Palmtop Ultrasound Diagnostic System (MT10P/MT10)
Device Facts
| Record ID | K260111 |
|---|---|
| Device Name | Palmtop Ultrasound Diagnostic System (MT10P/MT10) |
| Applicant | Mytech Intelligence (Shenzhen) Co., Ltd. |
| Product Code | IYN · Radiology |
| Decision Date | May 14, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
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.
Device Story
Portable, wireless ultrasound system; consists of hand-held battery-operated transducer (convex or linear array) and mobile device (iOS/Android) running ultrasound application. Transducer uses piezoelectric material to transmit ultrasound waves; receives reflected echoes; converts to electrical signals; transmits wirelessly to mobile device for processing and display. Used in hospital settings by trained professional doctors. Provides B-mode, B/M-mode, Color Doppler, and Pulsed Doppler (PW) imaging. Enables real-time visualization of internal anatomy; supports clinical decision-making for OB/GYN, abdominal, small organ, and peripheral vessel assessments. MT10P model includes ultrasound teaching atlas.
Clinical Evidence
No clinical data. Bench testing only, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), ultrasound safety (IEC 60601-2-37), and FCC RF testing.
Technological Characteristics
Wireless hand-held transducer with piezoelectric elements; convex (3.5 MHz) and linear (5 MHz) arrays. Connectivity via wireless protocol to iOS/Android mobile devices. Powered by internal battery. Software-controlled imaging (B, B/M, Color/PW Doppler). Biocompatibility per ISO 10993-5/10. Compliance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-37.
Indications for Use
Indicated for diagnostic ultrasound imaging, measurement, and analysis of the human body in all patients. Applications include obstetrics, gynecology, abdominal, small organ, and peripheral vessel imaging. Contraindications not specified.
Regulatory Classification
Identification
An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Predicate Devices
- Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C,Type L, Type CT, Type CL) (K211321)
- Wireless Probe Type Ultrasound Scanner (Model: UProbe-C; UProbe-L; BProbe) (K172750)
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
May 14, 2026
Mytech Intelligence (Shenzhen) Co., Ltd.
% Amos Zou
Regulatory Director
Dongguan Woer Biotechnology Consulting Co., Ltd.
Room 802, Building 37, Sunshine Guangdong Garden
No. 72, Hengli Zhongshan East Road, Hengli Town
Dongguan, 523000
China
Re: K260111
Trade/Device Name: Palmtop Ultrasound Diagnostic System (MT10P/MT10)
Regulation Number: 21 CFR 892.1550
Regulation Name: Ultrasonic Pulsed Doppler Imaging System
Regulatory Class: Class II
Product Code: IYN, IYO, ITX
Dated: April 9, 2026
Received: April 9, 2026
Dear Amos Zou:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K260111 - Xulei Shi
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Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13484 clause 8.3 (Nonconforming product), and ISO 13485 clause 8.5 (Corrective and preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the
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K260111 - Xulei Shi
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Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Digitally signed by Michael D.
O'hara -S
Date: 2026.05.14 17:26:45 -04'00' For
Yanna Kang, Ph.D.
Assistant Director
Mammography and Ultrasound Team
DHT8C: Division of Radiological
Imaging and Radiation Therapy Devices
OHT8: Office of Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K260111 | ? |
| Please provide the device trade name(s). | | ? |
| Palmtop Ultrasound Diagnostic System (MT10P/MT10) | | |
| Please provide your Indications for Use below. | | ? |
| 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. | | |
| Mode of operation: - Model B scan - Model B/M scan - Doppler(Color) - Pulse Doppler(PW) | | |
| Operator qualifications: The operator should be capable to understand the Instructions for Use; The operator must be a trained professional doctor. | | |
| Device use settings: hospital. | | |
| Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |
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510(k) Summary
--K260111
1. 510(k) Submitter
- Sponsor:
| Company Name: | Mytech Intelligence (Shenzhen) Co., Ltd. |
| --- | --- |
| Address: | Room 605, 606, 615 & 616, Block R3-B, High-tech industrial village, No. 018, South 7th Gaoxin Road, Gaoxin Community, Yuehai Street, Nanshan District, Shenzhen,518100,China |
| Contact person: | Xulei Shi |
| TEL: | Engineer |
| E-mail: | will.shi@myetch-group.com |
- Application Correspondent:
| Company Name: | Dongguan Woer Biotechnology Consulting Co., Ltd. |
| --- | --- |
| Address: | Room 802, Building 37, No. 72 Zhongshan East Road, Hengli Town, Dongguan,Guangdong,523000,China |
| Contact person: | Mr. Amos Zou |
| TEL: | +86-15015249549 |
| E-mail: | 546977693@qq.com |
Date 510(k) Summary Prepared: March 19, 2026
2. Proposed Device and code:
| Trade Name of Device: | Palmtop Ultrasound Diagnostic System(MT10P / MT10) |
| --- | --- |
| Common Name: | 21 CFR 892.1550 |
| Regulation Name: | Ultrasonic pulsed doppler imaging system |
| Regulatory Class: | II |
| Product code: | IYN, IYO, ITX |
| Review Panel: | Radiology |
3. Predicate Device:
| 510(K) | Trade or Proprietary or Model Name | Manufacturer |
| --- | --- | --- |
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| K211321 | Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C,Type L, Type CT, Type CL | Guangzhou Sonostar Technologies Co., Ltd. |
| --- | --- | --- |
| K172750 | Wireless Probe Type Ultrasound Scanner (Model: UProbe-C; UProbe-L; BProbe) | Guangzhou Sonostar Technologies Co., Ltd. |
The predicate device has not been subject to a design-related recall.
# 4. Device Description
The Palmtop Ultrasound Diagnostic System consists of a probe, control button, and host unit. Probe types include convex array and linear array. The product line includes two models: MT10P (with ultrasound teaching atlas) and MT10 (without ultrasound teaching atlas).
Operating modes of the Palmtop Ultrasound Diagnostic System include B-mode, B/M-mode, Color Doppler, Pulsed Doppler (PW).
The Palmtop Ultrasound Diagnostic System is a wireless ultrasound system that uses pulsed-echo technology to transmit ultrasound images via wireless communication to a mobile device running iOS or Android operating systems.
Mobile devices compatible with the Palmtop Ultrasound Diagnostic System include those running iOS or Android, i.e., Apple iPad or iPhone devices and Android tablets or phones equipped with Snapdragon 660 (or equivalent or higher performance).
The Palmtop Ultrasound Diagnostic System is a portable, general-purpose, software-controlled, hand-held diagnostic ultrasound system composed of:
(1) a commercial off-the-shelf iOS or Android mobile device;
(2) the Wireless Probe Type Ultrasound Scanner application running on the mobile device;
(3) the battery-operated, hand-held Wireless Probe Type Ultrasound Scanner transducer that communicates wirelessly with iOS or Android mobile devices; and
(4) the instructions for use manual.
Device components are not supplied as sterile and do not require sterilization prior to use.
# 5 Indications for Use
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.
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Mode of operation:
- Model B scan
- Model B/M scan
- Doppler(Color)
- Pulse Doppler(PW)
Operator qualifications: The operator should be capable to understand the Instructions for Use; The operator must be a trained professional doctor.
Device use settings: hospital.
# 6 Comparison of Technological Characteristics with the Predicate Device
# 6.1 Predicate Device 1 (Primary)
| Comparison Item | Predicate Device | Subject Device |
| --- | --- | --- |
| Classification & Intended Use | | |
| 510(k) No.: | K211321 | K260111 |
| Company | Guangzhou Sonostar Technologies Co., Ltd. | Mytech Intelligence (Shenzhen) Co., Ltd. |
| Predicate Device: | Wireless Probe Type Ultrasound Scanner (Model: C Probe) | Palmtop Ultrasound Diagnostic System (MT10P / MT10) |
| Classification | Class II | Class II |
| Product Code | IYN, IYO, ITX | IYN, IYO, ITX |
| Intended Use | 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. | 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. |
| Technological Characteristics | | |
| Environment of Use | Hospital, clinic, and medical office settings | Hospital |
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| Acoustic Output Levels | Below FDA Track 3 limits in accordance with the September 2008 Ultrasound Systems Guidance | Below FDA Track 3 limits in accordance with the September 2008 Ultrasound Systems Guidance |
| --- | --- | --- |
| Imaging Capabilities | - B-mode - BM-mode - Color Doppler - Pulsed Doppler (PW) | - B-mode - B/M-mode - Color Doppler - Pulsed Doppler (PW) |
| Patient Population | For use in all patients | For use in all patients |
| Principle of Operation | Piezoelectric material in the transducer transmits ultrasound waves into the body. Reflected waves are received by the transducer and converted into electrical signals, which are processed and displayed as anatomical images. | Piezoelectric material in the transducer transmits ultrasound waves into the body. Reflected waves are received by the transducer and converted into electrical signals, which are processed and displayed as anatomical images. |
| Image Display Unit | Mobile device (approximately 4–13 inches) | Mobile device (approximately 4–13 inches) |
| Probe Characteristics | Convex array, 3.5 MHz | Convex array, 3.5 MHz |
| Probe Connection | Wireless | Wireless |
| Operating System | iOS / Android | iOS / Android |
| Software | Runs as an application on off-the-shelf mobile devices | Runs as an application on off-the-shelf mobile devices |
| System Components | Commercial off-the-shelf iOS mobile device; ultrasound application software; battery-operated hand-held wireless transducer | Commercial off-the-shelf iOS/Android mobile device; ultrasound application software; battery-operated hand-held wireless transducer |
| Safety & Performance | | |
| Biocompatibility | Evaluated per FDA-recognized standards ISO 10993-5 and ISO 10993-10 | Evaluated per FDA-recognized standards ISO 10993-5 and ISO 10993-10 |
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| Electrical Safety | Evaluated per IEC 60601-1 | Evaluated per IEC 60601-1 |
| --- | --- | --- |
| EMC | Evaluated per IEC 60601-1-2 | Evaluated per IEC 60601-1-2 |
| Ultrasound Safety | Evaluated per IEC 60601-2-37 | Evaluated per IEC 60601-2-37 |
## Brief Summary
The subject device (Model C Probe) has identical classification and indications for use as the predicate device, forming the basis for substantial equivalence.
The subject device has nearly identical technological characteristics to the predicate device. Differences are limited to imaging capabilities and environment of use. These differences do not affect the core function or safety profile, and the intended use environment of the subject device is fully encompassed by that of the predicate device. These facts further support that the devices are substantially equivalent.
The safety and effectiveness of the subject device have been evaluated against the same FDA-recognized standards as the predicate device, ensuring the subject device is as safe and effective as the predicate device.
Therefore, it is concluded that the subject device (Model C Probe) is **substantially equivalent** to the predicate device.
## 6.2 Predicate device 2 (Secondary)
Comparison for Probe Model L
| Comparison Item | Predicate Device | Subject Device |
| --- | --- | --- |
| Classification & Intended Use | | |
| 510(k) No.: | K172750 | K260111 |
| Company | Guangzhou Sonostar Technologies Co., Ltd. | Mytech Intelligence (Shenzhen) Co., Ltd. |
| Predicate Device: | Palmtop Ultrasound Diagnostic System | Palmtop Ultrasound Diagnostic System (MT10P / MT10) |
| Classification | Class II | Class II |
| Product Code | IYN, IYO, ITX | IYO, ITX |
| Intended Use | Intended for diagnostic ultrasound echo imaging, measurement, and analysis of the human body for general clinical applications including small organ and peripheral vessel | Intended for diagnostic ultrasound echo imaging, measurement, and analysis of the human body for general clinical applications including small organ and peripheral vessel |
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| | imaging. | imaging. |
| --- | --- | --- |
| Technological Characteristics | | |
| Environment of Use | Hospital | Hospital, clinic, medical office settings |
| Acoustic Output | Below FDA Track 3 limits (Sept 2008 guidance) | Below FDA Track 3 limits (Sept 2008 guidance) |
| Imaging Capabilities | B-mode, B/M-mode, Color Doppler, Pulsed Doppler (PW) | B-mode, B/M-mode |
| Patient Population | All patients | All patients |
| Operating Principle | Pulsed-echo ultrasound; piezoelectric transducer; wireless transmission to mobile display | Pulsed-echo ultrasound; piezoelectric transducer; wireless transmission to mobile display |
| Display | Mobile device (4–13 inches) | Mobile device (4–13 inches) |
| Probe Type | Linear array, 5 MHz | Linear array, 5 MHz |
| Communication | Wireless | Wireless |
| Operating System | iOS, Android | iOS |
| Software | Application-based on off-the-shelf mobile devices | Application-based on off-the-shelf mobile devices |
| Safety & Performance | | |
| Biocompatibility | ISO 10993-5, ISO 10993-10 | ISO 10993-5, ISO 10993-10 |
| Electrical Safety | IEC 60601-1 | IEC 60601-1 |
| EMC | IEC 60601-1-2 | IEC 60601-1-2 |
| Ultrasound Safety | IEC 60601-2-37 | IEC 60601-2-37 |
## Brief Summary
The subject device (Model L Probe) has identical indications for use to the predicate device. Classification is consistent, and product codes are aligned, forming the basis for substantial equivalence.
Technological characteristics are nearly identical. Differences are limited to imaging capabilities,
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environment of use, and operating system support. The addition of Android support expands compatibility but does not alter safety or effectiveness. The intended use environment of the subject device is fully encompassed by that of the predicate device. These facts further support substantial equivalence.
The subject device is demonstrated to be substantially equivalent to the legally marketed predicate device, and is safe and effective for its intended use.
Therefore, it is concluded that the subject device (Model L Probe) is substantially equivalent to the predicate device.
## 6.3 Clinical Test
Clinical testing was not performed for the Palmtop Ultrasound Diagnostic System as part of this 510(k) submission.
## 6.4 Non-Clinical Tests
Non-clinical testing and analysis were performed per the following standards to assure safety and performance:
- Electrical Safety: IEC 60601-1:2005 + AMD1:2012 + AMD2:2020 (Medical electrical equipment – Part 1: General requirements for basic safety and essential performance)
- Electromagnetic Compatibility: IEC 60601-1-2:2014 + A1:2020; EN 60601-1-2:2015 + A1:2021
- Ultrasound Safety & Performance: IEC 60601-2-37 (2nd edition, 2007)
- FCC RF Testing: FCC 47 CFR Part 15 Subpart C §15.247 (frequency hopping, direct sequence spread spectrum, and hybrid systems in 902–928 MHz, 2400–2483.5 MHz, and 5725–5850 MHz bands)
## 7 Conclusion
Based on the above comparisons and testing, it is concluded that the Palmtop Ultrasound Diagnostic System (MT10P / MT10) is as safe and effective as the legally marketed predicate devices cleared by the FDA.
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