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3D Line Sterotactic Hardware Accessories

by 3D Line USA, Inc.

510(k) K011255

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

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 NumberK011255 Date20 Dec 2001ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-0138-2014 FDA Class II initiated 23 Jul 2013

    Potential for clinical errors.

    • Terminated Z-0319-2012 FDA Unclassified (pre-2012) initiated 25 Mar 2011

    Recent newspaper articles outlined improper use of SRS Cone Collimator accessories that injured patients on Brainlab and Varian systems.

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  • Withdrawn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
HAW
Device Class
Class II
Regulation
21 CFR Part 882.4560
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

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