510(k) · Cleared
ClearedSigma 5000 Series Imagic Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kontron Medical Systems Sas · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Nov 16, 2005 as substantially equivalent to K002239 (Kontron Medical Systems Sas, 2000) after a 14-day review. Its family tree reaches back 1 generation to 2000. 3 later devices descend from it.
- Decided
- Nov 16, 2005
- Review
- 14 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002239 (2000). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK002239 Sigma 110/330 Diagnostic Ultrasound SystemKontron Medical Systems Sas · 2000
- This deviceK053084 Sigma 5000 Series Imagic Ultrasound SystemKontron Medical Systems Sas · 2005
- Descendant · cites it directly · 2 of its ownK081919 UF-870 AG Diagnostic Ultrasound SystemFukuda Denshi Co., Ltd. · 2008
- Descendant · 2 generations on · 1 of its ownK110920 UF-760AGFukuda Denshi Co., Ltd. · 2011
- Descendant · 2 generations on · 0 of its ownK131973 Unexef-38G Ultrasound SystemToyota Tsusho Corporation · 2014
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002239 | Sigma 110/330 Diagnostic Ultrasound System | Kontron Medical Systems Sas | 2000 | — |
| 0 (this device) | K053084 | Sigma 5000 Series Imagic Ultrasound System | Kontron Medical Systems Sas | 2005 | — |
| +1 | K081919 | UF-870 AG Diagnostic Ultrasound System | Fukuda Denshi Co., Ltd. | 2008 | — |
| +2 | K110920 | UF-760AG | Fukuda Denshi Co., Ltd. | 2011 | — |
| +2 | K131973 | Unexef-38G Ultrasound System | Toyota Tsusho Corporation | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 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 |
|---|---|---|---|
| * | K002239 | Sigma 110/330 Diagnostic Ultrasound SystemSummary page 1…IYO Diagnostic Ultrasonic Transducer 21 CFR 892.1570 90-ITX 3. Equivalent Legally-Marketed Devices: Kontron Medical Sigma 110/330, K002239 The technological characteristics of the predicate device are the same as those of the new device. 4. Description The Sigm… | 2000 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081919 | UF-870 AG Diagnostic Ultrasound System | 2008 | 2 |
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?
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 as stated in the FDA summary.
https://510kreport.com/device/K053084 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053084: Sigma 5000 Series Imagic 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/K053084
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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