510(k) · Cleared
ClearedSpeqrt Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Signostics Pty, Ltd. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Apr 3, 2013 as substantially equivalent to K020112 (Pie Medical, 2002) and 3 other predicates after a 22-day review. Its family tree reaches back 9 generations to 1995. 4 later devices descend from it.
- Decided
- Apr 3, 2013
- Review
- 22 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K935595 (1995). 67 ancestors in all, the oldest K850478 (1985). 4 later devices descend from it, 3 citing it directly.
- Root · 9 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 5 generations between
- 3 generations backK052410 Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005
- 2 generations backK063761 Acuson P10 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 1 generation backK090505 Speq Ultrasound SystemSignostics Pty, Ltd. · 2009
- This deviceK130659 Speqrt Ultrasound SystemSignostics Pty, Ltd. · 2013
- Descendant · cites it directly · 1 of its ownK160420 SpeqTSignostics Limited · 2016
- Descendant · 2 generations on · 0 of its ownK181574 UscanEchoNous, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK152250 SpeqRTSignostics Limited · 2015
- Descendant · cites it directly · 0 of its ownK143493 SignosRT Bladder Ultrasound SystemSignostics, Ltd. · 2015
Show all 9 generations
- Root · 9 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 8 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 7 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 6 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 5 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 4 generations backK051139 Acuson Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005
- 3 generations backK052410 Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005
- 2 generations backK063761 Acuson P10 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 1 generation backK090505 Speq Ultrasound SystemSignostics Pty, Ltd. · 2009
- This deviceK130659 Speqrt Ultrasound SystemSignostics Pty, Ltd. · 2013
Most influential descendants
Showing 4 of 4 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −8 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −7 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −6 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −5 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −4 | K051139 | Acuson Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −3 | K052410 | Acuson Sequoia Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −2 | K063761 | Acuson P10 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −1 | K090505 | Speq Ultrasound System | Signostics Pty, Ltd. | 2009 | — |
| 0 (this device) | K130659 | Speqrt Ultrasound System | Signostics Pty, Ltd. | 2013 | — |
| +1 | K160420 | SpeqT | Signostics Limited | 2016 | — |
| +2 | K181574 | Uscan | EchoNous, Inc. | 2018 | — |
| +1 | K152250 | SpeqRT | Signostics Limited | 2015 | — |
| +1 | K143493 | SignosRT Bladder Ultrasound System | Signostics, Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1989 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 5 | 0 |
| 1996 | 2 | 0 |
| 1997 | 7 | 0 |
| 1998 | 4 | 0 |
| 1999 | 9 | 0 |
| 2000 | 5 | 0 |
| 2001 | 4 | 0 |
| 2002 | 5 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2018 | 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? (4)
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 |
|---|---|---|---|
| * | K020112 | 50S Tringa Ultrasound Imaging SystemSummary page 1…Ultrasound Transducer (21 CFR 892.1570, 90-ITX) Classification Panel: Radiology 8. Predicate Devices Pie Medical 50S Tringa (K0201 12) Siemens Acuson PlO (K063761) Sonosite iLook (K02 1628) Signos Personal Ultrasound (K090505) S… | 2002 |
| * | K063761 | Acuson P10 Diagnostic Ultrasound SystemSummary page 1…R 892.1570, 90-ITX) Classification Panel: Radiology 8. Predicate Devices Pie Medical 50S Tringa (K0201 12) Siemens Acuson PlO (K063761) Sonosite iLook (K02 1628) Signos Personal Ultrasound (K090505) September 25, 2012… | 2007 |
| * | K021628 | Sonosite Hand-Caried Untrasound System (Powerseries)Summary page 1…ification Panel: Radiology 8. Predicate Devices Pie Medical 50S Tringa (K0201 12) Siemens Acuson PlO (K063761) Sonosite iLook (K02 1628) Signos Personal Ultrasound (K090505) September 25, 2012… | 2002 |
| * | K090505 | Speq Ultrasound SystemSummary page 1…Devices Pie Medical 50S Tringa (K0201 12) Siemens Acuson PlO (K063761) Sonosite iLook (K02 1628) Signos Personal Ultrasound (K090505) September 25, 2012 Page 18 Signostics Ltd… | 2009 |
What descends from it? (4)
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?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 4 of the 67 ancestors have a recall of any class.
- Of its descendants, K160420 (Signostics Limited, 2016) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K020112.
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. 2013, this device’s year, is highlighted.
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 SpeqRT ultrasound system is for non-invasive imaging of the human body and is intended for the following applications: Fetal, Abdominal, Pediatric, Musculo-skeletal, Cardiac and Peripheral Vessel. Users must have ultrasound training before using the device. See the attached indications for Use form for specific imaging modes and applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130659 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130659: Speqrt 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/K130659
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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