510(k) · Cleared
ClearedTerason T3000 Ultrasound Systems with Updated Needle Guidance Graphics
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 Feb 3, 2012 as substantially equivalent to K080234 (Teratech Corp., 2008) after a 122-day review. Its family tree reaches back 5 generations to 1994. 74 later devices descend from it.
- Decided
- Feb 3, 2012
- Review
- 122 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K934041 (1994). 21 ancestors in all, the oldest K891689 (1989). 74 later devices descend from it, 7 citing it directly.
- Root · 5 generations backK934041 Hewlett Packard Conos Ultrasound Imaging System ModificationHewlett-Packard Co. · 1994
- 4 generations backK964309 Sonos 2000, Sonos 2500 (M2406 a)Hewlett-Packard Co. · 1997
- 3 generations backK982800 Ecton Lynx Ultrasound SystemEcton, Inc. · 1998
- 2 generations backK021497 Cypress Ultrasound SystemAcuson Corp. · 2002 · Recalled
- 1 generation backK080234 Terason Echo T/3000 Ultrasound System with Stress EchoTeratech Corp. · 2008
- This deviceK112953 Terason T3000 Ultrasound Systems with Updated Needle Guidance GraphicsTeratech Corp. · 2012
- Descendant · cites it directly · 52 of its ownK130173 Sonosite Maxx Series Ultrasound SystemFUJIFILM Sonosite, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 50 of its ownK133454 Sonosite Edge Ultrasound SystemFUJIFILM Sonosite, Inc. · 2013
- Descendant · 3 generations on · 46 of its ownK142017 X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc. · 2014
- Descendant · 3 generations on · 45 of its ownK152209 FUJIFILM SonoSite X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc. · 2015
- Descendant · 3 generations on · 42 of its ownK153626 SonoSite Edge II Ultrasound SystemFUJIFILM Sonosite, Inc. · 2016
Showing 5 of 74 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 74 · See all- K130173Sonosite Maxx Series Ultrasound SystemFUJIFILM Sonosite, Inc. · 2013 · cites it directly52descendants
- K133454Sonosite Edge Ultrasound SystemFUJIFILM Sonosite, Inc. · 2013 · 2 generations on50descendants
- K142017X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc. · 2014 · 3 generations on46descendants
- K152209FUJIFILM SonoSite X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc. · 2015 · 3 generations on45descendants
- K153626SonoSite Edge II Ultrasound SystemFUJIFILM Sonosite, Inc. · 2016 · 3 generations on42descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K934041 | Hewlett Packard Conos Ultrasound Imaging System Modification | Hewlett-Packard Co. | 1994 | — |
| −4 | K964309 | Sonos 2000, Sonos 2500 (M2406 a) | Hewlett-Packard Co. | 1997 | — |
| −3 | K982800 | Ecton Lynx Ultrasound System | Ecton, Inc. | 1998 | — |
| −2 | K021497 | Cypress Ultrasound System | Acuson Corp. | 2002 | 2 |
| −1 | K080234 | Terason Echo T/3000 Ultrasound System with Stress Echo | Teratech Corp. | 2008 | — |
| 0 (this device) | K112953 | Terason T3000 Ultrasound Systems with Updated Needle Guidance Graphics | Teratech Corp. | 2012 | — |
| +1 | K130173 | Sonosite Maxx Series Ultrasound System | FUJIFILM Sonosite, Inc. | 2013 | 1 |
| +2 | K133454 | Sonosite Edge Ultrasound System | FUJIFILM Sonosite, Inc. | 2013 | — |
| +3 | K142017 | X-Porte Ultrasound System | FUJIFILM Sonosite, Inc. | 2014 | — |
| +3 | K152209 | FUJIFILM SonoSite X-Porte Ultrasound System | FUJIFILM Sonosite, Inc. | 2015 | — |
| +3 | K153626 | SonoSite Edge II Ultrasound System | FUJIFILM Sonosite, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1997 | 2 | 0 |
| 1999 | 4 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 4 | 0 |
| 2016 | 7 | 0 |
| 2017 | 5 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2020 | 9 | 0 |
| 2021 | 7 | 0 |
| 2022 | 10 | 0 |
| 2023 | 4 | 0 |
| 2024 | 3 | 0 |
| 2025 | 6 | 0 |
| 2026 | 6 | 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 |
|---|---|---|---|
| * | K080234 | Terason Echo T/3000 Ultrasound System with Stress EchoSummary page 1…ing System (21 CFR 892.1560, 90-IYO) Diagnostic Ultrasonic Transducer (21 CFR 892.1570, 90-ITX) 3. Predicate Device Terason TM Echo/t3000 Ultrasound System (K080234) 4. Intended Use The Teratech Corporation Terason t3000TMA is a general purpose Ultrasound System intended for use by a qu… | 2008 |
What descends from it? (74)
See all 747 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130173 | Sonosite Maxx Series Ultrasound System | 2013 | 52 |
| K140254 | EZONO 4000 | 2014 | 13 |
| K131209 | Terason USMART3200T Ultrasound System | 2013 | 4 |
| K140524 | Terason USMART3200 and Benq UP200ULTRASOUND System | 2014 | 3 |
| K150533 | Terason uSmart3200T Ultrasound System | 2015 | 2 |
| K150148 | Terason uSmart3300 Ultrasound System | 2015 | 0 |
| K140834 | Terason USMART3400 Ultrasound System | 2014 | 0 |
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 4 companies; a new generation was cleared every 3.8 years on median.
- 3 of the 21 ancestors have a recall of any class.
- Of its descendants, K130173 (FUJIFILM Sonosite, Inc., 2013) has gone furthest, with 52 descendants of its own.
- 2 other devices also cite its predicate K080234.
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. 2012, 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 subject-modified device is a general purpose Ultrasound System intended for use by a qualified physician for the evaluation by ultrasound imaging or fluid-flow analysis of the human body. Specific clinical applications and exam types include: Fetal, Abdominal, Intra-Operative (spec. and Neuro), Laparoscopic, Pediatric, Small Organ (breast, testes, thyroid), Neonatal and Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-sketetal (Conventional and Superficial), Cardiac (adult and pediatric), and Peripheral Vascular.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112953 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112953: Terason T3000 Ultrasound Systems with Updated Needle Guidance Graphics.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112953
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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