Predicate Devices

Reference Devices

K180912, K181637, K170277, K171233, K180599

AI/ML (Artificial Intelligence / Machine Learning)

No
The document does not mention AI, ML, or any related terms in the device description or performance studies.

Therapeutic

No
The device description clearly states it is a "Diagnostic Ultrasound System" intended for "acquire and display ultrasound images". Therapeutic devices are used for treatment, not diagnosis.

Diagnostic

Yes

The device is explicitly named "Diagnostic Ultrasound System" in both the "Intended Use / Indications for Use" and "Device Description" sections, and its function is described as acquiring and displaying ultrasound images for various exams of the human body.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "Diagnostic Ultrasound System" and mentions employing "an array of probes that include linear array, convex array and phased array." These are hardware components essential for ultrasound imaging, indicating it is not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
Device Function: The description clearly states that this is a "Diagnostic Ultrasound System." Ultrasound systems work by sending sound waves into the body and receiving the echoes to create images of internal structures and fluid flow. This is an in vivo (within the living body) diagnostic method, not in vitro (in glass/outside the body).
Intended Use: The intended uses listed are all related to imaging various parts of the human body directly, not analyzing samples taken from the body.

Therefore, this device falls under the category of medical imaging devices, not IVDs.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Intended Use:

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

Clinical Application

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, Urology.

Mode of Operation

B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Combined modes (B+M, PW+B, Color + B, Power + B, PW+Color+B, Power + PW +B), Tissue Harmonic Imaging, iScape, TDI, Color M, Biopsy Guidance, Smart 3D, Strain Elastography, Contrast imaging (Contrast agent for LVO), Contrast imaging (Contrast agent for Liver), eSpacial Navi.

Product codes (comma separated list FDA assigned to the subject device)

IYN, IYO, ITX

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.

Mentions image processing

Yes, "perform post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body."

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

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, Urology.

Indicated Patient Age Range

adults, pregnant women, pediatric patients and neonates.

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.
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.

Biocompatibility testing/ evaluation: The biocompatibility evaluation for the Diagnostic Ultrasound System was conducted in accordance with AAMI / ANSI / ISO 10993-1. 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 were 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. 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 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K171034

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K180912, K181637, K170277, K171233, K180599

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

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

2

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)

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.

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.

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3

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	Color
Doppler	Amplitude
Doppler	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
Peripheral
vessel	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
Peripheral
vessel	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 (Track
1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	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
Peripheral
vessel	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 (Track
1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	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
Peripheral
vessel	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 (Track
1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	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
Peripheral
vessel	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 (Track
1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	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
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)
Prescription USE (Per 21 CFR 801.109)
Transducer:	L13-3s
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application		Mode of Operation
General (Track
1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	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
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:	L13-3Ns
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application		Mode of Operation
General (Track
1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	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
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:	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 (Track
1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	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
Peripheral
vessel	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 (Track
1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	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
Peripheral
vessel	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 (Track
1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	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
Peripheral
vessel	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

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:

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.

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 | Control |
|--------------------------------|--------------|-------|------------------|---------|
| 1. Primary
predicate device | Mindray | M9 | K171034 | |
| 2. Reference
device | Mindray | TE7 | K180912 | |
| 3. Reference
device | Mindray | DC-70 | K181637 | |
| 4. Reference
device | Mindray | DC-8 | K170277 | |

Page 2 of 7

18

| 5. Reference

device	Mindray	Resona 7
6. Reference
device	GE Medical Systems
Ultrasound and Primary
Care 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.

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. 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.

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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

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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.