510(k) · Cleared
ClearedProsound C3 / C3 CV Ultrasound Systems
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 Mar 18, 2011 as substantially equivalent to K080234 (Teratech Corp., 2008) after a 28-day review. Its family tree reaches back 5 generations to 1994. 4 later devices descend from it.
- Decided
- Mar 18, 2011
- Review
- 28 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). 4 later devices descend from it, 2 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 deviceK110482 Prosound C3 / C3 CV Ultrasound SystemsTeratech Corp. · 2011
- Descendant · cites it directly · 2 of its ownK150533 Terason uSmart3200T Ultrasound SystemTeratech Corp. · 2015
- Descendant · 2 generations on · 1 of its ownK193510 Terason uSmart3200T Ultrasound SystemTeratech Corporation · 2020
- Descendant · 3 generations on · 0 of its ownK201633 Terason uSmart 3200T Plus Ultrasound SystemTeratech Corporation · 2020
- Descendant · cites it directly · 0 of its ownK150148 Terason uSmart3300 Ultrasound SystemTeratech Corp. · 2015
Most influential descendants
Showing 4 of 4 · See all- K150533Terason uSmart3200T Ultrasound SystemTeratech Corp. · 2015 · cites it directly2descendants
- K193510Terason uSmart3200T Ultrasound SystemTeratech Corporation · 2020 · 2 generations on1descendant
- K201633Terason uSmart 3200T Plus Ultrasound SystemTeratech Corporation · 2020 · 3 generations on0descendants
- K150148Terason uSmart3300 Ultrasound SystemTeratech Corp. · 2015 · cites it directly0descendants
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) | K110482 | Prosound C3 / C3 CV Ultrasound Systems | Teratech Corp. | 2011 | — |
| +1 | K150533 | Terason uSmart3200T Ultrasound System | Teratech Corp. | 2015 | — |
| +2 | K193510 | Terason uSmart3200T Ultrasound System | Teratech Corporation | 2020 | — |
| +3 | K201633 | Terason uSmart 3200T Plus Ultrasound System | Teratech Corporation | 2020 | — |
| +1 | K150148 | Terason uSmart3300 Ultrasound System | Teratech Corp. | 2015 | — |
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 |
|---|---|---|
| 2015 | 2 | 0 |
| 2020 | 2 | 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…ging System (21 CFR 892.1560, 90-IYO) Diagnostic Ultrasonic Transducer (21 CFR 892.1570, 90-ITX) 3. Predicate Device Terason'm Echo/t3000 Ultrasound System (K080234) 4. Intended Use The Aloka ProSound 03 is a general purpose Ultrasound System intended for use by a qualified physician f… | 2008 |
| † | K992505 | Teratech, Model 2000 Imaging Imaging | 1999 |
| † | K012191 | Teratech Model 2000 Handheld Ultrasound System with Doppler and Harmonic Imaging Modes | 2001 |
| † | K010883 | Teratech Model 8EC4 Endocavity Smart Probe | 2001 |
| † | K030191 | Terason Model 2000/Bas Portable Ultrasound System | 2003 |
| † | K040840 | Teratech Model 10V5 Smart Probe | 2004 |
| † | K043278 | Teratech Model 8IOC4, 8IOL4 & 10LAP4 Probes | 2004 |
| † | K051334 | Terason Ultrasound System with Continuous Wave Soppler | 2005 |
What descends from it? (4)
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 17 years and passes through 4 companies; a new generation was cleared every 3.1 years on median.
- 3 of the 21 ancestors have a recall of any class.
- Of its descendants, K150533 (Teratech Corp., 2015) has gone furthest, with 2 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. 2011, 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 evaluation by ultrasound imaging or fluid-flow analysis of the human body. Specific clinical applications and exam types include: Fetal/OB; Abdominal (GYN & Urology); Intra-operative (abdominal, thoracic and PV); Laparoscopic; Pediatric; Small Organ (breast, testes, thyroid), Neonatal and Adult Cephalic; Transrectal and Transvaginal…
Read the full statement (138 words)
The subject-modified device is a general purpose Ultrasound System intended for use by a qualified physician for evaluation by ultrasound imaging or fluid-flow analysis of the human body. Specific clinical applications and exam types include: Fetal/OB; Abdominal (GYN & Urology); Intra-operative (abdominal, thoracic and PV); Laparoscopic; Pediatric; Small Organ (breast, testes, thyroid), Neonatal and Adult Cephalic; Transrectal and Transvaginal; Musculo-skeletal (Conventional and Superficial); Cardiac (adult & pediatric); Peripheral Vascular.
The subject-modified device is a general purpose Ultrasound System intended for use by a qualified physician for evaluation by ultrasound imaging or fluid-flow analysis of the human body. Specific clinical applications and exam types include: Fetal/OB3; Abdominal (GYN & Urology); Intra-operative (abdominal, thoracic and PV); Laparoscopic; Pediatric; Small Organ (breast, testes, thyroid), Neonatal and Adult Cephalic; Transrectal and Transvaginal; Musculo-skeletal (Conventional and Superficial); Cardiac (adult & pediatric); Peripheral Vascular.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110482 · printed Nov 3, 2026
Cite this page
510(k) Report. “K110482: Prosound C3 / C3 CV Ultrasound Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K110482
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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