510(k) · Cleared

Cleared

Galaxy Intravascular Ultrasound System, Model I5028

K980851510(k) TraditionalCleared Apr 22, 199848-day reviewClass II21 CFR 892.1560

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Boston Scientific Corp · IYO System, Imaging, Pulsed Echo, Ultrasonic

Cleared on Apr 22, 1998 as substantially equivalent to K921750 (Cardiovascular Imaging Systems, Inc., 1992) and 2 other predicates after a 48-day review. Its family tree reaches back 1 generation to 1992. 2 of the 87 devices in its family, counting itself, have a Class I recall. 83 later devices descend from it.

Decided: Apr 22, 1998
Review: 48 days
Class: Class II
Product code: IYO
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K921750 (1992). 3 ancestors in all. 83 later devices descend from it, 7 citing it directly. 2 of the 87 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK921750 Cvis Insight Iii SystemCardiovascular Imaging Systems, Inc. · 1992
This deviceK980851 Galaxy Intravascular Ultrasound System, Model I5028Boston Scientific Corp · 1998
Descendant · cites it directly · 36 of its ownK051679 Ilab Ultrasound Imaging SystemBoston Scientific Corp · 2005 · Recalled
Descendant · cites it directly · 29 of its ownK052348 IN Vision Gold with Spin Vision, Model 891 SVVolcano Corporation · 2005
Descendant · 2 generations on · 28 of its ownK071554 Volcano S5/S5I Intravascular Imaging and Pressure SystemVolcano Corporation · 2008 · Recalled
Descendant · 2 generations on · 28 of its ownK072517 Ilab Ultrasound Imaging System, Version 1.3Boston Scientific Corp · 2007 · Recalled
Descendant · 3 generations on · 27 of its ownK123535 Ilab Ultrasound Imaging SystemBoston Scientific Corp · 2013

Showing 5 of 83 descendants. See all descendants

Descendants cleared per year

2003high 9 (2015) · low 0 (2004)2026

Class I recalls in this family

K172258 Novasight Hybrid System3 generations on · 2018
K193183 ACIST HDi System, ACIST Kodama Intravascular…5 generations on · 2020

Most influential descendants

Showing 5 of 83 · See all

K051679Ilab Ultrasound Imaging SystemBoston Scientific Corp · 2005 · cites it directly36descendants
K052348IN Vision Gold with Spin Vision, Model 891 SVVolcano Corporation · 2005 · cites it directly29descendants
K071554Volcano S5/S5I Intravascular Imaging and Pressure SystemVolcano Corporation · 2008 · 2 generations on28descendants
K072517Ilab Ultrasound Imaging System, Version 1.3Boston Scientific Corp · 2007 · 2 generations on28descendants
K123535Ilab Ultrasound Imaging SystemBoston Scientific Corp · 2013 · 3 generations on27descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K921750	Cvis Insight Iii System	Cardiovascular Imaging Systems, Inc.	1992	—
0 (this device)	K980851	Galaxy Intravascular Ultrasound System, Model I5028	Boston Scientific Corp	1998	—
+1	K051679	Ilab Ultrasound Imaging System	Boston Scientific Corp	2005	2
+1	K052348	IN Vision Gold with Spin Vision, Model 891 SV	Volcano Corporation	2005	—
+2	K071554	Volcano S5/S5I Intravascular Imaging and Pressure System	Volcano Corporation	2008	2
+2	K072517	Ilab Ultrasound Imaging System, Version 1.3	Boston Scientific Corp	2007	1
+3	K123535	Ilab Ultrasound Imaging System	Boston Scientific Corp	2013	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2005	2	0
2006	1	0
2007	1	0
2008	3	0
2010	2	0
2011	3	0
2012	2	0
2013	7	0
2014	2	0
2015	9	0
2016	3	0
2017	8	0
2018	3	1
2019	9	0
2020	6	1
2021	6	0
2022	3	0
2023	6	0
2024	1	0
2025	2	0
2026	3	0

FIG. 1 — Lineage of K980851, 1992–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

2 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

Get a 510(k) Report

What was it cleared against? (4)

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	Applicant	Decided	Recalls
*	K921750	Cvis Insight Iii System Summary page 1 …y equivalent in intended use, design and / or method of operation to a combination of the following predicate devices: 1. BSC (formerly CVIS) Insight Il Imaging System (K921750) with - Automatic Pullback Device (K933517) - LongView (K930311) 2. EndoSonics In-Vision™ (Clearance number: Not available) BSC…	Cardiovascular Imaging Systems, Inc.	1992	—
*	K933517	Automatic Pull Back Device Summary page 1 …or method of operation to a combination of the following predicate devices: 1. BSC (formerly CVIS) Insight Il Imaging System (K921750) with - Automatic Pullback Device (K933517) - LongView (K930311) 2. EndoSonics In-Vision™ (Clearance number: Not available) BSC - San Jose March 4, 1998 4…	Cardiovascular Imaging Systems, Inc.	1993	—
*	K930311	Cvis Longview Summary page 1 …n to a combination of the following predicate devices: 1. BSC (formerly CVIS) Insight Il Imaging System (K921750) with - Automatic Pullback Device (K933517) - LongView (K930311) 2. EndoSonics In-Vision™ (Clearance number: Not available) BSC - San Jose March 4, 1998 4,/( - ’j:‘l"ﬁ I 9AC 3…	Cardiovascular Imaging Systems, Inc.	1993	—
*	—	EndoSonics In-Vision Named without a submission number			—

Also cleared against K921750: 2 other devices →

What descends from it? (83)

See all 83

7 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K051679	Ilab Ultrasound Imaging System	Boston Scientific Corp	2005	36
K052348	IN Vision Gold with Spin Vision, Model 891 SV	Volcano Corporation	2005	29
K093857	C7 XR Imaging System with C7 Dragonfly Imaging Catheter and Disposable Accessories	Lightlab Imaging, Inc.	2010	11
K151126	Foresight Intracardiac Echocardiography (ICE) System	Colibri Technologies, Inc.	2015	1
K072932	Infraredix Nir Imaging System, Gen. 1.0, Model MC-5	Infraredx, Inc.	2008	1
K121913	Reprocessed Ultrasound Intracardiac Echo Catheter	Stryker Sustainability Solutions, Inc.	2012	0
K024103	Ivus Plus	Indec Systems, Inc.	2003	0

Has anything in its family been recalled? (2 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 · 3 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
K193183ACIST HDi System, ACIST Kodama Intravascular Ultrasound CatheterAcist Medical Systems, Inc. · 2020 · 5 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall

What does this lineage say?

None of the 3 ancestors has a recall.
Of its descendants, K051679 (Boston Scientific Corp, 2005) has gone furthest, with 36 descendants of its own.
2 other devices also cite its predicate K921750.

How does its category compare?

All IYO devices

IYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IYO

7in 2025

2007high 20 (2007) · low 5 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYO

171in 2025

2007high 220 (2024) · low 17 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · IYO

1in 2022

2007high 11 (2021) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · IYO

485in 2025

2007high 640 (2024) · low 20 (2008)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 Galaxy Intravascular Ultrasound Imaging System is intended for ultrasound examination of intravascular pathology. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures such as angioplasty and atherectomy.

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/K980851 · printed Nov 6, 2026

Cite this page

510(k) Report. “K980851: Galaxy Intravascular Ultrasound System, Model I5028.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980851

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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