(30 days)
Not Found
Not Found
No
The provided text focuses on safety standards, manufacturing compliance, and user information, with no mention of AI, ML, or related concepts.
No
The description mentions the device is "safe and effective when used as directed in the Information for Users" and subject to "Federal Performance Standards, defined in 21CFR - part 1000", which suggests it is a diagnostic imaging system (X-ray system according to UL 187 and UL 2601 standards) rather than a therapeutic device. There is no information indicating it delivers therapy.
No
The device description mentions safety standards and effective use but does not indicate any function related to diagnosing medical conditions. The "Intended Use / Indications for Use" section is "Not Found".
No
The device description explicitly mentions "systems" and references hardware-related standards (UL 187, UL 2601), indicating it includes hardware components and is not software-only.
Based on the provided information, it is highly unlikely that this device is an IVD (In Vitro Diagnostic). Here's why:
- Lack of IVD Indicators: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.).
- Providing diagnostic information based on the analysis of these samples.
- Mentioning reagents, assays, or laboratory procedures.
- Focus on Performance Standards and Safety: The description heavily emphasizes compliance with Federal Performance Standards (21CFR - part 1000) and voluntary safety standards (UL 187 and UL 2601). These are common for medical devices that interact directly with the patient or produce images, but not typically the primary focus for IVDs.
- Anatomical Site Mentioned: The mention of "CARDIO / VASCULAR" as the anatomical site strongly suggests a device that interacts with or images the cardiovascular system, which is characteristic of imaging or interventional devices, not IVDs.
- Absence of IVD-Specific Information: There is no information about sample types, analytical methods, or performance metrics relevant to IVD testing (like sensitivity, specificity in a diagnostic context).
Conclusion:
The information provided points towards a medical device used in the CARDIO / VASCULAR system, likely an imaging or treatment device, rather than an In Vitro Diagnostic device. The focus on performance standards and safety, along with the anatomical site, are strong indicators against it being an IVD.
N/A
Intended Use / Indications for Use
Not Found
Product codes
Not Found
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1600 Angiographic x-ray system.
(a)
Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the Philips logo, which consists of the word "PHILIPS" in a bold, sans-serif font above a shield-like emblem. The emblem features a circle with two wavy lines across the middle, resembling water or sound waves. Above and below the wavy lines are four-pointed stars, adding a celestial or technological element to the design.
MAY 1 4 1997
Image /page/0/Picture/1 description: The image shows the word "PHILIPS" in a bold, sans-serif font. The letters are large and black, contrasting with the white background. The text appears to be a logo or brand name.
Philips Medical Systems
P.O. Box 10000, 5680 DA Best, The Netherlands Department of Health and Human Services Center for Devices and Radiological Health Office of Device Evaluation Pre-Market Notification section.
TOM XRD Best XDB087-970107/RR/TT
1997.02.25
SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
for
PHILIPS INTEGRIS H 5000 and BH 5000 CARDIO / VASCULAR SYSTEMS
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
The undersigned certifies that the 510(k) Pre-Market notification for the above referenced product contains adequate information and data to enable CDRH to determine substantial equivalence.
This information and data is summarized as follows:
-
- The Integris H 5000 / BH 5000 systems are subject to Federal Performance Standards, defined in 21CFR - part 1000;
-
- The Integris H5000 / BH 5000 systems will be manufactured in accordance with voluntary safety standards, such as UL 187 and UL 2601;
-
- The information for Users contains comprehensive information to insure safe and effective use;
-
- Past experience with substantially equivalent predicate devices has shown our device to be safe and effective when used as directed in the Information for Users.
Ing. R.W.Rijntjes
Approbation manager
Approbation manager Quality Assurance dept. XSB / XCB Philips Medical Systems Nederland BV Best, The Netherlands.
522 104 2893