510(k) · Cleared
ClearedSofia Automated Tomographic Ultrasound (Atus)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ivu Imaging Corporation · ITX Transducer, Ultrasonic, Diagnostic
Cleared on Jun 3, 2008 as substantially equivalent to K032640 (U-Systems, Inc., 2003) and 1 other predicate after a 96-day review. Its family tree reaches back 4 generations to 1992. 53 later devices descend from it.
- Decided
- Jun 3, 2008
- Review
- 96 days
- Class
- Class II
- Product code
- ITX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K922470 (1992). 9 ancestors in all. 53 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK922470 Ies, Image Enhancement SystemOpen Mri, Inc. · 1992
- 3 generations backK993802 Sharpview Image Enhancement SystemContext Vision AB · 2000
- 2 generations backK024028 Sharp View Image Enhancement SystemContext Vision AB · 2003
- 1 generation backK052355 Automated Breast Ultrasound System, Model AbusU-Systems, Inc. · 2005
- This deviceK080555 Sofia Automated Tomographic Ultrasound (Atus)Ivu Imaging Corporation · 2008
- Descendant · cites it directly · 50 of its ownK123209 SoftvueDelphinus Medical Technologies, Inc. · 2013
- Descendant · 2 generations on · 49 of its ownK142517 SoftVueDelphinus Medical Technologies, Inc. · 2014
- Descendant · 3 generations on · 42 of its ownK150949 FibroScanEchosens · 2015
- Descendant · 4 generations on · 41 of its ownK160524 FibroScan 530 CompactEchosens · 2016
- Descendant · 5 generations on · 19 of its ownK170445 Logiq S8GE Healthcare · 2017 · Recalled
Showing 5 of 53 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 53 · See all- K123209SoftvueDelphinus Medical Technologies, Inc. · 2013 · cites it directly50descendants
- K142517SoftVueDelphinus Medical Technologies, Inc. · 2014 · 2 generations on49descendants
- K150949FibroScanEchosens · 2015 · 3 generations on42descendants
- K160524FibroScan 530 CompactEchosens · 2016 · 4 generations on41descendants
- K170445Logiq S8GE Healthcare · 2017 · 5 generations on19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K922470 | Ies, Image Enhancement System | Open Mri, Inc. | 1992 | — |
| −3 | K993802 | Sharpview Image Enhancement System | Context Vision AB | 2000 | — |
| −2 | K024028 | Sharp View Image Enhancement System | Context Vision AB | 2003 | — |
| −1 | K052355 | Automated Breast Ultrasound System, Model Abus | U-Systems, Inc. | 2005 | — |
| 0 (this device) | K080555 | Sofia Automated Tomographic Ultrasound (Atus) | Ivu Imaging Corporation | 2008 | — |
| +1 | K123209 | Softvue | Delphinus Medical Technologies, Inc. | 2013 | — |
| +2 | K142517 | SoftVue | Delphinus Medical Technologies, Inc. | 2014 | — |
| +3 | K150949 | FibroScan | Echosens | 2015 | — |
| +4 | K160524 | FibroScan 530 Compact | Echosens | 2016 | — |
| +5 | K170445 | Logiq S8 | GE Healthcare | 2017 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 5 | 0 |
| 2019 | 3 | 0 |
| 2020 | 6 | 0 |
| 2021 | 3 | 0 |
| 2022 | 5 | 0 |
| 2023 | 5 | 0 |
| 2024 | 6 | 0 |
| 2025 | 5 | 0 |
| 2026 | 7 | 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 ITX? 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 ITX device
- #1 K260114 Align® Cover and Pad Guidance Toolscore 13.6 · 6 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 |
|---|---|---|---|
| * | K032640 | Full Field Breast Imaging (Ffbu) Diagnostic Ultrasound SystemSummary page 2…The Sofia TM (ATUS) device, as well as, the two predicate devices (Trade Name: FFBU Diagnostic Ultrasound System manufactured by U-Systems, Inc (K032640), Trade Name: ABUS Diagnostic Ultrasound System manufactured by U-Systems, Inc (K052355) utilize standard B-Mode grayscale ultr… | 2003 |
| * | K052355 | Automated Breast Ultrasound System, Model AbusSummary page 2…(Trade Name: FFBU Diagnostic Ultrasound System manufactured by U-Systems, Inc (K032640), Trade Name: ABUS Diagnostic Ultrasound System manufactured by U-Systems, Inc (K052355) utilize standard B-Mode grayscale ultrasound to achieve their intended use. Both the Sofia T M (ATUS) device and the U-Systems… | 2005 |
| † | K050126 | GE Logiq Twin | 2005 |
| † | K023720 | Sonoline Antares Ultrasound System | 2002 |
What descends from it? (53)
See all 533 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 16 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K123209 (Delphinus Medical Technologies, Inc., 2013) has gone furthest, with 50 descendants of its own.
- 1 other device also cites its predicate K032640.
How does its category compare?
All ITX devicesITX Transducer, Ultrasonic, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · ITX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ITX
126in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ITX
2in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · ITX
571in 2025
MAUDE reports naming product code ITX, 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 | 10 | 26 | 0 | 16 |
| 2008 | 12 | 73 | 4 | 39 |
| 2009 | 17 | 28 | 4 | 23 |
| 2010 | 10 | 42 | 4 | 30 |
| 2011 | 10 | 16 | 1 | 34 |
| 2012 | 7 | 25 | 1 | 29 |
| 2013 | 3 | 105 | 0 | 38 |
| 2014 | 4 | 41 | 1 | 43 |
| 2015 | 1 | — | 5 | 183 |
| 2016 | 4 | 151 | 0 | 269 |
| 2017 | 6 | 110 | 1 | 412 |
| 2018 | 2 | — | 15 | 130 |
| 2019 | 1 | — | 0 | 119 |
| 2020 | 3 | 120 | 3 | 116 |
| 2021 | 3 | 139 | 10 (10) | 146 |
| 2022 | 2 | — | 6 | 87 |
| 2023 | 6 | 213 | 1 | 138 |
| 2024 | 3 | 81 | 1 | 988 |
| 2025 | 4 | 126 | 2 | 571 |
| 2026 | 6 | 158 | 0 | — |
What is it indicated for?
The Sofia TM (ATUS) device is indicated for use as a B-mode ultrasonic imaging system for imaging of a patient's breast when used with an automatic scanning linear array transducer. The device is not intended to be used as a replacement for screening mammography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080555 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080555: Sofia Automated Tomographic Ultrasound (Atus).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080555
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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