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ExacTrac Dynamic, 2.0

by Brainlab SE

Ref 48520

ExacTrac Dynamic, 2.0 (48520) is a device classified as Class IIb in the EU and Class II in the US made by Brainlab SE, cleared under FDA 510(k) K254010 on 14 Jan 2026 (1 earlier submission), registered in EUDAMED on 17 Jul 2025 (Basic UDI-DI 4056481ExacTracEU) and listed in FDA GUDID since 19 Feb 2025 (UDI-DI 04056481144609), active as of 24 Oct 2026.

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 found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K254010↗

+1 more

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k) 510(k) NumberK254010 Date14 Jan 2026IssuedStatusActive
European UnionCE/MDR EUDAMED Number4056481ExacTracEU Basic UDI-DI 04056481144609UDI-DIDate17 Jul 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04056481144609 UDI-DI Date19 Feb 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK240431 Date24 Jul 2024DecidedStatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K254010 decided 14 Jan 2026 Active· +1 more in the status table
  • EUDAMED Basic UDI-DI 4056481ExacTracEU registered 17 Jul 2025 Active
  • FDA GUDID UDI-DI 04056481144609 listed 19 Feb 2025 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K240431
  2. Listed FDA GUDID 04056481144609
  3. Registered EUDAMED 4056481ExacTracEU
  4. Cleared FDA 510(k) K254010

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k) · GUDID

Trade name
ExacTrac Dynamic, 2.0 EUDAMED
ExacTrac Dynamic GUDID
Generic name
Radiological video camera patient positioning/tracking system
Model / reference
48520 EUDAMED
2.0 GUDID
Primary DI / UDI-DI
04056481144609
Basic UDI-DI
4056481ExacTracEU
510(k) Number
FDA product code
IYE
EMDN code
Z11019099 Various radiotherapy and radiosurgery instruments - other
GMDN term
Radiological video camera patient positioning/tracking system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.5050
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
48520
GUDID
2.0
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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

Similar devices in this category

Other devices filed under VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - OTHER.

Other devices from Brainlab SE

See all devices from Brainlab SE →

Properties

  • Prescription use
  • Lot / batch number
Other properties (23, all answered No)