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Calibration Phantom Intraoperative CT

by Brainlab SE

Ref 19148-01A

Calibration Phantom Intraoperative CT (19148-01A) is a device classified as Class I in the EU and Class II in the US made by Brainlab SE, cleared under FDA 510(k) K262257 on 30 Sep 2026 (5 earlier submissions), registered in EUDAMED on 16 May 2024 (Basic UDI-DI 4056481CaliPhantomICTHC) and listed in FDA GUDID since 15 Sep 2016 (UDI-DI 04056481004569), active as of 22 Oct 2026. 5 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

5 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K262257

+5 more

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK262257 Date30 Sep 2026DecidedStatusActive
European UnionCE/MDR EUDAMED Number4056481CaliPhantomICTHC Basic UDI-DI 04056481004569UDI-DIDate16 May 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number04056481004569 UDI-DI Date15 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • FDA 510(k) K262257 decided 30 Sep 2026 Active· +5 more in the status table
  • EUDAMED Basic UDI-DI 4056481CaliPhantomICTHC registered 16 May 2024 Active
  • FDA GUDID UDI-DI 04056481004569 listed 15 Sep 2016 Listed

Recalls

5 recalls · FDA

    • Terminated Z-0056-2021 FDA Class II initiated 31 Aug 2020

    Brainlab Ultrasound Navigation Software does not support the modification of the probe's image width.

    • Terminated Z-2925-2020 FDA Class II initiated 20 Aug 2020

    Holding force of the Positioning Arm can be reduced by prolonged non-use.

  • 2 recalls, same reason

    • Terminated Z-2793-2020 FDA Class II initiated 16 Jul 2020
    • Terminated Z-2792-2020 FDA Class II initiated 16 Jul 2020

    Incorrect manufacturer calibration

    • Terminated Z-0598-2016 FDA Class I initiated 22 Apr 2013

    Software Error: The effect of setup on overall navigation accuracy could potentially intensify small inaccuracies arising from individual steps of a complex navigation procedure that may cause an inaccurate display of instruments by the navigation system compared to the actual patient anatomy.

Timeline

13 dated events

  1. Cleared FDA 510(k) K183605
  2. Recall initiated FDA recalls Z-2793-2020
  3. Recall initiated FDA recalls Z-2792-2020
  4. Recall initiated FDA recalls Z-2925-2020
  5. Recall initiated FDA recalls Z-0056-2021
  6. Cleared FDA 510(k) K192703
  7. Cleared FDA 510(k) K234047
  8. Registered EUDAMED 4056481CaliPhantomICTHC
  9. Cleared FDA 510(k) K252562
  10. Cleared FDA 510(k) K262257

3 earlier events are in the sections above.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Calibration Phantom Intraoperative CT EUDAMED
Calibration Phantom Ict GUDID
Generic name
Robotic surgical navigation system
Device name
Calibration Phantom Interoperative CT
Model / Ref / Catalog
19148-01A
Primary DI / UDI-DI
04056481004569
Basic UDI-DI
4056481CaliPhantomICTHC
Direct marketing DI
04056481004569
510(k) Number
FDA product code
HAW, OLO
EMDN code
Z12011480 Surgical navigation instruments - hardware accessories
GMDN term
Robotic surgical navigation system
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.4560
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
DE-MF-000006183

Related devices

Category: Neurological stereotactic surgery system

Similar devices in this category

Other devices filed under SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from Brainlab SE

See all devices from Brainlab SE →

Properties

  • Prescription use
  • Serial number
Other properties (23, all answered No)