510(k) · Cleared

Cleared

AcuNav Volume ICE Catheter

K163478510(k) SpecialCleared Feb 9, 201759-day reviewClass II21 CFR 870.1200

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

Siemens Medical Solutions USA, Inc. · OBJ Catheter, Ultrasound, Intravascular

Cleared on Feb 9, 2017 as substantially equivalent to K081808 (Siemens Medical Solutions USA, Inc., 2008) after a 59-day review. Its family tree reaches back 1 generation to 2008. 24 later devices descend from it.

Decided: Feb 9, 2017
Review: 59 days
Class: Class II
Product code: OBJ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K081808 (2008). 24 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK081808 Acunav V Ultrasound CatheterSiemens Medical Solutions USA, Inc. · 2008
This deviceK163478 AcuNav Volume ICE CatheterSiemens Medical Solutions USA, Inc. · 2017
Descendant · cites it directly · 23 of its ownK173618 ACUSON AcuNav Volume Intracardiac Echocardiography CatheterSiemens Medical Solutions USA, Inc. · 2017 · Recalled
Descendant · 2 generations on · 19 of its ownK181098 ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2018
Descendant · 3 generations on · 9 of its ownK191467 Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation · 2019
Descendant · 3 generations on · 8 of its ownK200585 Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2020
Descendant · 4 generations on · 7 of its ownK201972 Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation · 2020

Showing 5 of 24 descendants. See all descendants

Descendants cleared per year

2017high 5 (2020) · low 1 (2017)2026

Most influential descendants

Showing 5 of 24 · See all

K173618ACUSON AcuNav Volume Intracardiac Echocardiography CatheterSiemens Medical Solutions USA, Inc. · 2017 · cites it directly23descendants
K181098ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2018 · 2 generations on19descendants
K191467Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation · 2019 · 3 generations on9descendants
K200585Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2020 · 3 generations on8descendants
K201972Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation · 2020 · 4 generations on7descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K081808	Acunav V Ultrasound Catheter	Siemens Medical Solutions USA, Inc.	2008	—
0 (this device)	K163478	AcuNav Volume ICE Catheter	Siemens Medical Solutions USA, Inc.	2017	—
+1	K173618	ACUSON AcuNav Volume Intracardiac Echocardiography Catheter	Siemens Medical Solutions USA, Inc.	2017	1
+2	K181098	ACUSON SC2000 Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc.	2018	—
+3	K191467	Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0	Canon Medical Systems Corporation	2019	—
+3	K200585	Acuson SC2000 Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc.	2020	—
+4	K201972	Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1	Canon Medical Systems Corporation	2020	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2017	1	0
2018	1	0
2019	1	0
2020	5	0
2021	3	0
2022	2	0
2023	1	0
2024	3	0
2025	3	0
2026	4	0

FIG. 1 — Lineage of K163478, 2008–2026Source: 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.

Planning a device in OBJ? 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

Get a 510(k) Report

What was it cleared against? (1)

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
*	K081808	Acunav V Ultrasound Catheter Summary page 5 …AcuNav Volume diagnostic ultrasound catheter is substantially equivalent to the company’s own previously cleared Acuson AcuNav V diagnostic ultrasound catheter (K081808) with regard to both intended use and technological characteristics. Both the subject catheter and the predicate catheter fun…	Siemens Medical Solutions USA, Inc.	2008	—

Also cleared against K081808: 1 other device →

What descends from it? (24)

See all 24

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K173618	ACUSON AcuNav Volume Intracardiac Echocardiography Catheter	Siemens Medical Solutions USA, Inc.	2017	23

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K173618 (Siemens Medical Solutions USA, Inc., 2017) has gone furthest, with 23 descendants of its own.
1 other device also cites its predicate K081808.

How does its category compare?

All OBJ devices

OBJ 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

2007high 7 (2025) · low 1 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OBJ

35in 2025

2007high 136 (2012) · low 29 (2021)2026

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

Recalls per year · OBJ

2in 2020

2007high 2 (2015) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · OBJ

791in 2025

2007high 1,154 (2024) · low 0 (2007)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 AcuNav Volume is intended for imaging guidance, not treatment delivery, of cardiac interventional percutaneous procedures; intraluminal visualization of great vessel anatomy and physiology; intracardiac visualization of cardiac anatomy, physiology, and devices within the heart of an adult or a pediatric patient.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K163478 · printed Nov 6, 2026

Cite this page

510(k) Report. “K163478: AcuNav Volume ICE Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163478

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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