MX6, MX6S, MX6T, MX6 Exp, MX6 Pro, MX6 Super, MXG, Emerus MX6, Emerus MX6 Exp, Anesus MX6, Anesus MX6 Exp, Crius MX6, Crius MX6 Exp, MX5, MX5S, MX5T, MX5 Exp, MX5 Pro, MX5 Super, MXI, Emerus MX5, Emerus MX5 Exp, Anesus MX5, Anesus MX5 Exp, Crius MX5, Crius MX5 Exp, MX3, MX3S, MX3T, MX3 Exp, MX3 Pro, MX3 Super, MXC, MX3 BW, MX2, MX2 BW Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in ophthalmic, fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional), musculo-skeletal(superficial), thoracic/pleural, cardiac adult, cardiac pediatric, peripheral vessel and urology, intra-operative(abdominal, thoracic, and vascular) , trans-esoph(Cardiac) exams.

This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals 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.

Modes of operation include: B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Combined mode (B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, iScape View, TDI, color M, Smart 3D, 4D(Real-time 3D), Strain Elastography, Contrast imaging (Contrast agent for LVO), Contrast imaging (Contrast agent for Liver).

Device Description

The MX6, MX6S, MX6T, MX6 Exp, MX6 Pro, MX6 Super, MXG, Emerus MX6, Emerus MX6 Exp, Anesus MX6, Anesus MX6 Exp, Crius MX6, Crius MX6 Exp, MX5, MX5S, MX5T, MX5 Exp, MX5 Pro, MX5 Super, MXI, Emerus MX5, Emerus MX5 Exp, Anesus MX5, Anesus MX5 Exp, Crius MX5, Crius MX5 Exp, MX3, MX3S, MX3T, MX3 Exp, MX3 Pro, MX3 Super, MXC, MX3 BW, MX2, MX2 BW Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound images in Modes of operation include: B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Combined mode(B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, iScape View, TDI, color M, Smart 3D, 4D(Real-time 3D), Strain Elastography, Contrast imaging (Contrast agent for LVO), Contrast imaging (Contrast agent for Liver).

AI/ML Overview

This FDA clearance letter for the Diagnostic Ultrasound System (MX6 series, MX5 series, and MX3 series) does not describe acceptance criteria for specific device performance, nor does it detail a study that proves the device meets such criteria.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices primarily through non-clinical tests related to general safety and design conformance.

Here's an analysis of why the requested information cannot be extracted from this document:

Table of acceptance criteria and reported device performance: This document explicitly states "Not applicable" for clinical studies and focuses on showing substantial equivalence based on comparison with predicate devices and conformance to general safety and design standards. There are no specific performance metrics (e.g., sensitivity, specificity, accuracy for a particular diagnostic task) or corresponding acceptance criteria presented.
Sample size, data provenance for test set: Since no clinical or performance study with a test set (in the context of AI/algorithm performance) is described, these details are not present.
Number of experts, qualifications for ground truth: Not applicable for the same reason as above. No ground truth establishment for a diagnostic performance test is mentioned.
Adjudication method: Not applicable.
Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not applicable. The document states "Clinical Studies: Not applicable." This type of study would typically be performed for devices with AI assistance measuring diagnostic performance.
Standalone (algorithm only) performance study: Not applicable. The device is a "general purpose diagnostic ultrasound system," implying human operation, and no mention of an "algorithm only" performance is made.
Type of ground truth used: Not applicable, as no external "ground truth" (like pathology or outcomes data) was used to assess diagnostic performance of the device itself in a clinical study. The equivalence is based on technical features and safety.
Sample size for training set: Not applicable. The document does not describe the development or training of any AI/ML models that would typically require a training set.
How ground truth for training set was established: Not applicable, as no training set is mentioned.

Summary of what the document does provide regarding acceptance criteria and "proof":

The "acceptance criteria" for this device's clearance are primarily conformance to established medical device safety standards and substantial equivalence to legally marketed predicate devices (Consona N9 (K221300) as the main predicate, and MX7 (K241432), Resona I9 (K241432), and Resona I9 (K210699) as reference devices).

The "study that proves the device meets the acceptance criteria" is a series of non-clinical tests and a comparison study.

1. Table of Acceptance Criteria (Inferred from the document) and "Reported Device Performance" (Comparison to Predicate):

Acceptance Criteria (Inferred)	Reported Device "Performance" / Conformance
1. Safety & Essential Performance: Conform to general safety and essential performance standards.	Device is designed in compliance with FDA recognized electrical and physical safety standards (e.g., ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-37). Assessed for thermal, electrical, and mechanical safety.
2. Electromagnetic Compatibility (EMC): Conform to EMC standards.	Device conforms to IEC 60601-1-2 (EMC requirements) and IEC TR 60601-4-2 (Guidance on Electromagnetic immunity).
3. Acoustic Output: Acoustic power levels below FDA guidance.	Acoustic power levels are "below the levels specified by FDA guidance 'Marketing Clearance of Diagnostic Ultrasound Systems and Transducers'". This was verified via testing against NEMA UD 2-2004 (R2009).
4. Biocompatibility: Patient-contact materials are safe.	Patient contact materials (transducers, needle-guided brackets) are either the same as predicate devices or "tested under ISO 10993-1."
5. Cleaning & Disinfection Effectiveness: Effective cleaning and disinfection.	Evaluated for cleaning and disinfection effectiveness (details not provided beyond being "evaluated").
6. Software Safety: Software development adheres to safety standards.	Conforms to IEC 62304 (medical device software life cycle processes) and IEC 62366-1 (usability engineering).
7. Risk Management: Application of risk management.	Adheres to ISO 14971 (application of risk management to medical devices).
8. Substantial Equivalence: Features, functions, and intended uses are comparable to predicate(s).	"Intended uses and other key features are consistent with traditional clinical practices, FDA guidelines and established methods of patient examination." Device is comparable to Consona N9 (K221300) and MX7 (K241432) regarding intended use, imaging modes, features, functions, and technological characteristics. The systems transmit ultrasonic energy, perform post-processing to display images, and allow measurements and calculations, similar to predicates. The only difference in Indications for Use (Ophthalmic) was covered by a reference predicate.

Study that Proves the Device Meets the Acceptance Criteria:

The "study" presented is a collection of non-clinical tests conducted to ensure the device meets safety and performance standards, and a comparison against predicate devices to demonstrate substantial equivalence.

Non-Clinical Tests: These tests confirmed adherence to various international and national standards:
- Acoustic Output: NEMA UD 2-2004 (R2009)
- Electrical Safety & Essential Performance: ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]
- Electromagnetic Disturbances: IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION, IEC TR 60601-4-2 Edition 1.0 2024-03
- Usability: IEC 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION, IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION
- Basic Safety & Performance of Ultrasonic Equipment: IEC 60601-2-37 Edition 2.1 2015
- Risk Management: ISO 14971 Third Edition 2019-12
- Biocompatibility: ISO 10993-1 Fifth edition 2018-08
- Software Life Cycle Processes: IEC 62304 Edition 1.1 2015-06
Comparison to Predicate Devices: The submission details a systematic comparison of the subject device (MX6/MX5/MX3 series) with its main predicate (Mindray Consona N9, K221300) and several reference predicates. This comparison covered:
- Intended Use: Minor differences were covered by reference predicates.
- Imaging Modes: Stated to be comparable.
- Features and Functions: Stated to be comparable.
- Technological Characteristics: Stated to be comparable.
- Patient Contact Materials: Verified to be the same or tested under ISO 10993-1.
- Acoustic Power Levels: Shown to be the same as predicate devices and within FDA guidance.
- Electrical and Physical Safety Standards: Device design shown to comply with the same standards as the predicate.

Additional Information (as requested, but N/A for this document):

Sample sized used for the test set and the data provenance: N/A (no clinical performance test set mentioned)
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (no ground truth for performance study mentioned)
Adjudication method: N/A
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: N/A (explicitly states "Clinical Studies: Not applicable." This is not an AI-assisted diagnostic device where such a study would be expected.)
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A (This is a diagnostic ultrasound system, implying human operation, not a standalone algorithm.)
The type of ground truth used (expert concensus, pathology, outcomes data, etc): N/A
The sample size for the training set: N/A (no AI/ML model training mentioned)
How the ground truth for the training set was established: N/A (no training set mentioned)

In conclusion, this document demonstrates that the Diagnostic Ultrasound System adheres to general safety and design standards and is substantially equivalent to existing cleared devices, rather than providing specific diagnostic performance metrics from a clinical study.

Summary

FDA Clearance Letter - Diagnostic Ultrasound System

Page 1

U.S. Food & Drug Administration

10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

May 16, 2025

Shenzhen Mindray Bio-medical Electronics Co., LTD.
Wei Zhang
Technical manager, Technical Regulation Department
Mindray Building, Keji 12th Road South,
Hi-tech Industrial Park, Nanshan
Shenzhen, Guangdong 518057
China

Re: K250110
Trade/Device Name: Diagnostic Ultrasound System (MX6); Diagnostic Ultrasound System (MX6S);
Diagnostic Ultrasound System (MX6T); Diagnostic Ultrasound System (MX6
Exp); Diagnostic Ultrasound System (MX6 Pro); Diagnostic Ultrasound System
(MX6 Super); Diagnostic Ultrasound System (MXG); Diagnostic Ultrasound
System (Emerus MX6); Diagnostic Ultrasound System (Emerus MX6 Exp);
Diagnostic Ultrasound System (Anesus MX6); Diagnostic Ultrasound System
(Anesus MX6 Exp); Diagnostic Ultrasound System (Crius MX6); Diagnostic
Ultrasound System (Crius MX6 Exp); Diagnostic Ultrasound System (MX5);
Diagnostic Ultrasound System (MX5S); Diagnostic Ultrasound System (MX5T);
Diagnostic Ultrasound System (MX5 Exp); Diagnostic Ultrasound System (MX5
Pro); Diagnostic Ultrasound System (MX5 Super); Diagnostic Ultrasound System
(MXI); Diagnostic Ultrasound System (Emerus MX5); Diagnostic Ultrasound
System (Emerus MX5 Exp); Diagnostic Ultrasound System (Anesus MX5);
Diagnostic Ultrasound System (Anesus MX5 Exp); Diagnostic Ultra
Regulation Number: 21 CFR 892.1550
Regulation Name: Ultrasonic Pulsed Doppler Imaging System
Regulatory Class: Class II
Product Code: IYN, IYO, ITX
Dated: January 15, 2025
Received: January 16, 2025

Dear Wei Zhang:

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

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K250110 - Wei Zhang Page 2

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
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 System (QS) regulation (21 CFR Part
820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming
product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a
change requires premarket review, the QS regulation requires device manufacturers to review and approve
changes to device design and production (21 CFR 820.30 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 systems (QS)
regulation (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.

Page 3

K250110 - Wei Zhang Page 3

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
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,

Lora D. Weidner, Ph.D.
Assistant Director
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

Page 4

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

Submission Number (if known)
K250110

Device Name
Diagnostic Ultrasound System (MX6);
Diagnostic Ultrasound System (MX6S);
Diagnostic Ultrasound System (MX6T);
Diagnostic Ultrasound System (MX6 Exp);
Diagnostic Ultrasound System (MX6 Pro);
Diagnostic Ultrasound System (MX6 Super);
Diagnostic Ultrasound System (MXG);
Diagnostic Ultrasound System (Emerus MX6);
Diagnostic Ultrasound System (Emerus MX6 Exp);
Diagnostic Ultrasound System (Anesus MX6);
Diagnostic Ultrasound System (Anesus MX6 Exp);
Diagnostic Ultrasound System (Crius MX6);
Diagnostic Ultrasound System (Crius MX6 Exp);
Diagnostic Ultrasound System (MX5);
Diagnostic Ultrasound System (MX5S);
Diagnostic Ultrasound System (MX5T);
Diagnostic Ultrasound System (MX5 Exp);
Diagnostic Ultrasound System (MX5 Pro);
Diagnostic Ultrasound System (MX5 Super);
Diagnostic Ultrasound System (MXI);
Diagnostic Ultrasound System (Emerus MX5);
Diagnostic Ultrasound System (Emerus MX5 Exp);
Diagnostic Ultrasound System (Anesus MX5);
Diagnostic Ultrasound System (Anesus MX5 Exp);
Diagnostic Ultrasound System (Crius MX5);
Diagnostic Ultrasound System (Crius MX5 Exp);
Diagnostic Ultrasound System (MX3);
Diagnostic Ultrasound System (MX3S);
Diagnostic Ultrasound System (MX3T);
Diagnostic Ultrasound System (MX3 Exp);
Diagnostic Ultrasound System (MX3 Pro);
Diagnostic Ultrasound System (MX3 Super);
Diagnostic Ultrasound System (MXC);
Diagnostic Ultrasound System (MX3 BW);
Diagnostic Ultrasound System (MX2);
Diagnostic Ultrasound System (MX2 BW)

Indications for Use (Describe)

Page 5

MX6, MX6S, MX6T, MX6 Exp, MX6 Pro, MX6 Super, MXG, Emerus MX6, Emerus MX6 Exp,
Anesus MX6, Anesus MX6 Exp, Crius MX6, Crius MX6 Exp, MX5, MX5S, MX5T, MX5 Exp, MX5
Pro, MX5 Super, MXI, Emerus MX5, Emerus MX5 Exp, Anesus MX5, Anesus MX5 Exp, Crius MX5,
Crius MX5 Exp, MX3, MX3S, MX3T, MX3 Exp, MX3 Pro, MX3 Super, MXC, MX3 BW, MX2, MX2
BW Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and
neonates. It is intended for use in ophthalmic, fetal, abdominal, pediatric, small organ(breast,
thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal
(conventional), musculo- skeletal(superficial), thoracic/pleural, cardiac adult, cardiac pediatric,
peripheral vessel and urology, intra-operative(abdominal, thoracic, and vascular) , trans-esoph
(Cardiac) exams.

This device is a general purpose diagnostic ultrasound system intended for use by qualified and
trained healthcare professionals 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.

Modes of operation include: B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Combined mode
(B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, iScape
View, TDI, color M, Smart 3D, 4D(Real-time 3D), Strain Elastography, Contrast imaging (Contrast
agent for LVO), Contrast imaging (Contrast agent for Liver).

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."

Page 6

510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in
accordance with the requirements of SMDA 1990 and 21 CFR §807.92(c).

The assigned 510(k) number: K250110

1. Submitter

Shenzhen Mindray Bio-medical Electronics Co., LTD
Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan,
Shenzhen, 518057, P. R. China

Tel: +86 755 8188 5655
Fax: +86 755 2658 2680

Contact Person

Zhang Wei
Shenzhen Mindray Bio-medical Electronics Co., LTD
Mindray Building, Keji 12th Road South, Hi-tech Industrial Park,
Nanshan, Shenzhen, 518057, P. R. China

Date Prepared: May 16, 2025

2. Device Name

Classification

Regulatory Class: II
Review Category: Tier II
21 CFR 892.1550 Ultrasonic Pulsed Doppler Imaging System (IYN)
21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System (IYO)
21 CFR 892.1570 Diagnostic Ultrasound Transducer (ITX)

3. Predicate devices

Page 7

MX6/MX5/MX3 series Diagnostic Ultrasound System is comparable with and
substantially equivalent to the predicate devices listed below. Consona N9 is the
main predicate devices.

Device	Manufacturer	Model	Device Class	Product Code	510K Number
1. Main predicate device	Mindray	Consona N9	II	IYN, IYO, ITX	K221300
2. Reference device	Mindray	MX7	II	IYN, IYO, ITX	K241432
3. Reference device	Mindray	Resona I9	II	IYN, IYO, ITX	K240684
4. Reference device	Mindray	Resona I9	II	IYN, IYO, ITX	K210699

The result shows the conformance of subject device to the predicate devices.
Regulation name and code
21 CFR 892.1550 Ultrasonic Pulsed Dopple Imaging System(IYN)
21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System (IYO)
21 CFR 892.1570 Diagnostic Ultrasound Transducer (ITX)

4. Device Description:

The MX6, MX6S, MX6T, MX6 Exp, MX6 Pro, MX6 Super, MXG, Emerus MX6,
Emerus MX6 Exp, Anesus MX6, Anesus MX6 Exp, Crius MX6, Crius MX6 Exp,
MX5, MX5S, MX5T, MX5 Exp, MX5 Pro, MX5 Super, MXI, Emerus MX5,
Emerus MX5 Exp, Anesus MX5, Anesus MX5 Exp, Crius MX5, Crius MX5 Exp,
MX3, MX3S, MX3T, MX3 Exp, MX3 Pro, MX3 Super, MXC, MX3 BW, MX2,
MX2 BW Diagnostic Ultrasound System is a general purpose, mobile, software
controlled, ultrasonic diagnostic system. Its function is to acquire and display
ultrasound images in Modes of operation include: B, M, PWD, CWD, Color
Doppler, Amplitude Doppler, Combined mode(B+M, PW+B, Color+B, Power+B,
PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, iScape View, TDI,
color M, Smart 3D, 4D(Real-time 3D), Strain Elastography, Contrast imaging
(Contrast agent for LVO), Contrast imaging (Contrast agent for Liver).

Page 8

5. Intended Use:

MX6, MX6S, MX6T, MX6 Exp, MX6 Pro, MX6 Super, MXG, Emerus MX6, Emerus
MX6 Exp, Anesus MX6, Anesus MX6 Exp, Crius MX6, Crius MX6 Exp, MX5,
MX5S, MX5T, MX5 Exp, MX5 Pro, MX5 Super, MXI, Emerus MX5, Emerus MX5
Exp, Anesus MX5, Anesus MX5 Exp, Crius MX5, Crius MX5 Exp, MX3, MX3S,
MX3T, MX3 Exp, MX3 Pro, MX3 Super, MXC, MX3 BW, MX2, MX2 BW
Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric
patients and neonates. It is intended for use in ophthalmic, fetal, abdominal, pediatric,
small organ(breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal,
trans-vaginal, musculo-skeletal(conventional), musculo-skeletal(superficial),
thoracic/pleural, cardiac adult, cardiac pediatric, peripheral vessel and urology, intra-
operative(abdominal, thoracic, and vascular) , trans-esoph(Cardiac) exams.

This device is a general purpose diagnostic ultrasound system intended for use by
qualified and trained healthcare professionals 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.

Modes of operation include: B, M, PWD, CWD, Color Doppler, Amplitude Doppler,
Combined mode(B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B),
Tissue Harmonic Imaging, iScape View, TDI, color M, Smart 3D, 4D(Real-time
3D), Strain Elastography, Contrast imaging (Contrast agent for LVO), Contrast
imaging (Contrast agent for Liver).

6. Comparison with Predicate Devices:

Subject device MX6, MX6S, MX6T, MX6 Exp, MX6 Pro, MX6 Super, MXG, Emerus
MX6, Emerus MX6 Exp, Anesus MX6, Anesus MX6 Exp, Crius MX6, Crius MX6
Exp, MX5, MX5S, MX5T, MX5 Exp, MX5 Pro, MX5 Super, MXI, Emerus MX5,
Emerus MX5 Exp, Anesus MX5, Anesus MX5 Exp, Crius MX5, Crius MX5 Exp,
MX3, MX3S, MX3T, MX3 Exp, MX3 Pro, MX3 Super, MXC, MX3 BW, MX2, MX2
BW Diagnostic Ultrasound System is comparable with and substantially equivalent to
these predicate devices mentioned in 3. Predicate Devices with regards to intended use,
imaging modes, features and functions and technological characteristics.

All systems transmit ultrasonic energy into patients, perform post processing of
received echoes to generate onscreen display of anatomic structures and fluid
flow within the body. All systems allow for specialized measurements of
structures and flow, as well as calculations.

Page 9

Subject device MX6, MX6S, MX6T, MX6 Exp, MX6 Pro, MX6 Super, MXG,
Emerus MX6, Emerus MX6 Exp, Anesus MX6, Anesus MX6 Exp, Crius MX6,
Crius MX6 Exp, MX5, MX5S, MX5T, MX5 Exp, MX5 Pro, MX5 Super, MXI,
Emerus MX5, Emerus MX5 Exp, Anesus MX5, Anesus MX5 Exp, Crius MX5,
Crius MX5 Exp, MX3, MX3S, MX3T, MX3 Exp, MX3 Pro, MX3 Super,MXC,
MX3 BW, MX2, MX2 BW Diagnostic Ultrasound System has the same intended
uses as the predicated device Consona N9 (K221300) except Ophthalmic
application. At the same time, Ophthalmic application have been cleared in
predicate device MX7(K241432).
The patient contact materials of the transducers and needle-guided brackets of
subject device MX6, MX6S, MX6T, MX6 Exp, MX6 Pro, MX6 Super, MXG,
Emerus MX6, Emerus MX6 Exp, Anesus MX6, Anesus MX6 Exp, Crius MX6,
Crius MX6 Exp, MX5, MX5S, MX5T, MX5 Exp, MX5 Pro, MX5 Super, MXI,
Emerus MX5, Emerus MX5 Exp, Anesus MX5, Anesus MX5 Exp, Crius MX5,
Crius MX5 Exp, MX3, MX3S, MX3T, MX3 Exp, MX3 Pro, MX3 Super, MXC,
MX3 BW, MX2, MX2 BW Diagnostic Ultrasound System are the same to the
predicate devices or tested under ISO 10993-1.
The acoustic power levels of MX6, MX6S, MX6T, MX6 Exp, MX6 Pro, MX6
Super, MXG, Emerus MX6, Emerus MX6 Exp, Anesus MX6, Anesus MX6 Exp,
Crius MX6, Crius MX6 Exp, MX5, MX5S, MX5T, MX5 Exp, MX5 Pro, MX5
Super, MXI, Emerus MX5, Emerus MX5 Exp, Anesus MX5, Anesus MX5 Exp,
Crius MX5, Crius MX5 Exp, MX3, MX3S, MX3T, MX3 Exp, MX3 Pro, MX3
Super, MXC, MX3 BW, MX2, MX2 BW Diagnostic Ultrasound System are are
below the levels specified by FDA guidance "Marketing Clearance of Diagnostic
Ultrasound Systems and Transducers", which are the same as the predicated devices
Consona N9 (K221300) and MX7(K241432).
MX6, MX6S, MX6T, MX6 Exp, MX6 Pro, MX6 Super, MXG, Emerus MX6,
Emerus MX6 Exp, Anesus MX6, Anesus MX6 Exp, Crius MX6, Crius MX6 Exp,
MX5, MX5S, MX5T, MX5 Exp, MX5 Pro, MX5 Super, MXI, Emerus MX5,
Emerus MX5 Exp, Anesus MX5, Anesus MX5 Exp, Crius MX5, Crius MX5 Exp,
MX3, MX3S, MX3T, MX3 Exp, MX3 Pro, MX3 Super, MXC, MX3 BW, MX2,
MX2 BW Diagnostic Ultrasound System is designed in compliance with the
FDA recognized electrical and physical safety standards, which are the same
as the predicated device Consona N9 (K221300).
MX6, MX6S, MX6T, MX6 Exp, MX6 Pro, MX6 Super, MXG, Emerus MX6,
Emerus MX6 Exp, Anesus MX6, Anesus MX6 Exp, Crius MX6, Crius MX6 Exp,
MX5, MX5S, MX5T, MX5 Exp, MX5 Pro, MX5 Super, MXI, Emerus MX5,
Emerus MX5 Exp, Anesus MX5, Anesus MX5 Exp, Crius MX5, Crius MX5 Exp,
MX3, MX3S, MX3T, MX3 Exp, MX3 Pro, MX3 Super, MXC, MX3 BW, MX2,
MX2 BW Diagnostic Ultrasound System has the equivalent features and
functions as the predicated devices Consona N9 (K221300).

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Main differences are between the subject and predicate device

Items	Subject Device MX6/MX5/MX3 series	Main predicate device Consona N9 (K221300)	Difference Description
Indications for use	It is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in ophthalmic, fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional), musculo-skeletal(superficial), thoracic/pleural, cardiac adult, cardiac pediatric, peripheral vessel and urology, intra-operative(abdominal, thoracic, and vascular) , trans-esoph(Cardiac) exams.	It is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, Intra-operative, pediatric, small organ(breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional), musculo-skeletal(superficial), Thoracic/Pleural, cardiac adult, cardiac pediatric, Trans-esoph., peripheral vessel and urology exams.	Ophthalmic application has been cleared in predicate device MX7 (K241432)
Features Options hardware	Probe Adapter PCM-Sm01 Probe Adapter PCM-CWm01 Mobile Trolley(MT3A/ MT3/ MT1)	Probe Adapter PCM-SA01 PCG	Main predicate device has different hardware options than Subject Device. The table shows the hardware options differences.
Options software	/	STE STQ SCV+ STIC Smart Pelvic Smart Hip Smart FLC Smart Fetal HR Ultra-Micro Angiography Smart ICV Smart Scene 3D Smart Volume Smart V Trace Smart Planes CNS	Main predicate device has more software options than Subject Device.

7. Non-clinical Tests:

Page 11

MX6, MX6S, MX6T, MX6 Exp, MX6 Pro, MX6 Super, MXG, Emerus MX6, Emerus
MX6 Exp, Anesus MX6, Anesus MX6 Exp, Crius MX6, Crius MX6 Exp, MX5,
MX5S, MX5T, MX5 Exp, MX5 Pro, MX5 Super, MXI, Emerus MX5, Emerus MX5
Exp, Anesus MX5, Anesus MX5 Exp, Crius MX5, Crius MX5 Exp, MX3, MX3S,
MX3T, MX3 Exp, MX3 Pro, MX3 Super, MXC, MX3 BW, MX2, MX2 BW
Diagnostic Ultrasound System has been evaluated for acoustic output,
biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical
and mechanical safety, and this device has been designed to conform with applicable
medical safety standards.

This device has been tested and evaluated under the following standards:

NEMA UD 2-2004 (R2009), acoustic output measurement standard for
diagnostic ultrasound equipment revision 3.
ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 &
A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] Medical electrical equipment
Part 1: General requirements for basic safety and essential performance (IEC
60601-1:2005, MOD) [Including Amendment 2 (2021)].
IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION, Medical
electrical equipment - Part 1-2: General requirements for basic safety and
essential performance - Collateral Standard: Electromagnetic disturbances -
Requirements and tests.
IEC TR 60601-4-2 Edition 1.0 2024-03 Medical electrical equipment - Part 4-2:
Guidance and interpretation - Electromagnetic immunity: performance of
medical electrical equipment and medical electrical systems
IEC 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION, Medical
electrical equipment - Part 1-6: General requirements for basic safety and
essential performance - Collateral standard: Usability.
IEC 60601-2-37 Edition 2.1 2015, Medical electrical equipment - Part 2-37:
Particular requirements for the basic safety and essential performance of
ultrasonic medical diagnostic and monitoring equipment.
ISO 14971 Third Edition 2019-12, Medical devices - Application of risk
management to medical devices.
ISO 10993-1 Fifth edition 2018-08, biological evaluation of medical devices -
part 1: evaluation and testing within a risk management process.
IEC 62304 Edition 1.1 2015-06, medical device software - software life cycle
processes.
IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION, Medical devices -
Part 1: Application of usability engineering to medical devices.

These non-clinical tests relied on in this premarket notification submission can
support the determination of substantial equivalence of the subject device.

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8. Clinical Studies

Not applicable. The subject of this submission, MX6, MX6S, MX6T, MX6 Exp, MX6
Pro, MX6 Super, MXG, Emerus MX6, Emerus MX6 Exp, Anesus MX6, Anesus MX6
Exp, Crius MX6, Crius MX6 Exp, MX5, MX5S, MX5T, MX5 Exp, MX5 Pro, MX5
Super, MXI, Emerus MX5, Emerus MX5 Exp, Anesus MX5, Anesus MX5 Exp, Crius
MX5, Crius MX5 Exp, MX3, MX3S, MX3T, MX3 Exp, MX3 Pro, MX3 Super, MXC,
MX3 BW, MX2, MX2 BW Diagnostic Ultrasound System, does not require clinical
studies to support substantial equivalence.

9. Summary

Based on the performance data as documented in the study, MX6, MX6S, MX6T,
MX6 Exp, MX6 Pro, MX6 Super, MXG, Emerus MX6, Emerus MX6 Exp, Anesus
MX6, Anesus MX6 Exp, Crius MX6, Crius MX6 Exp, MX5, MX5S, MX5T, MX5
Exp, MX5 Pro, MX5 Super, MXI, Emerus MX5, Emerus MX5 Exp, Anesus MX5,
Anesus MX5 Exp, Crius MX5, Crius MX5 Exp, MX3, MX3S, MX3T, MX3 Exp,
MX3 Pro, MX3 Super, MXC, MX3 BW, MX2, MX2 BW Diagnostic Ultrasound
System was found to have a safety and effectiveness profile that is similar to the
predicate device.

10. Conclusion:

Intended uses and other key features are consistent with traditional clinical practices,
FDA guidelines and established methods of patient examination. The design,
development and quality process of the manufacturer confirms with 21 CFR 820, ISO
9001 and ISO 13485 quality systems. The device conforms to applicable medical
device safety standards. Therefore, the MX6, MX6S, MX6T, MX6 Exp, MX6 Pro,
MX6 Super, MXG, Emerus MX6, Emerus MX6 Exp, Anesus MX6, Anesus MX6 Exp,
Crius MX6, Crius MX6 Exp, MX5, MX5S, MX5T, MX5 Exp, MX5 Pro, MX5 Super,
MXI, Emerus MX5, Emerus MX5 Exp, Anesus MX5, Anesus MX5 Exp, Crius MX5,
Crius MX5 Exp, MX3, MX3S, MX3T, MX3 Exp, MX3 Pro, MX3 Super, MXC, MX3
BW, MX2, MX2 BW Diagnostic Ultrasound System is substantially equivalent with
respect to safety and effectiveness to the predicate devices.

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
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.(b)
Classification. Class II.