510(k) · Cleared
ClearedAutomated Breast Ultrasound System, Model Abus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
U-Systems, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Sep 14, 2005 as substantially equivalent to K032640 (U-Systems, Inc., 2003) and 2 other predicates after a 16-day review. Its family tree reaches back 3 generations to 1992. 64 later devices descend from it.
- Decided
- Sep 14, 2005
- Review
- 16 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K922470 (1992). 8 ancestors in all. 64 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK922470 Ies, Image Enhancement SystemOpen Mri, Inc. · 1992
- 2 generations backK993802 Sharpview Image Enhancement SystemContext Vision AB · 2000
- 1 generation backK024028 Sharp View Image Enhancement SystemContext Vision AB · 2003
- This deviceK052355 Automated Breast Ultrasound System, Model AbusU-Systems, Inc. · 2005
- Descendant · cites it directly · 53 of its ownK080555 Sofia Automated Tomographic Ultrasound (Atus)Ivu Imaging Corporation · 2008
- Descendant · 2 generations on · 50 of its ownK123209 SoftvueDelphinus Medical Technologies, Inc. · 2013
- Descendant · 3 generations on · 49 of its ownK142517 SoftVueDelphinus Medical Technologies, Inc. · 2014
- Descendant · 4 generations on · 42 of its ownK150949 FibroScanEchosens · 2015
- Descendant · 5 generations on · 41 of its ownK160524 FibroScan 530 CompactEchosens · 2016
Showing 5 of 64 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 64 · See all- K080555Sofia Automated Tomographic Ultrasound (Atus)Ivu Imaging Corporation · 2008 · cites it directly53descendants
- K123209SoftvueDelphinus Medical Technologies, Inc. · 2013 · 2 generations on50descendants
- K142517SoftVueDelphinus Medical Technologies, Inc. · 2014 · 3 generations on49descendants
- K150949FibroScanEchosens · 2015 · 4 generations on42descendants
- K160524FibroScan 530 CompactEchosens · 2016 · 5 generations on41descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K922470 | Ies, Image Enhancement System | Open Mri, Inc. | 1992 | — |
| −2 | K993802 | Sharpview Image Enhancement System | Context Vision AB | 2000 | — |
| −1 | K024028 | Sharp View Image Enhancement System | Context Vision AB | 2003 | — |
| 0 (this device) | K052355 | Automated Breast Ultrasound System, Model Abus | U-Systems, Inc. | 2005 | — |
| +1 | K080555 | Sofia Automated Tomographic Ultrasound (Atus) | Ivu Imaging Corporation | 2008 | — |
| +2 | K123209 | Softvue | Delphinus Medical Technologies, Inc. | 2013 | — |
| +3 | K142517 | SoftVue | Delphinus Medical Technologies, Inc. | 2014 | — |
| +4 | K150949 | FibroScan | Echosens | 2015 | — |
| +5 | K160524 | FibroScan 530 Compact | Echosens | 2016 | — |
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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 5 | 0 |
| 2018 | 6 | 0 |
| 2019 | 4 | 0 |
| 2020 | 6 | 0 |
| 2021 | 4 | 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 IYO? 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 IYO device
- #1 K243937 Accuro 3Sscore 20.5 · 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? (3)
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 1…: blawrnece~u-sys.com A. Legally Marketed Predicate Device The ABUS System modification is substantially equivalent to the sponsor's original FFBU device (K032640) as well as Siemens Antares DUS (K023720) and the ContextVision Sharp Image View (K(024028). The intended use and the tech… | 2003 |
| * | K023720 | Sonoline Antares Ultrasound SystemSummary page 1…ted Predicate Device The ABUS System modification is substantially equivalent to the sponsor's original FFBU device (K032640) as well as Siemens Antares DUS (K023720) and the ContextVision Sharp Image View (K(024028). The intended use and the technological characteristics of the m… | 2002 |
| * | K024028 | Sharp View Image Enhancement SystemSummary page 1…fication is substantially equivalent to the original FFBU device (K032640) as well as Siemens Antares DUS (K023720) and the ContextVision Sharp Image View (K024028). E. PERFORMANCE DATA The ABUS System performance has been verified according to the U-Systemns process for Desi… | 2003 |
What descends from it? (64)
See all 645 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080555 | Sofia Automated Tomographic Ultrasound (Atus) | 2008 | 53 |
| K080930 | Modification to Automated Breast Ultrasound System, Model Abus | 2008 | 3 |
| K070477 | Orison Embrace System | 2007 | 3 |
| K141870 | Breast Volume Navigator | 2014 | 2 |
| K082543 | Sonocine Adjunctive Breast Ultrasound System (Abu), Model 100 | 2008 | 2 |
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 13 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K080555 (Ivu Imaging Corporation, 2008) has gone furthest, with 53 descendants of its own.
- 1 other device also cites its predicate K032640.
How does its category compare?
All IYO devicesIYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYO
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYO
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYO
485in 2025
MAUDE reports naming product code IYO, 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 | 20 | 17 | 4 | 39 |
| 2008 | 14 | 36 | 5 | 20 |
| 2009 | 13 | 79 | 9 | 27 |
| 2010 | 15 | 113 | 8 | 20 |
| 2011 | 11 | 69 | 0 | 58 |
| 2012 | 15 | 68 | 2 | 78 |
| 2013 | 17 | 50 | 3 | 436 |
| 2014 | 14 | 63 | 2 | 304 |
| 2015 | 19 | 46 | 1 | 268 |
| 2016 | 10 | 36 | 0 | 254 |
| 2017 | 19 | 72 | 0 | 238 |
| 2018 | 14 | 56 | 1 | 368 |
| 2019 | 13 | 59 | 1 | 537 |
| 2020 | 11 | 57 | 0 | 498 |
| 2021 | 15 | 64 | 11 | 617 |
| 2022 | 5 | 190 | 1 | 511 |
| 2023 | 11 | 177 | 0 | 527 |
| 2024 | 10 | 220 | 0 | 640 |
| 2025 | 7 | 171 | 0 | 485 |
| 2026 | 10 | 139 | 1 | — |
What is it indicated for?
An ultrasonic pulsed echo imaging system is intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
The device is indicated for use as an adjunct to mammography for B-mode ultrasonic imaging of a patient's breast when used with an automatic scanning linear array transducer.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052355 · printed Nov 5, 2026
Cite this page
510(k) Report. “K052355: Automated Breast Ultrasound System, Model Abus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052355
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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