DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic Ultrasound System

K192152 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · IYN · Dec 13, 2019 · Radiology

Device Facts

• Record ID: K192152
• Device Name: DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic Ultrasound System
• Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• Product Code: IYN · Radiology
• Decision Date: Dec 13, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows: The DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic Ultrasound System is applicable for adults, pregnant woments 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, musculo-skeletal(conventional, cardiac(adult, pediatric), trans-soph. (Cardiac), peripheral vessel, and urology exams.

Device Story

Diagnostic ultrasound system; acquires/displays ultrasound data in B-Mode, M-Mode, PW-Mode, CWD-Mode, Color-Mode, Power/Dirpower Mode, THI, Smart3D, 4D, iScape, TDI, Color M, Biopsy Guidance, Strain Elastography, Contrast imaging (Liver/LVO), STE, STQ, Ultrasound Fusion Imaging, GYN/Pelvic, and combined modes. Used in clinical settings (hospitals, clinics) by trained healthcare professionals (physicians, sonographers). Inputs: ultrasound signals from various probes (linear, convex, phased, volume, pencil). Outputs: real-time images and flow analysis on system display. Assists clinicians in visualizing anatomy and blood flow for diagnostic decision-making. Benefits: non-invasive diagnostic imaging for various patient populations and clinical applications.

Clinical Evidence

Bench testing only. No clinical studies were required to support substantial equivalence. Testing included biocompatibility (ISO 10993-1), electrical safety (IEC 60601-1, IEC 60601-2-37), EMC (IEC 60601-1-2), and acoustic output measurements per FDA guidance.

Technological Characteristics

Software-controlled diagnostic ultrasound system. Supports linear, convex, phased, volume, and pencil probes. Features: B-Mode, M-Mode, PW/CWD, Color/Power Doppler, THI, Smart3D, 4D, iScape, TDI, Color M, Biopsy Guidance, Strain Elastography, Contrast imaging, STE, STQ, Ultrasound Fusion Imaging. Connectivity: 128G SSD + 1T HDD, battery-powered operation, 4-5 transducer ports, 128 signal channels. Sterilization: Probes compatible with cleaning/disinfection protocols. Software: IEC 62304 compliant.

Indications for Use

Indicated for adults, pregnant women, pediatric patients, and neonates for diagnostic ultrasound imaging and fluid flow analysis in fetal, abdominal, intra-operative (abdominal, thoracic, vascular), pediatric, small organ (breast, thyroid, testes), neonatal/adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), cardiac (adult, pediatric), 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

• DC-70 (K181637)

Reference Devices

• Voluson E8 (K181985)
• Resona 7 (K171233)
• DC-90 (K190206)
• DC-80 (K173471)
• M9 (K171034)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains 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, with the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below that.

December 13, 2019

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

#### Re: K192152

Trade/Device Name: DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/ DC-TV/DC-TQ 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 and LLZ Dated: October 30, 2019 Received: November 21, 2019

#### Dear Zhang Wei:

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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

Sincerely,

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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#### Indications for Use

#### 510(k) Number (if known) K192152

Device Name

DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-86/DC-865/DC-89/DC-TV/DC-TQ Diagnostic Ultrasound System

#### Indications for Use (Describe)

The DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic Ultrasound System is applicable for adults, pregnant woments 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, musculo-skeletal(conventional, cardiac(adult, pediatric), trans-soph. (Cardiac), peripheral vessel, and urology exams.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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| System: | DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic Ultrasound<br>System | | | | | | | | | | | | | | | | | | |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------|------------------------|-------------------------------------------------------------------------------------------------------|-----|------------------|-------------------|-----------------------|-----------------------|--------------------------------------|------------------------------------|--|--|--|--|--|--|--|--|--|
| Transducer: | | | | | | | | | | | | | | | | | | | |
| 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 | Other (specify) | | | | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | | | | | | | | | | | | |
| Fetal Imaging<br>& Other | Fetal | P | P | P | | P | P | P | Note 1, 2,3, 4,6,7,13 | | | | | | | | | | |
| | Abdominal | P | P | P | P | P | P | P | Note 1, 2,<br>3,4,6,7,10,11,12,13,14 | | | | | | | | | | |
| | Intra-operative (Specify*) | P | P | P | | P | P | P | Note1,2,4 | | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | | | | | | | | | |
| | Pediatric | P | P | P | | P | P | P | Note 1, 2,3, 4,6,7,13 | | | | | | | | | | |
| | Small Organ (Specify**) | P | P | P | | P | P | P | Note 1,2,<br>4,7,8,11,12,13 | | | | | | | | | | |
| | Neonatal Cephalic | P | P | P | | P | P | P | Note 1,2, 4,6,7,13 | | | | | | | | | | |
| | Adult Cephalic | P | P | P | | P | P | P | Note 1, 2,4, 6,7,13 | | | | | | | | | | |
| | Trans-rectal | P | P | P | | P | P | P | Note 1, 2,3, 4,6,7,8 | | | | | | | | | | |
| | Trans-vaginal | P | P | P | | P | P | P | Note 1, 2,3, 4,6,7,8,14 | | | | | | | | | | |
| | Trans-urethral | | | | | | | | | | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | P | P | P | | P | P | P | Note 1, 2,<br>4,6,7,8,11,12,13 | | | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | P | P | P | | P | P | | Note 1,2,<br>4,7,8,11,12,13 | | | | | | | | | | |
| | Intravascular | | | | | | | | | | | | | | | | | | |
| Cardiac | Cardiac Adult | P | P | P | | P | P | P | Note 1, 2,4,5,6,7,9,13 | | | | | | | | | | |
| | Cardiac Pediatric | P | P | P | | P | P | P | Note 1, 2,4,5,6,7,13 | | | | | | | | | | |
| | Intravascular (Cardiac)<br>Trans-esoph. (Cardiac) | P | P | P | | P | P | P | Note 1, 5,6 | | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | | | | | | | | | | |
| Peripheral<br>vessel | Peripheral vessel | P | P | P | N | P | P | P | Note 1, 2, 4,6,7,13 | | | | | | | | | | |
| | Other (Specify***) | P | P | P | | P | P | P | Note 1, 2, 4,6,7 | | | | | | | | | | |
| | 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 | | | | | | | | | | | | | | | | | | |
| | **Small organ-breast, thyroid, testes. | | | | | | | | | | | | | | | | | | |
| | ***Other use includes Urology. | | | | | | | | | | | | | | | | | | |
| | Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | | | | | | | | | | | | | | | | | | |
| | Note 2: Smart3D | | | | | | | | | | | | | | | | | | |
| | Note 3:4D(Real-time 3D) | | | | | | | | | | | | | | | | | | |
| | Note 4: iScape | | | | | | | | | | | | | | | | | | |
| | Note 5: TDI | | | | | | | | | | | | | | | | | | |
| | Note 6: Color M | | | | | | | | | | | | | | | | | | |
| | Note 7: Biopsy Guidance | | | | | | | | | | | | | | | | | | |
| | Note 8: Strain Elastography | | | | | | | | | | | | | | | | | | |
| | Note 9: Contrast imaging(contrast agent for LVO) | | | | | | | | | | | | | | | | | | |
| | Note 10: Contrast imaging (Contrast agent for Liver) | | | | | | | | | | | | | | | | | | |
| | Note 11: STE | | | | | | | | | | | | | | | | | | |
| | Note 12: STQ | | | | | | | | | | | | | | | | | | |
| | Note 13: Ultrasound Fusion Imaging | | | | | | | | | | | | | | | | | | |
| | Note 14: GYN/Pelvic | | | | | | | | | | | | | | | | | | |
| | (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: | DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic Ultrasound<br>System | | | | | | | | | | | | | | | | | | |
| Transducer: | C5-1E | | | | | | | | | | | | | | | | | | |
| 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<br>Doppler | Amplitude Doppler | Combined<br>(specify) | Other (specify) | | | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | | | | | | | | | | | | |
| Fetal Imaging<br>& Other | Fetal | | P | P | P | | P | P | P | Note 1, 2, 4,6,7,13 | | | | | | | | | |
| | Abdominal | | P | P | P | | P | P | P | Note 1, 2,<br>4,6,7,10,11,12,13,14 | | | | | | | | | |
| | Intra-operative (Specify*) | | | | | | | | | | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | | | | | | | | | |
| | Pediatric | | P | P | P | | P | P | P | Note 1, 2, 4,6,7,13 | | | | | | | | | |
| | 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, 4,6,7,13 | | | | | | | | | |
| | Musculo-skeletal<br>(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, 4,6,7,13 | | | | | | | | | |
| | Other (Specify***) | | | | | | | | | | | | | | | | | | |
| | N=new indication; P=previously cleared by FDA(K173471); 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. The feature does not use contrast agents. | | | | | | | | | | | | | | | | | | |
| | Note 2: Smart3D | | | | | | | | | | | | | | | | | | |
| | Note 3:4D(Real-time 3D) | | | | | | | | | | | | | | | | | | |
| | Note 4: iScape | | | | | | | | | | | | | | | | | | |
| | Note 5: TDI | | | | | | | | | | | | | | | | | | |
| | Note 6: Color M | | | | | | | | | | | | | | | | | | |
| | Note 7: Biopsy Guidance | | | | | | | | | | | | | | | | | | |
| | Note 8: Strain Elastography | | | | | | | | | | | | | | | | | | |
| | Note 9: Contrast imaging(contrast agent for LVO) | | | | | | | | | | | | | | | | | | |
| | Note 10: Contrast imaging (Contrast agent for Liver) | | | | | | | | | | | | | | | | | | |
| | Note 11: STE | | | | | | | | | | | | | | | | | | |
| | Note 12: STQ | | | | | | | | | | | | | | | | | | |
| | Note 13: Ultrasound Fusion Imaging | | | | | | | | | | | | | | | | | | |
| | Note 14: GYN/Pelvic | | | | | | | | | | | | | | | | | | |
| | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | | | | | | | | | | | | | | | | | | |
| System: | DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic Ultrasound System | | | | | | | | | | | | | | | | | | |
| | System | | | | | | | | | | | | | | | | | | |
| Transducer: | L14-5WE | | | | | | | | | | | | | | | | | | |
| Intended Use: | Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | | | | | | | | | | |
| Clinical Application | | | | | | | | | | | | | | | | | | | |
| | General (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 | | | | | | | | | | | | | | | | | | |
| | Abdominal | | P | P | P | | P | P | P | Note 1,2, 4,7,13 | | | | | | | | | |
| | Intra-operative (Specify*) | | | | | | | | | | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | | | | | | | | | |
| | Pediatric | | P | P | P | | P | P | P | Note 1,2, 4,7,13 | | | | | | | | | |
| | Small Organ (Specify**) | | P | P | P | | P | P | P | Note 1,2,<br>4,7,8,11,12,13 | | | | | | | | | |
| | Neonatal Cephalic | | P | P | P | | P | P | P | Note 1,2, 4,7,13 | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | | | | | | | | | | |
| | Trans-rectal<br>Trans-vaginal | | | | | | | | | | | | | | | | | | |
| | Trans-urethral | | | | | | | | | | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | P | P | P | | P | P | P | Note 1,2,4,7,11,12,13 | | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | P | P | P | | P | P | P | Note 1,2,4,7,11,12,13 | | | | | | | | | |
| | 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, 4,7,13 | | | | | | | | | |
| | Other (Specify***) | | | | | | | | | | | | | | | | | | |
| | N=new indication; P=previously cleared by FDA(K173471); 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. The feature does not use contrast agents. | | | | | | | | | | | | | | | | | | |
| | Note 2: Smart3D | | | | | | | | | | | | | | | | | | |
| | Note 3:4D(Real-time 3D) | | | | | | | | | | | | | | | | | | |
| | Note 4: iScape | | | | | | | | | | | | | | | | | | |
| | Note 5: TDI | | | | | | | | | | | | | | | | | | |
| | Note 6: Color M | | | | | | | | | | | | | | | | | | |
| | Note 7: Biopsy Guidance | | | | | | | | | | | | | | | | | | |
| | Note 8: Strain Elastography | | | | | | | | | | | | | | | | | | |
| | Note 9: Contrast imaging(contrast agent for LVO) | | | | | | | | | | | | | | | | | | |
| | Note 10: Contrast imaging (Contrast agent for Liver) | | | | | | | | | | | | | | | | | | |
| | Note 11: STE | | | | | | | | | | | | | | | | | | |
| | Note 12: STQ | | | | | | | | | | | | | | | | | | |
| | Note 13: Ultrasound Fusion Imaging | | | | | | | | | | | | | | | | | | |
| | Note 14: GYN/Pelvic | | | | | | | | | | | | | | | | | | |
| | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | | | | |…