510(k) · Cleared
ClearedAloka SSD-5500 Diagnostic Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aloka Co., Ltd. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Aug 24, 1999 as substantially equivalent to K954022 (Aloka Co., Ltd., 1996) and 1 other predicate after a 15-day review. Its family tree reaches back 1 generation to 1996. 342 later devices descend from it.
- Decided
- Aug 24, 1999
- Review
- 15 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K954022 (1996). 2 ancestors in all. 342 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK954022 Aloka Omniview Diagnostic Ultrasound SystemAloka Co., Ltd. · 1996
- This deviceK992663 Aloka SSD-5500 Diagnostic Ultrasound SystemAloka Co., Ltd. · 1999
- Descendant · cites it directly · 207 of its ownK012080 SSD-5000 Diagnostic Ultrasound SystemAloka Co., Ltd. · 2001
- Descendant · cites it directly · 191 of its ownK060949 DP-6600 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006
- Descendant · 2 generations on · 189 of its ownK063500 DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006
- Descendant · 2 generations on · 188 of its ownK072164 DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007
- Descendant · 2 generations on · 182 of its ownK080640 M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008
Showing 5 of 342 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 342 · See all- K012080SSD-5000 Diagnostic Ultrasound SystemAloka Co., Ltd. · 2001 · cites it directly207descendants
- K060949DP-6600 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006 · cites it directly191descendants
- K063500DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006 · 2 generations on189descendants
- K072164DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007 · 2 generations on188descendants
- K080640M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008 · 2 generations on182descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954022 | Aloka Omniview Diagnostic Ultrasound System | Aloka Co., Ltd. | 1996 | — |
| 0 (this device) | K992663 | Aloka SSD-5500 Diagnostic Ultrasound System | Aloka Co., Ltd. | 1999 | — |
| +1 | K012080 | SSD-5000 Diagnostic Ultrasound System | Aloka Co., Ltd. | 2001 | — |
| +1 | K060949 | DP-6600 Digital Ultrasonic Diagnostic Imaging System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006 | — |
| +2 | K063500 | DC-6 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006 | — |
| +2 | K072164 | DC-6 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2007 | — |
| +2 | K080640 | M5 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2006 | 3 | 0 |
| 2007 | 5 | 0 |
| 2008 | 6 | 0 |
| 2009 | 6 | 0 |
| 2010 | 9 | 0 |
| 2011 | 12 | 0 |
| 2012 | 12 | 0 |
| 2013 | 13 | 0 |
| 2014 | 12 | 0 |
| 2015 | 17 | 0 |
| 2016 | 18 | 0 |
| 2017 | 35 | 0 |
| 2018 | 25 | 0 |
| 2019 | 31 | 0 |
| 2020 | 23 | 0 |
| 2021 | 19 | 0 |
| 2022 | 19 | 0 |
| 2023 | 18 | 0 |
| 2024 | 19 | 0 |
| 2025 | 22 | 0 |
| 2026 | 12 | 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? (6)
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 |
|---|---|---|---|
| * | K954022 | Aloka Omniview Diagnostic Ultrasound SystemSummary page 3…r and Color Flow imaging. It is based upon and substantially equivalent to the Aloka SSD-1700 and SSD-2000 systems, which received clearance for market under K963616 and K954022. The SSD-5500 is also equivalent to other high performance digital beamforming systems such as the Toshiba PowerVision, ATL HDI-5… | 1996 |
| * | K963616 | Aloka SSD-1700 Diagnostic Ultrasound SystemSummary page 3…ctral Doppler and Color Flow imaging. It is based upon and substantially equivalent to the Aloka SSD-1700 and SSD-2000 systems, which received clearance for market under K963616 and K954022. The SSD-5500 is also equivalent to other high performance digital beamforming systems such as the Toshiba PowerVisio… | 1997 |
| * | — | Toshiba PowerVision Named without a submission number | |
| * | — | H.P. Sonos 5500 Named without a submission number | |
| * | — | Vingmed (G.E.) System V Named without a submission number | |
| * | — | Atl Hdi-5000 Named without a submission number |
What descends from it? (342)
See all 3425 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K012080 | SSD-5000 Diagnostic Ultrasound System | 2001 | 207 |
| K060949 | DP-6600 Digital Ultrasonic Diagnostic Imaging System | 2006 | 191 |
| K032875 | Aloka Model SSD-5500 V6.0 Ultrasound System | 2003 | 124 |
| K070526 | DP-9900 Digital Ultrasonic Diagnostic Imaging System | 2007 | 117 |
| K040719 | Aloka Model SSD-4000 Diagnostic Ultrasound System W/Optional Sonoreal 3D System Accessory | 2004 | 27 |
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K012080 (Aloka Co., Ltd., 2001) has gone furthest, with 207 descendants of its own.
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?
Diagnostic ultrasound imaging or fluid flow analysis 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/K992663 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992663: Aloka SSD-5500 Diagnostic 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/K992663
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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