510(k) · Cleared

Cleared

Sonicath Ultra Imaging Catheter, 3.2F,20MHZ Models 37410/456221/C1020

K060947510(k) SpecialCleared Apr 19, 200613-day reviewClass II21 CFR 892.1570

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

Boston Scientific Corp · ITX Transducer, Ultrasonic, Diagnostic

Cleared on Apr 19, 2006 as substantially equivalent to K970049 (Cardiovascular Imaging Systems, Inc., 1997) after a 13-day review. Its family tree reaches back 1 generation to 1997. 11 later devices descend from it.

Decided: Apr 19, 2006
Review: 13 days
Class: Class II
Product code: ITX
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K970049 (1997). 11 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK970049 BSC, Sonicath Ultra Imaging Catheter 3.2F/20MHZ (37410/456221 & BSC…Cardiovascular Imaging Systems, Inc. · 1997
This deviceK060947 Sonicath Ultra Imaging Catheter, 3.2F,20MHZ Models 37410/456221/C1020Boston Scientific Corp · 2006
Descendant · cites it directly · 7 of its ownK092156 Cad 12, Colonoscopy Assist DeviceSoftscope Medical Technologies, Inc. · 2009
Descendant · 2 generations on · 6 of its ownK100624 Invendo C20 Colonoscopy SystemInvendo Medical Gbmh · 2012
Descendant · 3 generations on · 5 of its ownK121582 Invendo C25 Colonoscopy SystemInvendo Medical Gbmh · 2012
Descendant · 3 generations on · 2 of its ownK141286 Aer-O-Scope Colonoscope SystemGi View, Ltd. · 2014
Descendant · cites it directly · 2 of its ownK073623 Atlantis 018 Peripheral Imaging CatheterBoston Scientific Corp · 2008

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2008high 3 (2016) · low 0 (2010)2026

Most influential descendants

Showing 5 of 11 · See all

K092156Cad 12, Colonoscopy Assist DeviceSoftscope Medical Technologies, Inc. · 2009 · cites it directly7descendants
K100624Invendo C20 Colonoscopy SystemInvendo Medical Gbmh · 2012 · 2 generations on6descendants
K121582Invendo C25 Colonoscopy SystemInvendo Medical Gbmh · 2012 · 3 generations on5descendants
K141286Aer-O-Scope Colonoscope SystemGi View, Ltd. · 2014 · 3 generations on2descendants
K073623Atlantis 018 Peripheral Imaging CatheterBoston Scientific Corp · 2008 · cites it directly2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K970049	BSC, Sonicath Ultra Imaging Catheter 3.2F/20MHZ (37410/456221 & BSC, Sonicath…	Cardiovascular Imaging Systems, Inc.	1997	—
0 (this device)	K060947	Sonicath Ultra Imaging Catheter, 3.2F,20MHZ Models 37410/456221/C1020	Boston Scientific Corp	2006	—
+1	K092156	Cad 12, Colonoscopy Assist Device	Softscope Medical Technologies, Inc.	2009	—
+2	K100624	Invendo C20 Colonoscopy System	Invendo Medical Gbmh	2012	—
+3	K121582	Invendo C25 Colonoscopy System	Invendo Medical Gbmh	2012	—
+3	K141286	Aer-O-Scope Colonoscope System	Gi View, Ltd.	2014	—
+1	K073623	Atlantis 018 Peripheral Imaging Catheter	Boston Scientific Corp	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2009	1	0
2012	2	0
2014	1	0
2016	3	0
2018	1	0
2020	1	0
2022	1	0

FIG. 1 — Lineage of K060947, 1997–2022Source: 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 ITX? 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 ITX device

#1 K260114 Align® Cover and Pad Guidance Toolscore 13.6 · 6 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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
*	K970049	BSC, Sonicath Ultra Imaging Catheter 3.2F/20MHZ (37410/456221 & BSC, Sonicath Ultra… Summary page 1 …ing device: Predicate 510(k) Clearance Date Sonicath Ultra TM 3.2F K970049 June 20, 1997 20MHz Imaging Catheter Bosto…	Cardiovascular Imaging Systems, Inc.	1997	—

Also cleared against K970049: 4 other devices →

What descends from it? (11)

See all 11

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

Number	Device	Applicant	Decided	Descendants
K092156	Cad 12, Colonoscopy Assist Device	Softscope Medical Technologies, Inc.	2009	7
K073623	Atlantis 018 Peripheral Imaging Catheter	Boston Scientific Corp	2008	2

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, K092156 (Softscope Medical Technologies, Inc., 2009) has gone furthest, with 7 descendants of its own.
4 other devices also cite its predicate K970049.

How does its category compare?

All ITX devices

ITX Transducer, Ultrasonic, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · ITX

4in 2025

2007high 17 (2009) · low 1 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ITX

126in 2025

2007high 213 (2023) · low 16 (2011)2026

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

Recalls per year · ITX

2in 2025

2007high 15 (2018) · low 0 (2007)2026

Class I (10 since 2007) Class II/III not classified

Adverse event reports per year · ITX

571in 2025

2007high 988 (2024) · low 16 (2007)2025

MAUDE reports naming product code ITX, 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	10	26	0	16
2008	12	73	4	39
2009	17	28	4	23
2010	10	42	4	30
2011	10	16	1	34
2012	7	25	1	29
2013	3	105	0	38
2014	4	41	1	43
2015	1	—	5	183
2016	4	151	0	269
2017	6	110	1	412
2018	2	—	15	130
2019	1	—	0	119
2020	3	120	3	116
2021	3	139	10 (10)	146
2022	2	—	6	87
2023	6	213	1	138
2024	3	81	1	988
2025	4	126	2	571
2026	6	158	0	—

What is it indicated for?

The Sonicath Ultra Tm 3.2F 20MHz Imaging Catheter is intended for ultrasound examination of peripheral intravascular pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K060947 · printed Nov 4, 2026

Cite this page

510(k) Report. “K060947: Sonicath Ultra Imaging Catheter, 3.2F,20MHZ Models 37410/456221/C1020.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060947

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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