510(k) · Cleared
Recalled · Class II · 20263mensio Workstation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pie Medical Imaging BV · QIH Automated Radiological Image Processing Software
Cleared on Nov 3, 2025 as substantially equivalent to K153736 (Pie Medical Imaging BV, 2016) and 1 other predicate after a 271-day review. Its family tree reaches back 20 generations to 1995. It has been recalled once.
- Decided
- Nov 3, 2025
- Review
- 271 days
- Class
- Class II
- Product code
- QIH
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 20 generations to K935595 (1995). 156 ancestors in all, the oldest K891449 (1989). No later device cites it as a predicate yet.
- Root · 20 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 16 generations between
- 3 generations backK200974 QLAB Advanced Quantification SoftwarePhilips Health Care · 2020
- 2 generations backK201632 Tomtec-ArenaTomtec Imaging Systems GmbH · 2020
- 1 generation backK213544 Tomtec-ArenaTomtec Imaging Systems GmbH · 2022
- This deviceK250330 3mensio WorkstationPie Medical Imaging BV · 2025
Show all 20 generations
- Root · 20 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 19 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 18 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 17 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 16 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 15 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 14 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 13 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 12 generations backK061946 Acuson X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 11 generations backK071036 Modification to Acuson X300 Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007
- 10 generations backK072090 Siemens Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007
- 9 generations backK091286 Syngo US WorkplaceSiemens Medical Solutions USA, Inc. · 2009
- 8 generations backK130159 Qlab Quantification Software Heart ModelPhilips Health Care · 2013
- 7 generations backK132165 Qlab Quantification SoftwarePhilips Ultrasound, Inc. · 2013 · Recalled
- 6 generations backK171314 QLAB Advanced Quantification SoftwarePhilips Health Care · 2017
- 5 generations backK181264 QLAB Advanced Quantification SoftwarePhilips Ultrasound, Inc. · 2018
- 4 generations backK191647 QLAB Advanced Quantification SoftwarePhilips Health Care · 2019
- 3 generations backK200974 QLAB Advanced Quantification SoftwarePhilips Health Care · 2020
- 2 generations backK201632 Tomtec-ArenaTomtec Imaging Systems GmbH · 2020
- 1 generation backK213544 Tomtec-ArenaTomtec Imaging Systems GmbH · 2022
- This deviceK250330 3mensio WorkstationPie Medical Imaging BV · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −19 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −18 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −17 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −16 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −15 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −14 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −13 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −12 | K061946 | Acuson X300 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | 1 |
| −11 | K071036 | Modification to Acuson X300 Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | — |
| −10 | K072090 | Siemens Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | — |
| −9 | K091286 | Syngo US Workplace | Siemens Medical Solutions USA, Inc. | 2009 | — |
| −8 | K130159 | Qlab Quantification Software Heart Model | Philips Health Care | 2013 | — |
| −7 | K132165 | Qlab Quantification Software | Philips Ultrasound, Inc. | 2013 | 1 |
| −6 | K171314 | QLAB Advanced Quantification Software | Philips Health Care | 2017 | — |
| −5 | K181264 | QLAB Advanced Quantification Software | Philips Ultrasound, Inc. | 2018 | — |
| −4 | K191647 | QLAB Advanced Quantification Software | Philips Health Care | 2019 | — |
| −3 | K200974 | QLAB Advanced Quantification Software | Philips Health Care | 2020 | — |
| −2 | K201632 | Tomtec-Arena | Tomtec Imaging Systems GmbH | 2020 | — |
| −1 | K213544 | Tomtec-Arena | Tomtec Imaging Systems GmbH | 2022 | — |
| 0 (this device) | K250330 | 3mensio Workstation | Pie Medical Imaging BV | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 3 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 8 | 0 |
| 1995 | 9 | 0 |
| 1996 | 7 | 0 |
| 1997 | 9 | 0 |
| 1998 | 6 | 0 |
| 1999 | 12 | 0 |
| 2000 | 7 | 0 |
| 2001 | 6 | 0 |
| 2002 | 9 | 0 |
| 2003 | 5 | 0 |
| 2004 | 15 | 0 |
| 2005 | 5 | 0 |
| 2006 | 7 | 0 |
| 2007 | 4 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 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 23.6 · 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? (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 |
|---|---|---|---|
| * | K153736 | 3mensio WorkstationSummary page 5…1 CFR 892.2050 Classification Product Code: QIH, LLZ Predicate Devices Primary predicate device: 3mensio Workstation (K153736, 21 CFR 892.2050, LLZ) Secondary predicate device: TOMTEC-ARENA (K213544, 21 CFR 892.2050, LLZ,… | 2016 |
| * | K213544 | Tomtec-ArenaSummary page 5…es Primary predicate device: 3mensio Workstation (K153736, 21 CFR 892.2050, LLZ) Secondary predicate device: TOMTEC-ARENA (K213544, 21 CFR 892.2050, LLZ, QIH) II - Device Description 3mensio Workstation is an image post-processing software package for advance… | 2022 |
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 |
|---|---|---|---|---|
| May 7, 2026 | Class II | Z-2767-2026 | Software change control | User measurement value reported by diagnostic bioimaging software intended to measure/visualize cardiovascular structures may be larger (0.8% to 34.4%) than the actual anatomical dimension, if all the following occur: affected software is… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 7 companies; a new generation was cleared every 11 months on median.
- 32 of the 156 ancestors have a recall of any class.
- 10 other devices also cite its predicate K153736.
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?
Standalone software for medical image analysis intended for advanced visualization and quantitative analysis for diagnostics in the field of cardiology or radiology by means of enabling visualization and measurement of structures of the heart and vessels for: - Pre-operational planning and sizing for cardiovascular interventions and surgery - Postoperative evaluation - Support of clinical diagnosis by quantifying dimensions in coronary arteries - Support…
Read the full statement (121 words)
Standalone software for medical image analysis intended for advanced visualization and quantitative analysis for diagnostics in the field of cardiology or radiology by means of enabling visualization and measurement of structures of the heart and vessels for:
- Pre-operational planning and sizing for cardiovascular interventions and surgery
- Postoperative evaluation
- Support of clinical diagnosis by quantifying dimensions in coronary arteries
- Support of clinical diagnosis by quantifying calcifications (calcium scoring)
To facilitate the above, the 3mensio Workstation provides general functionality such as:
- Segmentation of cardiovascular structures
- Automatic and manual centerline detection
- Visualization and image reconstruction techniques: 2D review, Volume Rendering, MPR, Curved MPR, Stretched CMRP, Slabbing, MIP, AIP, MinlP
- Measurement and annotation tools
- Reporting tools
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250330 · printed Nov 4, 2026
Cite this page
510(k) Report. “K250330: 3mensio Workstation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K250330
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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