510(k) Report

510(k) · Cleared

Cleared

S8 Exp Portable Digital Color Doppler Ultrasound System

K132768510(k) SpecialCleared Oct 4, 201330-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 4, 2013 as substantially equivalent to K131088 (Sonoscape Company Limited, 2013) after a 30-day review. Its family tree reaches back 2 generations to 2011. 30 later devices descend from it.

Decided
Oct 4, 2013
Review
30 days
Class
Class II
Product code
IYN
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K112602 (2011). 30 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2017: 9 descendants cleared2015: 6 descendants cleared2024: 1 descendant cleared2014: 1 descendant cleared2016: 3 descendants cleared2022: 3 descendants cleared2025: 2 descendants cleared2020: 1 descendant cleared2019: 1 descendant cleared2023: 1 descendant cleared2026: 2 descendants clearedK112602 · S6 Diagnostic Ultrasound System · Sonoscape Company Limited · 2011K131088 · Portable Digital Color Doppler Ultrasound System · Sonoscape Company Limited · 20132010201520202025
Descendants, by generation 1 generation forward: 5 descendants2 generations forward: 5 descendants3 generations forward: 3 descendants4 generations forward: 3 descendants5 generations forward: 3 descendants6 generations forward: 6 descendants7 generations forward: 2 descendants8 generations forward: 3 descendants K131088 · Portable Digital Color Doppler Ultrasound System · Sonoscape Company Limited · 2013K112602 · S6 Diagnostic Ultrasound System · Sonoscape Company Limited · 20110+5
  1. Root · 2 generations backK112602 S6 Diagnostic Ultrasound SystemSonoscape Company Limited · 2011
  2. 1 generation backK131088 Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited · 2013
  3. This deviceK132768 S8 Exp Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited · 2013
  4. Descendant · cites it directly · 19 of its ownK142710 S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited · 2015
  5. Descendant · 2 generations on · 17 of its ownK150045 S30/S40 Digital Color Doppler Ultraound SystemSonoscape Company Limited · 2015
  6. Descendant · 3 generations on · 16 of its ownK152854 S50 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp. · 2016
  7. Descendant · 4 generations on · 15 of its ownK160283 S45 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp. · 2016
  8. Descendant · 5 generations on · 5 of its ownK172082 S60 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp. · 2017

Showing 5 of 30 descendants. See all descendants

Descendants cleared per year

2014: 12015: 62016: 32017: 92019: 12020: 12022: 32023: 12024: 12025: 22026: 2
2014high 9 (2017) · low 0 (2018)2026

Most influential descendants

Showing 5 of 30 · See all
  • 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
  • K172082S60 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp. · 2017 · 5 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K112602S6 Diagnostic Ultrasound SystemSonoscape Company Limited2011—
−1K131088Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited2013—
0 (this device)K132768S8 Exp Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited2013—
+1K142710S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited2015—
+2K150045S30/S40 Digital Color Doppler Ultraound SystemSonoscape Company Limited2015—
+3K152854S50 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.2016—
+4K160283S45 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.2016—
+5K172082S60 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201560
201630
201790
201910
202010
202230
202310
202410
202520
202620
FIG. 1 — Lineage of K132768, 2011–2026Source: 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 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. #1 K240850 EPIQ Series Diagnostic Ultrasound Systems…score 32.1 · 24 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
*K131088Portable Digital Color Doppler Ultrasound System
Summary page 1
…hin this submission are as follows: SonoScape Company Limited, Portable Digital Color Doppler Ultrasound System, Model S9 has been cleared by FDA through 510(k) No.K131088 (May 24, 2013). 5. Description of the Device [21 CFR 8O7.92(a)(4)] The SonoScape S8 Exp Portable Digital Color Doppler Ultra…
Sonoscape Company Limited2013—

Also cleared against K131088: 2 other devices →

What descends from it? (30)

See all 30

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

NumberDeviceApplicantDecidedDescendants
K142710S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited201519
K142714S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited20154
K142474S12 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20144
K231659MS55 Plus Digital Color Doppler Ultrasound System (MS55); P25 Expert Digital Color…Medisono20240
K170078Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12…Medisono, LLC20170

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 2 years and passes through 1 company; a new generation was cleared every 1.5 years on median.
  • None of the 2 ancestors has a recall.
  • Of its descendants, K142710 (Sonoscape Company Limited, 2015) has gone furthest, with 19 descendants of its own.
  • 2 other devices also cite its predicate K131088.

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

2007: 132008: 252009: 182010: 292011: 392012: 432013: 512014: 562015: 542016: 602017: 642018: 592019: 472020: 572021: 462022: 532023: 442024: 502025: 572026 (partial year): 44
2007high 64 (2017) · low 13 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYN

124in 2025

2007: 26 days median2008: 18 days median2009: 29 days median2010: 67 days median2011: 46 days median2012: 37 days median2013: 60 days median2014: 39 days median2015: 55 days median2016: 56 days median2017: 83 days median2018: 85 days median2019: 79 days median2020: 72 days median2021: 105 days median2022: 105 days median2023: 115 days median2024: 119 days median2025: 124 days median2026 (partial year): 107 days median
2007high 124 (2025) · low 18 (2008)2026

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

Recalls per year · IYN

10in 2025

2007: 162008: 122009: 82010: 102011: 82012: 32013: 82014: 22015: 32016: 22018: 72020: 42021: 82022: 102023: 42024: 12025: 102026 (partial year): 2, 1 Class I
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

2007: 32008: 22009: 92010: 172011: 182012: 202013: 182014: 482015: 1162016: 1452017: 1462018: 852019: 592020: 672021: 2132022: 1862023: 2292024: 2662025: 610
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071326163
20082518122
2009182989
201029671017
20113946818
20124337320
20135160818
20145639248
201554553116
201660562145
201764830146
20185985785
20194779059
20205772467
2021461058213
20225310510186
2023441154229
2024501191266
20255712410610
2026441072 (1)—

What is it indicated for?

The SonoScape S8 Exp 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.

Also cleared against K131088

2 other devices cite the same predicate.

  • K142982OPUS 5100 Diagnostic Doppler Ultrasound SystemChang Gung Medical Technology Co., Ltd. · 2015
  • K142710S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited · 2015

More from Sonoscape Company Limited

22 FDA decisions under this applicant name. See the company

  • K150045S30/S40 Digital Color Doppler Ultraound SystemSonoscape Company Limited · 2015
  • K142714S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited · 2015
  • K142815S22 Digital Color Doppler Ultrasound SystemSonoscape Company Limited · 2015
  • K142710S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited · 2015
  • K142474S12 Digital Color Doppler Ultrasound SystemSonoscape Company Limited · 2014

Recent decisions in IYN

The IYN category page

  • K261585Diagnostic Ultrasound System (Nuewa A20W); Diagnostic Ultrasound System (Nuewa A20); Diagnostic Ultrasound…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2026
  • K263150V10 Diagnostic Ultrasound System; cV10 Diagnostic Ultrasound System; H10 Diagnostic Ultrasound System; XV10…Samsung Medison Co., Ltd. · 2026
  • K261617Diagnostic Ultrasound System (Resona I10W);Diagnostic Ultrasound System (Resona I10 Exp);Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2026
  • K261933Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary care Diagnostics, LLC · 2026
  • K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC · 2026

https://510kreport.com/device/K132768 · printed Nov 6, 2026

Cite this page

510(k) Report. “K132768: S8 Exp 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/K132768

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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