510(k) Report

510(k) · Cleared

Recalled · Class II · 2020

ACUSON AcuNav Volume Intracardiac Echocardiography Catheter

K173618510(k) SpecialCleared Dec 19, 201727-day reviewClass II21 CFR 870.1200Recalls 1

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 Dec 19, 2017 as substantially equivalent to K163478 (Siemens Medical Solutions USA, Inc., 2017) after a 27-day review. Its family tree reaches back 2 generations to 2008. 23 later devices descend from it. It has been recalled once.

Decided
Dec 19, 2017
Review
27 days
Class
Class II
Product code
OBJ
Recalls
1
Predicates
1

Its longest line of descent runs back 2 generations to K081808 (2008). 23 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2018: 1 descendant cleared2021: 3 descendants cleared2020: 5 descendants cleared2019: 1 descendant cleared2025: 3 descendants cleared2026: 4 descendants cleared2022: 2 descendants cleared2024: 3 descendants cleared2023: 1 descendant clearedK081808 · Acunav V Ultrasound Catheter · Siemens Medical Solutions USA, Inc. · 2008K163478 · AcuNav Volume ICE Catheter · Siemens Medical Solutions USA, Inc. · 201720052010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 6 descendants4 generations forward: 5 descendants5 generations forward: 2 descendants6 generations forward: 2 descendants7 generations forward: 1 descendant8 generations forward: 2 descendants K163478 · AcuNav Volume ICE Catheter · Siemens Medical Solutions USA, Inc. · 2017K081808 · Acunav V Ultrasound Catheter · Siemens Medical Solutions USA, Inc. · 20080+5
  1. Root · 2 generations backK081808 Acunav V Ultrasound CatheterSiemens Medical Solutions USA, Inc. · 2008
  2. 1 generation backK163478 AcuNav Volume ICE CatheterSiemens Medical Solutions USA, Inc. · 2017
  3. This deviceK173618 ACUSON AcuNav Volume Intracardiac Echocardiography CatheterSiemens Medical Solutions USA, Inc. · 2017
  4. Descendant · cites it directly · 19 of its ownK181098 ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2018
  5. Descendant · 2 generations on · 9 of its ownK191467 Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation · 2019
  6. Descendant · 2 generations on · 8 of its ownK200585 Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2020
  7. Descendant · 3 generations on · 7 of its ownK201972 Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation · 2020
  8. Descendant · 4 generations on · 6 of its ownK212333 Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation · 2022 · Recalled

Showing 5 of 23 descendants. See all descendants

Descendants cleared per year

2018: 12019: 12020: 52021: 32022: 22023: 12024: 32025: 32026: 4
2018high 5 (2020) · low 1 (2018)2026

Most influential descendants

Showing 5 of 23 · See all
  • K181098ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2018 · cites it directly19descendants
  • K191467Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation · 2019 · 2 generations on9descendants
  • K200585Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2020 · 2 generations on8descendants
  • K201972Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation · 2020 · 3 generations on7descendants
  • K212333Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation · 2022 · 4 generations on6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K081808Acunav V Ultrasound CatheterSiemens Medical Solutions USA, Inc.2008—
−1K163478AcuNav Volume ICE CatheterSiemens Medical Solutions USA, Inc.2017—
0 (this device)K173618ACUSON AcuNav Volume Intracardiac Echocardiography CatheterSiemens Medical Solutions USA, Inc.2017—
+1K181098ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2018—
+2K191467Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation2019—
+2K200585Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020—
+3K201972Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation2020—
+4K212333Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation20221

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201810
201910
202050
202130
202220
202310
202430
202530
202640
FIG. 1 — Lineage of K173618, 2008–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K242893 VERAFEYE System VERAFEYE Imaging Catheter &…score 23.8 · 30 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #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.

TypeNumberDeviceApplicantDecidedRecalls
*K163478AcuNav Volume ICE Catheter
Summary page 4
…er COMMON NAME Ultrasound Catheter CLASSIFICATION NAME/PRODUCT CODE Diagnostic Intravascular Catheter/ OBJ CLASSIFICATION Class II, 21 CFR 870.1200 PREDICATE DEVICE #K163478, ACUSON AcuNav Volume ICE Catheter DESCRIPTION OF MODIFIED DEVICE The ACUSON AcuNav Volume ICE Catheter is a 12.5F catheter wi…
Siemens Medical Solutions USA, Inc.2017—

What descends from it? (23)

See all 23

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

NumberDeviceApplicantDecidedDescendants
K181098ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201819
K203726ACUSON AcuNav Volume Intracardiac Echocardiography (ICE) CatheterSiemens Medical Solutions USA, Inc.20215

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

Recalls of this device

DateClassRecallRoot causeReason
May 22, 2020Class IIZ-0090-2021Under Investigation by firmDue to adverse events received by the firm for left atrial perforations and Atrioventricular Node block.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 9 years and passes through 1 company; a new generation was cleared every 8.4 years on median.
  • None of the 2 ancestors has a recall.
  • Of its descendants, K181098 (Siemens Medical Solutions USA, Inc., 2018) has gone furthest, with 19 descendants of its own.

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

2007: 32008: 62009: 32010: 12011: 42012: 32013: 42014: 32015: 42016: 42017: 62018: 22019: 12020: 42021: 32022: 32023: 32024: 32025: 72026 (partial year): 4
2007high 7 (2025) · low 1 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OBJ

35in 2025

2007: 74 days median2008: 100 days median2009: 108 days median2011: 109 days median2012: 136 days median2013: 96 days median2014: 30 days median2015: 131 days median2016: 94 days median2017: 45 days median2020: 135 days median2021: 29 days median2022: 63 days median2023: 63 days median2024: 131 days median2025: 35 days median2026 (partial year): 81 days median
2007high 136 (2012) · low 29 (2021)2026

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

Recalls per year · OBJ

2in 2020

2015: 22017: 22018: 22020: 22026 (partial year): 1, 1 Class I
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

2008: 62009: 222010: 392011: 472012: 532013: 3282014: 6092015: 4012016: 5152017: 5242018: 5422019: 2372020: 2882021: 3532022: 4732023: 6972024: 1,1542025: 791
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200737400
2008610006
20093108022
20101—039
20114109047
20123136053
20134960328
20143300609
201541312401
20164940515
20176452524
20182—2542
20191—0237
202041352288
20213290353
20223630473
20233630697
2024313101,154
20257350791
20264811 (1)—

What is it indicated for?

The catheter is intended for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients.

The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.

Indications for use as stated in the FDA summary.

More from Siemens Medical Solutions USA, Inc.

798 FDA decisions under this applicant name. See the company

  • K260055syngo.CT Brain QuantificationSiemens Medical Solutions USA, Inc. · 2026
  • K261696ACUNAV Luxera 4D ICE CatheterSiemens Medical Solutions USA, Inc. · 2026
  • K260488MULTIX Impact; MULTIX Impact CSiemens Medical Solutions USA, Inc. · 2026
  • P140011/S009MAMMOMAT B.brilliant with Tomosynthesis OptionSiemens Medical Solutions USA, Inc. · 2026
  • K253786syngo.CT Coronary CockpitSiemens Medical Solutions USA, Inc. · 2026

Recent decisions in OBJ

The OBJ category page

  • K261696ACUNAV Luxera 4D ICE CatheterSiemens Medical Solutions USA, Inc. · 2026
  • K261849VERAFEYE Imaging Catheter (VF-VIC-002)Luma Vision Limited · 2026
  • K252945Novasight Hybrid SystemConavi Medical, Inc. · 2026
  • K260816OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter (H7495181160)…Boston Scientific · 2026
  • K253399Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS CatheterVolcano Corporation (Dba Philips Image Guided Therapy Device · 2025

https://510kreport.com/device/K173618 · printed Nov 6, 2026

Cite this page

510(k) Report. “K173618: ACUSON AcuNav Volume Intracardiac Echocardiography Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173618

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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