INTRACAVITY NEEDLE GUIDE KIT

• K Number: K955668
• Device Name: INTRACAVITY NEEDLE GUIDE KIT
• Manufacturer: ARLANDA MEDICINSKA INSTRUMENT CO. AB
• Date Cleared: 1997-07-30 ( 595 days)
• Product Code: ITX
• Regulation Number: 892.1570
• Type: Traditional
• Panel: Radiology
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

Not Found

Device Description

Intracavity Needle Guide Kit

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for an "Intracavity Needle Guide Kit." It states that the device has been determined to be substantially equivalent to devices marketed prior to May 28, 1976. This type of letter does not contain the detailed information about acceptance criteria or a study proving the device meets those criteria, as typically found in a clinical study report or a 510(k) summary.

Therefore, I cannot provide the requested information from this document. The letter itself is part of a regulatory process that determines marketability based on substantial equivalence to a predicate device, rather than a detailed performance study.

Regulation Number and Section

§ 892.1570 Diagnostic ultrasonic transducer.

(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.