510(k) · Cleared
Recalled · 2007Nemio XG, Saa-580A
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Toshiba America Medical Systems, In.C · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Jun 22, 2006 as substantially equivalent to K010631 (Toshiba America Medical Systems, In.C, 2001) after a 13-day review. Its family tree reaches back 1 generation to 2001. 5 later devices descend from it. It has been recalled 2 times.
- Decided
- Jun 22, 2006
- Review
- 13 days
- Class
- Class II
- Product code
- IYN
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K010631 (2001). 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK010631 NEMIOToshiba America Medical Systems, In.C · 2001
- This deviceK061605 Nemio XG, Saa-580AToshiba America Medical Systems, In.C · 2006
- Descendant · cites it directly · 4 of its ownK151060 Ultrasound System SONIMAGE HS1Konica Minolta, Inc. · 2015 · Recalled
- Descendant · cites it directly · 3 of its ownK152577 Ultrasound System Sonimage HS 1Konica Minolta, Inc. · 2015 · Recalled
- Descendant · cites it directly · 2 of its ownK162065 Ultrasound System SONIMAGE HS1Konica Minolta, Inc. · 2016 · Recalled
- Descendant · 2 generations on · 1 of its ownK180084 Ultrasound System SONIMAGE MX1Konica Minolta, Inc. · 2018
- Descendant · 3 generations on · 0 of its ownK220993 Ultrasound System SONIMAGE MX1Konica Minolta, Inc. · 2022
Most influential descendants
Showing 5 of 5 · See all- K151060Ultrasound System SONIMAGE HS1Konica Minolta, Inc. · 2015 · cites it directly4descendants
- K152577Ultrasound System Sonimage HS 1Konica Minolta, Inc. · 2015 · cites it directly3descendants
- K162065Ultrasound System SONIMAGE HS1Konica Minolta, Inc. · 2016 · cites it directly2descendants
- K180084Ultrasound System SONIMAGE MX1Konica Minolta, Inc. · 2018 · 2 generations on1descendant
- K220993Ultrasound System SONIMAGE MX1Konica Minolta, Inc. · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010631 | NEMIO | Toshiba America Medical Systems, In.C | 2001 | — |
| 0 (this device) | K061605 | Nemio XG, Saa-580A | Toshiba America Medical Systems, In.C | 2006 | — |
| +1 | K151060 | Ultrasound System SONIMAGE HS1 | Konica Minolta, Inc. | 2015 | 1 |
| +1 | K152577 | Ultrasound System Sonimage HS 1 | Konica Minolta, Inc. | 2015 | 2 |
| +1 | K162065 | Ultrasound System SONIMAGE HS1 | Konica Minolta, Inc. | 2016 | 2 |
| +2 | K180084 | Ultrasound System SONIMAGE MX1 | Konica Minolta, Inc. | 2018 | — |
| +3 | K220993 | Ultrasound System SONIMAGE MX1 | Konica Minolta, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 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 IYN? 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 IYN device
- #1 K240850 EPIQ Series Diagnostic Ultrasound Systems…score 32.1 · 24 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 |
|---|---|---|---|
| * | K010631 | NEMIOSummary page 1…America Medical Systems believes that this device is substantially equivalent to the Following device; SSA-55OA/NEMIO Diagnostic Ultrasound System, 510(k) control number K010631. Device Description: The Nemio XG will be offered in one variation which is a mobile system. It is a Track 3 device that employs… | 2001 |
What descends from it? (5)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 29, 2007 | Not classified | Z-0254-2008 | Software design | Multiple problems including : (1) The surface temperature of the transducer tip can rise and exceed the limit set by the international standard. (2) Incorrect display of the TI indices on the display monitor. The displayed value is… |
| Dec 19, 2006 | Not classified | Z-0771-2007 | Other | Transducer Surface Temperature : It was found during testing that when using the system in the 2DCDI + PW mode, with the Scale Graph function active, that the transducer surface temperature could exceed the 27 degrees Celsius limit as… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All IYN devicesIYN System, Imaging, Pulsed Doppler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYN
57in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYN
124in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYN
10in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · IYN
610in 2025
MAUDE reports naming product code IYN, 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 | 13 | 26 | 16 | 3 |
| 2008 | 25 | 18 | 12 | 2 |
| 2009 | 18 | 29 | 8 | 9 |
| 2010 | 29 | 67 | 10 | 17 |
| 2011 | 39 | 46 | 8 | 18 |
| 2012 | 43 | 37 | 3 | 20 |
| 2013 | 51 | 60 | 8 | 18 |
| 2014 | 56 | 39 | 2 | 48 |
| 2015 | 54 | 55 | 3 | 116 |
| 2016 | 60 | 56 | 2 | 145 |
| 2017 | 64 | 83 | 0 | 146 |
| 2018 | 59 | 85 | 7 | 85 |
| 2019 | 47 | 79 | 0 | 59 |
| 2020 | 57 | 72 | 4 | 67 |
| 2021 | 46 | 105 | 8 | 213 |
| 2022 | 53 | 105 | 10 | 186 |
| 2023 | 44 | 115 | 4 | 229 |
| 2024 | 50 | 119 | 1 | 266 |
| 2025 | 57 | 124 | 10 | 610 |
| 2026 | 44 | 107 | 2 (1) | — |
What is it indicated for?
The Nemio XG system is intended to be used for the following type of studies; fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, transrectal, transvaginal, transesophageal, peripheral vascular, musculo-skeletal (both conventional and superficial).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061605 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061605: Nemio XG, Saa-580A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061605
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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