510(k) · Cleared

Cleared

Sonoscape Ultrasound System Ssi-1000/Ssi-5000

K042369510(k) TraditionalCleared Oct 20, 200450-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

Sonoscape Company Limited · IYN System, Imaging, Pulsed Doppler, Ultrasonic

Cleared on Oct 20, 2004 as substantially equivalent to K970901 (GE Medical Systems, 1997) and 2 other predicates after a 50-day review. Its family tree reaches back 3 generations to 1994. 40 later devices descend from it.

Decided: Oct 20, 2004
Review: 50 days
Class: Class II
Product code: IYN
Recalls: None
Predicates: 3

Its longest line of descent runs back 3 generations to K933202 (1994). 4 ancestors in all. 40 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 3 generations backK933202 Venus Diagnostic Ultrasound SystemGE Medical Systems · 1994
2 generations backK970901 GE Logiq 500 Diagnostic Ultrasound SystemGE Medical Systems · 1997
1 generation backK991611 GE Logiq 500General Electric Co. · 1999
This deviceK042369 Sonoscape Ultrasound System Ssi-1000/Ssi-5000Sonoscape Company Limited · 2004
Descendant · cites it directly · 33 of its ownK052042 Sonoscape Ssi-1000/Ssi-5000 Ultrasound TransducersSonoscape Company Limited · 2005
Descendant · 2 generations on · 29 of its ownK102642 Sonoscape Ultrasound System and Transducers Model Ssi-8000, 2P1…Sonoscape Company Limited · 2011
Descendant · 3 generations on · 28 of its ownK132527 Digital Color Doppler Ultasound SystemSonoscape Company Limited · 2013
Descendant · 4 generations on · 19 of its ownK142710 S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited · 2015
Descendant · 4 generations on · 17 of its ownK150045 S30/S40 Digital Color Doppler Ultraound SystemSonoscape Company Limited · 2015

Showing 5 of 40 descendants. See all descendants

Descendants cleared per year

2005high 10 (2017) · low 0 (2006)2026

Most influential descendants

Showing 5 of 40 · See all

K052042Sonoscape Ssi-1000/Ssi-5000 Ultrasound TransducersSonoscape Company Limited · 2005 · cites it directly33descendants
K102642Sonoscape Ultrasound System and Transducers Model Ssi-8000, 2P1 Phased Array, 5P1 Phased…Sonoscape Company Limited · 2011 · 2 generations on29descendants
K132527Digital Color Doppler Ultasound SystemSonoscape Company Limited · 2013 · 3 generations on28descendants
K142710S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited · 2015 · 4 generations on19descendants
K150045S30/S40 Digital Color Doppler Ultraound SystemSonoscape Company Limited · 2015 · 4 generations on17descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K933202	Venus Diagnostic Ultrasound System	GE Medical Systems	1994	—
−2	K970901	GE Logiq 500 Diagnostic Ultrasound System	GE Medical Systems	1997	—
−1	K991611	GE Logiq 500	General Electric Co.	1999	—
0 (this device)	K042369	Sonoscape Ultrasound System Ssi-1000/Ssi-5000	Sonoscape Company Limited	2004	—
+1	K052042	Sonoscape Ssi-1000/Ssi-5000 Ultrasound Transducers	Sonoscape Company Limited	2005	—
+2	K102642	Sonoscape Ultrasound System and Transducers Model Ssi-8000, 2P1 Phased Array…	Sonoscape Company Limited	2011	—
+3	K132527	Digital Color Doppler Ultasound System	Sonoscape Company Limited	2013	—
+4	K142710	S9 Portable Digital Color Doppler Ultrasound System	Sonoscape Company Limited	2015	—
+4	K150045	S30/S40 Digital Color Doppler Ultraound System	Sonoscape Company Limited	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2009	2	0
2010	2	0
2011	1	0
2012	1	0
2013	1	0
2014	1	0
2015	6	0
2016	3	0
2017	10	0
2018	1	0
2019	2	0
2020	1	0
2022	2	0
2023	1	0
2024	1	0
2025	2	0
2026	2	0

FIG. 1 — Lineage of K042369, 1994–2026Source: 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 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? (3)

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
*	K970901	GE Logiq 500 Diagnostic Ultrasound System Summary page 1 …Quality & Regulatory Services, Inc. Dublin, CA 94568 Predicate Device: GE Logiq 500 - K970901, K991611, and K010329 Device Description: The SonoScape SSI-1000/SSI-5000 ultrasound system is an integrated p…	GE Medical Systems	1997	—
*	K991611	GE Logiq 500 Summary page 1 …Quality & Regulatory Services, Inc. Dublin, CA 94568 Predicate Device: GE Logiq 500 - K970901, K991611, and K010329 Device Description: The SonoScape SSI-1000/SSI-5000 ultrasound system is an integrated preprogram…	General Electric Co.	1999	—
*	K010329	LOGIQ 500 Summary page 1 …Quality & Regulatory Services, Inc. Dublin, CA 94568 Predicate Device: GE Logiq 500 - K970901, K991611, and K010329 Device Description: The SonoScape SSI-1000/SSI-5000 ultrasound system is an integrated preprogrammed color ult…	General Electric Co.	2001	—

Also cleared against K970901: 3 other devices →

What descends from it? (40)

See all 40

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

Number	Device	Applicant	Decided	Descendants
K052042	Sonoscape Ssi-1000/Ssi-5000 Ultrasound Transducers	Sonoscape Company Limited	2005	33
K102989	Opus Diagnostic Ultrasound System & Transducers	Chang Gung Medical Technology Co., Ltd. Linkou Fac	2010	4
K090229	Diagnostic Doppler Ultrasound System 2-5MHZ Curved Linear Array, 5-10MHZ Linear Array…	Chang Gung Medical Supplies & Equipment Corp.	2009	0

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 10 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
None of the 4 ancestors has a recall.
Of its descendants, K052042 (Sonoscape Company Limited, 2005) has gone furthest, with 33 descendants of its own.
3 other devices also cite its predicate K970901.

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?

The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Abdomen; Pediatric; Small Organ (breast, tests, thyroid); heart soft tissue; Peripheral Vascular, Musculo-skeletal (conventional) and Urology.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K042369 · printed Nov 5, 2026

Cite this page

510(k) Report. “K042369: Sonoscape Ultrasound System Ssi-1000/Ssi-5000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042369

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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