510(k) · Cleared

Cleared

Portable Digital Color Doppler Ultrasound System

K131088510(k) TraditionalCleared May 24, 201336-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 May 24, 2013 as substantially equivalent to K112602 (Sonoscape Company Limited, 2011) after a 36-day review. Its family tree reaches back 1 generation to 2011. 32 later devices descend from it.

Decided: May 24, 2013
Review: 36 days
Class: Class II
Product code: IYN
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K112602 (2011). 32 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK112602 S6 Diagnostic Ultrasound SystemSonoscape Company Limited · 2011
This deviceK131088 Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited · 2013
Descendant · cites it directly · 30 of its ownK132768 S8 Exp Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited · 2013
Descendant · cites it directly · 19 of its ownK142710 S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited · 2015
Descendant · 2 generations on · 17 of its ownK150045 S30/S40 Digital Color Doppler Ultraound SystemSonoscape Company Limited · 2015
Descendant · 3 generations on · 16 of its ownK152854 S50 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp. · 2016
Descendant · 4 generations on · 15 of its ownK160283 S45 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp. · 2016

Showing 5 of 32 descendants. See all descendants

Descendants cleared per year

2013high 9 (2017) · low 0 (2018)2026

Most influential descendants

Showing 5 of 32 · See all

K132768S8 Exp Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited · 2013 · cites it directly30descendants
K142710S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited · 2015 · cites it directly19descendants
K150045S30/S40 Digital Color Doppler Ultraound SystemSonoscape Company Limited · 2015 · 2 generations on17descendants
K152854S50 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp. · 2016 · 3 generations on16descendants
K160283S45 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp. · 2016 · 4 generations on15descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K112602	S6 Diagnostic Ultrasound System	Sonoscape Company Limited	2011	—
0 (this device)	K131088	Portable Digital Color Doppler Ultrasound System	Sonoscape Company Limited	2013	—
+1	K132768	S8 Exp Portable Digital Color Doppler Ultrasound System	Sonoscape Company Limited	2013	—
+1	K142710	S9 Portable Digital Color Doppler Ultrasound System	Sonoscape Company Limited	2015	—
+2	K150045	S30/S40 Digital Color Doppler Ultraound System	Sonoscape Company Limited	2015	—
+3	K152854	S50 Digital Color Doppler Ultrasound System	Sonoscape Medical Corp.	2016	—
+4	K160283	S45 Digital Color Doppler Ultrasound System	Sonoscape Medical Corp.	2016	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0
2014	1	0
2015	7	0
2016	3	0
2017	9	0
2019	1	0
2020	1	0
2022	3	0
2023	1	0
2024	1	0
2025	2	0
2026	2	0

FIG. 1 — Lineage of K131088, 2011–2026Source: 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? (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
*	K112602	S6 Diagnostic Ultrasound System Summary page 2 …stem 510(k) Submission SonoScape Company Limited, Diagnostic Ultrasound System, Model S6 has been cleared by FDA through 510(k) No.K1 12602 (Decision Date - November 071 2011). 5. Description of the Device [21 CFR 807.92(a)(4)] The SonoScape S9 Portable Digital C…	Sonoscape Company Limited	2011	—

Also cleared against K112602: 4 other devices →

What descends from it? (32)

See all 32

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

Number	Device	Applicant	Decided	Descendants
K132768	S8 Exp Portable Digital Color Doppler Ultrasound System	Sonoscape Company Limited	2013	30
K142710	S9 Portable Digital Color Doppler Ultrasound System	Sonoscape Company Limited	2015	19
K142982	OPUS 5100 Diagnostic Doppler Ultrasound System	Chang Gung Medical Technology Co., Ltd.	2015	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?

Its one ancestor has no recall.
Of its descendants, K132768 (Sonoscape Company Limited, 2013) has gone furthest, with 30 descendants of its own.
4 other devices also cite its predicate K112602.

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. 2013, this device’s year, is highlighted.

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 SonoScape S9 device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic(neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K131088 · printed Nov 6, 2026

Cite this page

510(k) Report. “K131088: Portable Digital Color Doppler Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131088

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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