# K213370: Veriqa

- Pathway: 510(k) (Traditional)
- Applicant: Ptw-Freiburg Physikalisch-Technische-Werkstaetten
- Decided: Mar 30, 2022 after 169 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K913770 (1991). 126 ancestors in all.
No later device cites it as a predicate yet.
0 of 127 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170307: SunCHECK, Sun Nuclear Corporation (2017) Summary page 4.
- K130393: Mirada RTX, Mirada Medical, Ltd. (2013) Summary page 4.

## Recalls of this device
- Aug 4, 2026 · Class II · Z-3174-2026: 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
- Feb 8, 2024 · Class II · Z-1181-2024: 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 correc

## Indications for use
VERIQA is a software package for display, evaluation and digital processing of medical image data sets and treatment plans in radiation oncology. VERIQA software is a tool for evaluation and data management of digital medical images and treatment plan information. It supports the medical imaging modalities CT, MR, PET according to the ACR/NEMA DICOM 3.0 standard and other modalities. VERIQA supports the following applications: a) Receiving, transmitting, storing, retrieving, display, and processing of medical images and DICOM objects. b) Creating, displaying and printing of reports containing medical images. c) Image registration, fusion display, and review of medical images for treatment evaluation and treatment planning. d) Localization and definition of structures such as tumors and normal tissue in medical image sets. e) Creation, transfer, and modification of contours and dose distributions for applications such as quantitative analysis, aiding adaptive radiation therapy, transferring contours and dose distributions to radiation treatment planning systems, and archiving contours and dose distributions for patient follow-up and management. f) Secondary Monte Carlo dose calculation and evaluation for patient specific quality assurance. VERIQA must not be used while a patient is present. VERIQA must not be used for treatment planning. The software must only be used by qualified personnel, usually medical professionals including, radiologists, nuclear medicine physicians, radiation oncologists, dosimetrists and medical physicists or authorized persons.

Source page: https://510kreport.com/device/K213370
Methodology: https://510kreport.com/methodology