510(k) · Cleared
ClearedVeriqa RT Epid 3D
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla · IYE Accelerator, Linear, Medical
Cleared on Apr 15, 2026 as substantially equivalent to K141800 (Sun Nuclear Corporation, 2014) after a 268-day review. Its family tree reaches back 5 generations to 1992.
- Decided
- Apr 15, 2026
- Review
- 268 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K914698 (1992). 13 ancestors in all, the oldest K874893 (1988). No later device cites it as a predicate yet.
- Root · 5 generations backK914698 Setup Computer with Software V-1261,62 and 63K.S., Inc. · 1992
- 4 generations backK980904 Mucheck Monitor Unit Validation ProgramMedical Dosimetry Services, Inc. · 1998
- 3 generations backK012227 Mucheck - Monitor Unit Validation Program, Model V4.1Oncology Data Systems, Inc. · 2001
- 2 generations backK072374 CompassScanditronix Wellhofer GmbH · 2007 · Recalled
- 1 generation backK141800 PerfractionSun Nuclear Corporation · 2014
- This deviceK252258 Veriqa RT Epid 3DPtw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K914698 | Setup Computer with Software V-1261,62 and 63 | K.S., Inc. | 1992 | — |
| −4 | K980904 | Mucheck Monitor Unit Validation Program | Medical Dosimetry Services, Inc. | 1998 | — |
| −3 | K012227 | Mucheck - Monitor Unit Validation Program, Model V4.1 | Oncology Data Systems, Inc. | 2001 | — |
| −2 | K072374 | Compass | Scanditronix Wellhofer GmbH | 2007 | 3 |
| −1 | K141800 | Perfraction | Sun Nuclear Corporation | 2014 | — |
| 0 (this device) | K252258 | Veriqa RT Epid 3D | Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 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? (1)
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 |
|---|---|---|---|
| * | K141800 | PerfractionSummary page 5…lass: Class II 3 Predicate Device Proprietary Name: PerFRACTION Common Name: Quality Assurance for Patient Radiation Treatment 510(k) number: K141800 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Classification Name: Ac… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 34 years and passes through 6 companies; a new generation was cleared every 6.2 years on median.
- 1 of the 13 ancestors has a recall of any class.
- 3 other devices also cite its predicate K141800.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
Software for quality assurance of ionizing radiation emitted by diagnostic imaging devices or radiotherapy devices.
VERIQA RT EPID 3D is a software to assist the user in detecting errors related to
– treatment planning,
– plan delivery by the treatment machine,
– changes in the patient anatomy, and/or patient setup deviations.
VERIQA RT EPID 3D must not be used to modify a patient´s treatment plan based exclusively on the results from VERIQA RT EPID 3D. VERIQA RT EPID 3D must not be used for treatment planning.
The clinical user of VERIQA RT EPID 3D is the medical physicist. Transport tasks are performed by the carrier. PTW service staff is responsible for service tasks.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252258 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252258: Veriqa RT Epid 3D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252258
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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