510(k) · Cleared
ClearedPalmtop Ultrasound Diagnostic System (MT10P/MT10)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mytech Intelligence (Shenzhen) Co., Ltd. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on May 14, 2026 as substantially equivalent to K211321 (Guangzhou Sonostar Technologies Co., Ltd., 2022) and 1 other predicate after a 120-day review. Its family tree reaches back 13 generations to 1995.
- Decided
- May 14, 2026
- Review
- 120 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K935595 (1995). 104 ancestors in all, the oldest K850478 (1985). No later device cites it as a predicate yet.
- Root · 13 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 9 generations between
- 3 generations backK151339 SONON Ultrasound Imaging System (Model: SONON 300C)Healcerion Co., Ltd. · 2015
- 2 generations backK172750 Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L…Guangzhou Sonostar Technologies Co., Ltd. · 2018
- 1 generation backK211321 Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C…Guangzhou Sonostar Technologies Co., Ltd. · 2022
- This deviceK260111 Palmtop Ultrasound Diagnostic System (MT10P/MT10)Mytech Intelligence (Shenzhen) Co., Ltd. · 2026
Show all 13 generations
- Root · 13 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 12 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 11 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 10 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 9 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 8 generations backK051139 Acuson Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005
- 7 generations backK052410 Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005
- 6 generations backK063761 Acuson P10 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 5 generations backK090505 Speq Ultrasound SystemSignostics Pty, Ltd. · 2009
- 4 generations backK102153 Mobius Ultrasound Imaging SystemMobisante, Inc. · 2011
- 3 generations backK151339 SONON Ultrasound Imaging System (Model: SONON 300C)Healcerion Co., Ltd. · 2015
- 2 generations backK172750 Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L…Guangzhou Sonostar Technologies Co., Ltd. · 2018
- 1 generation backK211321 Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C…Guangzhou Sonostar Technologies Co., Ltd. · 2022
- This deviceK260111 Palmtop Ultrasound Diagnostic System (MT10P/MT10)Mytech Intelligence (Shenzhen) Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −12 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −11 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −10 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −9 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −8 | K051139 | Acuson Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −7 | K052410 | Acuson Sequoia Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −6 | K063761 | Acuson P10 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −5 | K090505 | Speq Ultrasound System | Signostics Pty, Ltd. | 2009 | — |
| −4 | K102153 | Mobius Ultrasound Imaging System | Mobisante, Inc. | 2011 | — |
| −3 | K151339 | SONON Ultrasound Imaging System (Model: SONON 300C) | Healcerion Co., Ltd. | 2015 | — |
| −2 | K172750 | Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe) | Guangzhou Sonostar Technologies Co., Ltd. | 2018 | — |
| −1 | K211321 | Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L… | Guangzhou Sonostar Technologies Co., Ltd. | 2022 | — |
| 0 (this device) | K260111 | Palmtop Ultrasound Diagnostic System (MT10P/MT10) | Mytech Intelligence (Shenzhen) Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 4 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 4 | 0 |
| 1994 | 6 | 0 |
| 1995 | 5 | 0 |
| 1996 | 6 | 0 |
| 1997 | 7 | 0 |
| 1998 | 6 | 0 |
| 1999 | 11 | 0 |
| 2000 | 5 | 0 |
| 2001 | 5 | 0 |
| 2002 | 7 | 0 |
| 2003 | 4 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2007 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 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.
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
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K211321 | Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT…Summary page 6…0(K) Trade or Proprietary or Model Name Manufacturer 1/7 K211321 Wireless Probe Type Ultrasound Scanner (Model: CProbe; Guangzhou Sonostar… | 2022 |
| * | K172750 | Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe)Summary page 6…gzhou Sonostar Technologies Co., Ltd. Type: Type C,Type L, Type CT, Type CL K172750 Wireless Probe Type Ultrasound Scanner (Model: UProbe-C; Guangzhou Sonostar… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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 31 years and passes through 7 companies; a new generation was cleared every 2.3 years on median.
- 7 of the 104 ancestors have a recall of any class.
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. 2026, 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 Palmtop Ultrasound Diagnostic System (Probe Model: C3-5) is intended for diagnostic ultrasound echo imaging measurement, and analysis of the human body for general clinical applications including obstetrics(OB), gynecology (GY) and general(abdominal) imaging.
The Palmtop Ultrasound Diagnostic System (Probe Model: L7-10) is intended for diagnostic ultrasound echo imaging, measurement, and analysis of the human body for general clinical applications including small organ and peripheral vessel imaging.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260111 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260111: Palmtop Ultrasound Diagnostic System (MT10P/MT10).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260111
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026