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Doro Radiolucent Headrest System ( Also MRI-Compatible) and Components

by Pro-Med Instruments GmbH

510(k) K063494

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK063494 Date21 May 2007ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
HBL
Device Class
Class II
Regulation
21 CFR Part 882.4460
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 Doro Radiolucent Headrest System ( Also MRI-Compatible) and Components is a Holder, Head, Neurosurgical (Skull Clamp) device. It is substantially equivalent to predicate devices and has been cleared for use in neurology applications.

The device is supplied as a system with components and is intended for use as a mechanical support system. It is radiolucent and MRI-compatible, with authorization under FDA 510(k) K063494. The device is classified as Class II under regulation number 882.4460 and product code HBL.

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Questions

AI-generated answers, 24 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 Doro Radiolucent Headrest System used for?

    The Doro Radiolucent Headrest System is intended for use as a mechanical support system in neurology applications, specifically as a Holder, Head, Neurosurgical (Skull Clamp) device to provide stable positioning during procedures.

  • Is the Doro Radiolucent Headrest System MRI-compatible and radiolucent?

    Yes, the device is explicitly described as both radiolucent and MRI-compatible, which allows for clear imaging during neurological procedures without interference from the headrest material.

  • How is the Doro Radiolucent Headrest System supplied?

    The device is supplied as a complete system with components, meaning it includes all necessary parts for assembly and use as a mechanical support system in clinical settings.

  • What regulatory pathway was used for the Doro Radiolucent Headrest System?

    The device received authorization through the FDA 510(k) pathway under K063494, demonstrating substantial equivalence to predicate devices and is classified as a Class II medical device under regulation 882.4460.