510(k) · Cleared
ClearedFull Field Breast Imaging (Ffbu) Diagnostic Ultrasound System
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 11, 2003 as substantially equivalent to K022517 (U-Systems, Inc., 2002) after a 15-day review. Its family tree reaches back 1 generation to 2002. 65 later devices descend from it.
- Decided
- Sep 11, 2003
- Review
- 15 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K022517 (2002). 65 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK022517 Usi-2000 Ultrasound System with Automated Scanning AccessoryU-Systems, Inc. · 2002
- This deviceK032640 Full Field Breast Imaging (Ffbu) Diagnostic Ultrasound SystemU-Systems, Inc. · 2003
- Descendant · cites it directly · 64 of its ownK052355 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
Showing 5 of 65 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 65 · See all- K052355Automated Breast Ultrasound System, Model AbusU-Systems, Inc. · 2005 · cites it directly64descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K022517 | Usi-2000 Ultrasound System with Automated Scanning Accessory | U-Systems, Inc. | 2002 | — |
| 0 (this device) | K032640 | Full Field Breast Imaging (Ffbu) Diagnostic Ultrasound System | U-Systems, Inc. | 2003 | — |
| +1 | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K022517 | Usi-2000 Ultrasound System with Automated Scanning Accessory | 2002 |
What descends from it? (65)
See all 652 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?
- Its one ancestor has no recall.
- Of its descendants, K052355 (U-Systems, Inc., 2005) has gone furthest, with 64 descendants of its own.
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?
U-Systems FFBU Diagnostic Ultrasound System is intended for diagnostic breast examinations.
U-Systems L 9-5 XW MHz Transducer is intended for diagnostic breast examinations.
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/K032640 · printed Nov 5, 2026
Cite this page
510(k) Report. “K032640: Full Field Breast Imaging (Ffbu) Diagnostic Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032640
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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