M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic Ultrasound System, M8 Elite Diagnostic Ultrasound System

K171034 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · IYN · Jul 10, 2017 · Radiology

Device Facts

• Record ID: K171034
• Device Name: M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic Ultrasound System, M8 Elite Diagnostic Ultrasound System
• Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• Product Code: IYN · Radiology
• Decision Date: Jul 10, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The M9/M9CV/M9T/M8 Elite Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, Intra-operative, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-reginal, musculo-skeletal(conventional, superficial), adult and pediatric cardiac, trans-esoph.(Cardiac), peripheral vessel , urology exams.

Device Story

The M9/M9CV/M9T/M8 Elite is a software-controlled diagnostic ultrasound system. It acquires and displays ultrasound data using various modes: B, M, PW, CW, Color, Power/Dirpower, THI, iScape, TDI, Color M, Elastography, 3D/4D, and contrast imaging. The system utilizes an array of linear, convex, and phased-array probes to transmit ultrasonic energy into the body and process received echoes for anatomical and fluid flow visualization. Used in clinical settings by healthcare professionals, the device provides real-time imaging and specialized measurements (e.g., fetal weight, cardiac function) to assist in clinical diagnosis and patient management. It supports needle-guided procedures via compatible brackets. The system processes inputs to generate on-screen displays, aiding clinicians in assessing structures and hemodynamics.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including acoustic output measurements (UD 2, UD 3), biocompatibility (ISO 10993-1), and electrical/mechanical safety (AAMI/ANSI ES60601-1, IEC 60601-2-37).

Technological Characteristics

Diagnostic ultrasound system using linear, convex, and phased-array transducers. Features include B, M, PW, CW, Color, Power/Dirpower, THI, iScape, TDI, Color M, Elastography, 3D/4D, and contrast imaging. Patient-contact materials tested per ISO 10993-1. Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, and IEC 62304. Software-controlled with measurement/calculation functions.

Indications for Use

Indicated for diagnostic ultrasound imaging or fluid flow analysis in adults, pregnant women, pediatric patients, and neonates. Applications include fetal, abdominal, intra-operative, small organ (breast, thyroid, testes), neonatal/adult cephalic, trans-rectal, trans-vaginal, musculoskeletal (conventional, superficial), adult/pediatric cardiac, trans-esophageal (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

• M9/M9CV/M9T (K152543)
• DC-8 (K170277)
• Resona 7 (K162267)

Reference Devices

• CIVCO 658-001 (K093713)
• CIVCO 610-543 (K970514)
• CIVCO 610-1274 (K970514)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, with flowing lines extending from the bottom profile.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Shenzhen Mindray Bio-Medical Electronics Co., Ltd. % Mr. Chao Ma Engineer of Technical Regulation Department Keji 12th Road South Hi-tech Industrial Park, Nanshan Shenzhen 518057 Guangdong P R CHINA

July 10, 2017

Re: K171034

Trade/Device Name: M9/M9CV/M9T/M8 Elite Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: June 19, 2017 Received: June 21, 2017

Dear Mr. Ma:

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. 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D. O'Hara
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

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#### Indications for Use

510(k) Number (if known)

K171034

Device Name M9/M9CV/M9T/M8 Elite Diagnostic Ultrasound System

Indications for Use (Describe)

The M9/M9CV/M9T/M8 Elite Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, Intra-operative, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-reginal, musculo-skeletal(conventional, superficial), adult and pediatric cardiac, trans-esoph.(Cardiac), peripheral vessel , urology exams.

| <span>✔</span> Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|-------------------------------------------------------------|-----------------------------------------------|
|-------------------------------------------------------------|-----------------------------------------------|

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#### Diagnostic Ultrasound Indications For Use Format

| Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | | |
|--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|-------------------|-----|-----|------------------|--------------------------|-----------------------|-----------------------|-----------------|
| | Clinical Application | | | | | | 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 | P | P | P | | P | P | P | Note 1, 2,4,5,8,9 | |
| | Abdominal | P | P | P | P | P | P | P | Note 1, 2,4,5,8,9,10 | |
| | Intra-operative (Specify*) | N | N | N | | N | N | N | Note1,2,8 | |
| | Intra-operative (Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | P | P | P | P | P | P | P | Note 1, 2,4,5,8 | |
| | Small Organ (Specify**) | P | P | P | | P | P | P | Note 1,2,5,6,8 | |
| | Neonatal Cephalic | P | P | P | P | P | P | P | Note 1,2,4,5,8 | |
| Fetal Imaging<br>& Other | Adult Cephalic | P | P | P | P | P | P | P | Note 1, 2,4,5,8 | |
| | Trans-rectal | P | P | P | | P | P | P | Note 1,2,4,5,8 | |
| | Trans-vaginal | P | P | P | | P | P | P | Note 1, 2,4,5,8 | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | P | P | P | | P | P | P | Note 1,2,4,5,6,8 | |
| | Musculo-skeletal<br>(Superficial) | P | P | P | | P | P | P | Note 1,2,5,6,8 | |
| | Intravascular | | | | | | | | | |
| Cardiac | Cardiac Adult | P | P | P | P | P | P | P | Note 1,2,3,4,5,7,8 | |
| | Cardiac Pediatric | P | P | P | P | P | P | P | Note 1,2,3,4,5,8 | |
| | Intravascular (Cardiac) | | | | | | | | | |
| | Trans-esoph. (Cardiac) | P | P | P | P | P | P | P | Note 1, 3,4,8 | |
| | Intra-cardiac | | | | | | | | | |
| Peripheral<br>vessel | Peripheral vessel | P | P | P | | P | P | P | Note 1,2,4,5,8 | |
| | Other (Specify***) | P | P | P | | P | P | P | Note 1,2,4,5,8 | |
| Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | | |
| Clinical Application | | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) | |
| General<br>(Track 1 Only) | Specific (Track 1 & 3) | | | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| | Fetal | | | | | | | | | |
| | Abdominal | P | P | P | | P | P | P | Note 1,2,4,5,8 | |
| | Intra-operative (Specify*) | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | P | P | P | | P | P | P | Note 1,2,4,5,8 | |
| | Small Organ (Specify**) | | | | | | | | | |
| | Neonatal Cephalic | P | P | P | | P | P | P | Note 1,2,4,5,8 | |
| Fetal Imaging<br>& Other | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | | |
| | Intravascular | | | | | | | | | |
| | Cardiac Adult | | | | | | | | | |
| Cardiac | Cardiac Pediatric | P | P | P | | P | P | P | Note 1,2,4,5,8 | |
| | Intravascular (Cardiac) | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| Peripheral<br>vessel | Peripheral vessel | P | P | P | | P | P | P | Note 1,2,4,5,8 | |
| | Other (Specify***) | | | | | | | | | |
| | N=new indication; P=previously cleared by FDA(K152543); 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. The feature does not use contrast agents. | | | | | | | | | |
| | Note 2: iScape | | | | | | | | | |
| | Note 3:TDI | | | | | | | | | |
| | Note 4: Color M | | | | | | | | | |
| | Note5: Biopsy Guidance | | | | | | | | | |
| | Note6: Elastography | | | | | | | | | |
| | Note7: Contrast imaging (Contrast agent for LVO) | | | | | | | | | |
| | Note8: Smart 3D | | | | | | | | | |
| | | | | | | | | | | |
| | Note9: 4D(Real-time 3D) | | | | | | | | | |
| | Note10: Contrast imaging (Contrast agent for Liver) | | | | | | | | | |
| | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | | | | | | | | | |
| Clinical Application | | 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 | P | P | P | | P | P | P | Note 1,2,4,5,8 | |
| | Abdominal | P | P | P | | P | P | P | Note 1,2,4,5,8,10 | |
| | Intra-operative (Specify*) | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | P | P | P | | P | P | P | Note 1,2,4,5,8 | |
| | Small Organ (Specify**) | | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | | |
| Fetal Imaging<br>& Other | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Card.) | P | P | P | | P | P | P | Note 1,2,4,5,8 | |
| | Musculo-skeletal<br>(Conventional) | P | P | P | | P | P | P | Note 1,2,4,5,8 | |
| | (Conventional) | | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | | |
| | (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 1,2,4,5,8 | |
| | Other (Specify***) | | | | | | | | | |
| | N=new indication; P=previously cleared by FDA(K152543); | | | | | | 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. The feature does not use contrast agents. | | | | | | | | | |
| | | | | | | | | | | |
| | Note 2: iScape | | | | | | | | | |
| | Note 3:TDI | | | | | | | | | |
| | Note 4: Color M | | | | | | | | | |
| | Note5: Biopsy Guidance | | | | | | | | | |
| | Note6: Elastography | | | | | | | | | |
| | Note7: Contrast imaging (Contrast agent for LVO) | | | | | | | | | |
| | Note8: Smart 3D | | | | | | | | | |
| | Note9: 4D(Real-time 3D) | | | | | | | | | |
| | Note10: 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 | Specific (Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) | |
| (Track 1 Only) | | | | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| Fetal Imaging<br>& Other | Fetal | | | | | | | | | |
| | Abdominal | P | P | P | | P | P | P | Note 1,2,5,8 | |
| | Intra-operative (Specify*) | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | P | P | P | | P | P | P | Note 1,2,5,8 | |
| | Small Organ (Specify**) | P | P | P | | P | P | P | Note 1,2,5,6,8 | |
| | Neonatal Cephalic | P | P | P | | P | P | P | Note 1,2,5,8 | |
| | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | P | P | P | | P | P | P | Note 1,2,5,6,8 | |
| | Musculo-skeletal<br>(Superficial) | P | P | P | | P | P | P | Note 1,2,5,6,8 | |
| | 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 1,2,5,8 | |
| | Other (Specify***) | | | | | | | | | |
| | N=new indication; P=previously cleared by FDA(K152543); 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. The feature does not use contrast agents. | | | | | | | | | |
| | Note 2: iScape | | | | | | | | | |
| | Note 3:TDI | | | | | | | | | |
| | Note 4: Color M | | | | | | | | | |
| | Note5: Biopsy Guidance | | | | | | | | | |
| | Note6: Elastography | | | | | | | | | |
| | Note7: Contrast imaging (Contrast agent for LVO) | | | | | | | | | |
| | Note8: Smart 3D | | | | | | | | | |
| | Note9: 4D(Real-time 3D) | | | | | | | | | |
| | Note10: 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 | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | Amplitude | Combined | Other (specify) | |
| (Track 1 Only) | | | | | | Doppler | Doppler | (specify) | | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| | Fetal | | | | | | | | | |
| | Abdominal | | | | | | | | | |
| | Intra-operative (Specify*) | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | |
| | Laparoscopic | | | | |…