DC-60/DC-60S/DC-60 EXP/DC-55 Diagnostic Ultrasound Systems

K152545 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · IYN · Oct 2, 2015 · Radiology

Device Facts

• Record ID: K152545
• Device Name: DC-60/DC-60S/DC-60 EXP/DC-55 Diagnostic Ultrasound Systems
• Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• Product Code: IYN · Radiology
• Decision Date: Oct 2, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

DC-60/DC-60S/DC-60 Exp/DC-55 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), adult and pediatric cardiac, peripheral vessel and urology exam.

Device Story

The DC-60/DC-60S/DC-60 Exp/DC-55 is a software-controlled diagnostic ultrasound system. It acquires ultrasound data via an array of linear and convex probes (2.0–10.0 MHz). The system processes these signals to generate B-Mode, M-Mode, PW-Mode, CW-Mode, Color-Mode, Power/Dirpower Mode, Tissue Harmonic Imaging (THI), and combined modes. Used in clinical settings by healthcare professionals, the device displays anatomic structures and fluid flow on-screen. It supports specialized measurements, calculations, body marks, and reporting. The output assists clinicians in diagnostic imaging and fluid flow analysis, facilitating clinical decision-making across various patient populations and anatomical applications.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including acoustic output measurements, biocompatibility, cleaning/disinfection effectiveness, and thermal, electrical, and mechanical safety testing in accordance with FDA-recognized standards.

Technological Characteristics

Software-controlled diagnostic ultrasound system. Operates in B, M, PW, CW, Color, Power/Dirpower, and THI modes. Frequency range 2.0–10.0 MHz. Probes include linear and convex arrays. Complies with AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 14971, ISO 10993-1, IEC 62366, and IEC 62304.

Indications for Use

Indicated for adults, pregnant women, pediatric patients, and neonates for fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculoskeletal (conventional, superficial), adult and pediatric cardiac, peripheral vessel, and urology examinations.

Regulatory Classification

Identification

An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• DC-70 (K150204)
• DC-T6 (K120699)
• DC-8 (K150080)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 2, 2015

Shenzhen Mindray Bio-Medical Electronics Co., Ltd. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street, NW BUFFALO MN 55313

Re: K152545

Trade/Device Name: DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX, LLZ Dated: September 4, 2015 Received: September 8, 2015

Dear Mr. Job:

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 (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D'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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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

K152545

Device Name DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System

Indications for Use (Describe)

DC-60/DC-60 Exp/DC-55 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), adult and pediatric cardiac, peripheral vessel and urology exam.

✔ Prescription Use (Part 21 CFR 801 Subpart D)

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

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{3}------------------------------------------------

#### Diagnostic Ultrasound Indications For Use Format

DC-60/DC-60S/DC-60 Exp/DC-55 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 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined (specify) | Other (specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | N | N | N | | N | N | N | Note 1, 2,3,4,6,7 |
| | Abdominal | N | N | N | N | N | N | N | Note 1, 2,3,4,6,7 |
| | Intra-operative (Specify*) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | N | N | N | | N | N | N | Note 1,2,4,7 |
| | Small Organ (Specify**) | N | N | N | | N | N | N | Note 1,2,4,7 |
| | Neonatal Cephalic | N | N | N | N | N | N | N | Note 1, 2,4,6,7 |
| Fetal Imaging & Other | Adult Cephalic | N | N | N | N | N | N | N | Note 1, 2,4,6,7 |
| | Trans-rectal | N | N | N | | N | N | N | Note 1, 2,4,6,7 |
| | Trans-vaginal | N | N | N | | N | N | N | Note 1, 2,4,6,7 |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal (Conventional) | N | N | N | | N | N | N | Note 1,2,4,7 |
| | Musculo-skeletal (Superficial) | N | N | N | | N | N | N | Note 1, 2,4,7 |
| | Intravascular | | | | | | | | |
| | Cardiac Adult | N | N | N | N | N | N | N | Note 1, 2,4,5,6,7 |
| | Cardiac Pediatric | N | N | N | N | N | N | N | Note 1, 2,4,5,6,7 |
| Cardiac | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| Peripheral vessel | Peripheral vessel | N | N | N | N | N | N | N | Note 1, 2,4,6,7 |
| | 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 | | | | | | | | |
| | **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 | | | | | | | | |
| | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | | | | | | | | |
| | Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) | | | | | | | | |

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#### DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System System:

Transducer: 3C5A

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

| Clinical Application | | Mode of Operation | | | | | | | |
|--------------------------|--------------------------------------------------------------------------------------------|-------------------|---|-----|-----|------------------|----------------------|-----------------------|------------------|
| General<br>(Track 1 | Specific (Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | P | P | P | | P | P | P | Note 1, 2, 4,6,7 |
| | Abdominal | P | P | P | | P | P | P | Note 1, 2, 4,6,7 |
| | Intra-operative (Specify*) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (Specify**) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| Fetal Imaging<br>& Other | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | 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>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(k120699); 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 | | | | | | | | |
| | Note5: TDI | | | | | | | | |
| | Note6: Color M | | | | | | | | |
| | Note7: Biopsy Guidance | | | | | | | | |
| | Note8: Elastography | | | | | | | | |
| | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | | | | | | | | |
| | Concurrence of CDRH, Office of Device Evaluation(ODE) | | | | | | | | |

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

DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System System: Transducer: 6C2

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

| | Clinical Application | | | | | | Mode of Operation | | | |
|--------------------------|--------------------------------------------------------------------------------------------|-------------------|---|-----|-----|------------------|----------------------|-----------------------|------------------|--|
| General<br>(Track 1 | 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 | P | | P | P | P | Note 1, 2, 4,6,7 | |
| | Intra-operative (Specify*) | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | | | | | | | | | |
| | Small Organ (Specify**) | | | | | | | | | |
| | Neonatal Cephalic | P | P | P | | P | P | P | Note 1, 2, 4,6,7 | |
| Fetal Imaging<br>& Other | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | | |
| | Intravascular | | | | | | | | | |
| | Cardiac Adult | | | | | | | | | |
| | Cardiac Pediatric | P | P | P | | P | P | P | Note 1, 2, 4,6,7 | |
| Cardiac | 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(k120699); 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 | | | | | | | | | |
| | Note5: TDI | | | | | | | | | |
| | Note6: Color M | | | | | | | | | |
| | Note7: Biopsy Guidance | | | | | | | | | |
| | Note8: Elastography | | | | | | | | | |
| | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | | | | | | | | | |
| | Concurrence of CDRH, Office of Device Evaluation(ODE) | | | | | | | | | |
| Clinical Application | | Mode of Operation | | | | | | | | |
| General<br>(Track 1) | 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 | P | | P | P | P | Note 1, 2, 4,7 | |
| | Intra-operative (Specify*) | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | P | P | P | | P | P | P | Note 1, 2, 4,7 | |
| | Small Organ (Specify**) | P | P | P | | P | P | P | Note 1, 2, 4,7 | |
| | Neonatal Cephalic | | | | | | | | | |
| Fetal Imaging<br>& Other | 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, 4,7 | |
| | Musculo-skeletal<br>(Superficial) | P | P | P | | P | P | P | Note 1, 2, 4,7 | |
| | Intravascular | | | | | | | | | |
| | Cardiac Adult | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | |
| Cardiac | Intravascular (Cardiac) | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| Peripheral<br>vessel | Peripheral vessel | P | P | P | | P | P | P | Note 1, 2, 4,7 | |
| | Other (Specify***) | | | | | | | | | |
| | N=new indication; P=previously cleared by FDA(k120699); 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 | | | | | | | | | |
| | Note5: TDI | | | | | | | | | |
| | Note6: Color M | | | | | | | | | |
| | Note7: Biopsy Guidance | | | | | | | | | |
| | Note8: Elastography | | | | | | | | | |
| | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | | | | | | | | | |
| | Concurrence of CDRH, Office of Device Evaluation(ODE) | | | | | | | | | |

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

#### DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System System:

Transducer: 7L4A

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

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

#### DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System System:

Transducer: L14-6NE

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

| | Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | |
|--------------------------|--------------------------------------------------------------------------------------------------|---|---|-----|-----|------------------|----------------------|-----------------------|------------------|--|
| | Clinical Application | | | | | | Mode of Operation | | | |
| General<br>(Track 1 | Specific (Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| | Fetal | | | | | | | | | |
| | Abdominal | | | | | | | | | |
| | Intra-operative (Specify*) | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | P | P | P | | P | P | P | Note 1,2, 4,7 | |
| | Small Organ (Specify**) | P | P | P | | P | P | P | Note 1,2, 4,7 | |
| | Neonatal Cephalic | | | | | | | | | |
| Fetal Imaging<br>& Other | 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, 4,7 | |
| | Musculo-skeletal<br>(Superficial) | P | P | P | | P | P | P | Note 1,2, 4,7 | |
| | Intravascular | | | | | | | | | |
| | Cardiac Adult | | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| Peripheral<br>vessel | Peripheral vessel | N | N | N | | N | N | N | Note 1,2, 4,7 | |
| | Other (Specify***) | | | | | | | | | |
| | N=new indication; P=previously cleared by FDA(k150204); 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 | | | | | | | | | |
| | Note5: TDI | | | | | | | | | |
| | Note6: Color M | | | | | | | | | |
| | Note7: Biopsy Guidance | | | | | | | | | |
| | Note8: Elastography | | | | | | | | | |
| | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | | | | | | | | | |
| | Concurrence of CDRH, Office of Device Evaluation(ODE) | | | | | | | | | |
| | | | | | | | | | | |
| | Clinical Application | | | | | | Mode of Operation | | | |
| General<br>(Track 1 | Specific (Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| | Fetal | P | P | P | | P | P | P | Note 1, 2, 4,6,7 | |
| | Abdominal | | | | | | | | | |
| | Intra-operative (Specify*) | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | | | | | | | | | |
| | Small Organ (Specify**) | | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | | |
| Fetal Imaging<br>& Other | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | P | P | P | | P | P | P | Note 1, 2, 4,6,7 | |
| | Trans-vaginal | P | P | P | | P | P | P | Note 1, 2, 4,6,7 | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | | |
| | Intravascular | | | | | | | | | |
| | Cardiac Adult | | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| Peripheral<br>vessel | Peripheral vessel | | | | | | | | | |
| | Other (Specify***) | | | | | | | | | |
| | N=new indication; P=previously cleared by FDA(k150204); 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 | | | | | | | | | |
| | Note5: TDI | | | | | | | | | |
| | Note6: Color M | | | | | | | | | |
| | Note7: Biopsy Guidance | | | | | | | | | |
| | Note8: Elastography | | | | | | | | | |
| | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | | | | | | | | | |
| | Concurrence of CDRH, Office of Device Evaluation(ODE) | | | | | | | | | |

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

System: DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System

Transducer: V11-3

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

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

DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System System: Transducer: V11-3B

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

| Clinical Application | Mode of Operation | | | | | | | | |
|----------------------|------------------------------------------------------------------------------------------|---|---|-----|-----|------------------|--------------------------|-----------------------|------------------|
| General | Specific (Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) |
| (Track 1 | | | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | P | P | P | | P | P | P | Note 1, 2, 4,6,7 |
| | Abdominal | | | | | | | | |
| | Intra-operative (Specify*) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (Specify**) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| Fetal Imaging | Adult Cephalic | | | | | | | | |
| & Other | Trans-rectal | P | P | P | | P | P | P | Note 1, 2, 4,6,7 |
| | Trans-vaginal | P | P | P | | P | P | P | Note 1, 2, 4,6,7 |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal | | | | | | | | |
| | (Conventional) | | | | | | | | |
| | Musculo-skeletal | | | | | | | | |
| | (Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| Cardiac | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| Peripheral | Peripheral vessel | | | | | | | | |
| vessel | Other (Specify***) | | | | | | | | |
| | N=new indication; P=previously cleared by FDA(k150204); | | | | | | 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 | | | | | | | | |
| | Note5: TDI | | | | | | | | |
| | Note6: Color M | | | | | | | | |
| | Note7: Biopsy Guidance | | | | | | | | |
| | Note8: Elastography | | | | | | | | |
| | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | | | | | | | | |
| | Concurrence of CDRH, Office of Device Evaluation(ODE) | | | | | | | | |

{10}------------------------------------------------

DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System System: Transducer: P4-2

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

| Clinical Application | | Mode of Operation | | | | | | | Other (specify) |…