510(k) · Cleared

Cleared

CTS-5500/CTS-6600 Ultrasonic Pulsed Echo Imaging System

K061488510(k) SpecialCleared Jun 30, 200630-day reviewClass II21 CFR 892.1550

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

Shantou Institute of Ultrasonic Instruments (Siui · IYN System, Imaging, Pulsed Doppler, Ultrasonic

Cleared on Jun 30, 2006 as substantially equivalent to K012772 (Shantou Institute of Ultrasonic Instuments, 2001) after a 30-day review. Its family tree reaches back 2 generations to 2000.

Decided: Jun 30, 2006
Review: 30 days
Class: Class II
Product code: IYN
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K000030 (2000). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK000030 Sonoace 600 Diagnostic Ultrasound SystemMedison America, Inc. · 2000
1 generation backK012772 CTS-485 Ultrasound Imaging SystemShantou Institute of Ultrasonic Instuments · 2001
This deviceK061488 CTS-5500/CTS-6600 Ultrasonic Pulsed Echo Imaging SystemShantou Institute of Ultrasonic Instruments (Siui · 2006

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K000030	Sonoace 600 Diagnostic Ultrasound System	Medison America, Inc.	2000	—
−1	K012772	CTS-485 Ultrasound Imaging System	Shantou Institute of Ultrasonic Instuments	2001	—
0 (this device)	K061488	CTS-5500/CTS-6600 Ultrasonic Pulsed Echo Imaging System	Shantou Institute of Ultrasonic Instruments (Siui	2006	—

FIG. 1 — Lineage of K061488, 2000–2006Source: 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 IYN? 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 IYN device

#1 K240850 EPIQ Series Diagnostic Ultrasound Systems…score 32.1 · 24 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
*	K012772	CTS-485 Ultrasound Imaging System Summary page 1 …Dublin, CA 94568 Telephone: 1-925-556-1302 Fax: 1-866-718-3819 Predicate Device: SlU CTS-485, K012772 Device Description: The SlUI CTS-5500/CTS-6600 is a portable diagnostic ultrasound system capable of the following operating mo…	Shantou Institute of Ultrasonic Instuments	2001	—

Also cleared against K012772: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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?

The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
None of the 2 ancestors has a recall.
1 other device also cites its predicate K012772.

How does its category compare?

All IYN devices

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

FDA decisions per year · IYN

57in 2025

2007high 64 (2017) · low 13 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYN

124in 2025

2007high 124 (2025) · low 18 (2008)2026

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

Recalls per year · IYN

10in 2025

2007high 16 (2007) · low 0 (2017)2026

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

Adverse event reports per year · IYN

610in 2025

2007high 610 (2025) · low 2 (2008)2025

MAUDE reports naming product code IYN, 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	13	26	16	3
2008	25	18	12	2
2009	18	29	8	9
2010	29	67	10	17
2011	39	46	8	18
2012	43	37	3	20
2013	51	60	8	18
2014	56	39	2	48
2015	54	55	3	116
2016	60	56	2	145
2017	64	83	0	146
2018	59	85	7	85
2019	47	79	0	59
2020	57	72	4	67
2021	46	105	8	213
2022	53	105	10	186
2023	44	115	4	229
2024	50	119	1	266
2025	57	124	10	610
2026	44	107	2 (1)	—

What is it indicated for?

Ultrasonic pulsed echo imaging and measurement for abdominal, pediatric, small organ, cardiac, peripheral vascular applications

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K061488 · printed Nov 6, 2026

Cite this page

510(k) Report. “K061488: CTS-5500/CTS-6600 Ultrasonic Pulsed Echo Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061488

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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