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 Oct 23, 2017 as substantially equivalent to K122878 (Silicon Vally Medical Instruments, Inc., 2013) and 1 other predicate after a 24-day review. Its family tree reaches back 5 generations to 1992. 1 of the 11 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- Oct 23, 2017
- Review
- 24 days
- Class
- Class II
- Product code
- OBJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K921750 (1992). 8 ancestors in all. 2 later devices descend from it, 1 citing it directly. 1 of the 11 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK921750 Cvis Insight Iii SystemCardiovascular Imaging Systems, Inc. · 1992
- 4 generations backK980851 Galaxy Intravascular Ultrasound System, Model I5028Boston Scientific Corp · 1998
- 3 generations backK051679 Ilab Ultrasound Imaging SystemBoston Scientific Corp · 2005 · Recalled
- 2 generations backK112997 HD-Ivus Ultrasound Imaging SystemSilicon Vally Medical Instruments, Inc. · 2011
- 1 generation backK122878 HD-Ivus Ultrasound Imaging SystemSilicon Vally Medical Instruments, Inc. · 2013
- This deviceK173063 ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi SystemAcist Medical Systems, Inc. · 2017
- Descendant · cites it directly · 1 of its ownK191175 ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi SystemAcist Medical Systems, Inc. · 2019
- Descendant · 2 generations on · 0 of its ownK193183 ACIST HDi System, ACIST Kodama Intravascular Ultrasound CatheterAcist Medical Systems, Inc. · 2020 · Recalled (Class I)
Class I recalls in this family
- K193183 ACIST HDi System, ACIST Kodama Intravascular…2 generations on · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K921750 | Cvis Insight Iii System | Cardiovascular Imaging Systems, Inc. | 1992 | — |
| −4 | K980851 | Galaxy Intravascular Ultrasound System, Model I5028 | Boston Scientific Corp | 1998 | — |
| −3 | K051679 | Ilab Ultrasound Imaging System | Boston Scientific Corp | 2005 | 2 |
| −2 | K112997 | HD-Ivus Ultrasound Imaging System | Silicon Vally Medical Instruments, Inc. | 2011 | — |
| −1 | K122878 | HD-Ivus Ultrasound Imaging System | Silicon Vally Medical Instruments, Inc. | 2013 | — |
| 0 (this device) | K173063 | ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System | Acist Medical Systems, Inc. | 2017 | — |
| +1 | K191175 | ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System | Acist Medical Systems, Inc. | 2019 | — |
| +2 | 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 |
|---|---|---|
| 1993 | 2 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K122878 | HD-Ivus Ultrasound Imaging SystemSummary page 4…e System, imaging, pulsed echo, ultrasonic Classification Cardiovascular Panel Radiology Predicate HD-IVUS Ultrasound Imaging System, K122878 (cleared 11 January 2013) Devices Kodama Intravascular Ultrasound Catheter, K113008 (cleared 14 June 2012) Device… | 2013 |
| * | K113008 | Kodama Intravascular Ulrasound CatheterSummary page 4…Radiology Predicate HD-IVUS Ultrasound Imaging System, K122878 (cleared 11 January 2013) Devices Kodama Intravascular Ultrasound Catheter, K113008 (cleared 14 June 2012) Device The primary function of HDi System is to collect reflected ultrasonic (sound) Descriptio… | 2012 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191175 | ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System | 2019 | 1 |
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 · 2 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 5.8 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K191175 (Acist Medical Systems, Inc., 2019) has gone furthest, with 1 descendant of its own.
How does its category compare?
All OBJ devicesOBJ Catheter, Ultrasound, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 the intravascular ultrasound imaging assessment of coronary artery disease. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.
The ACIST Kodama Intravascular Ultrasound Catheter is a medical device for use by or on the order of a physician and is intended for ultrasound examination of coronary intravascular pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173063 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173063: 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/K173063
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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