Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System

K200411 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · IYN · Apr 8, 2020 · Radiology

Device Facts

• Record ID: K200411
• Device Name: Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System
• Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• Product Code: IYN · Radiology
• Decision Date: Apr 8, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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

Device Story

General-purpose, portable, software-controlled diagnostic ultrasound system; acquires/displays ultrasound data via linear and convex array probes. Operates in B, M, PW, CW, Color, Power/Dirpower, 4D, Smart3D, TDI, Color M, Elastography, Biopsy Guidance, and Contrast imaging (liver) modes. Used in clinical settings by healthcare professionals. Transforms ultrasonic energy inputs into anatomical/fluid flow images; supports specialized measurements and calculations. Output displayed on-screen for clinical assessment; aids in diagnosis and patient management. Benefits include non-invasive visualization of internal structures and blood flow.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including acoustic output, biocompatibility, cleaning/disinfection effectiveness, and thermal/electrical/mechanical safety testing per recognized standards (e.g., IEC 60601-1, IEC 60601-2-37, ISO 10993-1).

Technological Characteristics

Portable ultrasound system using linear and convex array transducers. Employs ultrasonic pulsed Doppler and echo imaging. Connectivity includes mobile trolley (UMT-170). Software-controlled with life cycle processes per IEC 62304. Compliance with AAMI/ANSI ES60601-1, IEC 60601-1-2, and IEC 60601-2-37. Features include Smart Face, Smart OB, and transducer element check.

Indications for Use

Indicated for adults, pregnant women, pediatric patients, and neonates for diagnostic ultrasound imaging or fluid flow analysis in fetal, abdominal, intra-operative, pediatric, small organ, cephalic, trans-rectal, trans-vaginal, musculoskeletal, cardiac, peripheral vessel, and urology exams.

Regulatory Classification

Identification

An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• Z6 (K182603)

Reference Devices

• DC-40 (K183377)

Submission Summary (Full Text)

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April 8, 2020

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

#### Re: K200411

Trade/Device Name: Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 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: February 12, 2020 Received: February 19, 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

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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 mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

510(k) Number (if known)

#### K200411

Device Name

Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System

Indications for Use (Describe)

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

| Type of Use (Select one or both, as applicable) | | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <table style="border:none"><tr><td><span style="display:inline-block; width:15px; height:15px; border:1px solid black; text-align:center;"><b>X</b></span> Prescription Use (Part 21 CFR 801 Subpart D) </td><td><span style="display:inline-block; width:15px; height:15px; border:1px solid black; text-align:center;"></span> Over-The-Counter Use (21 CFR 801 Subpart C) </td></tr></table> | <span style="display:inline-block; width:15px; height:15px; border:1px solid black; text-align:center;"><b>X</b></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="display:inline-block; width:15px; height:15px; border:1px solid black; text-align:center;"></span> Over-The-Counter Use (21 CFR 801 Subpart C) |
| <span style="display:inline-block; width:15px; height:15px; border:1px solid black; text-align:center;"><b>X</b></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="display:inline-block; width:15px; height:15px; border:1px solid black; text-align:center;"></span> Over-The-Counter Use (21 CFR 801 Subpart C) | |

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| Diagnostic Ultrasound System Indications For Use Format | | | | | | | | | | |
|---------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|---|---|-----|-----|---------------|-------------------|--------------------|-------------------------|--|
| System: | Z6/Z60/Z60T/Z60S/Z60 Pro Diagnostic Ultrasound System | | | | | | | | | |
| Transducer: | N/A | | | | | | | | | |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | |
| Clinical Application | Mode of Operation | | | | | | | | | |
| General | Specific (Track 1 & 3) | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined (specify) | Other (Specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| Fetal Imaging<br>& Other | Fetal | P | P | P | | P | P | P | Note 1,2,5,6,7 | |
| | Abdominal | P | P | P | P | P | P | P | Note<br>1,2,3,4,5,6,7,9 | |
| | Intra-operative (Specify*) | 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 | Note 1,2,3,6,8 | |
| | Neonatal Cephalic | P | P | P | P | P | P | P | Note 1,2,3,4,5,6 | |
| | Adult Cephalic | P | P | P | P | P | P | P | Note 1,2,4,5,6 | |
| | 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) | P | P | P | P | P | P | P | Note 1,2,3,4,5,6,8 | |
| | Musculo-skeletal (Superficial) | P | P | P | | P | P | P | Note 1,2,3,6,8 | |
| | Intravascular | | | | | | | | | |
| Cardiac | 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 | |
| | Intravascular (Cardiac) | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| Peripheral<br>vessel | Peripheral vessel | P | P | P | | P | P | P | Note 1,2,3,5,6 | |
| | Other (Specify***) | 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 | | | | | | | | | |
| | Note 5: Color M | | | | | | | | | |
| | Note 6: Smart3D | | | | | | | | | |
| | Note 7:4D(Real-time 3D) | | | | | | | | | |
| | Note 8: Strain Elastography | | | | | | | | | |
| | Note 9: Contrast imaging (Contrast agent for Liver)<br>(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | | | | | | | | | |
| | Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) | | | | | | | | | |

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| Diagnostic Ultrasound System Indications For Use Format | | | | | | | | | | | |
|--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|-------------------|------|--------------------------|--------------------------|----------------------|-----------------------|--------------------|--|--|
| System: | DP-60 Diagnostic Ultrasound System | | | | | | | | | | |
| Transducer: | N/A | | | | | | | | | | |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | | |
| Clinical Application | Mode of Operation | | | | | | | | | | |
| General | Specific (Track 1 & 3) | B | M | PW D | CW D | Color Doppler | Amplitude Doppler | Combined (specify) | Other (Specify) | | |
| (Track 1 Only) | | | | | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | | | | |
| Fetal Imaging<br>& Other | Fetal | N | N | N | N | N | N | N | Note 1,2,5,6 | | |
| | Abdominal | N | N | N | N | N | N | N | Note 1,2,3,4,5,6,9 | | |
| | Intra-operative (Specify*) | N | N | N | N | N | N | N | Note 1,2,3,6 | | |
| | Intra-operative (Neuro) | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | |
| | Pediatric | N | N | N | N | N | N | N | Note 1,2,3,4,5,6 | | |
| | Small Organ (Specify**) | N | N | N | N | N | N | N | Note 1,2,3,6,8 | | |
| | Neonatal Cephalic | N | N | N | N | N | N | N | Note 1,2,3,4,5,6 | | |
| | 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 1,2,5,6 | | |
| | Trans-vaginal | N | N | N | N | N | N | N | Note 1,2,5,6 | | |
| | Trans-urethral | | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | | |
| | Musculo-skeletal (Conventional) | N | N | N | N | N | N | N | Note 1,2,3,4,5,6,8 | | |
| | Musculo-skeletal (Superficial) | N | N | N | N | N | N | N | Note 1,2,3,6,8 | | |
| | Intravascular | | | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | | |
| Peripheral<br>vessel | Peripheral vessel | N | N | N | N | N | N | N | Note 1,2,3,5,6 | | |
| | Other (Specify***) | N | N | N | N | N | N | N | 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 | | | | | | | | | | |
| | Note 5: Color M | | | | | | | | | | |
| | Note 6: Smart3D | | | | | | | | | | |
| | Note 7:4D(Real-time 3D) | | | | | | | | | | |
| | Note 8: 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) | | | | | | | | | | |
| System: | Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System | | | | | | | | | | |
| Transducer: | 3C5P | | | | | | | | | | |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | | |
| Clinical Application<br>Mode of Operation | | | | | | | | | | | |
| General<br>(Track 1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other (Specify) | | |
| Ophthalmic | Ophthalmic | | | | | | | | | | |
| Fetal Imaging<br>& Other | Fetal | P | P | P | | P | P | P | Note 1,2,5,6 | | |
| | Abdominal | 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 | Note 1,2,5,6 | | |
| | Small Organ (Specify**) | | | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | | |
| | Trans-rectal | | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | | |
| | Trans-urethral | | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | P | P | P | | P | P | P | Note 1,2,5,6 | | |
| | Musculo-skeletal (Superficial) | | | | | | | | | | |
| | Intravascular | | | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | | |
| Peripheral<br>vessel | Peripheral vessel | P | P | P | | P | P | P | 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. | | | | | | | | | | |
| | ** Small organ-breast, thyroid, testes. | | | | | | | | | | |
| | ***Other use includes Urology. | | | | | | | | | | |
| | Note 1: Tissue Harmonic Imaging. | | | | | | | | | | |
| | Note 2: Biopsy Guidance | | | | | | | | | | |
| | Note 3: iScape | | | | | | | | | | |
| | Note 4: TDI | | | | | | | | | | |
| | Note 5: Color M | | | | | | | | | | |
| | Note 6: Smart3D | | | | | | | | | | |
| | Note 7:4D(Real-time 3D) | | | | | | | | | | |
| | Note 8: 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) | | | | | | | | | | |
| | Prescription USE (Per 21 CFR 801.109) | | | | | | | | | | |
| System: | Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System | | | | | | | | | | |
| Transducer: | C6-2P | | | | | | | | | | |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | | |
| Clinical Application<br>Mode of Operation | | | | | | | | | | | |
| General<br>(Track 1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other (Specify) | | |
| Ophthalmic | Ophthalmic | | | | | | | | | | |
| Fetal Imaging<br>& Other | Fetal | N | N | N | | N | N | N | Note 1,2,5,6 | | |
| | Abdominal | N | N | N | | N | N | N | Note 1,2,5,6,9 | | |
| | Intra-operative (Specify*) | | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | |
| | Pediatric | N | N | N | | N | N | N | Note 1,2,5,6 | | |
| | Small Organ (Specify**) | | | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | | |
| | Trans-rectal | | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | | |
| | Trans-urethral | | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | N | N | N | | N | N | N | Note 1,2,5,6 | | |
| | Musculo-skeletal (Superficial) | | | | | | | | | | |
| | Intravascular | | | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | | |
| Peripheral<br>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. | | | | | | | | | | |
| | ** Small organ-breast, thyroid, testes. | | | | | | | | | | |
| | ***Other use includes Urology. | | | | | | | | | | |
| | Note 1: Tissue Harmonic Imaging. | | | | | | | | | | |
| | Note 2: Biopsy Guidance…