Skip to content

VERIQA RT MonteCarlo 3D v3

by PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH

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 NumberEPTWS070031Q5200 UDI-DI Date17 Apr 2026ListedStatusListed GUDID: in commercial distribution

Recalls

2 recalls · 2 ongoing · FDA

    • Ongoing Z-3174-2026 FDA Class II initiated 4 Aug 2026

    When a bolus is included in a treatment plan and sent for secondary dose calculation, the software accounts for it but does not display this clearly, which may lead users to incorrectly omit the bolus during treatment and deliver the prescribed dose to the wrong tissue depth.

    • Ongoing Z-1181-2024 FDA Class II initiated 8 Feb 2024

    Software: If the user excludes voxels from the Gamma calculation that are below a dose threshold (Suppress gamma calculation), the Gamma Passing Rate (GPR) calculated for individual ROIs is not correct. The GPR calculated by VERIQA overestimates the correct GPR. The evaluation can therefore show false positive results.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Veriqa
Generic Name
Radiation therapy software
Model / Ref / Catalog
VERIQA RT MonteCarlo 3D v3, S070031.520
Primary DI / UDI-DI
EPTWS070031Q5200
510(k) Number
FDA Product Code
IYE
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 (K213370)

Other devices from PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH

See all devices from PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH →

Properties

Other properties (14)

  • 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
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No