510(k) · Cleared
ClearedPIUR tUS inside
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Piur Imaging GmbH · QIH Automated Radiological Image Processing Software
Cleared on Jun 30, 2025 as substantially equivalent to K240036 (Piur Imaging GmbH, 2024) after a 131-day review. Its family tree reaches back 10 generations to 1991.
- Decided
- Jun 30, 2025
- Review
- 131 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K913770 (1991). 28 ancestors in all. No later device cites it as a predicate yet.
- Root · 10 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 6 generations between
- 3 generations backK180006 AmCAD-UT Detection 2.2Amcad Biomed Corporation · 2018
- 2 generations backK203555 AmCAD-UTAmcad Biomed Corporation · 2021
- 1 generation backK240036 PIUR tUS InfinityPiur Imaging GmbH · 2024
- This deviceK250484 PIUR tUS insidePiur Imaging GmbH · 2025
Show all 10 generations
- Root · 10 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 9 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 8 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 7 generations backK033400 Seno AdvantageGe Medical Systems W-400 · 2003 · Recalled
- 6 generations backK043216 Cadstream Version 4.0Confirma, Inc. · 2005
- 5 generations backK050846 B-Cad System, Version 1.0The Medipattern Corporation · 2005
- 4 generations backK122536 Amcad-UT Detection Model 2.0Lin & Associates, LLC · 2013
- 3 generations backK180006 AmCAD-UT Detection 2.2Amcad Biomed Corporation · 2018
- 2 generations backK203555 AmCAD-UTAmcad Biomed Corporation · 2021
- 1 generation backK240036 PIUR tUS InfinityPiur Imaging GmbH · 2024
- This deviceK250484 PIUR tUS insidePiur Imaging GmbH · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −9 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −8 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −7 | K033400 | Seno Advantage | Ge Medical Systems W-400 | 2003 | 6 |
| −6 | K043216 | Cadstream Version 4.0 | Confirma, Inc. | 2005 | — |
| −5 | K050846 | B-Cad System, Version 1.0 | The Medipattern Corporation | 2005 | — |
| −4 | K122536 | Amcad-UT Detection Model 2.0 | Lin & Associates, LLC | 2013 | — |
| −3 | K180006 | AmCAD-UT Detection 2.2 | Amcad Biomed Corporation | 2018 | — |
| −2 | K203555 | AmCAD-UT | Amcad Biomed Corporation | 2021 | — |
| −1 | K240036 | PIUR tUS Infinity | Piur Imaging GmbH | 2024 | — |
| 0 (this device) | K250484 | PIUR tUS inside | Piur Imaging GmbH | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1997 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
| 2011 | 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 QIH? 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 QIH device
- #1 K213998 cvi42 Auto Imaging Software Applicationscore 23.5 · 7 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 |
|---|---|---|---|
| * | K240036 | PIUR tUS InfinitySummary page 5…Table 3: Predicate Devices Predicate Device Manufacturer FDA 510(k) PIUR tUS Infinity PIUR Imaging GmbH K240036 Device Description PIUR tUS inside is a medical device which enhances standard ultrasound devices with a three- dimensional (3D… | 2024 |
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 8 companies; a new generation was cleared every 3.0 years on median.
- 4 of the 28 ancestors have a recall of any class.
How does its category compare?
All QIH devicesQIH Automated Radiological Image Processing Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · QIH
94in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QIH
150in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QIH
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QIH
4in 2025
MAUDE reports naming product code QIH, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 11 | 145 | 0 | 0 |
| 2021 | 19 | 125 | 0 | 0 |
| 2022 | 25 | 134 | 0 | 0 |
| 2023 | 45 | 151 | 0 | 0 |
| 2024 | 64 | 141 | 0 | 2 |
| 2025 | 94 | 150 | 0 | 4 |
| 2026 | 78 | 130 | 1 | — |
What is it indicated for?
PIUR tUS inside System is a computer-aided detection device intended to assist and support medical professionals in the diagnostic workflow of thyroid and thyroid nodules acquired from FDA-cleared ultrasound systems, including image documentation, analysis, and reporting. The device supports the physician with additional information during image review, including quantification and visualization of sonographic characteristics of thyroid nodules. PIUR tUS…
Read the full statement (150 words)
PIUR tUS inside System is a computer-aided detection device intended to assist and support medical professionals in the diagnostic workflow of thyroid and thyroid nodules acquired from FDA-cleared ultrasound systems, including image documentation, analysis, and reporting. The device supports the physician with additional information during image review, including quantification and visualization of sonographic characteristics of thyroid nodules.
PIUR tUS inside System may be used on any adult patient aged 22 and older, independent of gender, linguistic and cultural background, or health status, unless any of the contraindications apply.
The PIUR tUS inside System acts as part of the diagnostic chain and must not be used as a sole source for treatment decisions, but as an add-on solution to regular 2D ultrasound imaging.
The PIUR tUS inside System is not intended for body contact (including skin, mucosal membrane, breached or compromised surfaces, blood path indirect, tissues, bones, dentin, or circulation blood).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250484 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250484: PIUR tUS inside.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250484
Report an extraction error
Are you the manufacturer?
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