510(k) · Cleared
ClearedTerason Ultrasound System with Continuous Wave Soppler
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teratech Corp. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Jun 3, 2005 as substantially equivalent to K991710 (Toshiba America Medical Systems, In.C, 1999) after an 11-day review. Its family tree reaches back 4 generations to 1989. 5 later devices descend from it.
- Decided
- Jun 3, 2005
- Review
- 11 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K894632 (1989). 16 ancestors in all, the oldest K891453 (1989). 5 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK894632 Model SSH-140A Ultrasound Imaging SystemToshiba America Medical Systems, In.C · 1989
- 3 generations backK941593 Diagnostic Ultrasonic TransducerToshiba America Medical Systems, In.C · 1996
- 2 generations backK970047 Phased Array Transducer - - PSK-20CTToshiba America Medical Systems, In.C · 1997
- 1 generation backK991710 Ssa-370A/Powervision 6000Toshiba America Medical Systems, In.C · 1999
- This deviceK051334 Terason Ultrasound System with Continuous Wave SopplerTeratech Corp. · 2005
- Descendant · cites it directly · 2 of its ownK082147 Bodymetrix BX2000Intelametrix, Inc. · 2009
- Descendant · 2 generations on · 1 of its ownK202514 EchoS FamilyEcholight S.P.A · 2021
- Descendant · cites it directly · 1 of its ownK072266 Acuson P50 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- Descendant · 3 generations on · 0 of its ownK212851 EchoSK and EchoSGyn modules for EchoS Family devicesEcholight S.P.A · 2022
- Descendant · 2 generations on · 0 of its ownK083114 Acuson P50 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2009
Most influential descendants
Showing 5 of 5 · See all- K082147Bodymetrix BX2000Intelametrix, Inc. · 2009 · cites it directly2descendants
- K202514EchoS FamilyEcholight S.P.A · 2021 · 2 generations on1descendant
- K072266Acuson P50 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007 · cites it directly1descendant
- K212851EchoSK and EchoSGyn modules for EchoS Family devicesEcholight S.P.A · 2022 · 3 generations on0descendants
- K083114Acuson P50 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2009 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K894632 | Model SSH-140A Ultrasound Imaging System | Toshiba America Medical Systems, In.C | 1989 | — |
| −3 | K941593 | Diagnostic Ultrasonic Transducer | Toshiba America Medical Systems, In.C | 1996 | — |
| −2 | K970047 | Phased Array Transducer - - PSK-20CT | Toshiba America Medical Systems, In.C | 1997 | — |
| −1 | K991710 | Ssa-370A/Powervision 6000 | Toshiba America Medical Systems, In.C | 1999 | — |
| 0 (this device) | K051334 | Terason Ultrasound System with Continuous Wave Soppler | Teratech Corp. | 2005 | — |
| +1 | K082147 | Bodymetrix BX2000 | Intelametrix, Inc. | 2009 | — |
| +2 | K202514 | EchoS Family | Echolight S.P.A | 2021 | — |
| +1 | K072266 | Acuson P50 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| +3 | K212851 | EchoSK and EchoSGyn modules for EchoS Family devices | Echolight S.P.A | 2022 | — |
| +2 | K083114 | Acuson P50 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 4 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K991710 | Ssa-370A/Powervision 6000Summary page 1…Ultrasonic Transducer (21 CFR 892.1570, 90-ITX) 3. PREDICATE DEVICES Toshiba Powervision 6000 (K991710) 4. INTENDED USE The TERASOIN' Ultrasound System with Continuous Wave (CW) Doppler is… | 1999 |
What descends from it? (5)
2 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 16 years and passes through 2 companies; a new generation was cleared every 6.0 years on median.
- None of the 16 ancestors has a recall.
- Of its descendants, K082147 (Intelametrix, Inc., 2009) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K991710.
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:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
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/K051334 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051334: Terason Ultrasound System with Continuous Wave Soppler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051334
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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