510(k) · Cleared
ClearedAloka SSD-900 Diagnostic Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aloka Co., Ltd. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Mar 22, 1999 after a 140-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.
- Decided
- Mar 22, 1999
- Review
- 140 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK983879 Aloka SSD-900 Diagnostic Ultrasound SystemAloka Co., Ltd. · 1999
- Descendant · cites it directly · 0 of its ownK070195 Broadsound, AL3C34A,AL7L50A, AL3C79B,AL7L24B, AT3P42A, AT3C52B…Broadsound Corporation · 2007
- Descendant · cites it directly · 0 of its ownK040926 Ultrasound Scanner, Hudson Models 8000 and 9000Hudson Diagnostic Imaging, LLC · 2004
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983879 | Aloka SSD-900 Diagnostic Ultrasound System | Aloka Co., Ltd. | 1999 | — |
| +1 | K070195 | Broadsound, AL3C34A,AL7L50A, AL3C79B,AL7L24B, AT3P42A, AT3C52B, ATL5L40B… | Broadsound Corporation | 2007 | — |
| +1 | K040926 | Ultrasound Scanner, Hudson Models 8000 and 9000 | Hudson Diagnostic Imaging, LLC | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 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 |
|---|---|---|---|
| * | — | Aloka SSD-1400 Named without a submission number |
What descends from it? (2)
2 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?
- Of its descendants, K070195 (Broadsound Corporation, 2007) has gone furthest, with 0 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?
Diagnostic Ultrasound imaging of the human body as follows: Diagnostic Ultrasound imaging of the human body as follows: Diagnostic Ultrasound imaging of the human body as follows: Diagnostic Ultrasound imaging of the human body as follows: Diagnostic Ultrasound imaging of the human body as follows: Diagnostic Ultrasound imaging of the human body as follows: Diagnostic Ultrasound imaging of the human body as follows: Diagnostic Ultrasound imaging of the…
Read the full statement (144 words)
Diagnostic Ultrasound imaging of the human body as follows:
Diagnostic Ultrasound imaging of the human body as follows:
Diagnostic Ultrasound imaging of the human body as follows:
Diagnostic Ultrasound imaging of the human body as follows:
Diagnostic Ultrasound imaging of the human body as follows:
Diagnostic Ultrasound imaging of the human body as follows:
Diagnostic Ultrasound imaging of the human body as follows:
Diagnostic Ultrasound imaging of the human body as follows:
Diagnostic Ultrasound imaging of the human body as follows:
Diagnostic Ultrasound imaging of the human body as follows:
Diagnostic Ultrasound imaging of the human body as follows:
Diagnostic Ultrasound imaging of the human body as follows:
Diagnostic Ultrasound imaging of the human body as follows:
Diagnostic Ultrasound imaging of the human body as follows:
Diagnostic Ultrasound imaging of the human body as follows:
Diagnostic Ultrasound imaging of the human body as follows:
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/K983879 · printed Nov 5, 2026
Cite this page
510(k) Report. “K983879: Aloka SSD-900 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/K983879
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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