510(k) · Cleared
ClearedSonix Health
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ontact Health Co., Ltd. · QIH Automated Radiological Image Processing Software
Cleared on Nov 27, 2024 as substantially equivalent to K230209 (Ontact Health Co., Ltd., 2023) after a 265-day review. Its family tree reaches back 21 generations to 1995.
- Decided
- Nov 27, 2024
- Review
- 265 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 21 generations to K935595 (1995). 148 ancestors in all, the oldest K891449 (1989). No later device cites it as a predicate yet.
- Root · 21 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 17 generations between
- 3 generations backK201632 Tomtec-ArenaTomtec Imaging Systems GmbH · 2020
- 2 generations backK213544 Tomtec-ArenaTomtec Imaging Systems GmbH · 2022
- 1 generation backK230209 Sonix HealthOntact Health Co., Ltd. · 2023
- This deviceK240645 Sonix HealthOntact Health Co., Ltd. · 2024
Show all 21 generations
- Root · 21 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 20 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 19 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 18 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 17 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 16 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 15 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 14 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 13 generations backK061946 Acuson X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 12 generations backK071036 Modification to Acuson X300 Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007
- 11 generations backK072090 Siemens Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007
- 10 generations backK091286 Syngo US WorkplaceSiemens Medical Solutions USA, Inc. · 2009
- 9 generations backK130159 Qlab Quantification Software Heart ModelPhilips Health Care · 2013
- 8 generations backK132165 Qlab Quantification SoftwarePhilips Ultrasound, Inc. · 2013 · Recalled
- 7 generations backK171314 QLAB Advanced Quantification SoftwarePhilips Health Care · 2017
- 6 generations backK181264 QLAB Advanced Quantification SoftwarePhilips Ultrasound, Inc. · 2018
- 5 generations backK191647 QLAB Advanced Quantification SoftwarePhilips Health Care · 2019
- 4 generations backK200974 QLAB Advanced Quantification SoftwarePhilips Health Care · 2020
- 3 generations backK201632 Tomtec-ArenaTomtec Imaging Systems GmbH · 2020
- 2 generations backK213544 Tomtec-ArenaTomtec Imaging Systems GmbH · 2022
- 1 generation backK230209 Sonix HealthOntact Health Co., Ltd. · 2023
- This deviceK240645 Sonix HealthOntact Health Co., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −20 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −19 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −18 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −17 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −16 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −15 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −14 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −13 | K061946 | Acuson X300 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | 1 |
| −12 | K071036 | Modification to Acuson X300 Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | — |
| −11 | K072090 | Siemens Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | — |
| −10 | K091286 | Syngo US Workplace | Siemens Medical Solutions USA, Inc. | 2009 | — |
| −9 | K130159 | Qlab Quantification Software Heart Model | Philips Health Care | 2013 | — |
| −8 | K132165 | Qlab Quantification Software | Philips Ultrasound, Inc. | 2013 | 1 |
| −7 | K171314 | QLAB Advanced Quantification Software | Philips Health Care | 2017 | — |
| −6 | K181264 | QLAB Advanced Quantification Software | Philips Ultrasound, Inc. | 2018 | — |
| −5 | K191647 | QLAB Advanced Quantification Software | Philips Health Care | 2019 | — |
| −4 | K200974 | QLAB Advanced Quantification Software | Philips Health Care | 2020 | — |
| −3 | K201632 | Tomtec-Arena | Tomtec Imaging Systems GmbH | 2020 | — |
| −2 | K213544 | Tomtec-Arena | Tomtec Imaging Systems GmbH | 2022 | — |
| −1 | K230209 | Sonix Health | Ontact Health Co., Ltd. | 2023 | — |
| 0 (this device) | K240645 | Sonix Health | Ontact Health Co., Ltd. | 2024 | — |
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 | 6 | 0 |
| 1997 | 9 | 0 |
| 1998 | 5 | 0 |
| 1999 | 11 | 0 |
| 2000 | 7 | 0 |
| 2001 | 6 | 0 |
| 2002 | 9 | 0 |
| 2003 | 5 | 0 |
| 2004 | 14 | 0 |
| 2005 | 5 | 0 |
| 2006 | 6 | 0 |
| 2007 | 4 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2015 | 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? (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 |
|---|---|---|---|
| * | K230209 | Sonix HealthSummary page 5…dentification of Predicate Device(s) The identified predicate devices within this submission are shown as follow: Predicate Device ● 510(k) Number: K230209 ● Trade/Device name: Sonix Health ● Manufacturer: ONTACT HEALTH Co., Ltd Reference Devices ●… | 2023 |
| † | K220940 | EchoPAC Software Only, EchoPAC Plug-in | 2022 |
| † | K213544 | Tomtec-Arena | 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)
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 29 years and passes through 7 companies; a new generation was cleared every 11 months on median.
- 30 of the 148 ancestors have a recall of any class.
- 1 other device also cites its predicate K230209.
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. 2024, 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?
Sonix Health is intended for quantifying and reporting echocardiography for use by or on the order of a licensed physician. Sonix Health accepts DICOM-compliant medical images acquired from ultrasound imaging devices. Sonix Health is indicated for use in adult populations.
Ultrasound images are acquired via the B (2D), M, Pulsed-wave Doppler, and Continuous-wave Doppler modes.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K240645 · printed Nov 4, 2026
Cite this page
510(k) Report. “K240645: Sonix Health.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K240645
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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