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Na 170730

by Nucletron B.V. 3 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

3 closed

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 Number08717213058118 UDI-DI Date13 Nov 2025ListedStatusListed GUDID: in commercial distribution

Recalls

3 recalls · FDA

    • 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  • Withdrawn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
170730
Primary DI / UDI-DI
08717213058118
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

Cleared under the same submission (K121448)

Other devices from Nucletron B.V.

See all devices from Nucletron B.V. →

Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: 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