Z6 Diagnostic Ultrasound System

K182603 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · IYN · Nov 14, 2018 · Radiology

Device Facts

• Record ID: K182603
• Device Name: Z6 Diagnostic Ultrasound System
• Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• Product Code: IYN · Radiology
• Decision Date: Nov 14, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Z6 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, intraoperative(abdominal, thoracic, and vascular), 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 exams.

Device Story

Z6 Diagnostic Ultrasound System is a portable, software-controlled device for diagnostic ultrasound imaging. It acquires and displays ultrasound data using various modes: B-Mode, M-Mode, PW-Mode, CW-Mode, Color-Mode, Power/Dirpower Mode, 4D, Smart3D, TDI, Color M, Elastography, Biopsy Guidance, and Contrast imaging. The system utilizes an array of probes (linear and convex) to transmit ultrasonic energy into the body and process received echoes to generate images of anatomic structures and fluid flow. It is operated by healthcare professionals in clinical settings. The output is displayed on-screen for the clinician to perform measurements and calculations, aiding in clinical diagnosis and patient management. The device supports various clinical exams including cardiac, abdominal, and fetal imaging.

Clinical Evidence

No clinical data. The device relies on bench testing, including acoustic output measurements, biocompatibility (ISO 10993-1), and electrical/mechanical safety testing (AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 60601-1-6).

Technological Characteristics

Portable, software-controlled ultrasound system. Employs linear and convex array transducers. Modes: B, M, PW, CW, Color, Power/Dirpower, 4D, Smart3D, TDI, Color M, Elastography. Connectivity includes ECG. Patient contact materials tested per ISO 10993-1. Complies with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-37 standards.

Indications for Use

Indicated for adults, pregnant women, pediatric patients, and neonates for diagnostic ultrasound imaging or fluid flow analysis in fetal, abdominal, intraoperative, pediatric, small organ, neonatal/adult cephalic, trans-rectal, trans-vaginal, musculoskeletal, cardiac, 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

• Z6 (K122010)

Reference Devices

• DC-30 (K173369)
• M7 (K172970)
• DC-70 (K163690)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

November 14, 2018

Shenzhen Mindray Bio-medical Electronics Co., LTD Jiang Xiaoyong Engineer of Technical Regulation Keji 12th Road South, Hi-tech Industrial Park Shenzhen, Guangdong 518057 CHINA

Re: K182603

Trade/Device Name: Z6 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: August 31, 2018 Received: September 21, 2018

Dear Jiang Xiaoyong:

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

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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 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 (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 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,

Hole 2. Nils

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

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

#### K182603

Device Name Z6 Diagnostic Ultrasound System

Indications for Use (Describe)

The Z6 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediativ, small organ(breast, thyroid, testes), neonatal and adult cephalic, transrectal, trans-vaginal, musculo-skeletal(conventional, superficial), adult and pediatric cardiac, peripheral vessel , intraoperative(abdominal, thoracic, and vascular) and urology exams.

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

| <div> <span> <span style="text-decoration: underline;"></span> <span style="text-decoration: overline;"></span> </span> <span style="text-decoration: line-through;"></span> </div> | <div style="display:inline-block;"> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div style="display:inline-block;"> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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FORM FDA 3881 (7/17)

---

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#### Diagnostic Ultrasound Indications For Use Format

System: Z6 Diagnostic Ultrasound System

Transducer: N

Transducer: N/A
Intenueu
Liamsducer: Diagr 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 | P | Note 1,2,5,6,7 | |
| | Abdominal | P | P | P | P | P | P | P | Note 1,2,3,4,5,6,7,9 | |
| | Intra-operative (Specify*) | P | P | P | P | P | P | P | Note 1,2,3,6 | |
| | Intra-operative (Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | P | P | P | P | P | P | P | Note 1,2,3,4,5,6 | |
| | Small Organ (Specify**) | P | P | P | P | P | P | P | Note 1,2,3,6,8 | |
| | Neonatal Cephalic | P | P | P | P | P | P | P | Note 1,2,3,4,5,6 | |
| Fetal<br>Imaging &<br>Other | Adult Cephalic | P | P | P | P | P | P | P | Note 1,2,4,5,6 | |
| | Trans-rectal | P | P | P | P | P | P | P | Note 1,2,5,6 | |
| | Trans-vaginal | P | P | P | P | P | P | P | Note 1,2,5,6 | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | P | P | P | P | P | P | P | Note 1,2,3,4,5,6,8 | |
| | Musculo-skeletal<br>(Superficial) | P | P | P | P | P | P | P | Note 1,2,3,6,8 | |
| | Intravascular | | | | | | | | | |
| | Cardiac Adult | P | P | P | P | P | P | P | Note 1,2,4,5,6 | |
| | Cardiac Pediatric | P | P | P | P | P | P | P | Note 1,2,4,5,6 | |
| Cardiac | Intravascular (Cardiac) | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| Peripheral<br>vessel | Peripheral vessel | P | P | P | P | P | P | P | Note 1,2,3,5,6 | |
| | Other (Specify***) | P | P | P | P | P | P | P | Note 1,2,5,6 | |
| | 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. | | | | | | | | | |
| | Note 2: Biopsy Guidance | | | | | | | | | |
| | Note 3: iScape | | | | | | | | | |
| | Note 4: TDI | | | | | | | | | |
| | Note5: Color M | | | | | | | | | |
| | Note6: Smart3D | | | | | | | | | |
| | Note7: 4D(Real-time 3D) | | | | | | | | | |
| | Note8: Strain Elastography | | | | | | | | | |
| | Note 9: Contrast imaging (Contrast agent for Liver) | | | | | | | | | |
| | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | | | | | | | | | |
| Transducer: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | |
| | Clinical Application<br>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 | P | Note 1,2,5,6 | |
| | Abdominal | P | P | P | P | P | P | P | Note 1,2,5,6,9 | |
| | Intra-operative (Specify*) | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | P | P | P | P | P | P | P | Note 1,2,5,6 | |
| | Small Organ (Specify**) | | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | | |
| Fetal<br>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 1,2,5,6 | |
| | 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 1,2,5,6 | |
| | Other (Specify***) | | | | | | | | | |
| | N=new indication; P=previously cleared by FDA(K122010); 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. | | | | | | | | | |
| | Note 2: Biopsy Guidance | | | | | | | | | |
| | Note 3: iScape | | | | | | | | | |
| | Note 4: TDI | | | | | | | | | |
| | Note5: Color M | | | | | | | | | |
| | Note6: Smart3D | | | | | | | | | |
| | Note7: 4D(Real-time 3D) | | | | | | | | | |
| | Note8: Strain Elastography | | | | | | | | | |
| | Note 9: 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) | | | | | | | | | |
| | | | | | | | | | | |

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

Transducer:

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

| System: | Z6 Diagnostic Ultrasound System |
|---------|---------------------------------|
|---------|---------------------------------|

Transducer: 6C2P Internutu
Haasta Diagn

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 1,2,5,6 |
| | Intra-operative (Specify*) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | P | | P | P | P | Note 1,2,5,6 |
| | Small Organ (Specify**) | | | | | | | | |
| | Neonatal Cephalic | P | P | P | | P | P | P | Note 1,2,5,6 |
| Fetal<br>Imaging &<br>Other | Adult Cephalic | P | P | P | | P | P | P | Note 1,2,5,6 |
| | 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 | | | | | | | | |
| | Other (Specify***) | | | | | | | | |
| | N=new indication; P=previously cleared by FDA(K122010); 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. | | | | | | | | |
| | Note 2: Biopsy Guidance | | | | | | | | |
| | Note 3: iScape | | | | | | | | |
| | Note 4: TDI | | | | | | | | |
| | Note5: Color M | | | | | | | | |
| | Note6: Smart3D | | | | | | | | |
| | Note7: 4D(Real-time 3D) | | | | | | | | |
| | Note8: Strain Elastography | | | | | | | | |
| | Note 9: 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) | | | | | | | | |
| Transducer: | 6CVIP<br>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 1,2,5,6 |
| | Abdominal | | | | | | | | |
| | Intra-operative (Specify*) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (Specify**) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| Fetal<br>Imaging &<br>Other | Adult Cephalic | | | | | | | | |
| | Trans-rectal | P | P | P | | P | P | P | Note 1,2,5,6 |
| | Trans-vaginal | P | P | P | | P | P | P | Note 1,2,5,6 |
| | 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 | | | | | | | | |
| | Other (Specify***) | P | P | P | | P | P | P | Note 1,2,5,6 |
| | N=new indication; P=previously cleared by FDA(K122010); | | | | | | 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. | | | | | | | | |
| | Note 2: Biopsy Guidance | | | | | | | | |
| | Note 3: iScape | | | | | | | | |
| | Note 4: TDI | | | | | | | | |
| | Note5: Color M | | | | | | | | |
| | Note6: Smart3D | | | | | | | | |
| | Note7: 4D(Real-time 3D) | | | | | | | | |
| | Note8: Strain Elastography | | | | | | | | |
| | Note 9: 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) | | | | | | | | |

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

Transducer: 6CV1P
Diagnos

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

| System: | Z6 Diagnostic Ultrasound System |
|---------|---------------------------------|
|---------|---------------------------------|

Transducer: 7L4P IIIvinusu Diagn

| included | 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 1,2,3,6 |
| | Intra-operative (Specify*) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | P | | P | P | P | Note 1,2,3,6 |
| | Small Organ (Specify**) | P | P | P | | P | P | P | Note 1,2,3,6,8 |
| | Neonatal Cephalic | P | P | P | | P | P | P | Note 1,2,3,6 |
| Fetal<br>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 1,2,3,6,8 |
| | Musculo-skeletal<br>(Superficial) | P | P | P | | P | P | P | Note 1,2,3,6,8 |
| | 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 1,2,3,6 |
| | Other (Specify***) | | | | | | | | |

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

| System: | Z6 Diagnostic Ultrasound System |
|---------|---------------------------------|
|---------|---------------------------------|

Transducer: 7L5P
Diagn

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 1,2,3,6 | |
| | Intra-operative (Specify*) | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | P | P | P | | P | P | P | Note 1,2,3,6 | |
| | Small Organ (Specify**) | P | P | P | | P | P | P | Note 1,2,3,6 | |
| | Neonatal Cephalic | P | P | P | | P | P | P | Note 1,2,3,6 | |
| Fetal<br>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 1,2,3,6 | |
| | Musculo-skeletal<br>(Superficial) | P | P | P | | P | P | P | Note 1,2,3,6 | |
| | 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 1,2,3,6 | |
| | Other (Specify***) | | | | | | | | | |
| | N=new indication; P=previously cleared by FDA(K122010); 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. | | | | | | | | | |
| | Note 2: Biopsy Guidance | | | | | | | | | |
| | Note 3: iScape | | | | | | | | | |
| | Note 4: TDI | | | | | | | | | |
| | Note5: Color M | | | | | | | | | |
| | Note6: Smart3D | | | | | | | | | |
| | Note7: 4D(Real-time 3D) | | | | | | | | | |
| | Note8: Strain Elastography | | | | | | | | | |
| | Note 9: Contrast imaging (Contrast agent for Liver) | | | | | | | | | |
| | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | | | | | | | | | |

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

| System: | Z6 Diagnostic Ultrasound System |
|---------|---------------------------------|
|---------|---------------------------------|

Transducer: - L14-6P
Diagno

| 11966 | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: |
|-------|------------------------------------------------------------------------------------|
|-------|------------------------------------------------------------------------------------|

| Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | |
|----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|-------------------|---|-----|-----|-------------------|----------------------|-----------------------|-----------------------|
| General<br>(Track 1 | Clinical Application | Mode of Operation | | | | | Other (specify) | | |
| | Specific (Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | | Amplitude<br>Doppler | Combined<br>(specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | | | | | | | | |
| | Abdominal | P | P | P | | P | P | P | Note 1,2,3,6 |
| | Intra-operative (Specify*) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | P | | P | P | P | Note 1,2,3,6 |
| | Small Organ (Specify**) | P | P | P | | P | P | P | Note 1,2,3,6 |
| | Neonatal Cephalic | P | P | P | | P | P | P | Note 1,2,3,6 |
| | Adult Cephalic | | | | | | | | |
| Fetal<br>Imaging &<br>Other | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | P | P | P | | P | P | P | Note 1,2,3,6 |
| | | | | | | | | | |
| | | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | P | P | P | | P | P | P | Note 1,2,3,6 |
| | | | | | | | | | |
| | 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 1,2,3,6 |
| | Other (Specify***) | | | | | | | | |
| | N=new indication; P=previously cleared by FDA(K122010); 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. | | | | | | | | |
|…