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Na 170003-28

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 Number08717213052314 UDI-DI Date20 Mar 2018ListedStatusListed GUDID: in commercial distribution

Recalls

6 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

    • Terminated Z-0987-2017 FDA Class II initiated 23 Dec 2016

    Cross profile for Varian 60 degree wedge shows "horns."

    • Terminated Z-0604-2016 FDA Class II initiated 18 Dec 2015

    When using the option "Tumor Overlap Fraction" in VMAT planning it has been observed that in rare cases the system does include an organ at risk as target volume. This could result in open MLC, and open jaws in areas away from the target volume.

    • Terminated Z-1712-2015 FDA Class II initiated 21 May 2015

    Incorrect dose calculation for Regions of Interest (ROIs) defined on a secondary image series.

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  • Withdrawn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
170003-28
Primary DI / UDI-DI
08717213052314
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 (K121448)

Cleared under the same submission (K132816)

Other devices from Nucletron B.V.

See all devices from Nucletron B.V. →

Properties

  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number

Other properties (11)

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