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ExacTrac Dynamic

by Brainlab AG 4 variants

510(k) K201276

ExacTrac Dynamic is a Class II device made by Brainlab AG, cleared under FDA 510(k) K201276 on 13 Jul 2020, active as of 22 Oct 2026. One FDA recall is linked to it.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK201276 Date13 Jul 2020ClearedStatusActive

Official records

Recalls

1 recall · FDA

    • Terminated Z-1185-2021 FDA Class II initiated 1 Mar 2021

    In case of a failed automatic marker detection, a software error causes parts of the display to incorrectly behave as if the current patient position is within predefined tolerances and may allow the user to proceed to treatment despite potentially exceeding shift values.

Timeline

2 dated events

  1. Cleared FDA 510(k) K201276
  2. Recall initiated FDA recalls Z-1185-2021

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  • Withdrawn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
IYE
Device class
Class II
Regulation
21 CFR Part 892.5050
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

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