Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and does not describe any features or functionalities that would typically involve AI or ML.

Therapeutic

No
The device is described as a "Diagnostic Ultrasound System" intended for acquiring and displaying ultrasound data for a wide range of diagnostic exams, and its function is to diagnose rather than treat medical conditions.

Diagnostic

Yes

The device is explicitly named "Z6 Diagnostic Ultrasound System" and its intended use is for various diagnostic exams. The description also states its function is to "acquire and display ultrasound data," which is a core function of diagnostic imaging devices.

SaMD (Software as a Medical Device)

No

The device is described as a "Diagnostic Ultrasound System" which is a hardware device that uses probes to acquire ultrasound data. While it is "software controlled," it is not solely software.

IVD (In Vitro Diagnostic)

Based on the provided information, the Z6 Diagnostic Ultrasound System is not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
Z6 Function: The Z6 Diagnostic Ultrasound System uses ultrasound waves to create images of internal structures within the body. This is an in vivo diagnostic method.
Intended Use: The intended use describes imaging various anatomical sites within the body for diagnostic purposes.
Device Description: The description details the ultrasound imaging modes and probes used for imaging the body.

The information clearly indicates that the Z6 system is used for imaging directly on or within the patient's body, not for testing samples taken from the patient.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Z6 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediativ, small organ(breast, thyroid, testes), neonatal and adult cephalic, transrectal, trans-vaginal, musculo-skeletal(conventional, superficial), adult and pediatric cardiac, peripheral vessel , intraoperative(abdominal, thoracic, and vascular) and urology exams.

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

IYN, IYO, ITX

Device Description

Z6 Diagnostic Ultrasound System is a general purpose, portable, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, PW-Mode, CW-Mode, Color-Mode, Power/Dirpower Mode, 4D, Smart3D,TDI, Color M, Elastography, Biopsy Guidance, Contrast imaging (Contrast agent for Liver) or the combined mode (i.e. B/M-Mode, B/PW-mode, B/PW/Color). This system is a Track 3 device that employs an array of probes that include linear array and convex array.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), adult and pediatric cardiac, peripheral vessel, intraoperative(abdominal, thoracic, and vascular), 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: Z6 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 designed to conform with applicable medical safety standards. This device has been tested and evaluated under the following standards:

AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2 Edition 3: 2007: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (Edition 3)
IEC 60601-2-37 Edition 2.0 2007: Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
IEC 60601-1-6 Edition 3.1 2013: medical electrical equipment - part 1-6: general requirements for basic safety and essential performance - collateral standard: usability.
ISO 14971 Second edition 2007: Medical devices Application of risk management to medical devices
UD 2: Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment. Revision 3
ISO10993-1 Fourth edition 2009: Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process

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.

K122010

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.

K173369, K172970, K163690

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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

November 14, 2018

Shenzhen Mindray Bio-medical Electronics Co., LTD Jiang Xiaoyong Engineer of Technical Regulation Keji 12th Road South, Hi-tech Industrial Park Shenzhen, Guangdong 518057 CHINA

Re: K182603

Trade/Device Name: Z6 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: August 31, 2018 Received: September 21, 2018

Dear Jiang Xiaoyong:

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

1

statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Hole 2. Nils

for Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 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.

510(k) Number (if known)

K182603

Device Name Z6 Diagnostic Ultrasound System

Indications for Use (Describe)

The Z6 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediativ, small organ(breast, thyroid, testes), neonatal and adult cephalic, transrectal, trans-vaginal, musculo-skeletal(conventional, superficial), adult and pediatric cardiac, peripheral vessel , intraoperative(abdominal, thoracic, and vascular) 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.

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

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

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

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

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

FORM FDA 3881 (7/17)

3

Diagnostic Ultrasound Indications For Use Format

System: Z6 Diagnostic Ultrasound System

Transducer: N

Transducer: N/A
Intenueu
Liamsducer: Diagr Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
General
(Track 1	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P	P	P	P	P	Note 1,2,5,6,7
	Abdominal	P	P	P	P	P	P	P	Note 1,2,3,4,5,6,7,9
	Intra-operative (Specify*)	P	P	P	P	P	P	P	Note 1,2,3,6
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P	Note 1,2,3,4,5,6
	Small Organ (Specify**)	P	P	P	P	P	P	P	Note 1,2,3,6,8
	Neonatal Cephalic	P	P	P	P	P	P	P	Note 1,2,3,4,5,6
Fetal
Imaging &
Other	Adult Cephalic	P	P	P	P	P	P	P	Note 1,2,4,5,6
	Trans-rectal	P	P	P	P	P	P	P	Note 1,2,5,6
	Trans-vaginal	P	P	P	P	P	P	P	Note 1,2,5,6
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)	P	P	P	P	P	P	P	Note 1,2,3,4,5,6,8
	Musculo-skeletal
(Superficial)	P	P	P	P	P	P	P	Note 1,2,3,6,8
	Intravascular
	Cardiac Adult	P	P	P	P	P	P	P	Note 1,2,4,5,6
	Cardiac Pediatric	P	P	P	P	P	P	P	Note 1,2,4,5,6
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel	P	P	P	P	P	P	P	Note 1,2,3,5,6
	Other (Specify***)	P	P	P	P	P	P	P	Note 1,2,5,6
	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
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging.
	Note 2: Biopsy Guidance
	Note 3: iScape
	Note 4: TDI
	Note5: Color M
	Note6: Smart3D
	Note7: 4D(Real-time 3D)
	Note8: Strain Elastography
	Note 9: Contrast imaging (Contrast agent for Liver)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Transducer:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Clinical Application
Mode of Operation
General
(Track 1	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P	P	P	P	P	Note 1,2,5,6
	Abdominal	P	P	P	P	P	P	P	Note 1,2,5,6,9
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P	Note 1,2,5,6
	Small Organ (Specify**)
	Neonatal Cephalic
Fetal
Imaging &
Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)	P	P	P		P	P	P	Note 1,2,5,6
	Musculo-skeletal
(Superficial)
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel	P	P	P		P	P	P	Note 1,2,5,6
	Other (Specify***)
	N=new indication; P=previously cleared by FDA(K122010); 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.
	Note 1: Tissue Harmonic Imaging.
	Note 2: Biopsy Guidance
	Note 3: iScape
	Note 4: TDI
	Note5: Color M
	Note6: Smart3D
	Note7: 4D(Real-time 3D)
	Note8: Strain Elastography
	Note 9: Contrast imaging (Contrast agent for Liver)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

4

Transducer:

5

System:	Z6 Diagnostic Ultrasound System
---------	---------------------------------

Transducer: 6C2P Internutu
Haasta Diagn

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

Clinical Application		Mode of Operation
General
(Track 1	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P		P	P	P	Note 1,2,5,6
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	Note 1,2,5,6
	Small Organ (Specify**)
	Neonatal Cephalic	P	P	P		P	P	P	Note 1,2,5,6
Fetal
Imaging &
Other	Adult Cephalic	P	P	P		P	P	P	Note 1,2,5,6
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel
	Other (Specify***)
	N=new indication; P=previously cleared by FDA(K122010); 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.
	Note 1: Tissue Harmonic Imaging.
	Note 2: Biopsy Guidance
	Note 3: iScape
	Note 4: TDI
	Note5: Color M
	Note6: Smart3D
	Note7: 4D(Real-time 3D)
	Note8: Strain Elastography
	Note 9: Contrast imaging (Contrast agent for Liver)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Transducer:	6CVIP
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Clinical Application	Mode of Operation
General
(Track 1	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P	Note 1,2,5,6
	Abdominal
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)
	Neonatal Cephalic
Fetal
Imaging &
Other	Adult Cephalic
	Trans-rectal	P	P	P		P	P	P	Note 1,2,5,6
	Trans-vaginal	P	P	P		P	P	P	Note 1,2,5,6
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel
	Other (Specify***)	P	P	P		P	P	P	Note 1,2,5,6
	N=new indication; P=previously cleared by FDA(K122010);						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.
	Note 1: Tissue Harmonic Imaging.
	Note 2: Biopsy Guidance
	Note 3: iScape
	Note 4: TDI
	Note5: Color M
	Note6: Smart3D
	Note7: 4D(Real-time 3D)
	Note8: Strain Elastography
	Note 9: Contrast imaging (Contrast agent for Liver)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

6

Transducer: 6CV1P
Diagnos

7

System:	Z6 Diagnostic Ultrasound System
---------	---------------------------------

Transducer: 7L4P IIIvinusu Diagn

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

Clinical Application		Mode of Operation
General
(Track 1	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P		P	P	P	Note 1,2,3,6
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	Note 1,2,3,6
	Small Organ (Specify**)	P	P	P		P	P	P	Note 1,2,3,6,8
	Neonatal Cephalic	P	P	P		P	P	P	Note 1,2,3,6
Fetal
Imaging &
Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)	P	P	P		P	P	P	Note 1,2,3,6,8
	Musculo-skeletal
(Superficial)	P	P	P		P	P	P	Note 1,2,3,6,8
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel	P	P	P		P	P	P	Note 1,2,3,6
	Other (Specify***)

8

System:	Z6 Diagnostic Ultrasound System
---------	---------------------------------

Transducer: 7L5P
Diagn

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

	Clinical Application		Mode of Operation
General
(Track 1	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P		P	P	P	Note 1,2,3,6
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	Note 1,2,3,6
	Small Organ (Specify**)	P	P	P		P	P	P	Note 1,2,3,6
	Neonatal Cephalic	P	P	P		P	P	P	Note 1,2,3,6
Fetal
Imaging &
Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)	P	P	P		P	P	P	Note 1,2,3,6
	Musculo-skeletal
(Superficial)	P	P	P		P	P	P	Note 1,2,3,6
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel	P	P	P		P	P	P	Note 1,2,3,6
	Other (Specify***)
	N=new indication; P=previously cleared by FDA(K122010); 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.
	Note 1: Tissue Harmonic Imaging.
	Note 2: Biopsy Guidance
	Note 3: iScape
	Note 4: TDI
	Note5: Color M
	Note6: Smart3D
	Note7: 4D(Real-time 3D)
	Note8: Strain Elastography
	Note 9: Contrast imaging (Contrast agent for Liver)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)

9

System:	Z6 Diagnostic Ultrasound System
---------	---------------------------------

Transducer: - L14-6P
Diagno

11966	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
-------	------------------------------------------------------------------------------------

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
General
(Track 1	Clinical Application	Mode of Operation					Other (specify)
	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler		Amplitude
Doppler	Combined
(specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P		P	P	P	Note 1,2,3,6
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	Note 1,2,3,6
	Small Organ (Specify**)	P	P	P		P	P	P	Note 1,2,3,6
	Neonatal Cephalic	P	P	P		P	P	P	Note 1,2,3,6
	Adult Cephalic
Fetal
Imaging &
Other	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)

	Musculo-skeletal
(Conventional)	P	P	P		P	P	P	Note 1,2,3,6


	Musculo-skeletal
(Superficial)	P	P	P		P	P	P	Note 1,2,3,6

	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel	P	P	P		P	P	P	Note 1,2,3,6
	Other (Specify***)
	N=new indication; P=previously cleared by FDA(K122010); 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.
	Note 1: Tissue Harmonic Imaging.
	Note 2: Biopsy Guidance
	Note 3: iScape
	Note 4: TDI
	Note5: Color M
	Note6: Smart3D
	Note7: 4D(Real-time 3D)
	Note8: Strain Elastography
	Note 9: Contrast imaging (Contrast agent for Liver)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Clinical Application						Mode of Operation
General
(Track 1)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)
	Neonatal Cephalic
	Adult Cephalic
Fetal
Imaging &
Other	Trans-rectal	P	P	P		P	P	P	Note 1,2,5,6
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel
	Other (Specify***)	P	P	P	P	P	P	P	Note 1,2,5,6
N=new indication; P=previously cleared by FDA(K122010); 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.
Note 1: Tissue Harmonic Imaging.
Note 2: Biopsy Guidance
Note 3: iScape
Note 4: TDI
Note5: Color M
Note6: Smart3D
Note7: 4D(Real-time 3D)
Note8: Strain Elastography
Note 9: Contrast imaging (Contrast agent for Liver)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Clinical Application		Mode of Operation
General
(Track 1	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P	P	P	P	P	Note 1,2,4,5,6
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P	Note 1,2,4,5,6
	Small Organ (Specify**)
	Neonatal Cephalic	P	P	P	P	P	P	P	Note 1,2,4,5,6
Fetal
Imaging &
Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Cardiac Adult	P	P	P	P	P	P	P	Note 1,2,4,5,6
	Cardiac Pediatric	P	P	P	P	P	P	P	Note 1,2,4,5,6
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel
	Other (Specify***)
	N=new indication; P=previously cleared by FDA(K122010); 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.
	Note 1: Tissue Harmonic Imaging.
	Note 2: Biopsy Guidance
	Note 3: iScape
	Note 4: TDI
	Note5: Color M
	Note6: Smart3D
	Note7: 4D(Real-time 3D)
	Note8: Strain Elastography
	Note 9: Contrast imaging (Contrast agent for Liver)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)

10

System: Z6 Diagnostic Ultrasound System

Transducer: CB10-4P

11

Transducer: 2P2P Internusu
Diagn

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

12

System:	Z6 Diagnostic Ultrasound System
---------	---------------------------------

Transducer: Diagnostic

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

Clinical Application						Mode of Operation
General
(Track 1	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P	Note 1,2,5,6
	Abdominal
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)
	Neonatal Cephalic
Fetal
Imaging &
Other	Adult Cephalic
	Trans-rectal	P	P	P		P	P	P	Note 1,2,5,6
	Trans-vaginal	P	P	P		P	P	P	Note 1,2,5,6
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel
	Other (Specify***)	P	P	P		P	P	P	Note 1,2,5,6
	N=new indication; P=previously cleared by FDA(K122010); 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.)
	Note 1: Tissue Harmonic Imaging.
	Note 2: Biopsy Guidance
	Note 3: iScape
	Note 4: TDI
	Note5: Color M
Note6: Smart3D
Note7: 4D(Real-time 3D)
	Note8: Strain Elastography
Note 9: Contrast imaging (Contrast agent for Liver)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)

	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application		Mode of Operation
General
(Track 1	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P	P	P	P	P	Note 1,2,3,6
	Intra-operative (Specify*)	P	P	P	P	P	P	P	Note 1,2,3,6
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P	Note 1,2,3,6
	Small Organ (Specify**)	P	P	P	P	P	P	P	Note 1,2,3,6
	Neonatal Cephalic	P	P	P	P	P	P	P	Note 1,2,3,6
	Adult Cephalic
Fetal
Imaging &
Other	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)	P	P	P	P	P	P	P	Note 1,2,3,6
	Musculo-skeletal
(Superficial)	P	P	P	P	P	P	P	Note 1,2,3,6
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac

Peripheral
vessel	Peripheral vessel	P	P	P	P	P	P	P	Note 1,2,3,6
	Other (Specify***)
Transducer:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Clinical Application	Mode of Operation
General
(Track 1	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)
	Neonatal Cephalic
Fetal
Imaging &
Other	Adult Cephalic
	Trans-rectal	P	P	P		P	P	P	Note 1,2,5,6
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel
	Other (Specify***)	P	P	P		P	P	P	Note 1,2,5,6
	N=new indication; P=previously cleared by FDA(K122010); 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.
	Note 1: Tissue Harmonic Imaging.
	Note 2: Biopsy Guidance
	Note 3: iScape
	Note 4: TDI
	Note5: Color M
	Note6: Smart3D
	Note7: 4D(Real-time 3D)
	Note8: Strain Elastography
	Note 9: Contrast imaging (Contrast agent for Liver)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Clinical Application									Mode of Operation
General
(Track 1	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (specify)
Ophthalmic	Ophthalmic
	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
Fetal
Imaging &
Other	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
	Cardiac Adult	N	N	N	N	N	N	N	Note 1,2,4,5,6
	Cardiac Pediatric	N	N	N	N	N	N	N	Note 1,2,4,5,6
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel
	Other (Specify***)
	N=new indication; P=previously cleared by FDA(K172970); 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.
	Note 1: Tissue Harmonic Imaging.
	Note 2: Biopsy Guidance
	Note 3: iScape
	Note 4: TDI
	Note5: Color M
	Note6: Smart3D
	Note7: 4D(Real-time 3D)
	Note8: Strain Elastography
	Note 9: Contrast imaging (Contrast agent for Liver)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

13

Transducer: 7LT4P
Diagno

14

Transducer: 6LE7P Diagnos

15

Transducer:

16

Transducer:	35C50P
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Clinical Application						Mode of Operation
General
(Track 1	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P	P	P	P	P	Note 1,2,5,6
	Abdominal	P	P	P	P	P	P	P	Note 1,2,5,6,9
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P	Note 1,2,5,6
	Small Organ (Specify**)
	Neonatal Cephalic
Fetal
Imaging &
Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)	P	P	P	P	P	P	P	Note 1,2,5,6
	Musculo-skeletal
(Superficial)
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel	P	P	P	P	P	P	P	Note 1,2,5,6
	Other (Specify***)
	N=new indication; P=previously cleared by FDA(K173369); 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.
	Note 1: Tissue Harmonic Imaging.
	Note 2: Biopsy Guidance
	Note 3: iScape
	Note 4: TDI
	Note5: Color M
	Note6: Smart3D
	Note7: 4D(Real-time 3D)
	Note8: Strain Elastography
	Note 9: Contrast imaging (Contrast agent for Liver)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Transducer: 35C50P
Diagnostic

17

Transducer:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application		Mode of Operation
General
(Track 1	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P	P	P	P	P	Note 1,2,3,6
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P	Note 1,2,3,6
	Small Organ (Specify**)	P	P	P	P	P	P	P	Note 1,2,3,6,8
	Neonatal Cephalic	P	P	P	P	P	P	P	Note 1,2,3,6
	Adult Cephalic
Fetal
Imaging &
Other	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)	P	P	P	P	P	P	P	Note 1,2,3,6,8
	Musculo-skeletal
(Superficial)	P	P	P	P	P	P	P	Note 1,2,3,6,8
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel	P	P	P	P	P	P	P	Note 1,2,3,6
	Other (Specify***)
	N=new indication; P=previously cleared by FDA(K173369); 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.
	Note 1: Tissue Harmonic Imaging.
	Note 2: Biopsy Guidance
	Note 3: iScape
	Note 4: TDI
	Note5: Color M
	Note6: Smart3D
	Note7: 4D(Real-time 3D)
	Note8: Strain Elastography
	Note 9: Contrast imaging (Contrast agent for Liver)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Transducer:	D6-2P
	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Clinical Application	Mode of Operation
General
(Track 1	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P	Note 1,2,5,7
	Abdominal	P	P	P		P	P	P	Note 1,2,5,7
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)
	Neonatal Cephalic
	Adult Cephalic
Fetal
Imaging &
Other	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Peripheral
vessel	Peripheral vessel
		Other (Specify***)
	N=new indication; P=previously cleared by FDA(K173369); 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.
	Note 1: Tissue Harmonic Imaging.
	Note 2: Biopsy Guidance
	Note 3: iScape
	Note 4: TDI
	Note5: Color M
	Note6: Smart3D
	Note7: 4D(Real-time 3D)
	Note8: Strain Elastography
	Note 9: Contrast imaging (Contrast agent for Liver)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Transducer:

18

Transducer:
Imenucu D6-2P

19

510(K) SUMMARY

K182603

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

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 6238 Fax: +86 755 2658 2680

Contact Person:

Jiang Xiaoyong 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: September 15, 2018

2. Device Name: Z6 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)

3. Device Description:

Z6 Diagnostic Ultrasound System is a general purpose, portable, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, PW-Mode, CW-Mode, Color-Mode, Power/Dirpower Mode, 4D,

20

Smart3D,TDI, Color M, Elastography, Biopsy Guidance, Contrast imaging (Contrast agent for Liver) or the combined mode (i.e. B/M-Mode, B/PW-mode, B/PW/Color). This system is a Track 3 device that employs an array of probes that include linear array and convex array.

4. Intended Use:

The Z6 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, intraoperative(abdominal, thoracic, and vascular), pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), adult and pediatric cardiac, peripheral vessel and urology exams.

5. Summary of Modifications

This submission device is a modification to Z6 Diagnostic Ultrasound System previously cleared in K122010.

● New Added Transducers:

P7-3P 75L38P 35C50P D6-2P

New Added Needle-Guided Bracket: .

NGB-001

NGB-002

Main Added Features: .

Contrast Imaging (Contrast agent for Liver)

TDI 4D Smart 3D

Color M

ECG

21

Free Xros M iNeedle Medsight iWorks iLive ExFov Elastography to 75L38P and 7L4P Probe

6. Comparison with Predicate Devices:

Z6 Diagnostic Ultrasound System is comparable with and substantially equivalent to these predicate devices:

| Predicate Device | Manufacturer | Model | 510(k) Control
Number |
|-----------------------------|--------------|-------|--------------------------|
| 1. Primary predicate device | Mindray | Z6 | K122010 |
| 2. Reference device | Mindray | DC-30 | K173369 |
| 3. Reference device | Mindray | M7 | K172970 |
| 4. Reference device | Mindray | DC-70 | K163690 |

Z6 has the same technological characteristics, is comparable in key safety and effectiveness features, and has the same intended uses and basic operating modes as the predicate devices. All systems transmit ultrasonic energy into patients and 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.

Subject device Z6 has the same intended uses as the predicated device Z6(K122010) ●

Subject Device	Predicate device
Z6	Z6(K122010)
The Z6 Diagnostic Ultrasound System is
applicable for adults, pregnant women,
pediatric patients and neonates. It is intended	The Z6 Diagnostic Ultrasound System is
applicable for adults, pregnant women, pediatric
patients and neonates. It is intended for use in

22

| for use in fetal, abdominal,
intraoperative(abdominal, thoracic, and
vascular), pediatric, small organ(breast,
thyroid, testes), neonatal and adult cephalic,
trans-rectal, trans-vaginal,
musculo-skeletal(conventional, superficial),
adult and pediatric cardiac, peripheral vessel
and urology exams. | fetal, abdominal, intraoperative(abdominal,
thoracic, and vascular), pediatric, small
organ(breast, thyroid, testes), neonatal and adult
cephalic, trans-rectal, trans-vaginal,
musculo-skeletal(conventional, superficial),
adult and pediatric cardiac, peripheral vessel
and urology exams. |

--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Compared to the predicated devices Z6(K122010):

The acoustic power levels of Z6 are below the limits of FDA, which is the same as the predicated device Z6(K122010).
Z6 is designed in compliance with the FDA recognized electrical and physical safety standard, which is the same as the predicated device Z6(K122010).
Z6 has the same performance specification as the predicate device Z6(K122010) except adding ECG, 4D, Smart 3D, Contrast imaging (Contrast agent for Liver), Elastography, Free Xros X. New added features are substantial equivalent with the predicated device DC-30( K173369) .
. Z6 has the same performance specification as the predicate device Z6(K122010) except adding TDI, Color M. New added features are substantial equivalent with the predicated device M7( K172970)
. Z6 has the same function specification as the predicate device Z6(K122010) except adding iNeedle, Medsight. New added features are substantial equivalent with the predicated device M7( K172970).
. Z6 has the same function specification as the predicate device Z6(K122010) except adding iWoks, iLive. New added features are substantial equivalent with the predicated device DC-70( K163690).
The patient contact material of the new added transducers are tested under ISO 10993-1.
The patient contact materials of the new added needle-guided bracket are cleared along with NGB-001(K172970) and NGB-002(K172970).
The transducers are same except for adding P7-3P, 75L38P, 35C50P, D6-2P. All of

23

Subject device	Predicated device
Z6
P7-3P	P7-3s(M7)
75L38P	75L38P(DC-30)
35C50P	35C50P(DC-30)
D6-2P	D6-2P(DC-30)

the new added probes are substantial equivalent with the predicated device listed below:

7. Non-clinical Tests:

Z6 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 designed to conform with applicable medical safety standards. This device has been tested and evaluated under the following standards:

AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2 Edition 3: 2007: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (Edition 3)
. IEC 60601-2-37 Edition 2.0 2007: Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
. IEC 60601-1-6 Edition 3.1 2013: medical electrical equipment - part 1-6: general requirements for basic safety and essential performance - collateral standard: usability.
ISO 14971 Second edition 2007: Medical devices Application of risk management ● to medical devices
UD 2: Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment . Revision 3
. ISO10993-1 Fourth edition 2009: Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process

These non-clinical tests relied on in this premarket notification submission can support the

24

determination of substantial equivalence of the subject device.

8. Clinical Studies

Not applicable. The subject of this submission, Z6 Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence.

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 Z6 Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.