510(k) · Cleared
ClearedACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acist Medical Systems, Inc. · OBJ Catheter, Ultrasound, Intravascular
Cleared on Jun 27, 2019 as substantially equivalent to K143701 (Volcano Corporation, 2015) and 1 other predicate after a 57-day review. Its family tree reaches back 9 generations to 1995. 1 of the 23 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Jun 27, 2019
- Review
- 57 days
- Class
- Class II
- Product code
- OBJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K934139 (1995). 21 ancestors in all, the oldest K921750 (1992). 1 later device descends from it, 1 citing it directly. 1 of the 23 devices in this family, counting this one, has a Class I recall.
- Root · 9 generations backK934139 Tomtec Echo-ViewTomtec Tomographic Technologies GmbH · 1995
- 5 generations between
- 3 generations backK092596 Eagle Eye Platinum Digital Ivus CatheterVolcano Corporation · 2009
- 2 generations backK120697 Eagle Eye Platinum ST CatheterVolcano Corporation · 2012
- 1 generation backK143701 Eagle Eye Platinum Catheter, Eagle Eye Platinum Short Tip Catheter…Volcano Corporation · 2015
- This deviceK191175 ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi SystemAcist Medical Systems, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK193183 ACIST HDi System, ACIST Kodama Intravascular Ultrasound CatheterAcist Medical Systems, Inc. · 2020 · Recalled (Class I)
Show all 9 generations
- Root · 9 generations backK934139 Tomtec Echo-ViewTomtec Tomographic Technologies GmbH · 1995
- 8 generations backK993398 Echo View, Easy View, Omni ViewTomtec Imaging Systems GmbH · 1999
- 7 generations backK022824 Echo-View 5.X, Easy-View 2.X, Omni View 2.X, Cardio-View 1.X, LV…Tomtec Imaging Systems GmbH · 2002
- 6 generations backK042188 Volcano Therapeutics, Inc. Volcano Ivus SystemVolcano Therapeutics, Inc. · 2004
- 5 generations backK051337 Eagle Eye Gold Ivus Imaging Catheter, Model 85900/859XX; Volcano…Volcano Corporation · 2005
- 4 generations backK073473 Eagle Eye Gold Ivus Imaging Catheter, Model 85900, Avabar F/X Ivus…Volcano Corporation · 2008
- 3 generations backK092596 Eagle Eye Platinum Digital Ivus CatheterVolcano Corporation · 2009
- 2 generations backK120697 Eagle Eye Platinum ST CatheterVolcano Corporation · 2012
- 1 generation backK143701 Eagle Eye Platinum Catheter, Eagle Eye Platinum Short Tip Catheter…Volcano Corporation · 2015
- This deviceK191175 ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi SystemAcist Medical Systems, Inc. · 2019
Class I recalls in this family
- K193183 ACIST HDi System, ACIST Kodama Intravascular…cites it directly · 2020
Most influential descendants
Showing 1 of 1 · See all- K193183ACIST HDi System, ACIST Kodama Intravascular Ultrasound CatheterAcist Medical Systems, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K934139 | Tomtec Echo-View | Tomtec Tomographic Technologies GmbH | 1995 | — |
| −8 | K993398 | Echo View, Easy View, Omni View | Tomtec Imaging Systems GmbH | 1999 | — |
| −7 | K022824 | Echo-View 5.X, Easy-View 2.X, Omni View 2.X, Cardio-View 1.X, LV Analysis 1.X… | Tomtec Imaging Systems GmbH | 2002 | — |
| −6 | K042188 | Volcano Therapeutics, Inc. Volcano Ivus System | Volcano Therapeutics, Inc. | 2004 | — |
| −5 | K051337 | Eagle Eye Gold Ivus Imaging Catheter, Model 85900/859XX; Volcano VH-Ivus… | Volcano Corporation | 2005 | — |
| −4 | K073473 | Eagle Eye Gold Ivus Imaging Catheter, Model 85900, Avabar F/X Ivus Imaging… | Volcano Corporation | 2008 | — |
| −3 | K092596 | Eagle Eye Platinum Digital Ivus Catheter | Volcano Corporation | 2009 | — |
| −2 | K120697 | Eagle Eye Platinum ST Catheter | Volcano Corporation | 2012 | — |
| −1 | K143701 | Eagle Eye Platinum Catheter, Eagle Eye Platinum Short Tip Catheter, Visions PV… | Volcano Corporation | 2015 | — |
| 0 (this device) | K191175 | ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System | Acist Medical Systems, Inc. | 2019 | — |
| +1 | K193183 | ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter | Acist Medical Systems, Inc. | 2020 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 1 |
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 OBJ device
- #1 K242893 VERAFEYE System VERAFEYE Imaging Catheter &…score 23.8 · 30 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K143701 | Eagle Eye Platinum Catheter, Eagle Eye Platinum Short Tip Catheter, Visions PV .014…Summary page 4…pulsed echo, ultrasonic Classification Cardiovascular Panel Radiology Predicate Volcano Eagle Eye Platinum Catheter, K143701 (cleared 26 August 2015) Devices HD-IVUS Ultrasound Imaging System and Kodama Intravascular Ultrasound… | 2015 |
| * | K173063 | ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi SystemSummary page 4…K143701 (cleared 26 August 2015) Devices HD-IVUS Ultrasound Imaging System and Kodama Intravascular Ultrasound Catheter, K173063 (cleared 23 October 2017) Device The primary function of HDi System is to collect reflected ultrasonic (soun… | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K193183 | ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter Class I | 2020 | 0 |
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.
- K193183ACIST HDi System, ACIST Kodama Intravascular Ultrasound CatheterAcist Medical Systems, Inc. · 2020 · Cites it directly · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 24 years and passes through 5 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 21 ancestors has a recall of any class.
- Of its descendants, K193183 (Acist Medical Systems, Inc., 2020) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K143701.
How does its category compare?
All OBJ devicesOBJ Catheter, Ultrasound, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · OBJ
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OBJ
35in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OBJ
2in 2020
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · OBJ
791in 2025
MAUDE reports naming product code OBJ, 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 | 3 | 74 | 0 | 0 |
| 2008 | 6 | 100 | 0 | 6 |
| 2009 | 3 | 108 | 0 | 22 |
| 2010 | 1 | — | 0 | 39 |
| 2011 | 4 | 109 | 0 | 47 |
| 2012 | 3 | 136 | 0 | 53 |
| 2013 | 4 | 96 | 0 | 328 |
| 2014 | 3 | 30 | 0 | 609 |
| 2015 | 4 | 131 | 2 | 401 |
| 2016 | 4 | 94 | 0 | 515 |
| 2017 | 6 | 45 | 2 | 524 |
| 2018 | 2 | — | 2 | 542 |
| 2019 | 1 | — | 0 | 237 |
| 2020 | 4 | 135 | 2 | 288 |
| 2021 | 3 | 29 | 0 | 353 |
| 2022 | 3 | 63 | 0 | 473 |
| 2023 | 3 | 63 | 0 | 697 |
| 2024 | 3 | 131 | 0 | 1,154 |
| 2025 | 7 | 35 | 0 | 791 |
| 2026 | 4 | 81 | 1 (1) | — |
What is it indicated for?
The ACIST HDi System is intended to be used for ultrasound examination of coronary and peripheral intravascular pathology. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.
The ACIST Kodama Intravascular Ultrasound Catheter is intended for use with the ACIST HDi System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191175 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191175: ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191175
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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