DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System

K173369 · Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. · IYN · Dec 13, 2017 · Radiology

Device Facts

• Record ID: K173369
• Device Name: DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System
• Applicant: Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.
• Product Code: IYN · Radiology
• Decision Date: Dec 13, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), cardiac(adult, pediatric) , peripheral vessel and urology exams.

Device Story

General-purpose, mobile, software-controlled diagnostic ultrasound system; acquires/displays images in B, M, PW, Color, Power/DirPower, THI, 3D/4D, iScape, Biopsy Guidance, Elastography, and Contrast imaging (liver) modes. Employs linear, convex, and phased array probes. Used in clinical settings by healthcare professionals to visualize anatomic structures and fluid flow. System processes received ultrasonic echoes to generate onscreen displays and perform measurements/calculations. Output assists clinicians in diagnostic assessment of various body regions. Benefits include non-invasive diagnostic imaging and guidance for clinical procedures.

Clinical Evidence

Bench testing only. No clinical data required. Evidence includes acoustic output measurements, biocompatibility testing, and verification of compliance with electrical/mechanical safety standards (IEC 60601-1, 60601-1-2, 60601-2-37) and software life cycle processes (IEC 62304).

Technological Characteristics

Mobile ultrasound system; linear, convex, and phased array transducers. Patient contact materials tested per ISO 10993-1. Modes: B, M, PW, Color, Power/DirPower, THI, 3D/4D, iScape, Elastography, Contrast imaging. Connectivity: standard ultrasound system interfaces. Software-controlled; complies with IEC 62304, IEC 60601-1, and NEMA UD 2/3 standards.

Indications for Use

Indicated for adults, pregnant women, pediatric patients, and neonates for fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal/adult cephalic, trans-rectal, trans-vaginal, musculoskeletal (conventional, superficial), cardiac (adult, pediatric), 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-N3 (K140030)

Reference Devices

• DC-8 (K170277)
• M9 (K171034)

Submission Summary (Full Text)

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December 13, 2017

Image /page/0/Picture/1 description: The image contains 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 includes a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

## Re: K173369

Trade/Device Name: DC-30/DC-32/DC-28/DC-26/DC-25 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: October 27, 2017 Received: October 27, 2017

Dear Mrs. Lei:

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 manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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 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 ([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)

K173369

Device Name

DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System

Indications for Use (Describe)

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), neonatal and adult cephalic, transvaginal, musculo-skeletal(conventional, superficial), cardiac(adult, pediatric) , peripheral vessel and urology exams.

| <span> <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
|---------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
|---------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|

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

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Transducer:

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