Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound System

K200251 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · IYN · Apr 2, 2020 · Radiology

Device Facts

• Record ID: K200251
• Device Name: Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound System
• Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• Product Code: IYN · Radiology
• Decision Date: Apr 2, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in Fetal, Abdominal, Pediatric, Musculo-sketal (conventional, superficial) , Peripheral Vascular, Trans-rectal, Trans-vaginal, Small organ (breast, thyroid and testes) , Cephalic (neonatal and adult) , Cardiac (adult and pediatric) and Urology exams.

Device Story

The Z5/Z50/Z50T/Z50S/Z50 Pro is a portable, software-controlled diagnostic ultrasound system. It utilizes linear and convex array probes to transmit ultrasonic energy into the body and receive echoes. The system processes these signals to generate real-time images and fluid flow data in various modes: B-Mode, M-Mode, PW-Mode, Color-Mode, Power/Dirpower Mode, Tissue Harmonic Imaging (THI), Smart3D, 4D, and iScape. It is operated by healthcare professionals in clinical settings. The system provides automated measurements and analysis tools (e.g., iNeedle, Smart OB, Smart Face, Free Xros M) to assist clinicians in visualizing anatomic structures and assessing blood flow. Output is displayed on-screen for clinical interpretation, supporting diagnostic decision-making and patient management across multiple specialties.

Clinical Evidence

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

Technological Characteristics

Portable diagnostic ultrasound system; linear and convex array transducers; B, M, PW, Color, Power/Dirpower, THI, 4D, and Smart3D modes. Complies with AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, IEC 62366, ISO 14971, and ISO 10993-1. Software-controlled; supports biopsy guidance and various automated measurement tools.

Indications for Use

Indicated for adults, pregnant women, pediatric patients, and neonates for diagnostic ultrasound imaging or fluid flow analysis in fetal, abdominal, pediatric, musculoskeletal (conventional/superficial), peripheral vascular, trans-rectal, trans-vaginal, small organ (breast, thyroid, testes), cephalic (neonatal/adult), cardiac (adult/pediatric), 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

• Z5 (K130695)

Reference Devices

• Z6 (K182603)
• DC-40 (K183377)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

ShenZhen Mindray Bio-Medical Electronics Co., Ltd. % Shi Jufang Engineer of Technical Regulation Mindray Building, Keji 12th Road South Hi-Tech Industrial Park Shenzhen, Guangdong 518057 CHINA

April 2, 2020

#### Re: K200251

Trade/Device Name: Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: January 20, 2020 Received: February 3, 2020

#### Dear Shi Jufang:

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

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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known)

#### K200251

Device Name Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound System

Indications for Use (Describe)

Z5/Z50/Z50S/Z50 Pro Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in Fetal, Abdominal, Pediatric, Musculo-sketal (conventional, superficial) , Peripheral Vascular, Trans-rectal, Trans-vaginal, Small organ (breast, thyroid and testes) , Cephalic (neonatal and adult) , Cardiac (adult and pediatric) and Urology exams.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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| Diagnostic Ultrasound Indications for Use Format | | | | | | | | | | |
|---------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|-------------------|---|-------------------|--------------------------|------------------|----------------------|-----------------------|-----------------|--|
| System: | Z5/Z50/Z50T/Z50S/Z50 Pro 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<br>(Track 1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other (Specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| Fetal Imaging<br>& Other | Fetal | P | P | P | | P | P | P | Note 1,2,3,6,7 | |
| | Abdominal | P | P | P | | P | P | P | Note 1,2,3,6,7 | |
| | 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 | P | P | P | | P | P | P | Note 1,2,3,6 | |
| | Trans-rectal | P | P | P | | P | P | P | Note 1,2,3,6 | |
| | Trans-vaginal | P | P | P | | P | P | P | Note 1,2,3,6 | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | |
| | Musculo-skeletal (Conventional) | P | P | P | | P | P | P | Note 1,2,3,6 | |
| | Musculo-skeletal (Superficial) | P | P | P | | P | P | P | Note 1,2,3,6 | |
| | Intravascular | | | | | | | | | |
| Cardiac | Cardiac Adult | P | P | P | | P | P | P | Note 1,2,3,6 | |
| | Cardiac Pediatric | P | P | P | | P | P | P | Note 1,2,3,6 | |
| | 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***) | P | P | P | | P | P | P | Note 1,2,3,6 | |
| | 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 | | | | | | | | | |
| | Note 5: Color M | | | | | | | | | |
| | Note 6: Smart3D | | | | | | | | | |
| | Note 7:4D(Real-time 3D) | | | | | | | | | |
| | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | | | | | | | | | |
| | Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) | | | | | | | | | |
| Prescription USE (Per 21 CFR 801.109) | | | | | | | | | | |
| Diagnostic Ultrasound Indications for Use Format | | | | | | | | | | |
| System: | Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound System | | | | | | | | | |
| Transducer: | 35C50EA | | | | | | | | | |
| 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 Imaging<br>& Other | Fetal | P | P | P | | P | P | P | Note 1,2,3,6 | |
| | 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**) | | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | | |
| | 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 (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 1,2,3,6 | |
| | 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. | | | | | | | | | |
| | Note 2: Biopsy Guidance | | | | | | | | | |
| | Note 3: iScape | | | | | | | | | |
| | Note 4: TDI | | | | | | | | | |
| | Note 5: Color M | | | | | | | | | |
| | Note 6: Smart3D | | | | | | | | | |
| | Note 7:4D(Real-time 3D) | | | | | | | | | |
| | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | | | | | | | | | |
| | Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) | | | | | | | | | |
| Prescription USE (Per 21 CFR 801.109) | | | | | | | | | | |
| Diagnostic Ultrasound Indications for Use Format | | | | | | | | | | |
| System: | Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound System | | | | | | | | | |
| Transducer: | 35C20EA | | | | | | | | | |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | |
| Clinical Application | Specific (Track 1 & 3) | Mode of Operation | | | | | | | | |
| General (Track<br>1 Only) | | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other (Specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| Fetal Imaging<br>& Other | 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**) | | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | | | |
| | Intravascular | | | | | | | | | |
| Cardiac | Cardiac Adult | P | P | P | | P | P | P | Note 1,2,3,6 | |
| | Cardiac Pediatric | P | P | P | | P | P | P | Note 1,2,3,6 | |
| | Intravascular (Cardiac) | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| Peripheral<br>vessel | Peripheral vessel | | | | | | | | | |
| | 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. | | | | | | | | | |
| | Note 2: Biopsy Guidance | | | | | | | | | |
| | Note 3: iScape | | | | | | | | | |
| | Note 4: TDI | | | | | | | | | |
| | | Note 5: Color M | | | | | | | | |
| | Note 6: Smart3D | | | | | | | | | |
| | Note 7:4D(Real-time 3D) | | | | | | | | | |
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | | | | | | | | | | |
| | Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) | | | | | | | | | |
| Prescription USE (Per 21 CFR 801.109) | | | | | | | | | | |
| Diagnostic Ultrasound Indications for Use Format | | | | | | | | | | |
| System: | Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound System | | | | | | | | | |
| Transducer: | 65C15EA | | | | | | | | | |
| 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 Imaging<br>& Other | 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**) | | | | | | | | | |
| | Neonatal Cephalic | P | P | P | | P | P | P | Note 1,2,3,6 | |
| | Adult Cephalic | P | P | P | | P | P | P | Note 1,2,3,6 | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | | | |
| | Intravascular | | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| Peripheral<br>vessel | Peripheral vessel | | | | | | | | | |
| | Other (Specify***) | | | | | | | | | |
| | N=new indication; P=previously cleared by FDA; 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 | | | | | | | | | |
| | Note 5: Color M | | | | | | | | | |
| Note 6: Smart3D | | | | | | | | | | |
| | Note 7:4D(Real-time 3D) | | | | | | | | | |
| | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | | | | | | | | | |
| | Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) | | | | | | | | | |
| Diagnostic Ultrasound Indications for Use Format | | | | | | | | | | |
| System: | Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound System | | | | | | | | | |
| Transducer: | 65EC10EA | | | | | | | | | |
| 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 Imaging &<br>Other | Fetal | P | P | P | | P | P | P | Note 1,2,3,6 | |
| | Abdominal | | | | | | | | | |
| | Intra-operative (Specify*) | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | | | | | | | | | |
| | Small Organ (Specify**) | | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | P | P | P | | P | P | P | Note 1,2,3,6 | |
| | Trans-vaginal | P | P | P | | P | P | P | Note 1,2,3,6 | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | | | |
| | Intravascular | | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| Peripheral vessel…