RATATIONAL ANGIOGRAPHY OPTION FOR PHILIPS MULTIDIAGNOST 4

• K Number: K971489
• Device Name: RATATIONAL ANGIOGRAPHY OPTION FOR PHILIPS MULTIDIAGNOST 4
• Manufacturer: PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
• Date Cleared: 1997-07-03 ( 71 days)
• Product Code: IZI
• Regulation Number: 892.1600
• Type: Traditional
• Panel: RA
• Reference & Predicate Devices: K923813
• Predicate For: N/A

Intended Use

The Rotational Angiography Option for Philips MultiDIAGNOST 4 is indicated for use in Angiographic diagnostic imaging examinations.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) pre-market notification for the Philips MultiDIAGNOST 4 - Rotational Angiography Option. It primarily focuses on demonstrating substantial equivalence to a predicate device and outlines regulatory compliance. It does not contain information regarding acceptance criteria or the study details typically associated with AI/ML device performance evaluation.

Therefore, I cannot extract the requested information as it is not present in the provided document.

Specifically, the document does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets or data provenance.
3. Details about experts used for ground truth establishment or their qualifications.
4. Adjudication methods.
5. Information about multi-reader multi-case (MRMC) comparative effectiveness studies.
6. Standalone algorithm performance.
7. The type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

Regulation Number and Section

§ 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.