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VERIQA software

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

Ref S070031

VERIQA software (S070031) is a device classified as Class IIb in the EU and Class II in the US made by PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH, registered in EUDAMED on 16 Jul 2026 (Basic UDI-DI B-+EPTWS0700310), cleared under FDA 510(k) K213370 on 30 Mar 2022 and listed in FDA GUDID since 8 Feb 2024 (UDI-DI +EPTWS0700310), active as of 23 Oct 2026. 2 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K213370

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-+EPTWS0700310 Basic UDI-DI +EPTWS0700310UDI-DIDate16 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number+EPTWS0700310 UDI-DI Date8 Feb 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK213370 Date30 Mar 2022DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-+EPTWS0700310 registered 16 Jul 2026 Active
  • FDA 510(k) K213370 decided 30 Mar 2022 Active
  • FDA GUDID UDI-DI +EPTWS0700310 listed 8 Feb 2024 Listed

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.

Timeline

5 dated events

  1. Cleared FDA 510(k) K213370
  2. Listed FDA GUDID +EPTWS0700310
  3. Recall initiated FDA recalls Z-1181-2024
  4. Registered EUDAMED B-+EPTWS0700310
  5. Recall initiated FDA recalls Z-3174-2026

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Veriqa
Generic name
Radiation therapy software
Model / Ref / Catalog
S070031, VERIQA software
Description
VERIQA is a software package for display, evaluation and digital processing of medical image data sets and treatment plans in radiation oncology.
Primary DI / UDI-DI
+EPTWS0700310 EUDAMED
EPTWS070031 GUDID
Basic UDI-DI
B-+EPTWS0700310
510(k) Number
FDA product code
IYE
EMDN code
Z119002 Dosimeters
GMDN term
Radiation therapy software
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.5050
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
S070031
GUDID
VERIQA software
Primary DI / UDI-DIEUDAMED
+EPTWS0700310
GUDID
EPTWS070031
Device classEUDAMED
Class IIb
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists +EPTWS0700310; FDA GUDID lists EPTWS070031), so their flags are not compared. Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Radiation therapy software

Cleared under the same submission (K213370)

Similar devices in this category

Other devices filed under VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS.

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

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

Properties

  • Prescription use
Other properties (22, all answered No)