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NA Oncentra Brachy

by Nucletron B.V.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

2 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08717213038660 UDI-DI Date20 Oct 2016ListedStatusListed GUDID: in commercial distribution

Recalls

3 recalls · 2 ongoing · FDA

    • Ongoing Z-0719-2023 FDA Class II initiated 5 Dec 2022

    A reconstruction error may occur when using the Catheter Bending functionality in Applicator Modeling or Implant Modeling

    • Ongoing Z-0182-2022 FDA Class II initiated 13 Oct 2021

    Under certain circumstances, there can be a difference between the planned and delivered dose of the two ovoid channels.

    • Terminated Z-0050-2018 FDA Class II initiated 10 Aug 2017

    Incorrect source step size may occur in the software plans

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Radiation therapy software
Model / Reference
Oncentra Brachy
Primary DI / UDI-DI
08717213038660
510(k) Number
FDA Product Code
MUJ
GMDN Term
Radiation therapy software
Device Class
Class II
Regulation Number
892.5050
GUDID distribution status
In Commercial Distribution

Related devices

Category: Radiation therapy software

Cleared under the same submission (K132816)

Other devices from Nucletron B.V.

See all devices from Nucletron B.V. →

Properties

  • Lot / Batch Number

Other properties (13)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No