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ExacTrac Dynamic, 1.1

by Brainlab SE

Ref 48519A

ExacTrac Dynamic, 1.1 (48519A) is a device classified as Class IIb in the EU and Class II in the US made by Brainlab SE, registered in EUDAMED on 17 Jul 2025 (Basic UDI-DI 4056481ExacTracEU), cleared under FDA 510(k) K231052 on 11 May 2023 (1 earlier submission) and listed in FDA GUDID since 20 May 2022 (UDI-DI 04056481143978), withdrawn (EUDAMED), active (FDA 510(k)), not in commercial distribution (GUDID) as of 25 Oct 2026. One FDA recall is linked to it.

Active Active in United States. Withdrawn in European Union. Also listed in GUDID (US), not in commercial distribution.

CE MDR, withdrawn 510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K231052

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4056481ExacTracEU Basic UDI-DI 04056481143978UDI-DIDate17 Jul 2025RegisteredStatusWithdrawn No longer placed on the EU market
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK231052 Date11 May 2023DecidedStatusActive
United StatesGUDID listing GUDID Number04056481143978 UDI-DI Date20 May 2022ListedStatusListed GUDID: not in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 4056481ExacTracEU registered 17 Jul 2025 Withdrawn
  • FDA 510(k) K231052 decided 11 May 2023 Active· +1 more in the status table
  • FDA GUDID UDI-DI 04056481143978 listed 20 May 2022 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1259-2023 FDA Class II initiated 14 Feb 2023

    Deep Inspiration Breath Hold (DIBH) functionality may not work as specified when based on a standard-workflow Treatment Template

Timeline

5 dated events

  1. Cleared FDA 510(k) K220338
  2. Listed FDA GUDID 04056481143978
  3. Recall initiated FDA recalls Z-1259-2023
  4. Cleared FDA 510(k) K231052
  5. Registered EUDAMED 4056481ExacTracEU

Coverage

2 jurisdictions

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

Specification

EUDAMED · GUDID

Trade name
ExacTrac Dynamic, 1.1 EUDAMED
ExacTrac Dynamic GUDID
Generic name
Radiation therapy software
Model / reference
48519A EUDAMED
1.1 GUDID
Primary DI / UDI-DI
04056481143978
Basic UDI-DI
4056481ExacTracEU
510(k) Number
FDA product code
IYE
EMDN code
Z11019099 Various radiotherapy and radiosurgery instruments - other
GMDN term
Radiation therapy software
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
Not in Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
48519A
GUDID
1.1
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
  • Manufacturing date
Other properties (22, all answered No)