(43 days)
Not Found
No
The summary describes standard image processing and analysis software from the Windows NT era, with no mention of AI, ML, or related concepts.
No
Explanation: The device is intended for viewing and processing cardiac images for quantitative and qualitative data used to estimate cardiac function. It does not directly provide therapy or intervention.
Yes
The device processes and views cardiac/cardiovascular images to produce quantitative/qualitative data for estimating cardiac/cardiovascular function, which is a diagnostic purpose.
Yes
The device description explicitly states it is "software that can be loaded on a workstation" and describes its function as processing and viewing images. There is no mention of accompanying hardware components being part of the device itself.
Based on the provided information, the PHILIPS Inturis Cardio Image Viewing Package is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device is software used for processing and viewing cardiac or cardiovascular images. These images are obtained from imaging modalities (like those producing DICOM Cardiac images), not from in vitro samples.
- Lack of Biological Sample Analysis: There is no mention of the device analyzing any biological samples. Its function is solely focused on the manipulation and interpretation of medical images.
Therefore, while it's a medical device used for diagnosis and assessment, it falls under the category of medical imaging software rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
90 LLZ
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiac or cardiovascular
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
Not Found
Key Metrics
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).
0
DEC 1 1 1998
Image /page/0/Picture/1 description: The image shows a logo for Philips. The logo is a shield shape with the word "PHILIPS" written in bold, sans-serif font at the top. Below the text, there is a circular emblem containing two stars and two wavy lines. The logo is black and white.
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 System |
| Class II (90 LLZ) | |
| Common/Usual name: | Workstation |
Intended use:
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.
System 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.
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
1
Image /page/1/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in a bold, sans-serif font. The text is black and the background is white. The text is centered in the image.
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
2
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Philips Inturis Cardio Image Viewing Package Device Name :
Indications For Use :
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.
(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)