510(k) · Cleared
ClearedATUSA™ Automated 3D Breast Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Isono Health, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Apr 22, 2022 as substantially equivalent to K080555 (Ivu Imaging Corporation, 2008) after a 157-day review. Its family tree reaches back 5 generations to 1992.
- Decided
- Apr 22, 2022
- Review
- 157 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K922470 (1992). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK922470 Ies, Image Enhancement SystemOpen Mri, Inc. · 1992
- 4 generations backK993802 Sharpview Image Enhancement SystemContext Vision AB · 2000
- 3 generations backK024028 Sharp View Image Enhancement SystemContext Vision AB · 2003
- 2 generations backK052355 Automated Breast Ultrasound System, Model AbusU-Systems, Inc. · 2005
- 1 generation backK080555 Sofia Automated Tomographic Ultrasound (Atus)Ivu Imaging Corporation · 2008
- This deviceK213620 ATUSA™ Automated 3D Breast Ultrasound SystemIsono Health, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K922470 | Ies, Image Enhancement System | Open Mri, Inc. | 1992 | — |
| −4 | K993802 | Sharpview Image Enhancement System | Context Vision AB | 2000 | — |
| −3 | K024028 | Sharp View Image Enhancement System | Context Vision AB | 2003 | — |
| −2 | K052355 | Automated Breast Ultrasound System, Model Abus | U-Systems, Inc. | 2005 | — |
| −1 | K080555 | Sofia Automated Tomographic Ultrasound (Atus) | Ivu Imaging Corporation | 2008 | — |
| 0 (this device) | K213620 | ATUSA™ Automated 3D Breast Ultrasound System | Isono Health, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 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? (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 |
|---|---|---|---|
| * | K080555 | Sofia Automated Tomographic Ultrasound (Atus)Summary page 4…sonic 21 CFR 892.1560 / 21 CFR 892.1570 Product Code: IYO, ITX a3 PREDICATE DEVICE: Predicate Device: K080555 [Cleared 03 Jun 2008] The FDA database for recalls was searched on 24 Sep 2021 during the preparation of the 510(k)… | 2008 |
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 30 years and passes through 5 companies; a new generation was cleared every 3.0 years on median.
- 2 of the 10 ancestors have a recall of any class.
- 2 other devices also cite its predicate K080555.
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. 2022, 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?
The 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.
Operator: Trained Healthcare Professional
Patient Population: Ages 18 and above
Environment of use: Facilities where healthcare is provided - e.g. hospitals, clinics, physician offices, mobile care units.
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/K213620 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213620: ATUSA™ Automated 3D Breast Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213620
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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