510(k) · Cleared
ClearedVolcano S51 Family of Imaging Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Volcano Corporation · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Aug 10, 2006 as substantially equivalent to K944004 (Endosonics Corp., 1995) and 4 other predicates after a 100-day review. Its family tree reaches back 3 generations to 1995. 1 of the 619 devices in its family, counting itself, has a Class I recall. 613 later devices descend from it.
- Decided
- Aug 10, 2006
- Review
- 100 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to K944004 (1995). 5 ancestors in all. 613 later devices descend from it, 4 citing it directly. 1 of the 619 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK944004 Visions 2.9F Ultrasonic Imaging Catheter (Model 84300)Endosonics Corp. · 1995
- 2 generations backK031148 IN-Vision Imaging SystemJomed, Inc. · 2003
- 1 generation backK051920 Volcano S5 Imaging System, Model 804200-001Volcano Corporation · 2005 · Recalled
- This deviceK061215 Volcano S51 Family of Imaging SystemsVolcano Corporation · 2006
- Descendant · cites it directly · 582 of its ownK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- Descendant · 2 generations on · 569 of its ownK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
- Descendant · 3 generations on · 472 of its ownK110943 Logiq E9GE Healthcare · 2011 · Recalled
- Descendant · 4 generations on · 469 of its ownK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
- Descendant · 3 generations on · 367 of its ownK111582 Logiq S8GE Healthcare · 2011 · Recalled
Showing 5 of 613 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K172258 Novasight Hybrid System2 generations on · 2018
Most influential descendants
Showing 5 of 613 · See all- K083095Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008 · cites it directly582descendants
- K092271GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4GE Healthcare · 2009 · 2 generations on569descendants
- K110943Logiq E9GE Healthcare · 2011 · 3 generations on472descendants
- K113690GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · 4 generations on469descendants
- K111582Logiq S8GE Healthcare · 2011 · 3 generations on367descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K944004 | Visions 2.9F Ultrasonic Imaging Catheter (Model 84300) | Endosonics Corp. | 1995 | — |
| −2 | K031148 | IN-Vision Imaging System | Jomed, Inc. | 2003 | — |
| −1 | K051920 | Volcano S5 Imaging System, Model 804200-001 | Volcano Corporation | 2005 | 1 |
| 0 (this device) | K061215 | Volcano S51 Family of Imaging Systems | Volcano Corporation | 2006 | — |
| +1 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| +2 | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | 1 |
| +3 | K110943 | Logiq E9 | GE Healthcare | 2011 | 2 |
| +4 | K113690 | GE Logiq I, Logiq E and Vivid E | GE Healthcare | 2011 | 1 |
| +3 | K111582 | Logiq S8 | GE Healthcare | 2011 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 4 | 0 |
| 2009 | 3 | 0 |
| 2010 | 4 | 0 |
| 2011 | 11 | 0 |
| 2012 | 21 | 0 |
| 2013 | 23 | 0 |
| 2014 | 35 | 0 |
| 2015 | 32 | 0 |
| 2016 | 37 | 0 |
| 2017 | 52 | 0 |
| 2018 | 50 | 1 |
| 2019 | 39 | 0 |
| 2020 | 53 | 0 |
| 2021 | 39 | 0 |
| 2022 | 44 | 0 |
| 2023 | 39 | 0 |
| 2024 | 46 | 0 |
| 2025 | 48 | 0 |
| 2026 | 33 | 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.
1 device in this family has 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? (5)
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 |
|---|---|---|---|
| * | K944004 | Visions 2.9F Ultrasonic Imaging Catheter (Model 84300)Summary page 1…Ultrasonic pulsed echo imaging system Number, Product Code: 21 CFR 892.1560, Product Code: IYO Predicate Device: Cathscanner III Imaging System cleared under K944004; ColorFlo Option for the Oracle ]nVision Intravascular Ultrasound Imaging System cleared under K963290; Resolve Option for the Or… | 1995 |
| * | K963290 | Colorflo Option for the Oracle Invision Intravascular Ultrasonic Imaging SystemSummary page 1…O Predicate Device: Cathscanner III Imaging System cleared under K944004; ColorFlo Option for the Oracle ]nVision Intravascular Ultrasound Imaging System cleared under K963290; Resolve Option for the Oracle InVision Intravascular Ultrasound Imaging System cleared under K965223; InVision Imaging System cl… | 1997 |
| * | K965223 | Resolve Option for the Oracle in Vision Intravascular Ultrasonic Imaging SystemSummary page 1…acle ]nVision Intravascular Ultrasound Imaging System cleared under K963290; Resolve Option for the Oracle InVision Intravascular Ultrasound Imaging System cleared under K965223; InVision Imaging System cleared under K031148, and Volcano s5 Imaging System cleared under K051920. Device Description: The Vo… | 1998 |
| * | K031148 | IN-Vision Imaging SystemSummary page 1…System cleared under K963290; Resolve Option for the Oracle InVision Intravascular Ultrasound Imaging System cleared under K965223; InVision Imaging System cleared under K031148, and Volcano s5 Imaging System cleared under K051920. Device Description: The Volcano s5i Family of Imaging Systems consists of… | 2003 |
| * | K051920 | Volcano S5 Imaging System, Model 804200-001Summary page 1…Oracle InVision Intravascular Ultrasound Imaging System cleared under K965223; InVision Imaging System cleared under K031148, and Volcano s5 Imaging System cleared under K051920. Device Description: The Volcano s5i Family of Imaging Systems consists of the imaging catheter, the patient interface module,… | 2005 |
What descends from it? (613)
See all 6134 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 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.
- K172258Novasight Hybrid SystemConavi Medical, Inc. · 2018 · 2 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K083095 (Ultrasonix Medical Corporation, 2008) has gone furthest, with 582 descendants of its own.
- 4 other devices also cite its predicate K944004.
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.
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 Volcano s5i Family of Imaging Systems is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. It is also indicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures.
ChromaFlo® is indicated for qualitative blood flow information from peripheral and coronary vasculature; flow information can be an adjunct to other methods of estimating blood flow and blood perfusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061215 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061215: Volcano S51 Family of Imaging Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061215
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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