DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System

K183377 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · IYN · Apr 4, 2019 · Radiology

Device Facts

• Record ID: K183377
• Device Name: DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System
• Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• Product Code: IYN · Radiology
• Decision Date: Apr 4, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The DC-40/DC-35/DC-45/DC-40S/DC-40 Pro 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 cephalic.adult.cephalic.trans-rectal, trans-vaginal, musculo-skeletal (conventional), musculo- skeletal (superficial), cardiac adult, cardiac pediatric, peripheral vessel and urology exams.

Device Story

General-purpose, mobile, software-controlled diagnostic ultrasound system; acquires/displays images in B, M, PW, CW, Color, Power/Dirpower, THI, 3D/4D, iScape, TDI, Color M, biopsy guidance, elastography, and contrast imaging (liver) modes. Operates via array probes (linear, phased, convex). Used by clinicians in clinical settings for anatomical imaging and fluid flow analysis. Input: ultrasonic echoes; Output: visual display of structures/flow. Assists in clinical decision-making through specialized measurements and calculations. Benefits patients by providing non-invasive diagnostic imaging.

Clinical Evidence

Bench testing only. No clinical data was required to support substantial equivalence. Testing included acoustic output measurement, biocompatibility, cleaning/disinfection effectiveness, and thermal/electrical/mechanical safety per IEC/ANSI/AAMI standards.

Technological Characteristics

Mobile diagnostic ultrasound system; linear, phased, and convex array transducers. Modes: B, M, PW, CW, Color, Power/Dirpower, THI, 3D/4D, iScape, TDI, Color M, biopsy guidance, elastography, contrast imaging. Connectivity: DVD recorder, exportable MP4 format. Software-controlled. Biocompatibility per ISO 10993-1. Safety compliance: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, IEC 62366-1.

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, musculo-skeletal (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-40 (K162845)

Reference Devices

• M6 (K171579)
• DC-7 (K103583)
• Resona 7 (K171233)
• DC-70 (K163690)
• Z6 (K122010)

Submission Summary (Full Text)

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April 9, 2019

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and full name on the right. The Department of Health & Human Services logo is a stylized human figure. The FDA acronym is in a blue square, and the full name "U.S. Food & Drug Administration" is in blue text.

Shenzhen Mindray Bio-Medical Electronics Co., LTD % Shi Jufang Engineer of Technical Regulation Keji 12th Road South, Hi-tech Industrial Park Shenzhen, Guangdong, 518057 P.R. CHINA

# Re: K183377

Trade/Device Name: DC-40/DC-35/DC-45/DC-40S/DC-40 Pro 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: March 19, 2019 Received: March 21, 2019

Dear Shi Jufang:

This letter corrects our substantially equivalent letter of April 4, 2019.

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

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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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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.

David Don

for Thalia T. Mills, 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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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K183377

Device Name

DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System

### Indications for Use (Describe)

The DC-40/DC-35/DC-40S/DC-40 Pro 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 cephalic.adult.cephalic.trans-rectal, trans-vaginal, musculo-skeletal (conventional), musculo- skeletal (superficial), cardiac adult, cardiac pediatric, peripheral vessel and urology exams.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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#### DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System 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 | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other<br>(Specify) | | | |
| (Track 1 Only) | (Track 1 & 3) | | | | | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | | | | | |
| Fetal Imaging<br>& Other | Fetal | P | P | P | P | P | P | P | Note 1, 2,3, 4,6,7 | | | |
| | Abdominal | P | P | P | P | P | P | P | Note 1, 2,3, 4,6,7, 9 | | | |
| | Intra-operative (Specify*) | | | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | | |
| | Pediatric | P | P | P | N | P | P | P | Note 1, 2, 4,6,7 | | | |
| | Small Organ (Specify**) | P | P | P | | P | P | P | Note 1,2, 4,6,7,8 | | | |
| | Neonatal Cephalic | P | P | P | N | P | P | P | Note 1, 2, 4,6,7 | | | |
| | Adult Cephalic | P | P | P | P | P | P | P | Note 1, 2,4,6,7 | | | |
| | Trans-rectal | P | P | P | | P | P | P | Note 1, 2, 3,4,6,7 | | | |
| | Trans-vaginal | P | P | P | | P | P | P | Note 1, 2, 3,4,6,7 | | | |
| | Trans-urethral | | | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | P | P | P | | P | P | P | Note 1, 2, 4,6,7,8 | | | |
| | Musculo-skeletal<br>(Superficial) | P | P | P | | P | P | P | Note 1,2, 4,6,7,8 | | | |
| | Intravascular | | | | | | | | | | | |
| Cardiac | Cardiac Adult | P | P | P | P | P | P | P | Note 1, 2,4,5,6,7 | | | |
| | Cardiac Pediatric | P | P | P | P | P | P | P | Note 1, 2,4,5,6,7 | | | |
| | Intravascular (Cardiac) | | | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | | | |
| Peripheral<br>vessel | Peripheral vessel | P | P | P | | P | P | P | Note 1, 2, 4,6,7 | | | |
| | Other (Specify***) | N | N | N | | N | N | N | Note 1, 2, 4,6,7 | | | |
| | N=new indication; P=previously cleared by FDA (K162845); | | | E=added under Appendix E | | | | | | | | |
| | Additional comments: Combined modes--B+M、PW+B、Color + B、PW +Color+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 | | | | | | | | | | | |
| | Note5: TDI | | | | | | | | | | | |
| | Note6: Color M | | | | | | | | | | | |
| | Note7: Biopsy Guidance | | | | | | | | | | | |
| | Note8: Elastography | | | | | | | | | | | |
| | Note9: 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) | | | | | | | | | | | |

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#### DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System System:

Transducer: 3C5A

#### Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:

| Clinical Application | | | | | | Mode of Operation | | | |
|----------------------|-----------------------------------------------------------------------------------------|---|---|-----|-----|-------------------|-----------|-----------|--------------------|
| General | Specific | | | PWD | CWD | Color | Amplitude | Combined | Other |
| (Track 1 Only) | (Track 1 & 3) | B | M | | | Doppler | Doppler | (specify) | (Specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging | Fetal | P | P | P | | P | P | P | Note 1, 2, 4,6,7 |
| & Other | Abdominal | P | P | P | | P | P | P | Note 1, 2, 4,6,7,9 |
| | Intra-operative (Specify*) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | P | | P | P | P | Note 1, 2, 4,6,7 |
| | Small Organ (Specify**) | | | | | | | | |
| | Neonatal Cephalic | P | P | P | | P | P | P | Note 1, 2, 4,6,7 |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal | P | P | P | | P | P | P | Note 1, 2, 4,6,7 |
| | (Conventional) | | | | | | | | |
| | Musculo-skeletal | | | | | | | | |
| | (Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| Peripheral | Peripheral vessel | P | P | P | | P | P | P | Note 1, 2, 4,6,7 |
| vessel | Other (Specify***) | | | | | | | | |
| | N=new indication; P=previously cleared by FDA (k162845); 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. | | | | | | | | |
| | *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 | | | | | | | | |
| | Note5: TDI | | | | | | | | |
| | Note6: Color M | | | | | | | | |
| | Note7: Biopsy Guidance | | | | | | | | |
| | Note8: Elastography | | | | | | | | |
| | Note9: 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) | | | | | | | | |

{5}------------------------------------------------

#### DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System System:

Transducer: 7L4A

### Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:

| 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 | | | | | | | | | | | |
| | Abdominal | P | P | P | | P | P | P | Note 1,2, 4,6,7 | | | |
| | Intra-operative (Specify*) | | | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | | |
| | Pediatric | P | P | P | | P | P | P | Note 1,2, 4,6,7 | | | |
| | Small Organ (Specify**) | P | P | P | | P | P | P | Note 1,2, 4,6,7,8 | | | |
| | Neonatal Cephalic | P | P | P | | P | P | P | Note 1,2, 4,6,7 | | | |
| | 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, 4,6,7,8 | | | |
| | Musculo-skeletal<br>(Superficial) | P | P | P | | P | P | P | Note 1,2, 4,6,7,8 | | | |
| | 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, 4,6,7 | | | |
| | Other (Specify***) | | | | | | | | | | | |
| N=new indication; P=previously cleared by FDA (k162845); 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 | | | | | | | | | | | | |
| Note5: TDI | | | | | | | | | | | | |
| Note6: Color M | | | | | | | | | | | | |
| Note7: Biopsy Guidance | | | | | | | | | | | | |
| Note8: Elastography | | | | | | | | | | | | |
| Note9: 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) | | | | | | | | | | | | |
| | | | | | | | | | | | | |

{6}------------------------------------------------

#### DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System System:

Transducer: L7-3

#### Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:

| Clinical Application | | | | | | Mode of Operation | | | |
|----------------------|----------------------------------------------------------------------------------------------------------|---|---|-----|-----|-------------------|-----------|-----------|-----------------|
| General | Specific | B | M | PWD | CWD | Color | Amplitude | Combined | Other |
| (Track 1 Only) | (Track 1 & 3) | | | | | Doppler | Doppler | (specify) | (Specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging | Fetal | | | | | | | | |
| & Other | Abdominal | P | P | P | | P | P | P | Note 1,2, 4,6,7 |
| | Intra-operative (Specify*) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | P | | P | P | P | Note 1,2, 4,6,7 |
| | Small Organ (Specify**) | P | P | P | | P | P | P | Note 1,2, 4,6,7 |
| | Neonatal Cephalic | P | P | P | | P | P | P | Note 1,2, 4,6,7 |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal | P | P | P | | P | P | P | Note 1,2, 4,6,7 |
| | (Conventional) | | | | | | | | |
| | Musculo-skeletal | P | P | P | | P | P | P | Note 1,2, 4,6,7 |
| | (Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| Peripheral | Peripheral vessel | P | P | P | | P | P | P | Note 1,2, 4,6,7 |
| vessel | Other (Specify***) | | | | | | | | |
| | N=new indication; P=previously cleared by FDA (k162845); E=added under Appendix E | | | | | | | | |
| | Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW +Color+B、PW +Color+B、Power + PW +B. | | | | | | | | |
| | Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW +Color+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 | | | | | | | | |
| | Note5: TDI | | | | | | | | |
| | Note6: Color M | | | | | | | | |
| | Note7: Biopsy Guidance | | | | | | | | |
| | Note8: Elastography | | | | | | | | |
| | Note9: 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) | | | | | | | | |

{7}------------------------------------------------

#### DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System System:

D7-2E Transducer:

| 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<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, 3, 4, 6 |
| | Abdominal | P | P | P | | P | P | P | Note 1, 3, 4, 6 |
| | 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) | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| Peripheral<br>vessel | Peripheral vessel | | | | | | | | |
| | Other (Specify***) | | | | | | | | |
| | N=new indication; P=previously cleared by FDA (k162845); 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 | | | | | | | | |
| | Note5: TDI | | | | | | | | |
| | Note6: Color M | | | | | | | | |
| | Note7: Biopsy Guidance | | | | | | | | |
| | Note8: Elastography | | | | | | | | |
| | Note9: 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 | Specific | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other<br>(Specify) |
| (Track 1 Only) | (Track 1 & 3) | | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging<br>& Other | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative (Specify*) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | P | P | P | P | P | Note 1,2, 4,7 |
| | Small Organ (Specify**) | P | P | P | P | P | P | P | Note 1,2, 4,7,8 |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | P | P | P | P | P | P | P | Note 1,2, 4,7,8 |
| | Musculo-skeletal<br>(Superficial) | P | P | P | P | P | P | P | Note 1,2, 4,7,8 |
| | Intravascular | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| Peripheral<br>vessel | Peripheral vessel | P | P | P | P | P | P | P | Note 1,2, 4,7 |
| | Other (Specify***) | | | | | | | | |
| | N=new indication; P=previously cleared by FDA (k162845); 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 | | | | | | | | |
| | Note5: TDI | | | | | | | | |
| | Note6: Color M | | | | | | | | |
| | Note7: Biopsy Guidance | | | | | | | | |
| | Note8: Elastography | | | | | | | | |
| | Note9: 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) | |…