510(k) · Cleared
Recalled · Class II · 2014S9 Portable Digital Color Doppler Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sonoscape Medical Corp. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Aug 26, 2015 as substantially equivalent to K142710 (Sonoscape Company Limited, 2015) after a 23-day review. Its family tree reaches back 20 generations to 1995. 6 of the 208 devices in its family, counting itself, have a Class I recall. It has been recalled 2 times.
- Decided
- Aug 26, 2015
- Review
- 23 days
- Class
- Class II
- Product code
- IYN
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 20 generations to K935595 (1995). 207 ancestors in all, the oldest K852159 (1985). No later device cites it as a predicate yet. 6 of the 208 devices in this family, counting this one, have a Class I recall.
- Root · 20 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 16 generations between
- 3 generations backK102642 Sonoscape Ultrasound System and Transducers Model Ssi-8000, 2P1…Sonoscape Company Limited · 2011
- 2 generations backK132527 Digital Color Doppler Ultasound SystemSonoscape Company Limited · 2013
- 1 generation backK142710 S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited · 2015
- This deviceK152165 S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Medical Corp. · 2015
Show all 20 generations
- Root · 20 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 19 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 18 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 17 generations backK032111 Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 16 generations backK040060 Sonoline G50 and G60 S Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2004
- 15 generations backK043078 Nemio Diagnostic Ultrasound System, Model Ssa-550AToshiba America Medical Systems, In.C · 2004 · Recalled
- 14 generations backK051500 Famio Diagnostic Ultrasound Systems, Model Ssa-530AToshiba America Medical Systems, In.C · 2005
- 13 generations backK053346 Modification to: DP-9900 Digital Ultrasonic Diagnostic Imaging…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2005
- 12 generations backK061189 DP-9900 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006
- 11 generations backK063500 DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006
- 10 generations backK072164 DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007
- 9 generations backK080640 M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008
- 8 generations backK081320 DC-3, DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008
- 7 generations backK083505 DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008
- 6 generations backK091941 DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2009
- 5 generations backK092691 DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2009
- 4 generations backK092922 Ssi-8000/S8/S6 Digital Color Doppler Ultrasound System, 2P1 Phased…Sonoscape Company Limited · 2010
- 3 generations backK102642 Sonoscape Ultrasound System and Transducers Model Ssi-8000, 2P1…Sonoscape Company Limited · 2011
- 2 generations backK132527 Digital Color Doppler Ultasound SystemSonoscape Company Limited · 2013
- 1 generation backK142710 S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited · 2015
- This deviceK152165 S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Medical Corp. · 2015
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −19 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −18 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −17 | K032111 | Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2003 | 1 |
| −16 | K040060 | Sonoline G50 and G60 S Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −15 | K043078 | Nemio Diagnostic Ultrasound System, Model Ssa-550A | Toshiba America Medical Systems, In.C | 2004 | 1 |
| −14 | K051500 | Famio Diagnostic Ultrasound Systems, Model Ssa-530A | Toshiba America Medical Systems, In.C | 2005 | — |
| −13 | K053346 | Modification to: DP-9900 Digital Ultrasonic Diagnostic Imaging System, Model… | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2005 | — |
| −12 | K061189 | DP-9900 Digital Ultrasonic Diagnostic Imaging System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006 | — |
| −11 | K063500 | DC-6 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006 | — |
| −10 | K072164 | DC-6 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2007 | — |
| −9 | K080640 | M5 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | — |
| −8 | K081320 | DC-3, DC-3T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | — |
| −7 | K083505 | DC-3/DC-3T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | — |
| −6 | K091941 | DC-3/DC-3T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2009 | — |
| −5 | K092691 | DC-7 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2009 | — |
| −4 | K092922 | Ssi-8000/S8/S6 Digital Color Doppler Ultrasound System, 2P1 Phased Array… | Sonoscape Company Limited | 2010 | — |
| −3 | K102642 | Sonoscape Ultrasound System and Transducers Model Ssi-8000, 2P1 Phased Array… | Sonoscape Company Limited | 2011 | — |
| −2 | K132527 | Digital Color Doppler Ultasound System | Sonoscape Company Limited | 2013 | — |
| −1 | K142710 | S9 Portable Digital Color Doppler Ultrasound System | Sonoscape Company Limited | 2015 | — |
| 0 (this device) | K152165 | S9 Portable Digital Color Doppler Ultrasound System | Sonoscape Medical Corp. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 8 | 0 |
| 1995 | 6 | 0 |
| 1996 | 6 | 1 |
| 1997 | 8 | 0 |
| 1998 | 11 | 3 |
| 1999 | 14 | 0 |
| 2000 | 14 | 1 |
| 2001 | 17 | 0 |
| 2002 | 17 | 0 |
| 2003 | 14 | 0 |
| 2004 | 16 | 1 |
| 2005 | 14 | 0 |
| 2006 | 11 | 0 |
| 2007 | 6 | 0 |
| 2008 | 3 | 0 |
| 2009 | 4 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
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.
6 devices in this family have a Class I recall. 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
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 | Decided |
|---|---|---|---|
| * | K142710 | S9 Portable Digital Color Doppler Ultrasound SystemSummary page 34…FR 807.92(a) (3)] The identified predicate device within this submission is as follows: SonoScape S9 Portable Digital Color Doppler Ultrasound System K142710 4. Device Description [21 CFR 807.92(a) (4)] This SonoScape S9 Portable Digital Color Doppler Ultrasound System is an integr… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (6 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 9, 2014 | Class II | Z-2110-2014 | Software change control | The QLAB a2DQ and aCMQ features have a defect that may use incorrect measurement values under specific conditions. |
| Jul 9, 2014 | Class II | Z-2109-2014 | Software change control | The QLAB a2DQ and aCMQ features have a defect that may use incorrect measurement values under specific conditions. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K040050Instatrak System with Multiple Dataset Navigation, Model IT3500Ge Medical Systems Navigation and Visualization IN · 2004 · 5 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K994270Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · 5 generations back · ◆ in the 2000 ancestors bar of FIG. 12 Class I recalls
- K983529Instatrak 3000Visualization Technology, Inc. · 1998 · 5 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K982994Skull Base Instatrak SystemVisualization Technology, Inc. · 1998 · 5 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K981998Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · 5 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K960330InstatrakVisualization Technology, Inc. · 1996 · 5 generations back · ◆ in the 1996 ancestors bar of FIG. 11 Class I recall
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- The line of descent spans 20 years and passes through 6 companies; a new generation was cleared every 7 months on median.
- 60 of the 207 ancestors have a recall of any class; 6 have a Class I recall.
- 1 other device also cites its predicate K142710.
How does its category compare?
All IYN devicesIYN System, Imaging, Pulsed Doppler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · IYN
57in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYN
124in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYN
10in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · IYN
610in 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 system 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, Cerebral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), Trans-esoph.(Cardiac), Laparoscopic, OB/Gyn and Urology.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K152165 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152165: S9 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/K152165
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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