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PQASoft 1.x

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

1 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 NumberEPTWS0700300 UDI-DI Date15 Apr 2026ListedStatusListed GUDID: in commercial distribution

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-2577-2023 FDA Class II initiated 7 Jun 2023

    Generated calibration file will not be correct in case of a relative calibration of an OCTAVIUS Detector 1000 or OCTAVIUS Detector 1600, if a Tiff file or a DICOM data set is used as reference matrix. Therefore, the measurement result will be incorrect by using such a calibration file.

    • Terminated Z-0479-2022 FDA Class II initiated 27 Aug 2021

    When a measurement with a PTW detector array is performed with the software BeamAdjust 2.2 or VeriSoft 8.0, a measurement error can occur under specific conditions. This error can lead to a too-low or too-high measured absolute dose which affects patient plan verification results

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
PQASoft
Generic Name
Radiation therapy software
Model / Ref / Catalog
PQASoft 1.x, S070030
Primary DI / UDI-DI
EPTWS0700300
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

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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