510(k) · Cleared
ClearedSpeqT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Signostics Limited · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Mar 21, 2016 as substantially equivalent to K130659 (Signostics Pty, Ltd., 2013) and 3 other predicates after a 34-day review. Its family tree reaches back 18 generations to 1995. 6 of the 180 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Mar 21, 2016
- Review
- 34 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 18 generations to K935595 (1995). 178 ancestors in all, the oldest K850478 (1985). 1 later device descends from it, 1 citing it directly. 6 of the 180 devices in this family, counting this one, have a Class I recall.
- Root · 18 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 14 generations between
- 3 generations backK132304 Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2013 · Recalled
- 2 generations backK133833 Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2014 · Recalled
- 1 generation backK152899 Philips Lumify Diagnostic Ultrasound SystemPhilips Healthcare, Inc. · 2015 · Recalled
- This deviceK160420 SpeqTSignostics Limited · 2016
- Descendant · cites it directly · 0 of its ownK181574 UscanEchoNous, Inc. · 2018
Show all 18 generations
- Root · 18 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 17 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 16 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 15 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 14 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 13 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 12 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 11 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 10 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 9 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 8 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 7 generations backK091970 Aixplorer Ultrasound SystemSupersonic Imagine · 2009
- 6 generations backK102041 AixplorerSupersonic Imagine · 2010
- 5 generations backK112255 AixplorerSupersonic Imagine · 2012
- 4 generations backK130499 IU22 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2013 · Recalled
- 3 generations backK132304 Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2013 · Recalled
- 2 generations backK133833 Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2014 · Recalled
- 1 generation backK152899 Philips Lumify Diagnostic Ultrasound SystemPhilips Healthcare, Inc. · 2015 · Recalled
- This deviceK160420 SpeqTSignostics Limited · 2016
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K181574UscanEchoNous, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −17 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −16 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −15 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −14 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −13 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −12 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −11 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −10 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −9 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −8 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −7 | K091970 | Aixplorer Ultrasound System | Supersonic Imagine | 2009 | — |
| −6 | K102041 | Aixplorer | Supersonic Imagine | 2010 | — |
| −5 | K112255 | Aixplorer | Supersonic Imagine | 2012 | — |
| −4 | K130499 | IU22 Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2013 | 2 |
| −3 | K132304 | Epiq Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2013 | 36 |
| −2 | K133833 | Nuvis Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2014 | 3 |
| −1 | K152899 | Philips Lumify Diagnostic Ultrasound System | Philips Healthcare, Inc. | 2015 | 4 |
| 0 (this device) | K160420 | SpeqT | Signostics Limited | 2016 | — |
| +1 | K181574 | Uscan | EchoNous, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 3 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 6 | 0 |
| 1995 | 7 | 0 |
| 1996 | 8 | 1 |
| 1997 | 9 | 0 |
| 1998 | 13 | 3 |
| 1999 | 16 | 0 |
| 2000 | 14 | 1 |
| 2001 | 13 | 0 |
| 2002 | 18 | 0 |
| 2003 | 9 | 0 |
| 2004 | 11 | 1 |
| 2005 | 9 | 0 |
| 2006 | 2 | 0 |
| 2007 | 4 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
6 devices in this family have a Class I recall. 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? (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 |
|---|---|---|---|
| * | K130659 | Speqrt Ultrasound SystemSummary page 6…sound Transducer (21 CFR 892.1570, 90-ITX) Classification Panel: Radiology 8. Predicate Devices SpeqRT Ultrasound System (K130659). Speq Ultrasound System (K090505). Philips Lumify Diagnostic Ultrasound System (K152899) Ver… | 2013 |
| * | K090505 | Speq Ultrasound SystemSummary page 6…, 90-ITX) Classification Panel: Radiology 8. Predicate Devices SpeqRT Ultrasound System (K130659). Speq Ultrasound System (K090505). Philips Lumify Diagnostic Ultrasound System (K152899) Verathon BVI 9400 bladder scanner (K071217) M… | 2009 |
| * | K152899 | Philips Lumify Diagnostic Ultrasound SystemSummary page 6…Predicate Devices SpeqRT Ultrasound System (K130659). Speq Ultrasound System (K090505). Philips Lumify Diagnostic Ultrasound System (K152899) Verathon BVI 9400 bladder scanner (K071217) March 18, 2016… | 2015 |
| * | K071217 | Bladderscan Bvi 9400 UltrasoundSummary page 6…(K130659). Speq Ultrasound System (K090505). Philips Lumify Diagnostic Ultrasound System (K152899) Verathon BVI 9400 bladder scanner (K071217) March 18, 2016 Page 1… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181574 | Uscan | 2018 | 0 |
Has anything in its family been recalled? (6 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K040050Instatrak System with Multiple Dataset Navigation, Model IT3500Ge Medical Systems Navigation and Visualization IN · 2004 · 6 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K994270Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · 6 generations back · ◆ in the 2000 ancestors bar of FIG. 12 Class I recalls
- K983529Instatrak 3000Visualization Technology, Inc. · 1998 · 6 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K982994Skull Base Instatrak SystemVisualization Technology, Inc. · 1998 · 6 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K981998Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · 6 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K960330InstatrakVisualization Technology, Inc. · 1996 · 6 generations back · ◆ in the 1996 ancestors bar of FIG. 11 Class I recall
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- The line of descent spans 21 years and passes through 7 companies; a new generation was cleared every 11 months on median.
- 46 of the 178 ancestors have a recall of any class; 6 have a Class I recall.
- Of its descendants, K181574 (EchoNous, Inc., 2018) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K130659.
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. 2016, this device’s year, is highlighted.
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?
The SpeqT is for non-invasive imaging of the human body and is intended for the following applications: Abdominal, Musculoskeletal, Pediatric, and Small Organ. Users must have ultrasound training for abdominal, musculoskeletal, pediatric, and small organ imaging.
The SpeqT can also be used to obtain an image of the bladder that is used to automatically determine bladder volume.
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/K160420 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160420: SpeqT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160420
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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