The PHILIPS Inturis Cardio Image Viewing Package is intended for use in processing and viewing cardiac or cardiovascular images, resulting in quantitative and/or qualitative data that can be used to estimate cardiac or cardiovascular function.

Device Description

PHILIPS Inturis Cardio Image Viewing Package is software that can be loaded on a workstation which has a Windows NT (4.0) Operating System. The Inturis Cardio Image Viewing workstation provides for viewing and analysis of DICOM Cardiac images which are transported to the workstation via CD-Rom. Quantitative Coronary and Left Ventricular analysis may be performed on these images.

AI/ML Overview

The provided text is a 510(k) premarket notification for the Philips Inturis Cardio Image Viewing Package. This document outlines the intended use, system description, and substantial equivalence to a predicate device. However, it does not contain any information regarding acceptance criteria, study details, device performance metrics, sample sizes, ground truth establishment, or expert qualifications necessary to answer your request.

Therefore, I cannot extract the requested information from the provided text. The document is primarily focused on demonstrating substantial equivalence for regulatory approval, not on presenting performance study results.

Summary

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DEC 1 1 1998

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Philips Medical Systems

510(k) Summary

Company name:	Philips Medical Systems North America Company
Address:	710 Bridgeport Avenue, Shelton, CT 06484
Contact person:	P. Altman
Telephone number:	203-926-7031
Prepared:	October 28, 1998
Device name:	Philips Inturis Cardio Image Viewing Package
Classification name:	Image Processing SystemClass II (90 LLZ)
Common/Usual name:	Workstation

Intended use:

System description:

Substantial equivalence Information:

The PHILIPS Inturis Cardio Image Viewing Package is substantially equivalent to the Philips CD-Medical Viewstation (a.k.a. CDM-3500), K945460.

10 Bridgeport Avenue Shelton, Connecticut 06484-0 Tel: (203) 926-7674 Fax: (203) 979-609

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 1 1998

Peter Altman Director of Regulatory Affairs Philips Medical Systems North America Company 710 Bridgeport Avenue P.O. Box 860 Shelton, Connecticut 06484-0917

K983821 Re:

Philips Inturis Cardio Image Viewing Package Dated: October 28, 1998 Received: October 29, 1998 Regulatory class: II 21 CFR 892.2050/Procode: 90 LLZ

Dear Mr. Altman:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the We have reviews your boden I for the indications for use stated in the enclosure) to 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). 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 (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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (11 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announce concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in ritto diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdr/dsma/dsmamain.html".

Sincerely yours,

Kiliai Yin

Lillian Kiu, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Philips Inturis Cardio Image Viewing Package Device Name :

Indications For Use :

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

Concurrence of CDRH, Office of Device Evaluation (ODE)


Prescription Use (Per 21 CFR 801.109	OR	Over-The-Counter Use ______

	(Division Sign-Off)
	Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number	K983821

(Optional Format 1-2-96)

Regulation Number and Section

§ 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).