510(k) · Cleared
ClearedS90 Exp Series 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 Feb 10, 2023 as substantially equivalent to K201059 (Sonoscape Medical Corp., 2020) after a 168-day review. Its family tree reaches back 25 generations to 1995. 6 of the 217 devices in its family, counting itself, have a Class I recall. 3 later devices descend from it.
- Decided
- Feb 10, 2023
- Review
- 168 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 25 generations to K935595 (1995). 213 ancestors in all, the oldest K852159 (1985). 3 later devices descend from it, 3 citing it directly. 6 of the 217 devices in this family, counting this one, have a Class I recall.
- Root · 25 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 21 generations between
- 3 generations backK160283 S45 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp. · 2016
- 2 generations backK172082 S60 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp. · 2017
- 1 generation backK201059 S60 Elite Series/S70 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp. · 2020
- This deviceK222596 S90 Exp Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp. · 2023
- Descendant · cites it directly · 0 of its ownK254027 Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95…Sonoscape Medical Corp. · 2026
- Descendant · cites it directly · 0 of its ownK254028 Digital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra…Sonoscape Medical Corp. · 2026
- Descendant · cites it directly · 0 of its ownK252498 Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11…Sonoscape Medical Corp. · 2025
Show all 25 generations
- Root · 25 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 24 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 23 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 22 generations backK032111 Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 21 generations backK040060 Sonoline G50 and G60 S Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2004
- 20 generations backK043078 Nemio Diagnostic Ultrasound System, Model Ssa-550AToshiba America Medical Systems, In.C · 2004 · Recalled
- 19 generations backK051500 Famio Diagnostic Ultrasound Systems, Model Ssa-530AToshiba America Medical Systems, In.C · 2005
- 18 generations backK053346 Modification to: DP-9900 Digital Ultrasonic Diagnostic Imaging…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2005
- 17 generations backK061189 DP-9900 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006
- 16 generations backK063500 DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006
- 15 generations backK072164 DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007
- 14 generations backK080640 M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008
- 13 generations backK081320 DC-3, DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008
- 12 generations backK083505 DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008
- 11 generations backK091941 DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2009
- 10 generations backK092691 DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2009
- 9 generations backK092922 Ssi-8000/S8/S6 Digital Color Doppler Ultrasound System, 2P1 Phased…Sonoscape Company Limited · 2010
- 8 generations backK102642 Sonoscape Ultrasound System and Transducers Model Ssi-8000, 2P1…Sonoscape Company Limited · 2011
- 7 generations backK132527 Digital Color Doppler Ultasound SystemSonoscape Company Limited · 2013
- 6 generations backK142710 S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited · 2015
- 5 generations backK150045 S30/S40 Digital Color Doppler Ultraound SystemSonoscape Company Limited · 2015
- 4 generations backK152854 S50 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp. · 2016
- 3 generations backK160283 S45 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp. · 2016
- 2 generations backK172082 S60 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp. · 2017
- 1 generation backK201059 S60 Elite Series/S70 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp. · 2020
- This deviceK222596 S90 Exp Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp. · 2023
Class I recalls in this family
Most influential descendants
Showing 3 of 3 · See all- K254027Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90…Sonoscape Medical Corp. · 2026 · cites it directly0descendants
- K254028Digital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra Senior, Autra CV…Sonoscape Medical Corp. · 2026 · cites it directly0descendants
- K252498Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11…Sonoscape Medical Corp. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −25 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −24 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −23 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −22 | K032111 | Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2003 | 1 |
| −21 | K040060 | Sonoline G50 and G60 S Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −20 | K043078 | Nemio Diagnostic Ultrasound System, Model Ssa-550A | Toshiba America Medical Systems, In.C | 2004 | 1 |
| −19 | K051500 | Famio Diagnostic Ultrasound Systems, Model Ssa-530A | Toshiba America Medical Systems, In.C | 2005 | — |
| −18 | K053346 | Modification to: DP-9900 Digital Ultrasonic Diagnostic Imaging System, Model… | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2005 | — |
| −17 | K061189 | DP-9900 Digital Ultrasonic Diagnostic Imaging System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006 | — |
| −16 | K063500 | DC-6 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006 | — |
| −15 | K072164 | DC-6 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2007 | — |
| −14 | K080640 | M5 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | — |
| −13 | K081320 | DC-3, DC-3T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | — |
| −12 | K083505 | DC-3/DC-3T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | — |
| −11 | K091941 | DC-3/DC-3T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2009 | — |
| −10 | K092691 | DC-7 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2009 | — |
| −9 | K092922 | Ssi-8000/S8/S6 Digital Color Doppler Ultrasound System, 2P1 Phased Array… | Sonoscape Company Limited | 2010 | — |
| −8 | K102642 | Sonoscape Ultrasound System and Transducers Model Ssi-8000, 2P1 Phased Array… | Sonoscape Company Limited | 2011 | — |
| −7 | K132527 | Digital Color Doppler Ultasound System | Sonoscape Company Limited | 2013 | — |
| −6 | K142710 | S9 Portable Digital Color Doppler Ultrasound System | Sonoscape Company Limited | 2015 | — |
| −5 | K150045 | S30/S40 Digital Color Doppler Ultraound System | Sonoscape Company Limited | 2015 | — |
| −4 | K152854 | S50 Digital Color Doppler Ultrasound System | Sonoscape Medical Corp. | 2016 | — |
| −3 | K160283 | S45 Digital Color Doppler Ultrasound System | Sonoscape Medical Corp. | 2016 | — |
| −2 | K172082 | S60 Series Digital Color Doppler Ultrasound System | Sonoscape Medical Corp. | 2017 | — |
| −1 | K201059 | S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System | Sonoscape Medical Corp. | 2020 | — |
| 0 (this device) | K222596 | S90 Exp Series Digital Color Doppler Ultrasound System | Sonoscape Medical Corp. | 2023 | — |
| +1 | K254027 | Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo… | Sonoscape Medical Corp. | 2026 | — |
| +1 | K254028 | Digital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra Senior… | Sonoscape Medical Corp. | 2026 | — |
| +1 | K252498 | Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11… | Sonoscape Medical Corp. | 2025 | — |
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 | 5 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K201059 | S60 Elite Series/S70 Series Digital Color Doppler Ultrasound SystemSummary page 4…follows: Type Manufacturer Device 510 (K) Number Primary Predicate SONOSCAPE S60 Elite Series/S70 Series K201059 510(k) Summary Page 1 of 7 SONOSCAPE MEDICAL C… | 2020 |
| † | K171000 | P60 Series Digital Color Doppler Ultrasound System | 2017 |
| † | K221140 | P20 Elite Series Digital Color Doppler Ultrasound System | 2022 |
| † | K171233 | Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System | 2017 |
| † | K202785 | Resona R9,Resona R9 Exp,Resona R9 Pro,Resona R9S, Nuewa R9,Nuewa R9 Exp,Nuewa R9… | 2021 |
| † | K210053 | LVivo Software Application | 2021 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K254027 | Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90… | 2026 | 0 |
| K254028 | Digital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra Senior, Autra CV… | 2026 | 0 |
| K252498 | Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11… | 2025 | 0 |
Has anything in its family been recalled? (6 Class I)
No FDA recall names this device.
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 · 10 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K994270Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · 10 generations back · ◆ in the 2000 ancestors bar of FIG. 12 Class I recalls
- K983529Instatrak 3000Visualization Technology, Inc. · 1998 · 10 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K982994Skull Base Instatrak SystemVisualization Technology, Inc. · 1998 · 10 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K981998Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · 10 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K960330InstatrakVisualization Technology, Inc. · 1996 · 10 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 28 years and passes through 6 companies; a new generation was cleared every 7 months on median.
- 60 of the 213 ancestors have a recall of any class; 6 have a Class I recall.
- Of its descendants, K254027 (Sonoscape Medical Corp., 2026) has gone furthest, with 0 descendants of its own.
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. 2023, 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 S90 Exp Series Digital Color Doppler Ultrasound System (S90 Exp, S80, S80T, S80 Pro, S80 Exp, S80 Plus, S80 Elite, S80 Senior, S80 Super, S70i, S100 Exp, P90i, P80, P80T, P80 Pro, P80 Exp, P80 Plus, P80 Elite, P80 Senior, P80 Super, P70i, I80-Endo, I80-Surg, I75-Endo, I70-Endo) is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician or sonographer with sufficient clinical ultrasound training for ultrasound…
Read the full statement (196 words)
The S90 Exp Series Digital Color Doppler Ultrasound System (S90 Exp, S80, S80T, S80 Pro, S80 Exp, S80 Plus, S80 Elite, S80 Senior, S80 Super, S70i, S100 Exp, P90i, P80, P80T, P80 Pro, P80 Exp, P80 Plus, P80 Elite, P80 Senior, P80 Super, P70i, I80-Endo, I80-Surg, I75-Endo, I70-Endo) is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician or sonographer with sufficient clinical ultrasound training for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic. The system is applicable for people who need clinical ultrasound examination.
The system is intended for use in the following clinical applications: 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 (pediatric and adult), Trans-esophageal (Cardiac), Laparoscopic, OB/Gyn and Urology.
Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Directional Power Doppler, Tissue Harmonic Imaging, Tissue Doppler Imaging, 3D/4D Imaging mode, Strain Elastography, Shear Wave Elastography, Contrast and Combined modes: B/M, B/PWD, B/THI, M/Color M, B/Color Doppler, B/Color Doppler/PWD, B/Power Doppler/PWD.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222596 · printed Nov 5, 2026
Cite this page
510(k) Report. “K222596: S90 Exp Series Digital Color Doppler Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K222596
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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