510(k) · Cleared
ClearedSonoace 600 Diagnostic Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medison America, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Jan 19, 2000 after a 14-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.
- Decided
- Jan 19, 2000
- Review
- 14 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 3 citing it directly.
- This deviceK000030 Sonoace 600 Diagnostic Ultrasound SystemMedison America, Inc. · 2000
- Descendant · cites it directly · 3 of its ownK012772 CTS-485 Ultrasound Imaging SystemShantou Institute of Ultrasonic Instuments · 2001
- Descendant · cites it directly · 2 of its ownK041455 Ssi-600/Ssi-800 Diagnostic Ultrasound Imaging SystemSonoscape Company Limited · 2004
- Descendant · 2 generations on · 1 of its ownK101337 A6 Portable Ultrasonic Diagnostic SystemSonoscape Company Limited · 2010
- Descendant · 2 generations on · 1 of its ownK061083 CTS-7700Shantou Institute of Ultrasonic Instuments · 2006
- Descendant · 3 generations on · 0 of its ownK123616 Portable Ultrasonic Diagnostic SystemSonoscape Company Limited · 2012
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K012772CTS-485 Ultrasound Imaging SystemShantou Institute of Ultrasonic Instuments · 2001 · cites it directly3descendants
- K041455Ssi-600/Ssi-800 Diagnostic Ultrasound Imaging SystemSonoscape Company Limited · 2004 · cites it directly2descendants
- K101337A6 Portable Ultrasonic Diagnostic SystemSonoscape Company Limited · 2010 · 2 generations on1descendant
- K061083CTS-7700Shantou Institute of Ultrasonic Instuments · 2006 · 2 generations on1descendant
- K123616Portable Ultrasonic Diagnostic SystemSonoscape Company Limited · 2012 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000030 | Sonoace 600 Diagnostic Ultrasound System | Medison America, Inc. | 2000 | — |
| +1 | K012772 | CTS-485 Ultrasound Imaging System | Shantou Institute of Ultrasonic Instuments | 2001 | — |
| +1 | K041455 | Ssi-600/Ssi-800 Diagnostic Ultrasound Imaging System | Sonoscape Company Limited | 2004 | — |
| +2 | K101337 | A6 Portable Ultrasonic Diagnostic System | Sonoscape Company Limited | 2010 | — |
| +2 | K061083 | CTS-7700 | Shantou Institute of Ultrasonic Instuments | 2006 | — |
| +3 | K123616 | Portable Ultrasonic Diagnostic System | Sonoscape Company Limited | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (8)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K012772 (Shantou Institute of Ultrasonic Instuments, 2001) has gone furthest, with 3 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 | — |
https://510kreport.com/device/K000030 · printed Nov 6, 2026
Cite this page
510(k) Report. “K000030: Sonoace 600 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/K000030
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026