MX7/ MX7T/ Vaus7/ Zeus/ ME7/ Anesus ME7/ Anesus ME7T/ MX8/ MX8T/ Vaus8/ ME8 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, trans-rectal, transvaginal, musculo-skeletal(conventional), musculo- skeletal(superficial), thoracic/pleural, cardiac pediatric, peripheral vessel and urology exams.

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Ophthalmic, Fetal, Abdominal, Intra-operative (Specify*), Intra-operative (Neuro), Laparoscopic, Pediatric, Small Organ (Specify**), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Trans-esoph. (non-Card.), Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Intravascular, Thoracic/Pleural (Specify****), Cardiac Adult, Cardiac Pediatric, Intravascular (Cardiac), Trans-esoph. (Cardiac), Intra-cardiac, Peripheral vessel, Other (Specify***)

*Intraoperative includes abdominal, thoracic, and vascular etc.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
****For detection of fluid and pleural motion/sliding.

Device Description

MX7/ MX7T/ Vaus7/ Zeus/ ME7/ Anesus ME7/ Anesus ME7T/ MX8/ MX8T/ Vaus8/ ME8 Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-mode, M-mode, PW-mode, CW mode, Color-mode, Color M-mode, Power/Dirpower mode, TDI mode, THI, iScape, Biopsy Guidance, eSpacial Navi, Smart 3D mode, Strain Elastography, Contrast imaging (Contrast agent for Liver and LVO) or the combined mode (i.e. B/M-Mode).This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array.

AI/ML Overview

This document is a 510(k) Premarket Notification summary for a diagnostic ultrasound system. It does not describe an AI/ML-driven device, therefore, a detailed acceptance criteria table and study results for such a device are not present. However, I can extract the information related to the device's general performance and safety evaluations as presented in the document, which serves as a form of acceptance criteria for a medical device cleared via the 510(k) pathway.

The provided document describes the MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System. This is a general-purpose ultrasound system and not an AI/ML device in the sense of providing automated diagnoses or assisting human readers with AI. The "acceptance criteria" for such a device primarily revolve around safety, effectiveness, and substantial equivalence to legally marketed predicate devices, rather than AI performance metrics like sensitivity, specificity, or AUC.

Here's an analysis of the provided information concerning the device's acceptance criteria and the studies performed:

1. Acceptance Criteria and Reported Device Performance:

The document doesn't present a table with specific quantitative performance metrics as one would expect for an AI/ML device (e.g., accuracy, sensitivity, specificity). Instead, the acceptance criteria are met by demonstrating compliance with recognized medical device standards and showing substantial equivalence to predicate devices in terms of technology, intended use, and safety/effectiveness.

The reported "performance" is qualitative, focusing on whether the device meets regulatory and safety standards:

Acceptance Criterion (Implicit)	Reported Device Performance
Technological Equivalence	Employs same technology as predicate devices (ultrasonic energy transmission, post-processing for imaging and fluid flow).
Clinical Indications Equivalence	Comparable clinical indications for use as predicate devices. New applications (ophthalmic, thoracic/pleural) are cleared on reference predicates.
Imaging Modes Equivalence	Identical imaging modes to predicate M9 (K171034), with additional special functions (Auto EF, R-VQS, RIMT, eSpacial Navi, Smart B-line, Smart VTI, Smart IVC) cleared on other reference predicates.
System Features Equivalence	Similar capability in comments, body marks, report, cine, file system, preset and other options. Supports iVocal (cleared on predicate TE7).
Material Safety (Biocompatibility)	Manufactured with materials evaluated and found safe. Probes and biopsy brackets passed biocompatibility (Haemolysis, Acute systemic toxicity, Cytotoxicity, Intracutaneous reactivity, Sensitization).
Acoustic Output Power	Levels are below applicable FDA limits. ALARA principle is explained in the operator's manual.
Electrical and Physical Safety (EMC, Thermal, Mechanical)	Compliant with AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37. In-house testing for thermal, mechanical, and electrical safety.
Software Safety and Lifecycle	Compliant with IEC 62304 (Software Life Cycle Processes), ISO 14971 (Risk Management), IEC 62366-1 (Usability Engineering), IEC 60601-1-6 (Usability). Software level of concern determined as "moderate".
Cleaning and Disinfection Effectiveness	Validated for proper maintenance, inspection, cleaning, disinfection, and sterilization. No components are provided sterile.

2. Sample Size Used for the Test Set and Data Provenance:

The document explicitly states "7. Clinical Tests: Not Applicable." This indicates that no clinical study involving human subjects or real patient data (test sets) was performed for this 510(k) submission to demonstrate performance in a clinical setting. The evaluation relied entirely on non-clinical tests (bench testing, engineering validation, adherence to standards).

Therefore, there is no sample size for a test set, nor specific data provenance (country of origin, retrospective/prospective) related to patient data. The "tests" mentioned are primarily engineering and compliance tests.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Since no clinical tests or human reader studies were conducted as part of this submission, there is no information provided regarding experts establishing ground truth for a test set.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set was used for performance evaluation that would require adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. The device is a diagnostic ultrasound system (hardware and general software features), not an AI-assisted diagnostic tool that would typically undergo MRMC studies to evaluate human reader improvement. The document does not mention any AI capabilities that assist human readers.

6. Standalone (Algorithm Only) Performance:

Not applicable. This is a medical device, not a standalone algorithm. The "performance" is inherent to the system's ability to acquire and display ultrasound images and perform basic measurements, which is evaluated through engineering and safety standards.

7. Type of Ground Truth Used:

For the evaluation described, the "ground truth" is established by:

Compliance with recognized standards: The device's technical specifications and safety features are compared against established industry and regulatory standards (e.g., IEC, ISO).
Substantial equivalence to predicate devices: The functionality, safety, and performance characteristics are determined to be similar enough to already-cleared devices, implying that if the predicate is safe and effective, so is the new device.
Engineering validation and bench testing: Physical measurements and tests demonstrating that the device operates within specified parameters and does not pose undue risks (e.g., acoustic output, temperature, electrical safety).

8. Sample Size for the Training Set:

Not applicable. This is not an AI/ML device, so there is no training set in the machine learning sense. The device's "training" and validation are part of its design, manufacturing, and quality control processes to ensure it meets its specifications and regulatory requirements.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for an AI/ML model. The "ground truth" for the device's development and validation relies on engineering principles, scientific understanding of ultrasound physics, and established medical device safety and performance standards.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 9, 2020

Shenzhen Mindray Bio-Medical Electronics Co., Ltd. % Shi Jufang Engineer of Technical Regulation Keji 12th Road South, Hi-tech Industrial Park Shenzhen, Guangdong 518057 CHINA

Re: K200001

Trade/Device Name: MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/ MX8T/ Vaus8/ME8 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: March 18, 2020 Received: March 23, 2020

Dear Shi Jufang:

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 (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 located 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.

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

{1}------------------------------------------------

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-device-safety/medical-device-reportingmdr-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/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

K200001

Device Name

MX7/ MX7T/ Vaus7/ Zeus/ ME7/ Anesus ME7/ Anesus ME7T/ MX8/ MX8T/ Vaus8/ ME8 Diagnostic Ultrasound System

Indications for Use (Describe)

510(k) Number (if known)

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.

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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
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"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."

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System:	MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound
Transducer:	/

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:

Clinical Application	Specific (Track 1 & 3)	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Combined (specify)	Other (specify)
General (Track 1 Only)
Ophthalmic	Ophthalmic	N		N		N		N
Fetal Imaging & Other	Fetal	N	N	N		N	N	N	Note 1,2,4,5,6
	Abdominal	N	N	N	N	N	N	N	Note 1,2,4,5,6,9,1
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N	N	N	N	N	Note 1,2,4,5,6,10
	Small Organ (Specify**)	N	N	N	N	N	N	N	Note 1,2,4,5,6,7,1
	Neonatal Cephalic	N	N	N	N	N	N	N	Note 1,2,4,5,6
	Adult Cephalic	N	N	N	N	N	N	N	Note 1,2,4,5,6
	Trans-rectal	N	N	N	N	N	N	N	Note 1,2,4,5,6,7
	Trans-vaginal	N	N	N	N	N	N	N	Note 1,2,4,5,6,7
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)	N	N	N		N	N	N	Note 1,2,4,5,6,7,1
	Musculo-skeletal (Superficial)	N	N	N		N	N	N	Note 1,2,4,5,6,7,1
	Intravascular
	Thoracic/Pleural (Specify****)	N	N	N		N	N	N	Note 1,2,4,5,6,10
Cardiac	Cardiac Adult	N	N	N	N	N	N	N	Note 1,2,3,4,5,6,8
	Cardiac Pediatric	N	N	N	N	N	N	N	Note 1,2,3,4,5,6
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral vessel	Peripheral vessel	N	N	N		N	N	N	Note 1,2,4,5,6,7,1
vessel	Other (Specify***)	N	N	N		N	N	N	Note 1,2,4,5,6,7
	N=new indication; P=previously cleared by FDA; E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power + PW +B.
	*Intraoperative includes abdominal, thoracic, and vascular etc.
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	****For detection of fluid and pleural motion/sliding.
	Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
	Note 2: iScape
	Note 3: TDI
	Note 4: Color M
	Note 5: Biopsy Guidance
	Note 6: Smart 3D
	Note 7: Strain Elastography
	Note 8: Contrast imaging (Contrast agent for LVO)
	Note 9: Contrast imaging (Contrast agent for Liver)
	Note 10: eSpacial Navi

	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application							Mode of Operation
General (Track	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
1 Only)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal	N	N	N	N	N	N	N	Note 1,2,4,5,6
	Abdominal	N	N	N	N	N	N	N	Note 1,2,4,5,6,9
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N	N	N	N	N	Note 1,2,4,5,6
	Small Organ (Specify**)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
	(Conventional)	N	N	N	N	N	N	N	Note 1,2,4,5,6
	Musculo-skeletal
	(Superficial)
	Intravascular
	Thoracic/Pleural
	(Specify****)	N	N	N	N	N	N	N	Note 1,2,4,5,6
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel	N	N	N	N	N	N	N	Note 1,2,4,5,6
	Other (Specify***)	N	N	N	N	N	N	N	Note 1,2,4,5,6
	N=new indication; P=previously cleared by FDA; E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW +Color+B、Power + PW +B.
	*Intraoperative includes abdominal, thoracic, and vascular etc.
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	****For detection of fluid and pleural motion/sliding.
	Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
	Note 2: iScape
	Note 3: TDI
	Note 4: Color M
	Note 5: Biopsy Guidance
	Note 6: Smart 3D
	Note 7: Strain Elastography
	Note 8: Contrast imaging (Contrast agent for LVO)
	Note 9: Contrast imaging (Contrast agent for Liver)
	Note 10: eSpacial Navi
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

	Prescription USE (Per 21 CFR 801.109)
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application	Mode of Operation
General (Track	Specific (Track 1 & 3)	B	M	PWD	CWD	Color	Amplitude	Combined	Other (specify)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal	N	N	N		N	N	N	Note 1,2,4,5,6
	Abdominal	N	N	N		N	N	N	Note 1,2,4,5,6,9
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	N	N	Note 1,2,4,5,6
	Small Organ (Specify**)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)	N	N	N		N	N	N	Note 1,2,4,5,6
	Musculo-skeletal(Superficial)
	Intravascular
	Thoracic/Pleural(Specify****)	N	N	N		N	N	N	Note 1,2,4,5,6
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel	N	N	N		N	N	N	Note 1,2,4,5,6
	Other (Specify***)	N	N	N		N	N	N	Note 1,2,4,5,6
	N=new indication; P=previously cleared by FDA; E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power + PW +B.
	*Intraoperative includes abdominal, thoracic, and vascular etc.
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	****For detection of fluid and pleural motion/sliding.
	Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
	Note 2: iScape
	Note 3: TDI
	Note 4: Color M
	Note 5: Biopsy Guidance
	Note 6: Smart 3D
	Note 7: Strain Elastography
	Note 8: Contrast imaging (Contrast agent for LVO)
	Note 9: Contrast imaging (Contrast agent for Liver)
	Note 10: eSpacial Navi
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of Device Evaluation(ODE)
	Prescription USE (Per 21 CFR 801.109)
Transducer:	V11-3s
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application								Mode of Operation
General (Track1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal	N	N	N	N	N	N	N	Note 1,2,4,5,6
	Abdominal
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	N	N	N	N	N	N	N	Note 1,2,4,5,6,7
	Trans-vaginal	N	N	N	N	N	N	N	Note 1,2,4,5,6,7
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Intravascular
	Thoracic/Pleural(Specify****)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel
	Other (Specify***)	N	N	N	N	N	N	N	Note 1,2,4,5,6,7
	N=new indication; P=previously cleared by FDA; E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW +Color+B、Power + PW +B.
	*Intraoperative includes abdominal, thoracic, and vascular etc.
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	****For detection of fluid and pleural motion/sliding.
	Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
	Note 2: iScape
	Note 3: TDI
	Note 4: Color M
	Note 5: Biopsy Guidance
	Note 6: Smart 3D
	Note 7: Strain Elastography
	Note 8: Contrast imaging (Contrast agent for LVO)
	Note 9: Contrast imaging (Contrast agent for Liver)
	Note 10: eSpacial Navi
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of Device Evaluation(ODE)
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application							Mode of Operation
General (Track1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal	N	N	N		N	N	N	Note 1,2,4,5,6
	Abdominal
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	N	N	N		N	N	N	Note 1,2,4,5,6,7
	Trans-vaginal	N	N	N		N	N	N	Note 1,2,4,5,6,7
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Intravascular
	Thoracic/Pleural(Specify****)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel
	Other (Specify***)	N	N	N		N	N	N	Note 1,2,4,5,6,7
	N=new indication; P=previously cleared by FDA; E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW +Color+ B、Power + PW +B.
	*Intraoperative includes abdominal, thoracic, and vascular etc.
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	****For detection of fluid and pleural motion/sliding.
	Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
	Note 2: iScape
	Note 3: TDI
	Note 4: Color M
	Note 5: Biopsy Guidance
	Note 6: Smart 3D
	Note 7: Strain Elastography
	Note 8: Contrast imaging (Contrast agent for LVO)
	Note 9: Contrast imaging (Contrast agent for Liver)
	Note 10: eSpacial Navi
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of Device Evaluation(ODE)
	Prescription USE (Per 21 CFR 801.109)
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application							Mode of Operation
General (Track1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal
	Abdominal	N	N	N	N	N	N	N	Note 1,2,6,10
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N	N	N	N	N	Note 1,2,6,10
	Small Organ (Specify**)	N	N	N	N	N	N	N	Note 1,2,6,7,10
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)	N	N	N	N	N	N	N	Note 1,2,6,10
	Musculo-skeletal(Superficial)	N	N	N	N	N	N	N	Note 1,2,6,10
	Intravascular
	Thoracic/Pleural(Specify****)	N	N	N	N	N	N	N	Note 1,2,6,10
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel	N	N	N	N	N	N	N	Note 1,2,6,10
	Other (Specify***)
	N=new indication; P=previously cleared by FDA; E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power + PW+B.
	*Intraoperative includes abdominal, thoracic, and vascular etc.
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	****For detection of fluid and pleural motion/sliding.
	Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
	Note 2: iScape
	Note 3: TDI
	Note 4: Color M
	Note 5: Biopsy Guidance
	Note 6: Smart 3D
	Note 7: Strain Elastography
	Note 8: Contrast imaging (Contrast agent for LVO)
	Note 9: Contrast imaging (Contrast agent for Liver)
	Note 10: eSpacial Navi
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of Device Evaluation(ODE)
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application							Mode of Operation
General (Track1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal
	Abdominal	N	N	N		N	N	N	Note 1,2,5,6
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	N	N	Note 1,2,5,6
	Small Organ (Specify**)	N	N	N		N	N	N	Note 1,2,5,6,7
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)	N	N	N		N	N	N	Note 1,2,5,6
	Musculo-skeletal(Superficial)	N	N	N		N	N	N	Note 1,2,5,6
	Intravascular
	Thoracic/Pleural(Specify****)	N	N	N		N	N	N	Note 1,2,5,6
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel	N	N	N		N	N	N	Note 1,2,5,6
	Other (Specify***)
N=new indication; P=previously cleared by FDA; E=added under Appendix E
Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power + PW+B.
*Intraoperative includes abdominal, thoracic, and vascular etc.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
****For detection of fluid and pleural motion/sliding.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: iScape
Note 3: TDI
Note 4: Color M
Note 5: Biopsy Guidance
Note 6: Smart 3D
Note 7: Strain Elastography
Note 8: Contrast imaging (Contrast agent for LVO)
Note 9: Contrast imaging (Contrast agent for Liver)
Note 10: eSpacial Navi
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)
Prescription USE (Per 21 CFR 801.109)
Transducer:	L13-3sDiagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application		Mode of Operation
General (Track1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic	N		N		N		N
Fetal Imaging& Other	Fetal
	Abdominal	N	N	N		N	N	N	Note 1,2,5,6
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	N	N	Note 1,2,5,6
	Small Organ (Specify**)	N	N	N		N	N	N	Note 1,2,5,6,7
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)	N	N	N		N	N	N	Note 1,2,5,6
	Musculo-skeletal(Superficial)	N	N	N		N	N	N	Note 1,2,5,6
	Intravascular
	Thoracic/Pleural(Specify****)	N	N			N	N	N	Note 1,2,5,6
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel	N	N	N		N	N	N	Note 1,2,5,6
	Other (Specify***)
	N=new indication; P=previously cleared by FDA; E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW +Color+B、Power + PW +B.
	*Intraoperative includes abdominal, thoracic, and vascular etc.
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	****For detection of fluid and pleural motion/sliding.
	Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
	Note 2: iScape
	Note 3: TDI
	Note 4: Color M
	Note 5: Biopsy Guidance
	Note 6: Smart 3D
	Note 7: Strain Elastography
	Note 8: Contrast imaging (Contrast agent for LVO)
	Note 9: Contrast imaging (Contrast agent for Liver)
	Note 10: eSpacial Navi
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of Device Evaluation(ODE)
Transducer:	L13-3Ns
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application		Mode of Operation
General (Track1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic	N		N		N		N
Fetal Imaging& Other	Fetal
	Abdominal	N	N	N		N	N	N	Note 1,2,5,6
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	N	N	Note 1,2,5,6
	Small Organ (Specify**)	N	N	N		N	N	N	Note 1,2,5,6,7
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)	N	N	N		N	N	N	Note 1,2,5,6
	Musculo-skeletal	N	N	N		N	N	N	Note 1,2,5,6
	Intravascular
	Thoracic/Pleural	N	N			N	N	N	Note 1,2,5,6
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel	N	N	N		N	N	N	Note 1,2,5,6
	Other (Specify***)
	N=new indication; P=previously cleared by FDA; E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power + PW +B.
	*Intraoperative includes abdominal, thoracic, and vascular etc.
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	****For detection of fluid and pleural motion/sliding.
	Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
	Note 2: iScape
	Note 3: TDI
	Note 4: Color M
	Note 5: Biopsy Guidance
	Note 6: Smart 3D
	Note 7: Strain Elastography
	Note 8: Contrast imaging (Contrast agent for LVO)
	Note 9: Contrast imaging (Contrast agent for Liver)
	Note 10: eSpacial Navi
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of Device Evaluation(ODE)
Transducer:	L14-6Ns
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application	Specific (Track 1 & 3)	Mode of Operation						Other (specify)
		B	M	PWD	CWD	Color Doppler	Amplitude Doppler		Combined (specify)
General (Track 1 Only)	Ophthalmic	N		N		N		N
Fetal Imaging & Other	Fetal
	Abdominal	N	N	N		N	N	N	Note 1,2,5,6
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	N	N	Note 1,2,5,6
	Small Organ (Specify**)	N	N	N		N	N	N	Note 1,2,5,6,7
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal	N	N	N		N	N	N	Note 1,2,5,6
	Musculo-skeletal	N	N	N		N	N	N	Note 1,2,5,6
	Intravascular
	Thoracic/Pleural	N	N	N		N	N	N	Note 1,2,5,6
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral vessel	Peripheral vessel	N	N	N		N	N	N	Note 1,2,5,6
	Other (Specify***)
	N=new indication; P=previously cleared by FDA; E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power + PW +B.
	*Intraoperative includes abdominal, thoracic, and vascular etc.
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	****For detection of fluid and pleural motion/sliding.
	Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
	Note 2: iScape
	Note 3: TDI
	Note 4: Color M
	Note 5: Biopsy Guidance
	Note 6: Smart 3D
	Note 7: Strain Elastography
	Note 8: Contrast imaging (Contrast agent for LVO)
	Note 9: Contrast imaging (Contrast agent for Liver)
	Note 10: eSpacial Navi
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of Device Evaluation(ODE)
Transducer:	L20-5s
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
		Mode of Operation
General (Track1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic	N		N		N		N
Fetal Imaging& Other	Fetal
	Abdominal
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	N	N	Note 1,2,6
	Small Organ (Specify**)	N	N	N		N	N	N	Note 1,2,6,7
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal	N	N	N		N	N	N	Note 1,2,6,7
	Musculo-skeletal	N	N	N		N	N	N	Note 1,2,6,7
	Intravascular
	Thoracic/Pleural
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel	N	N	N		N	N	N	Note 1,2,6
	Other (Specify***)
	N=new indication; P=previously cleared by FDA; E=added under Appendix E
	Additional comments: Combined modes--B+M, PW+B, Color + B, Power + B, PW+Color+B, Power + PW +B.
	*Intraoperative includes abdominal, thoracic, and vascular etc.
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	****For detection of fluid and pleural motion/sliding.
	Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
	Note 2: iScape
	Note 3: TDI
	Note 4: Color M
	Note 5: Biopsy Guidance
	Note 6: Smart 3D
	Note 7: Strain Elastography
	Note 8: Contrast imaging (Contrast agent for LVO)
	Note 9: Contrast imaging (Contrast agent for Liver)
	Note 10: eSpacial Navi
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of Device Evaluation(ODE)
General (Track1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal
	Abdominal	N	N	N	N	N	N	N	Note 1,2,4,5,6
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N	N	N	N	N	Note 1,2,4,5,6
	Small Organ (Specify**)
	Neonatal Cephalic	N	N	N	N	N	N	N	Note 1,2,4,5,6
	Adult Cephalic	N	N	N	N	N	N	N	Note 1,2,4,5,6
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
	Musculo-skeletal
	Intravascular
	Thoracic/Pleural	N	N	N	N	N	N	N	Note 1,2,4,5,6
Cardiac	Cardiac Adult	N	N	N	N	N	N	N	Note 1,2,3,4,5,6,8
	Cardiac Pediatric	N	N	N	N	N	N	N	Note 1,2,3,4,5,6
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel
	Other (Specify***)
N=new indication; P=previously cleared by FDA; E=added under Appendix E
Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular etc.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
****For detection of fluid and pleural motion/sliding.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: iScape
Note 3: TDI
Note 4: Color M
Note 5: Biopsy Guidance
Note 6: Smart 3D
Note 7: Strain Elastography
Note 8: Contrast imaging (Contrast agent for LVO)
Note 9: Contrast imaging (Contrast agent for Liver)Note 10: eSpacial Navi
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)
Prescription USE (Per 21 CFR 801.109)
Transducer:	SP5-1Ns
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application							Mode of Operation
General (Track1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal
	Abdominal	N	N	N	N	N	N	N	Note 1,2,4,5,6
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N	N	N	N	N	Note 1,2,4,5,6
	Small Organ (Specify**)
	Neonatal Cephalic	N	N	N	N	N	N	N	Note 1,2,4,5,6
	Adult Cephalic	N	N	N	N	N	N	N	Note 1,2,4,5,6
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
	Musculo-skeletal
	Intravascular
	Thoracic/Pleural	N	N	N	N	N	N	N	Note 1,2,4,5,6
Cardiac	Cardiac Adult	N	N	N	N	N	N	N	Note 1,2,3,4,5,6,8
	Cardiac Pediatric	N	N	N	N	N	N	N	Note 1,2,3,4,5,6
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel
	Other (Specify***)
	N=new indication; P=previously cleared by FDA; E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power + PW +B.
	*Intraoperative includes abdominal, thoracic, and vascular etc.
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	****For detection of fluid and pleural motion/sliding.
	Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
	Note 2: iScape
	Note 3: TDI
	Note 4: Color M
	Note 5: Biopsy Guidance
	Note 6: Smart 3D
	Note 7: Strain ElastographyNote 8: Contrast imaging (Contrast agent for LVO)
	Note 9: Contrast imaging (Contrast agent for Liver)
	Note 10: eSpacial Navi

{4}------------------------------------------------

MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System: Transducer: C5-1s

{5}------------------------------------------------

System: MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound Transducer: SC5-1Ns

{6}------------------------------------------------

System: MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound Transducer: V 11-3s

{7}------------------------------------------------

System: MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound Transducer: V 1 1 - 3 Hs

{8}------------------------------------------------

System: MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound Transducer: L11-3VNs

d imaging or fluid flow analysis of the human body as follo

{9}------------------------------------------------

System: MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound Transducer: L12-3RCs

{10}------------------------------------------------

MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System: Transducer: L13-3s

{11}------------------------------------------------

System: MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound Transducer:
Intended Use L13-3Ns

{12}------------------------------------------------

System: MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound Transducer:

Intended Use L14-6Ns

{13}------------------------------------------------

System: MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound Transducer:
Intended Use L20-5s

{14}------------------------------------------------

System: MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound Transducer: P4-2s

{15}------------------------------------------------

System: MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound Transducer:

Intended Use SP5-1Ns

{16}------------------------------------------------

K200001

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.

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 6293 Fax: +86 755 2658 2680

Contact Person:

Shi Jufang 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: D December 27, 2019

Device Name: MX7/ MX7T/ Vaus7/ Zeus/ ME7/ Anesus ME7/ Anesus ME7T/ MX8/ MX8T/ Vaus8/ ME8 Diagnostic Ultrasound System

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)

{17}------------------------------------------------

3. Device Description:

4. Intended Use:

The MX7/ MX7T/ Vaus7/ Zeus/ ME7/ Anesus ME7/ Anesus ME7T/ MX8/ MX8T/ Vaus8/ ME8 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), musculoskeletal(superficial), thoracic/pleural, cardiac adult, cardiac pediatric, peripheral vessel and urology exams.

5. Comparison with Predicate Devices:

MX7/ MX7T/ Vaus7/ Zeus/ ME7/ Anesus ME7/ Anesus ME7T/ MX8/ MX8T/ Vaus8/ ME8 Diagnostic Ultrasound System is comparable with and substantially equivalent to these predicate devices:

Predicate Device	Manufacturer	Model	510(k)Number
1. Primarypredicate device	Mindray	M9	K171034
2. Referencedevice	Mindray	TE7	K180912
3. Referencedevice	Mindray	DC-70	K181637
4. Referencedevice	Mindray	DC-8	K170277

Page 2 of 7

{18}------------------------------------------------

5. Referencedevice	Mindray	Resona 7	K171233
6. Referencedevice	GE Medical SystemsUltrasound and PrimaryCare Diagnostics, LLC	Venue	K180599

MX7/ MX7T/ Vaus7/ Zeus/ ME7/ Anesus ME7/ Anesus ME7T/ MX8/ MX8T/ Vaus8/ ME8 Diagnostic Ultrasound System employs the same technology as the predicate devices. All systems transmit ultrasonic energy into patients, then 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, and calculations.

The subject and predicate devices are based on the following same technological elements:

The systems are all intended for ultrasound imaging, measurement and analysis of the human body and fluid for multiple clinical applications.
. The subject device and predicate M9 (K171034) have similar clinical indications for use however the proposed subject device has the ophthalmic and thoracic/pleural applications which has been cleared on predicate Venue (K180599).
. The systems are all mainly consisted of main units and transducers.
. The subject device and predicate M9 (K171034) have identical imaging modes, similar special functions however the proposed subject device has the Auto EF, R-VQS, RIMT, eSpacial Navi, Smart B-line, Smart VTI and Smart IVC functions which has been cleared on predicate DC-70(K181637)/Resona7(K171233)/TE7 (K180912)/ (Venue (K180599) .
. The subject device and predicate M9 (K171034) have similar capability in terms of comments, body marks, report, cine, file system and preset and other options however the proposed subject device supports iVocal which has been cleared on predicate TE7 (K180912).
. The system is manufactured with materials which have been evaluated and found to be safe for the intended use of the device.

Page 3 of 7

{19}------------------------------------------------

. The systems have acoustic power levels which are below the applicable FDA limits.
. The subject device is designed in compliance with the FDA recognized electrical and physical safety standards, which are the same as the predicated device predicate M9 (K171034).

The following technological differences exist between the subject and predicate devices:

. Most of transducers of subject device and predicate M9 (K171034) and TE7 (K180912) are same, but rest transducers have same transducer types, modes of operation and applications compared with predicate device. And the subject device has been tested under the AAMI / ANSI ES60601-1, IEC60601-1-2 etc, they are safe and effective.
The subject device is not intended to have intra-operative application, which is already cleared in the predicated M9 (K171034).

6. Non-clinical Tests:

MX7/ MX7T/ Vaus7/ Zeus/ ME7/ Anesus ME7/ Anesus ME7T/ MX8/ MX8T/ Vaus8/ ME8 Diagnostic Ultrasound System has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety, and has been found to conform with applicable medical safety standards.

Non-clinical tests relied on in this premarket notification submission for a determination of substantial equivalence include testing showing compliance with the following standards:

AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, c1:2009/(r)2012 and a2:2010/(r)2012 (consolidated text) medical electrical equipment - part 1: general requirements for basic safety and essential performance (iec 60601-1:2005, mod).
. IEC 60601-1-2 Edition 4.0 2014-02, medical electrical equipment - part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility - requirements and tests.
. 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.

Page 4 of 7

{20}------------------------------------------------

IEC 62304 Edition 1.1 2015-06, medical device software software life cycle . processes.
ISO 14971 Second edition 2007-03-01, medical devices application of risk ■ management to medical devices.
ISO 10993-1 Fourth edition 2009-10-15, biological evaluation of medical devices -. part 1: evaluation and testing within a risk management process.
. IEC 62366-1 Edition 1.0 2015-02, medical devices - part 1: application of usability engineering to medical devices [including CORRIGENDUM 1 (2016)].
. IEC 60601-1-6 Edition 3.1 2013-10, medical electrical equipment - part 1-6: general requirements for basic safety and essential performance - collateral standard: usability.

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility testing/ evaluation

The biocompatibility evaluation for the Diagnostic Ultrasound System was conducted in accordance with AAMI / ANSI / ISO 10993-1, biological evaluation of medical devices part 1: evaluation and testing within a risk management process. The following biocompatibility tests are required:

Haemolysis testing
. Acute systemic toxicity
Cytotoxicity
Intracutaneous reactivity
Sensitization

For Diagnostic Ultrasound System, only probes and biopsy brackets will contact the patient's body. They are all passed biocompatibility testing/ evaluation.

Thermal, Mechanical and Electrical Safety

EMC testing is according to IEC 6060-1-2 and IEC 60601-2-37. All mechanical and electrical safety testing according to AAMI/ ANSI ES60601-1, Medical electrical equipment- Part 1: General requirements for basic safety and essential performance, were Page 5 of 7

{21}------------------------------------------------

performed in-house testing laboratory. Transducers temperature testing was conducted in home lab according to IEC 60601-2-37. None of the testing demonstrated by design characteristics violated the requirements of relevant standards.

Acoustic output power and Excessive temperature

Emitting energy has been evaluated during design phase. Acoustic output power has been measured and calculated after the design was finished. In addition the ALARA (as low as reasonably achievable) rule is also explained in detail in the operator's manual in order to guide the operator to use the system correctly.

Excessive temperature has been evaluated during design phase and tested after the design was finished. It meets the requirements in the harmonized standard IEC 60601-2-37 and FDA Guidance, "Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" issue on June 27, 2019. Tests in the phase of design verification have proved that the Diagnostic Ultrasound System is safe and reliable.

Cleaning and Disinfection Effectiveness

The Diagnostic Ultrasound System with transducers require proper maintenance, inspection, cleaning, disinfection and sterilization to ensure maximum safety of operation and equipment protection. No device components are provided sterile to the user. The cleaning and disinfection effectiveness has been validated.

Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Issue on May 11, 2015. The level of concern for the Diagnostic Ultrasound System software was determined to be moderate in that failures may result in minor to moderate injury to the patient or to a user of the device, or a malfunction of, or a latent design flaw in, the software device lead to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to Minor Injury.

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7. Clinical Tests:

Not Applicable.

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 MX7/ MX7T/ Vaus7/ Zeus/ ME7/ Anesus ME7/ Anesus ME7T/ MX8/ MX8T/ Vaus8/ ME8 Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

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.