510(k) · Cleared
Recalled · Class II · 2013Modification to Automated Breast Ultrasound System, Model Abus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
U-System, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Aug 7, 2008 as substantially equivalent to K052355 (U-Systems, Inc., 2005) and 1 other predicate after a 127-day review. Its family tree reaches back 4 generations to 1992. 3 later devices descend from it. It has been recalled once.
- Decided
- Aug 7, 2008
- Review
- 127 days
- Class
- Class II
- Product code
- IYO
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 4 generations to K922470 (1992). 9 ancestors in all. 3 later devices descend from it, 1 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 deviceK080930 Modification to Automated Breast Ultrasound System, Model AbusU-System, Inc. · 2008
- Descendant · cites it directly · 2 of its ownK092067 Abvs WorkplaceSiemens AG Medical Solutions · 2009
- Descendant · 2 generations on · 1 of its ownK151075 BR-ABVS Viewer 1.0Taihao Medical, Inc. · 2016
- Descendant · 3 generations on · 0 of its ownK180641 Invenia ABUS ViewerGE Healthcare · 2018
Most influential descendants
Showing 3 of 3 · See allView 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) | K080930 | Modification to Automated Breast Ultrasound System, Model Abus | U-System, Inc. | 2008 | — |
| +1 | K092067 | Abvs Workplace | Siemens AG Medical Solutions | 2009 | — |
| +2 | K151075 | BR-ABVS Viewer 1.0 | Taihao Medical, Inc. | 2016 | — |
| +3 | K180641 | Invenia ABUS Viewer | GE Healthcare | 2018 | — |
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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 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 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? (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 |
|---|---|---|---|
| * | K052355 | Automated Breast Ultrasound System, Model AbusSummary page 1…ems.com A. Legally Marketed Predicate Device The Company believes that the modified ABUS is substantially equivalent to the previously cleared U-Systems - ABUS (K052355), as well as the Siemens - Antares DUS (K023720). The intended use and the technological characteristics of the device are… | 2005 |
| * | K023720 | Sonoline Antares Ultrasound SystemSummary page 1…The Company believes that the modified ABUS is substantially equivalent to the previously cleared U-Systems - ABUS (K052355), as well as the Siemens - Antares DUS (K023720). The intended use and the technological characteristics of the device are the same as the predicate devices. B. Device D… | 2002 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092067 | Abvs Workplace | 2009 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 16, 2013 | Class II | Z-1587-2013 | Software design | Devices labeled for an intended use not included in the existing 510(k) or PMA, in that, the user manual contains the Indication for Use of the soma v Platinum ABUS [a 510(k) product]. |
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, K092067 (Siemens AG Medical Solutions, 2009) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K052355.
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. 2008, this device’s year, is highlighted.
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 ultrasound pulsed echo imaging system is intended to project a pulsed sound beam into body tissue to determine the depth of 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…
Read the full statement (114 words)
An ultrasound pulsed echo imaging system is intended to project a pulsed sound beam into body tissue to determine the depth of 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 or a handheld 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/K080930 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080930: Modification to Automated Breast Ultrasound System, Model Abus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080930
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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