510(k) · Cleared
ClearedColorflo Option for the Oracle Invision Intravascular Ultrasonic Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Endosonics Corp. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Aug 6, 1997 after a 350-day review. The FDA summary names its predicate without a number. 6 of the 650 devices in its family, counting itself, have a Class I recall. 649 later devices descend from it.
- Decided
- Aug 6, 1997
- Review
- 350 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 0
649 later devices descend from it, 5 citing it directly. 6 of the 650 devices in this family, counting this one, have a Class I recall.
- This deviceK963290 Colorflo Option for the Oracle Invision Intravascular Ultrasonic…Endosonics Corp. · 1997
- Descendant · cites it directly · 648 of its ownK031148 IN-Vision Imaging SystemJomed, Inc. · 2003
- Descendant · cites it directly · 614 of its ownK051920 Volcano S5 Imaging System, Model 804200-001Volcano Corporation · 2005 · Recalled
- Descendant · cites it directly · 613 of its ownK061215 Volcano S51 Family of Imaging SystemsVolcano Corporation · 2006
- Descendant · 2 generations on · 582 of its ownK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- Descendant · 3 generations on · 569 of its ownK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
Showing 5 of 649 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 649 · See all- K031148IN-Vision Imaging SystemJomed, Inc. · 2003 · cites it directly648descendants
- K051920Volcano S5 Imaging System, Model 804200-001Volcano Corporation · 2005 · cites it directly614descendants
- K061215Volcano S51 Family of Imaging SystemsVolcano Corporation · 2006 · cites it directly613descendants
- K083095Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008 · 2 generations on582descendants
- K092271GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4GE Healthcare · 2009 · 3 generations on569descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K963290 | Colorflo Option for the Oracle Invision Intravascular Ultrasonic Imaging System | Endosonics Corp. | 1997 | — |
| +1 | K031148 | IN-Vision Imaging System | Jomed, Inc. | 2003 | — |
| +1 | K051920 | Volcano S5 Imaging System, Model 804200-001 | Volcano Corporation | 2005 | 1 |
| +1 | K061215 | Volcano S51 Family of Imaging Systems | Volcano Corporation | 2006 | — |
| +2 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| +3 | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2008 | 4 | 0 |
| 2009 | 6 | 0 |
| 2010 | 5 | 0 |
| 2011 | 12 | 0 |
| 2012 | 26 | 0 |
| 2013 | 23 | 0 |
| 2014 | 38 | 0 |
| 2015 | 33 | 0 |
| 2016 | 38 | 0 |
| 2017 | 52 | 0 |
| 2018 | 51 | 1 |
| 2019 | 41 | 1 |
| 2020 | 53 | 0 |
| 2021 | 40 | 0 |
| 2022 | 44 | 0 |
| 2023 | 42 | 1 |
| 2024 | 49 | 2 |
| 2025 | 52 | 1 |
| 2026 | 35 | 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? (12)
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 |
|---|---|---|---|
| * | — | Endosonic Cathscanner III Intravascular Imaging System Named without a submission number | |
| * | — | Endosonics Visions Five 64 3.5F model 84700 Intravascular Imaging Catheter Named without a submission number | |
| * | — | Endosonics Visions Five 64 F/X Model 82700 Intravascular Imaging Catheter Named without a submission number | |
| * | — | Endosonics Visions Microrail catheters Named without a submission number | |
| * | — | Visions Model 54700 catheters Named without a submission number | |
| * | — | Cathscanner II Imaging System Named without a submission number | |
| * | — | Cathscanner III Imaging System Named without a submission number | |
| * | — | Millar Mikro-Tip Doppler Catheter Model DC-101 Named without a submission number | |
| * | — | Small Vessel Balloon Angioplasty Catheter Named without a submission number | |
| * | — | ATL Ultramark 8 Ultrasound Imaging System Named without a submission number | |
| * | — | CVIS Insight System Named without a submission number | |
| * | — | Platinum System with the CVI Option Named without a submission number |
What descends from it? (649)
See all 6495 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031148 | IN-Vision Imaging System | 2003 | 648 |
| K051920 | Volcano S5 Imaging System, Model 804200-001 | 2005 | 614 |
| K061215 | Volcano S51 Family of Imaging Systems | 2006 | 613 |
| K071554 | Volcano S5/S5I Intravascular Imaging and Pressure System | 2008 | 28 |
| K082229 | S5/S5I Series Intravascular Imaging and Pressure System, Combomap Pressure and Flow System | 2008 | 25 |
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.
- K172258Novasight Hybrid SystemConavi Medical, Inc. · 2018 · 2 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
- K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire…Centerline Biomedical, Inc. · 2019 · 6 generations on · ◆ in the 2019 descendants bar of FIG. 11 Class I recall
- K242133Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System…Centerline Biomedical, Inc. · 2024 · 7 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
- K241243Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning…Centerline Biomedical, Inc. · 2024 · 7 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
- K230309Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve…Centerline Biomedical, Inc. · 2023 · 7 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
- K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc. · 2025 · 7 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- Of its descendants, K031148 (Jomed, Inc., 2003) has gone furthest, with 648 descendants of its own.
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?
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
This system is indicated for intra-luminal use in both peripheral and coronary applications. There is no difference in operation on acoustic outputs when used for coronary or peripheral vascular imaging.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
This system is indicated for intra-luminal use in both peripheral and coronary applications. There is no difference in operation on acoustic outputs when used for coronary or peripheral vascular imaging.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K963290 · printed Nov 4, 2026
Cite this page
510(k) Report. “K963290: Colorflo Option for the Oracle Invision Intravascular Ultrasonic Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963290
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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