510(k) · Cleared
Recalled · Class II · 2026Veriqa
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ptw-Freiburg Physikalisch-Technische-Werkstaetten · IYE Accelerator, Linear, Medical
Cleared on Mar 30, 2022 as substantially equivalent to K170307 (Sun Nuclear Corporation, 2017) and 1 other predicate after a 169-day review. Its family tree reaches back 12 generations to 1991. It has been recalled 2 times.
- Decided
- Mar 30, 2022
- Review
- 169 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 12 generations to K913770 (1991). 126 ancestors in all, the oldest K871859 (1987). No later device cites it as a predicate yet.
- Root · 12 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 8 generations between
- 3 generations backK101228 Mirada XDMirada Medical, Ltd. · 2010
- 2 generations backK102687 Mirada RTMirada Medical, Ltd. · 2010
- 1 generation backK130393 Mirada RTXMirada Medical, Ltd. · 2013
- This deviceK213370 VeriqaPtw-Freiburg Physikalisch-Technische-Werkstaetten · 2022
Show all 12 generations
- Root · 12 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 11 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 10 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 9 generations backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- 8 generations backK033374 Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2003
- 7 generations backK041484 UndecidedSiemens Medical Solutions USA, Inc. · 2004
- 6 generations backK053301 Cedara I-Response Cedara Pet/CTCedara Software Corp. · 2006
- 5 generations backK071950 Syngo TruedSiemens Medical Solutions USA, Inc. · 2007
- 4 generations backK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- 3 generations backK101228 Mirada XDMirada Medical, Ltd. · 2010
- 2 generations backK102687 Mirada RTMirada Medical, Ltd. · 2010
- 1 generation backK130393 Mirada RTXMirada Medical, Ltd. · 2013
- This deviceK213370 VeriqaPtw-Freiburg Physikalisch-Technische-Werkstaetten · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −11 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −10 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −9 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −8 | K033374 | Lungcare CT Software Package with Extended Functionality | Siemens AG Medical Solutions | 2003 | — |
| −7 | K041484 | Undecided | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −6 | K053301 | Cedara I-Response Cedara Pet/CT | Cedara Software Corp. | 2006 | — |
| −5 | K071950 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −4 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| −3 | K101228 | Mirada XD | Mirada Medical, Ltd. | 2010 | — |
| −2 | K102687 | Mirada RT | Mirada Medical, Ltd. | 2010 | — |
| −1 | K130393 | Mirada RTX | Mirada Medical, Ltd. | 2013 | — |
| 0 (this device) | K213370 | Veriqa | Ptw-Freiburg Physikalisch-Technische-Werkstaetten | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 4 | 0 |
| 1992 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 5 | 0 |
| 1996 | 5 | 0 |
| 1997 | 5 | 0 |
| 1998 | 8 | 0 |
| 1999 | 3 | 0 |
| 2000 | 9 | 0 |
| 2001 | 15 | 0 |
| 2002 | 11 | 0 |
| 2003 | 8 | 0 |
| 2004 | 10 | 0 |
| 2005 | 4 | 0 |
| 2006 | 4 | 0 |
| 2007 | 5 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IYE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new IYE device
- #1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K170307 | SunCHECKSummary page 4…IYE Device class: Class II 2 Predicate Device Information Proprietary Name: SUNCHECK Common Name: Secondary check QA software 510(k) number: K170307 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Classification Name: Ac… | 2017 |
| * | K130393 | Mirada RTXSummary page 4…ear Corporation Submitted: October 25, 2017 Proprietary Name: Mirada RTx Common Name/s: RTx, RT Server, RTx Server, Workflow Box 510(k) number: K130393 Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Classification Name: Syste… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 4, 2026 | Class II | Z-3174-2026 | Software design | 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… |
| Feb 8, 2024 | Class II | Z-1181-2024 | Software design | 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… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 31 years and passes through 7 companies; a new generation was cleared every 1.5 years on median.
- 26 of the 126 ancestors have a recall of any class.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · IYE
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYE
170in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYE
101in 2025
MAUDE reports naming product code IYE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 23 | 44 | 78 | 155 |
| 2008 | 14 | 69 | 49 | 114 |
| 2009 | 20 | 63 | 22 | 174 |
| 2010 | 23 | 74 | 27 | 246 |
| 2011 | 11 | 94 | 73 | 280 |
| 2012 | 28 | 106 | 20 | 128 |
| 2013 | 18 | 88 | 11 | 96 |
| 2014 | 20 | 100 | 14 | 124 |
| 2015 | 20 | 108 | 8 | 100 |
| 2016 | 21 | 97 | 7 | 97 |
| 2017 | 23 | 94 | 7 | 125 |
| 2018 | 21 | 58 | 7 | 85 |
| 2019 | 19 | 83 | 2 | 91 |
| 2020 | 20 | 67 | 4 | 74 |
| 2021 | 19 | 86 | 5 | 68 |
| 2022 | 12 | 172 | 3 | 66 |
| 2023 | 18 | 129 | 7 | 128 |
| 2024 | 9 | 239 | 1 | 81 |
| 2025 | 12 | 170 | 1 | 101 |
| 2026 | 14 | 120 | 4 | — |
What is it indicated for?
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…
Read the full statement (218 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213370 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213370: Veriqa.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213370
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026