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Head/Neck Vascular Phased Array Coil Package

FDA 510(k)

Class II (US FDA 510(k))

510(k) K952530

by Philips Medical Systems (Cleveland), Inc.

Identifiers

510(k) Number
K952530 FDA 510(k)
FDA Product Code
LNH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1000 FDA 510(k)
Regulation Number
892.1000 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Head/Neck Vascular Phased Array Coil Package is a system for nuclear magnetic resonance imaging. It is designed to facilitate diagnostic imaging of the head and neck regions.

This device is classified as a Class II medical device under regulation number 892.1000. It has received FDA 510(k) clearance, identified by k-number K952530.

Frequently asked questions

What is the primary purpose of this device?

The Head/Neck Vascular Phased Array Coil Package is a system designed to facilitate diagnostic imaging of the head and neck regions using nuclear magnetic resonance imaging technology.

What is the regulatory status of this coil package?

This device is classified as a Class II medical device under regulation number 892.1000 and has received FDA 510(k) clearance, identified by k-number K952530.

Who is the manufacturer of this imaging system?

This device is manufactured by Philips Medical Systems (Cleveland), Inc., located in Cleveland, Ohio.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: HEAD/NECK VASCULAR PHASED ARRAY COIL PACKAGE (K952530) - FDA 510 (k ..., Head/Neck Vascular Phased Array Coil Package, Philips Head/neck Vascular Phased Array Coil… | allmed.wiki, MRI coils - Philips

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Philips Medical Systems (Cleveland), Inc.

Sources (1)

  • FDA 510(k) K952530 24 fields · synced Sep 22, 2026