DP-10/DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging System

K183660 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · IYN · Apr 9, 2019 · Radiology

Device Facts

• Record ID: K183660
• Device Name: DP-10/DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging System
• Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• Product Code: IYN · Radiology
• Decision Date: Apr 9, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

DP-10/DP-30/DP-30 Digital Ultrasonic Diagnostic Imaging 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, musculo-skeletal (conventional, superficial), cardiac (adult, pediatric), peripheral vascular and urology exams.

Device Story

The DP-10/DP-20/DP-30 is a portable/mobile digital ultrasonic diagnostic imaging system. It uses an array of probes (linear, convex) to acquire ultrasound signals from the human body. The system processes these signals to generate images in B-Mode, M-Mode, PW-Mode, and Power Mode, or combined modes (e.g., B/M, B/PW, Power+B, Power+PW+B). It includes the iScanHelper feature. The device is operated by healthcare professionals in clinical settings to visualize anatomic structures and fluid flow. Output is displayed on-screen for diagnostic assessment, measurement, and calculation. The device aids clinicians in clinical decision-making by providing real-time diagnostic imaging and biopsy guidance, potentially benefiting patients through non-invasive diagnostic evaluation.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including acoustic output measurement, biocompatibility, cleaning/disinfection effectiveness, and thermal, electrical, and mechanical safety testing in accordance with FDA-recognized standards (e.g., IEC 60601-1, IEC 60601-2-37, ISO 10993-1).

Technological Characteristics

Portable/mobile ultrasound system using linear and convex array probes. Modes: B, M, PW, Power, THI, and combined modes. Complies with AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, IEC 62366-1, IEC 60601-1-6, ISO 10993-1, ISO 14971, and NEMA UD 2. Software-controlled. Biocompatible materials used for patient-contacting parts.

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, cardiac, peripheral vascular, and urology ultrasound 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

• DP-20/DP-30 (K130833)

Reference Devices

• Z5 (K130695)
• M9 (K171034)

Submission Summary (Full Text)

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April 9, 2019

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

## Re: K183660

Trade/Device Name: DP-10/DP-30 Digital Ultrasonic Diagnostic Imaging 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 22, 2019 Received: March 25, 2019

Dear Jiang Haosen:

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

{1}------------------------------------------------

devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) 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 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,

For

Thalia 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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## Indications for Use

510(k) Number (if known)

### K183660

Device Name DP-10/DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging System

### Indications for Use (Describe)

DP-10/DP-30/DP-30 Digital Ultrasonic Diagnostic Imaging 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, musculo-skeletal (conventional, superficial), cardiac (adult, pediatric), peripheral vascular 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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## Diagnostic Ultrasound Indications For Use Format

DP-10/DP-20 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(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 | P | P | N | | | | P | Note1, Note 2 |
| | Abdominal | P | P | N | | | | P | Note1, Note 2 |
| | Intra-operative (Specify*) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | P | Note1, Note 2 |
| | Pediatric | P | P | N | | | | P | Note1, Note 2 |
| | Small Organ (Specify**) | P | P | N | | | | P | Note 2 |
| | Neonatal Cephalic | P | P | N | | | | P | Note 2 |
| Fetal Imaging &<br>Other | Adult Cephalic | P | P | N | | | | P | Note 2 |
| | Trans-rectal | P | P | N | | | | P | Note 2 |
| | Trans-vaginal | P | P | N | | | | P | Note 2 |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | P | P | N | | | | P | Note1, Note 2 |
| | Musculo-skeletal<br>(Superficial) | P | P | N | | | | P | Note 2 |
| | Intravascular | | | | | | | | |
| | Cardiac Adult | P | P | N | | | | P | Note 2 |
| | Cardiac Pediatric | P | P | N | | | | P | Note 2 |
| Cardiac | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| Peripheral<br>Vascular | Peripheral Vascular | P | P | N | | | | P | Note 2 |
| | Other (Specify***) | P | P | N | | | | P | Note1, Note 2 |
| | N=new indication; P=previously cleared by FDA; E=added under Appendix E | | | | | | | | |
| | Additional comments: Combined modes--B+M, 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: Biopsy Guidance | | | | | | | | |
| | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | | | | | | | | |
| | Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) | | | | | | | | |

{4}------------------------------------------------

## 35C20EA

#### System: DP-10/DP-20 Diagnostic Ultrasound 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(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 | | | | | | | | |
| | Abdominal | P | P | N | | | | P | Note 2 |
| | Intra-operative (Specify*) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | N | | | | P | Note 2 |
| | Small Organ (Specify**) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| Fetal Imaging & | Adult Cephalic | | | | | | | | |
| Other | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | P | P | N | | | | P | Note 2 |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Cardiac Adult | P | P | N | | | | P | Note 2 |
| | Cardiac Pediatric | | | | | | | | |
| Cardiac | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| Peripheral | Peripheral Vascular | P | P | N | | | | P | Note 2 |
| Vascular | Other (Specify***) | | | | | | | | |
| | N=new indication; P=previously cleared by FDA; E=added under Appendix E | | | | | | | | |
| | Additional comments: Combined modes -- B+M, 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: Biopsy Guidance | | | | | | | | |
| | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | | | | | | | | |
| | Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) | | | | | | | | |

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

### 35C50EB

#### System: DP-10/DP-20 Diagnostic Ultrasound System

Transducer: N/A

| Intended Use: | | |
|---------------|--|--|
| | | |

| Clinical Application | | Mode of Operation | | | | | | | |
|--------------------------|----------------------------------------------------------------------------|-------------------|---|-----|-----|------------------|----------------------|-----------------------|-----------------|
| General(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 | P | P | N | | | | P | Note1, Note 2 |
| | Abdominal | P | P | N | | | | P | Note1, Note 2 |
| | Intra-operative (Specify*) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | N | | | | P | Note1, Note 2 |
| | Small Organ (Specify**) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| Fetal Imaging & | Adult Cephalic | | | | | | | | |
| Other | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | P | P | N | | | | P | Note1, Note 2 |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| Cardiac | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| Peripheral | Peripheral Vascular | | | | | | | | |
| Vascular | Other (Specify***) | P | P | N | | | | P | Note1, Note 2 |
| | N=new indication; P=previously cleared by FDA; E=added under Appendix E | | | | | | | | |
| | Additional comments: Combined modes--B+M, 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: Biopsy Guidance | | | | | | | | |
| | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | | | | | | | | |

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

### 65C15EA

#### System: DP-10/DP-20 Diagnostic Ultrasound System

Transducer: N/A

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

| Clinical Application | Specific (Track 1 & 3) | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined (specify) | Other (specify) | |
|--------------------------|-----------------------------------------------------------------------------------|---|---|-----|-----|---------------|-------------------|--------------------|-----------------|--|
| General(Track 1<br>Only) | Ophthalmic | | | | | | | | | |
| Ophthalmic | Fetal | | | | | | | | | |
| | Abdominal | P | P | N | | | | P | Note 2 | |
| | Intra-operative (Specify*) | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | P | P | N | | | | P | Note 2 | |
| | Small Organ (Specify**) | | | | | | | | | |
| | Neonatal Cephalic | P | P | N | | | | P | Note 2 | |
| Fetal Imaging &<br>Other | Adult Cephalic | P | P | N | | | | P | Note 2 | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | P | P | N | | | | P | Note 2 | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | | |
| | Intravascular | | | | | | | | | |
| | Cardiac Adult | | | | | | | | | |
| | Cardiac Pediatric | P | P | N | | | | P | Note 2 | |
| Cardiac | Intravascular (Cardiac) | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| Peripheral<br>Vascular | Peripheral Vascular | P | P | N | | | | P | Note 2 | |
| | Other (Specify***) | | | | | | | | | |
| | N=new indication; P=previously cleared by FDA; E=added under Appendix E | | | | | | | | | |
| | Additional comments: Combined modes--B+M, 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: Biopsy Guidance | | | | | | | | | |
| | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | | | | | | | | | |
| | Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) | | | | | | | | | |

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

### 65EC10EB

#### System: DP-10/DP-20 Diagnostic Ultrasound System

Transducer: N/A

| Intended Use: | | |
|---------------|--|--|

| Clinical Application | | Mode of Operation | | | | | | | | |
|--------------------------|-----------------------------------------------------------------------------------|-------------------|---|-----|-----|------------------|----------------------|-----------------------|-----------------|--|
| General(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 | P | P | N | | | | P | Note 2 | |
| | Abdominal | | | | | | | | | |
| | Intra-operative (Specify*) | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | | | | | | | | | |
| | Small Organ (Specify**) | | | | | | | | | |
| | Neonatal Cephalic | P | P | N | | | | P | Note 2 | |
| Fetal Imaging &<br>Other | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | P | P | N | | | | P | Note 2 | |
| | Trans-vaginal | P | P | N | | | | P | Note 2 | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | | |
| | Intravascular | | | | | | | | | |
| | Cardiac Adult | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | |
| Cardiac | Intravascular (Cardiac) | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| Peripheral<br>Vascular | Peripheral Vascular | | | | | | | | | |
| | Other (Specify***) | P | P | N | | | | P | Note 2 | |
| | N=new indication; P=previously cleared by FDA; E=added under Appendix E | | | | | | | | | |
| | Additional comments: Combined modes--B+M, 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: Biopsy Guidance | | | | | | | | | |
| | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | | | | | | | | | |
| | Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) | | | | | | | | | |

{8}------------------------------------------------

## 75L38EB

#### System: DP-10/DP-20 Diagnostic Ultrasound System

Transducer: N/A

| | | Intended Use: | | | |
|--|--|---------------|--|--|--|
|--|--|---------------|--|--|--|

| Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows | | | | | | | | | |
|-------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|-------------------|---|-----|-----|------------------|----------------------|-----------------------|-----------------|
| Clinical Application | | Mode of Operation | | | | | | | |
| General(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 | | | | | | | | |
| | Abdominal | P | P | N | | | | P | Note 2 |
| | Intra-operative (Specify*) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | N | | | | P | Note 2 |
| | Small Organ (Specify**) | P | P | N | | | | P | Note 2 |
| | Neonatal Cephalic | P | P | N | | | | P | Note 2 |
| Fetal Imaging &<br>Other | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | P | P | N | | | | P | Note 2 |
| | Musculo-skeletal<br>(Superficial) | P | P | N | | | | P | Note 2 |
| | Intravascular | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| Cardiac | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| Peripheral<br>Vascular | Peripheral Vascular | P | P | N | | | | P | Note 2 |
| | Other (Specify***) | | | | | | | | |
| | N=new indication; P=previously cleared by FDA; E=added under Appendix E | | | | | | | | |
| | Additional comments: Combined modes--B+M, 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: Biopsy Guidance | | | | | | | | |
| | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | | | | | | | | |
| | Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) | | | | | | | | |

{9}------------------------------------------------

## 75L53EA

#### System: DP-10/DP-20 Diagnostic Ultrasound 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(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 | | | | | | | | | |
| | Abdominal | P | P | N | | | | P | Note 2 | |
| | Intra-operative (Specify*) | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | P | P | N | | | | P | Note 2 | |
| | Small Organ (Specify**) | P | P | N | | | | P | Note 2 | |
| | Neonatal Cephalic | P | P | N | | | | P | Note 2 | |
| Fetal Imaging & | Adult Cephalic | | | | | | | | | |
| Other | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | P | P | N | | | | P | Note 2 | |
| | Musculo-skeletal<br>(Superficial) | P | P | N | | | | P | Note 2 | |
| | Intravascular | | | | | | | | | |
| | Cardiac Adult | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | |
| Cardiac | Intravascular (Cardiac) | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| | Peripheral Vascular | P | P | N | | | | P | Note 2 | |
| | Other (Specify***) | | | | | | | | | |
| | N=new indication; P=previously cleared by FDA; E=added under Appendix E | | | | | | | | | |
| | Additional comments: Combined modes--B+M, 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: Biopsy Guidance | | | | | | | | | |
| | (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(Track 1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined (specify) | Other (specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| | Fetal | P | P | N | | | N | P | Note1, Note 2 | |
| | Abdominal | P | P | N | | | N | P | Note1, Note 2 | |
| | Intra-operative (Specify*) | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | P | P | N | | | N | P | Note1, Note 2 | |
| | Small Organ (Specify**) | P | P | N | | | N | P | Note 2 | |
| | Neonatal Cephalic | P | P | N | | | N | P | Note 2 | |
| Fetal Imaging & Other | Adult Cephalic | P | P | N | | | N | P | Note 2 | |
| | Trans-rectal | P | P | N | | | N | P | Note 2 | |
| | Trans-vaginal | P | P | N | | | N | P | Note 2 | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | P | P | N | | | N | P | Note1, Note 2 | |
| | Musculo-skeletal<br>(Superficial) | P | P | N | | | N | P | Note 2 | |
| | Intravascular | | | | | | | | | |
| | Cardiac Adult | P | P | N | | | N | P | Note 2 | |
| | Cardiac Pediatric | P | P | N | | | N | P | Note 2 | |
| Cardiac | Intravascular (Cardiac) | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| Peripheral Vascular | Peripheral Vascular | P | P | N | | | N | P | Note 2 | |
| | Other (Specify***) | P | P | N | | | N | P | Note1, Note 2 | |
| | N=new indication; P=previously cleared by FDA; E=added under Appendix E | | | | | | | | | |
| | Additional comments: Co…