Code: LLZ
Dated: January 2, 1996
Received: January 3, 1996

Dear Mr. Keys:

This letter corrects our substantially equivalent letter of March 27, 1996.

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of *In Vitro Diagnostic Device Evaluation and Safety* at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH’s Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/cdrh/industry/support/index.html.


Enclosure