DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S

K150080 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · IYN · Jun 12, 2015 · Radiology

Device Facts

• Record ID: K150080
• Device Name: DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S
• Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• Product Code: IYN · Radiology
• Decision Date: Jun 12, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The DC-8/DC-8 PRO/DC-8 CV/DC-8S/DC-8 EXP 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, transvaginal,musculo-skeletal (conventional, superficial), cardiac adult, cardiac pediatric, peripheral vessel, urology and transesophageal (cardiac) exams.

Device Story

The DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S is a mobile, software-controlled diagnostic ultrasound system. It acquires and displays ultrasound images using various modes (B, M, PW, CW, Color, Color M, Power/Dirpower, TDI, 3D/4D, Elastography, and combined modes). The system utilizes an array of probes (linear, convex, phased) with a frequency range of 3 MHz to 10.0 MHz. It is operated by healthcare professionals in clinical settings. The device transforms ultrasonic echoes into visual representations of anatomic structures and fluid flow. Healthcare providers use these images and automated measurements (e.g., cardiac formulas) to assist in clinical diagnosis and patient management. The system includes software features like IVF, SCV+, iPage+, and ART Flow to enhance image visualization and analysis, potentially improving diagnostic accuracy and patient outcomes.

Clinical Evidence

No clinical data was required or provided. Substantial equivalence is supported by non-clinical bench testing, including acoustic output measurements, biocompatibility (ISO 10993-1), cleaning/disinfection effectiveness, and electrical/mechanical safety testing in compliance with recognized standards (e.g., AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 62304, IEC 62366, ISO 14971, NEMA UD 2, NEMA UD 3).

Technological Characteristics

Mobile, software-controlled ultrasound system. Operates in B, M, PW, CW, Color, Color M, Power/Dirpower, TDI, 3D/4D, and Elastography modes. Uses linear, convex, and phased array transducers (3-10 MHz). Connectivity includes standard ultrasound interfaces. Software runs on Windows 7. Biocompatibility per ISO 10993-1. Complies with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-37. Software lifecycle follows IEC 62304.

Indications for Use

Indicated for adults, pregnant women, pediatric patients, and neonates for diagnostic ultrasound imaging or fluid flow analysis in fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal/adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), cardiac (adult/pediatric), peripheral vessel, urology, and transesophageal (cardiac) 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-8 (K132341)
• M9 (K141010)
• Voluson E8 (K132913)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, with flowing lines connecting them.

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

June 12, 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: K150080

Trade/Device Name: DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S 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: May 28, 2015 Received: May 29, 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

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forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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,

Robert A Ocks

Robert Ochs, Ph.D. Acting 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)

### K150080

Device Name DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S

### Indications for Use (Describe)

The DC-8/DC-8 PRO/DC-8 CV/DC-8S/DC-8 EXP 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, transvaginal,musculo-skeletal (conventional, superficial), cardiac adult, cardiac pediatric, peripheral vessel, urology and transesophageal (cardiac) exams.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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### Diagnostic Ultrasound Indications For Use Format

| System: | DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System | | | | | | | | | |
|-------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|-------------------|---|-----|-----|--------------------------|----------------------|-----------------------|-------------------|----------------------|
| Transducer: | N/A | | | | | | | | | |
| 510(k) Number: | | | | | | | | | | |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | |
| Clinical Application | | | | | | | Mode of Operation | | | |
| General (Track | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | Amplitude | Combined | | Other (specify) |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| | Fetal | 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 |
| | Intra-operative (Specify*) | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | P | P | P | P | P | P | P | | Note 1, 2,3, 4,6,7 |
| | Small Organ (Specify**) | P | P | P | | P | P | P | | Note 1,2, 4,6,7,8 |
| | Fetal Imaging & Neonatal Cephalic | P | P | P | P | P | P | P | | Note 1, 2,4,6,7 |
| Other | 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, 4,6,7,8 |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | |
| | Musculo-skeletal (Conventional) | P | P | P | P | P | P | P | | Note 1, 2, 4,6,7 |
| | Musculo-skeletal (Superficial) | P | P | P | | P | P | P | | Note 1, 2, 4,6,7 |
| | Intravascular | | | | | | | | | |
| | Cardiac Adult | P | P | P | P | P | P | P | | Note 1, 2,4,5,6,7,9 |
| | Cardiac Pediatric | P | P | P | P | P | P | P | | Note 1, 2,4,5,6,7 |
| Cardiac | Intravascular (Cardiac) | | | | | | | | | |
| | Trans-esoph. (Cardiac) | P | P | P | P | P | P | P | | Note 1, 5,6 |
| | Intra-cardiac | | | | | | | | | |
| Peripheral | Peripheral vessel | P | P | P | P | P | P | P | | Note 1, 2, 4,6,7 |
| vessel | Other (Specify***) | P | P | P | | P | P | P | | Note 1, 2, 4,6,7 |
| | N=new indication; P=previously cleared by FDA-(K132341); | | | | | 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. | | | | | | | | | |
| | * Intraoperative includes abdominal, thoracic, and vascular. | | | | | | | | | |
| | ** Small organ-breast, thyroid, testes. | | | | | | | | | |
| | ***Other use includes Urology. | | | | | | | | | |
| | Note 1: Tissue Harmonic Imaging. | | | | | | | | | |
| | Note 2: Smart3D | | | | | | | | | |
| | Note 3: 4D(Real-time 3D) | | | | | | | | | |
| | Note 4: iScape | | | | | | | | | |
| | Note 5: TDI | | | | | | | | | |
| | Note 6: Color M | | | | | | | | | |
| | Note 7: Biopsy Guidance | | | | | | | | | |
| | Note 8: Elastography | | | | | | | | | |
| | Note 9: Contrast imaging(contrast agent for LVO) | | | | | | | | | |
| | (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<br>1 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 | 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 | P | P | P | | P | P | P | Note 1, 2, 4,6,7 | |
| | Small Organ (Specify**) | | | | | | | | | |
| Fetal Imaging &<br>Other | Neonatal Cephalic | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | |
| | Musculo-skeletal (Conventional) | P | P | P | | P | P | P | Note 1, 2, 4,6,7 | |
| | Musculo-skeletal (Superficial) | | | | | | | | | |
| | Intravascular | | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| Peripheral<br>vessel | Peripheral vessel | P | P | P | | P | P | P | Note 1, 2, 4,6,7 | |
| | Other (Specify***) | | | | | | | | | |
| N=new indication; P=previously cleared by FDA-(K132341); 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.<br>**Small organ-breast, thyroid, testes. | | | | | | | | | | |
| ***Other use includes Urology. | | | | | | | | | | |
| Note 1: Tissue Harmonic Imaging. | | | | | | | | | | |
| Note 2: Smart3D | | | | | | | | | | |
| Note 3: 4D(Real-time 3D) | | | | | | | | | | |
| Note 4: iScape | | | | | | | | | | |
| Note 5: TDI | | | | | | | | | | |
| Note 6: Color M | | | | | | | | | | |
| Note 7: Biopsy Guidance | | | | | | | | | | |
| Note 8: Elastography | | | | | | | | | | |
| Note 9 :Contrast imaging(contrast agent for LVO) | | | | | | | | | | |
| (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<br>1 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 | P | P | P | P | P | Note 1, 2, 4,6,7 | |
| | Abdominal | P | 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 | P | Note 1, 2, 4,6,7 | |
| | Small Organ (Specify**) | | | | | | | | | |
| Fetal Imaging & | Neonatal Cephalic | | | | | | | | | |
| Other | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | 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 | P | P | P | P | P | P | P | Note 1, 2, 4,6,7 | |
| vessel | Other (Specify***) | | | | | | | | | |
| | N=new indication; P=previously cleared by FDA-(K132341); E=added under Appendix E | | | | | | | | | |
| | Additional comments: Combined modes--B+M、PW+B, Color + B, Power + B, PW +Color+B, Power + PW +B. | | | | | | | | | |
| | * Intraoperative includes abdominal, thoracic, and vascular. | | | | | | | | | |
| | ** Small organ-breast, thyroid, testes. | | | | | | | | | |
| | ***Other use includes Urology. | | | | | | | | | |
| | Note 1: Tissue Harmonic Imaging. | | | | | | | | | |
| | Note 2: Smart3D | | | | | | | | | |
| | Note 3: 4D(Real-time 3D) | | | | | | | | | |
| Note 4: iScape | | | | | | | | | | |
| | Note 5: TDI | | | | | | | | | |
| | Note 6: Color M | | | | | | | | | |
| | Note 7: Biopsy Guidance | | | | | | | | | |
| | Note 8: Elastography | | | | | | | | | |
| | Note 9: Contrast imaging(contrast agent for LVO) | | | | | | | | | |
| | (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<br>1 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 | 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 | |
| Fetal Imaging &<br>Other | 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 (Conventional) | P | P | P | | P | P | P | Note 1, 2, 4,6,7 | |
| | Musculo-skeletal (Superficial) | P | P | P | | P | P | P | Note 1, 2, 4,6,7 | |
| | 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, 4,6,7 | |
| | Other (Specify***) | | | | | | | | | |
| | N=new indication; P=previously cleared by FDA-(K132341); 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.<br>***Other use includes Urology. | | | | | | | | | |
| | Note 1: Tissue Harmonic Imaging. | | | | | | | | | |
| | Note 2: Smart3D | | | | | | | | | |
| | Note 3: 4D(Real-time 3D) | | | | | | | | | |
| | Note 4: iScape | | | | | | | | | |
| | Note 5: TDI | | | | | | | | | |
| | Note 6: Color M<br>Note 7: Biopsy Guidance | | | | | | | | | |
| | Note 8: Elastography | | | | | | | | | |
| | Note 9: Contrast imaging(contrast agent for LVO) | | | | | | | | | |
| | (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-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System System: Transducer: C5-2E 510(k) Number:

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Transducer: C7-3E

510(k) Number:

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Transducer: L12-3E

510(k) Number:

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

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Transducer: L14-6NE

510(k) Number:

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

| Clinical Application | | Mode of Operation | | | | | | | |
|---------------------------|---------------------------------|-------------------|---|-----|-----|------------------|----------------------|-----------------------|-------------------|
| General (Track<br>1 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 | 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 |
| Fetal Imaging & | Neonatal Cephalic | P | P | P | | P | P | P | Note 1,2, 4,6,7 |
| Other | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal (Conventional) | P | P | P | | P | P | P | Note 1,2, 4,6,7 |
| | Musculo-skeletal (Superficial) | P | P | P | | P | P | P | Note 1,2, 4,6,7 |
| | Intravascular | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| Cardiac | 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***) | | | | | | | | |

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#### Transducer: L14-6WE

510(k) Number:

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

| Clinical Application | | | | | | | Mode of Operation | | | |
|-----------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|---|---|-----|-----|--------------------------|----------------------|-----------------------|-------------------|--|
| General (Track<br>1 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 | 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 | |
| Fetal Imaging &<br>Other | Neonatal Cephalic | P | P | P | | P | P | P | Note 1,2, 4,6,7 | |
| | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal…