Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite Diagnostic Ultrasound System/Resona 6S/Resona 6PRO/Resona 6OB Diagnostic Ultrasound System /Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite Diagnostic Ultrasound System

K172860 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · IYN · Jan 2, 2018 · Radiology

Device Facts

• Record ID: K172860
• Device Name: Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite Diagnostic Ultrasound System/Resona 6S/Resona 6PRO/Resona 6OB Diagnostic Ultrasound System /Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite Diagnostic Ultrasound System
• Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• Product Code: IYN · Radiology
• Decision Date: Jan 2, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite/Resona 6S/Resona 6PRO/Resona 6OB/Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ (breast, thyroid, testes), adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), adult and pediatric cardiac, peripheral vessel, urology exam.

Device Story

Mobile, software-controlled diagnostic ultrasound system; acquires/displays ultrasound images for clinical diagnosis. Inputs: ultrasonic signals from array probes (linear, phased, convex). Processing: system transmits ultrasonic energy into patient; receives/processes echoes to generate real-time anatomical/flow images. Modes: B, M, PW, CW, Color, Power/Dirpower, THI, iScape, TDI, Color M, Strain Elastography, 3D/4D, Contrast (Liver/LVO), Fusion, V Flow, STE, STQ. Output: onscreen display of structures/flow; measurements/calculations. Used in clinical settings by trained healthcare professionals. Output assists clinicians in visualizing anatomy/pathology, guiding biopsies, and assessing blood flow/tissue characteristics, facilitating diagnostic decision-making.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including acoustic output measurement (NEMA UD 2-2004), electrical/mechanical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and software life cycle processes (IEC 62304).

Technological Characteristics

Mobile diagnostic ultrasound system; array probes (linear, phased, convex). Materials tested per ISO 10993-1. Energy: ultrasonic pulsed Doppler/echo. Connectivity: standard ultrasound system interfaces. Software: life cycle per IEC 62304. Sterilization: compatible with standard transducer cleaning/disinfection protocols.

Indications for Use

Indicated for adults, pregnant women, pediatric patients, and neonates. Used for fetal, abdominal, pediatric, small organ (breast, thyroid, testes), adult cephalic, trans-rectal, trans-vaginal, musculoskeletal (conventional, superficial), adult/pediatric 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

• Resona 7 (K171233)

Reference Devices

• M9 (K171034)

Submission Summary (Full Text)

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January 2, 2018

Image /page/0/Picture/1 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

### Re: K172860

Trade/Device Name: Resona 6/Resona 6T/Resona 6Elite/Resona 6Elite/Resona 6S/Resona 6PRO/Resona 6OB/Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite 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: December 1, 2017 Received: December 4, 2017

Dear Ma Chao:

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 of medical device-related adverse events) (21 CFR 803); good

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manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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

Sincerely.

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)

### K172860

#### Device Name

Resona 6/Resona 6T/Resona 6Elite/Resona 6S/Resona 6PRO/Resona 6OB/Resona 5/Resona 57/Resona 5EXP/Resona 5Elite Diagnostic Ultrasound System

#### Indications for Use (Describe)

The Resona 6/Resona 6T/Resona 6Elite/Resona 6S/Resona 6PRO/Resona 6OB/Resona 6/Resona 5/Resona 57/ Resona 5EXP/Resona 5Elite Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ (breast, thyroid, testes), adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), adult and pediatric cardiac, peripheral vessel, urology exam.

Type of Use (Select one or both, as applicable)

| <div> <span> <span style="font-size:16px">✔</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:

Resona 6/Resona 6T/Resona 6Elite/Resona 6S/Resona 6S/Resona 6OB/Resona 5/Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite Diagnostic Ultrasound System

N/A Transducer:

| Clinical Application | | Mode of Operation | | | | | | | |
|---------------------------|------------------------------------|-------------------|---|-----|-----|------------------|----------------------|-----------------------|------------------------------------------|
| General<br>(Track 1 Only) | Specific<br>(Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging<br>& Other | Fetal | N | N | N | N | N | N | N | Note 1, 2, 3, 4, 5, 6, 7 |
| | Abdominal | N | N | N | N | N | N | N | Note 1, 2, 3, 4, 5, 6, 7,<br>10, 14 |
| | Intra-operative (Specify*) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | N | N | N | N | N | N | N | Note 1, 2, 4, 7 |
| | Small Organ (Specify**) | N | N | N | N | N | N | N | Note 1, 2, 4, 7, 8, 12, 13 |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | N | N | N | N | N | N | N | Note 1, 2, 4, 5, 6, 7, 10 |
| | Trans-rectal | N | N | N | N | N | N | N | Note 1, 2, 3, 4, 6, 7 |
| | Trans-vaginal | N | N | N | N | N | N | N | Note 1, 2, 3, 4, 6, 7 |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | N | N | N | N | N | N | N | Note 1, 2, 4, 6, 7, 8, 10,<br>12, 13 |
| | Musculo-skeletal<br>(Superficial) | N | N | N | N | N | N | N | Note 1, 2, 4, 7, 8, 12, 13 |
| | Intravascular | | | | | | | | |
| Cardiac | Cardiac Adult | N | N | N | N | N | N | N | Note 1, 2, 4, 5, 6, 7,9,10 |
| | Cardiac Pediatric | N | N | N | N | N | N | N | Note 1, 2, 4, 5, 6, 7,10 |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| Peripheral<br>vessel | Peripheral vessel | N | N | N | N | N | N | N | Note 1, 2, 4, 6, 7, 8, 10,<br>11, 12, 13 |
| | Other (Specify***) | N | N | N | N | N | N | N | Note 1, 2, 4, 6, 7 |

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System:

Resona 6/Resona 6T/Resona 6Elite/Resona 6S/Resona 6S/Resona 6OB/Resona 5/Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite Diagnostic Ultrasound System

| C5-1U |
|-------|
| |

| Clinical Application | Mode of Operation | | | | | | | | | |
|----------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|---|--------------------------|--------------------------|--------------------------|----------------------|-----------------------|----------------------------|--|
| General<br>(Track 1 Only) | Specific<br>(Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other<br>(Specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| Fetal Imaging<br>& Other | Fetal | P | P | P | | P | P | P | Note 1, 2, 4, 6, 7,10 | |
| | Abdominal | P | P | P | | P | P | P | Note 1, 2, 4, 6, 7,10,14 | |
| | Intra-operative (Specify*) | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | | | | | | | | | |
| | 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, 7,10 | |
| | 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, 7,10 | |
| | Other (Specify***) | | | | | | | | | |
| | N=new indication; P=previously cleared by FDA (K171233); 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: Smart3D | | | | | | | | | |
| | Note 3:4D(Real-time 3D) | | | | | | | | | |
| | Note 4: iScape | | | | | | | | | |
| | Note 5: TDI | | | | | | | | | |
| | Note 6: Color M | | | | | | | | | |
| | Note 7: Biopsy Guidance | | | | | | | | | |
| | Note8: Strain Elastography | | | | | | | | | |
| | Note 9: Contrast imaging (Contrast agent for LVO) | | | | | | | | | |
| | Note 10: Ultrasound Fusion Imaging | | | | | | | | | |
| | Note 11: V Flow | | | | | | | | | |
| | Note12: STE | | | | | | | | | |
| | Note13: STQ | | | | | | | | | |
| | Note14: 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) | | | | | | | | | |
| Clinical Application | | Mode of Operation | | | | | | | | |
| General<br>(Track 1 Only) | Specific<br>(Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other<br>(Specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| Fetal Imaging<br>& Other | Fetal | P | P | P | | P | P | P | Note 1, 2, 4, 5, 6, 10 | |
| | Abdominal | P | P | P | | P | P | P | Note 1, 2, 4, 6, 10 | |
| | Intra-operative (Specify*) | | | | | | | | | |
| | Intra-operative (Neuro)…