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PHSL-63 Pediatric Head and Spine Array Coil

by Mri Devices Corp.

510(k) K013514

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK013514 Date2 Jan 2002ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MOS
Device Class
Class II
Regulation
21 CFR Part 892.1000
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The PHSL-63 Pediatric Head and Spine Array Coil is a radiofrequency (RF) receiver coil designed for use with Magnetic Resonance (MR) scanners. It functions to capture MR signals from the pediatric head and spine, enabling the host MRI system to process these signals and generate diagnostic images of pediatric head and spine anatomy.

This device is supplied as an accessory for MR systems and is used in clinical settings. It is a Class II device with product code MOS, cleared under FDA 510(k) K013514, and is subject to special controls. The coil is reusable and designed for pediatric applications, with no claims made regarding sterility, single-use status, MRI safety conditions, sizes, storage, or additional authorizations beyond those explicitly stated in the data.

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Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the PHSL-63 Pediatric Head and Spine Array Coil used for?

    The PHSL-63 Pediatric Head and Spine Array Coil is designed to capture magnetic resonance (MR) signals from the pediatric head and spine, enabling the host MRI system to process these signals and generate diagnostic images of pediatric head and spine anatomy.

  • Is the PHSL-63 Pediatric Head and Spine Array Coil reusable or single-use?

    The PHSL-63 Pediatric Head and Spine Array Coil is reusable, as explicitly stated in the device data, which notes it is designed for repeated use in clinical settings with no claims regarding single-use status.

  • What type of device is the PHSL-63 Pediatric Head and Spine Array Coil and how is it supplied?

    The PHSL-63 Pediatric Head and Spine Array Coil is a radiofrequency (RF) receiver coil supplied as an accessory for Magnetic Resonance (MR) scanners, intended for use in clinical settings to support diagnostic imaging of pediatric patients.