DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System
Device Facts
| Record ID | K181637 |
|---|---|
| Device Name | DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System |
| Applicant | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. |
| Product Code | IYN · Radiology |
| Decision Date | Jan 9, 2019 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
The DC-70/ DC-70T / DC-70 Pro/ DC-70 Exp/ DC-78/ DC-78/ DC-70S 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, Trans-esoph. (Cardiac), peripheral vessel , intra-operative(abdominal, thoracic, and vascular) and urology exams.
Device Story
Diagnostic ultrasound system; acquires/displays ultrasound data via various modes (B, M, PW, CW, Color, Power/Dirpower, THI, Smart3D, 4D, iScape, TDI, Color M, Biopsy Guidance, Elastography, Contrast imaging). Inputs: ultrasonic echoes from array probes (linear, convex, phased, volume, pencil). Transforms inputs into anatomical/fluid flow images. Used in clinical settings by trained professionals. Output: onscreen display of structures/flow; supports measurements/calculations. Benefits: non-invasive visualization for clinical decision-making.
Clinical Evidence
No clinical studies were performed. Substantial equivalence is supported by non-clinical bench testing, including acoustic output measurements, biocompatibility, cleaning/disinfection effectiveness, and thermal/electrical/mechanical safety testing per FDA-recognized standards (e.g., IEC 60601-1, IEC 60601-2-37, ISO 10993-1).
Technological Characteristics
Software-controlled ultrasonic diagnostic system. Probes: linear, convex, phased, volume, pencil. Modes: B, M, PW, CW, Color, Power/Dirpower, THI, Smart3D, 4D, iScape, TDI, Color M, Biopsy Guidance, Elastography, Contrast imaging. Connectivity: standard ultrasound system interfaces. Safety standards: AAMI/ANSI ES60601-1, IEC 60601-2-37, ISO 10993-1. Software: IEC 62304 compliant.
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, musculoskeletal (conventional, superficial), adult/pediatric cardiac, trans-esophageal (cardiac), peripheral vessel, intra-operative (abdominal, thoracic, vascular), 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
- DC-70 (K163690)
Reference Devices
Related Devices
- K192152 — DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic Ultrasound System · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Dec 13, 2019
- K183377 — DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Apr 4, 2019
- K172860 — Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite Diagnostic Ultrasound System/Resona 6S/Resona 6PRO/Resona 6OB Diagnostic Ultrasound System /Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite Diagnostic Ultrasound System · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jan 2, 2018
- K163690 — DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Apr 20, 2017
- K152763 — Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Oct 21, 2015
Submission Summary (Full Text)
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows 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. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Shenzhen Mindray Bio-Medical Electronics Co., LTD Zhang Wei Engineer of Technical Regulation Keji 12th Road South, Hi-tech Industrial Park Shenzhen, Guangdong 518057 CHINA
January 9, 2019
Re: K181637
Trade/Device Name: DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S 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, LLZ Dated: December 25, 2018 Received: December 28, 2018
Dear Zhang Wei:
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 mav, 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
{1}------------------------------------------------
requirements, including, but not limited to: registration and listing (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.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Michael D.'Hara For
Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
#### Indications for Use
510(k) Number (if known) K181637
#### Device Name
DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System
#### Indications for Use (Describe)
The DC-70/ DC-70T / DC-70 Pro/ DC-70 Exp/ DC-78/ DC-70S 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, Trans-esoph. (Cardiac), peripheral vessel , intra-operative(abdominal, thoracic, and vascular) and urology exams.
| <span style="text-decoration: underline;"></span> | <table border="0"><tr><td><div style="display:inline-block;"><img alt="checkbox" src="checkbox_checked.png"/> Prescription Use (Part 21 CFR 801 Subpart D)</div></td><td><div style="display:inline-block;"><img alt="checkbox" src="checkbox_unchecked.png"/> Over-The-Counter Use (21 CFR 801 Subpart C)</div></td></tr></table> | <div style="display:inline-block;"><img alt="checkbox" src="checkbox_checked.png"/> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:inline-block;"><img alt="checkbox" src="checkbox_unchecked.png"/> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |
|----------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:inline-block;"><img alt="checkbox" src="checkbox_checked.png"/> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:inline-block;"><img alt="checkbox" src="checkbox_unchecked.png"/> Over-The-Counter Use (21 CFR 801 Subpart C)</div> | | |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
***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:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
*PRAStaff@fda.hhs.gov*
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Type of Use (Select one or both, as applicable)
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
EF
PSC Publishing Services (301) 443-6740
{3}------------------------------------------------
#### Diagnostic Ultrasound Indications For Use Format
System: DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System Transducer: N/A
Intended
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use:
| Clinical Application | | Mode of Operation | | | | | | | | |
|----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|---------------------------------|-------------------|-----|---------|------------------|--------------------------|-----------------------|-------------------------|-----------------------|
| General<br>(Track 1<br>Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| | Fetal | P | P | P | P | P | P | P | Note 1, 2,3, 4,6,7 | |
| | Abdominal | P | P | P | P | P | P | P | Note 1, 2,3,4,6,7,9 | |
| | Intra-operative (Specify*) | P | P | P | P | P | P | P | Note 1, 2, 4 | |
| | Intra-operative (Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | P | P | P | P | P | P | P | Note 1, 2, 4,6,7 | |
| | Small Organ (Specify**) | P | P | P | P | P | P | P | Note 1,2, 4,7,8 | |
| Fetal<br>Imaging &<br>Other | Neonatal Cephalic | P | P | P | P | P | P | P | Note 1, 2,4,6,7 | |
| | Adult Cephalic | P | P | P | P | P | P | P | Note 1, 2,4,6,7 | |
| | Trans-rectal | P | P | P | P | P | P | P | Note 1, 2, 3,4,6,7 | |
| | Trans-vaginal | P | 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, 4,6,7,8 | |
| | Musculo-skeletal (Superficial) | P | P | P | P | P | P | P | Note 1, 2, 4,7,8 | |
| | Intravascular | | | | | | | | Note 1, | |
| | Cardiac Adult | P | P | P | P | P | P | P | 2,4,5,6,7,10 | |
| | Cardiac Pediatric | P | P | P | P | P | P | P | Note 1, 2,4,5,6,7 | |
| Cardiac | Intravascular (Cardiac) | | | | | | | | | |
| | Trans-esoph. (Cardiac) | N | N | N | N | N | N | N | Note 1, 5,6 | |
| | Intra-cardiac | | | | | | | | | |
| Peripheral<br>vessel | Peripheral vessel | P | P | P | P | P | P | P | Note 1, 2, 4,6,7 | |
| | Other (Specify***) | P | P | P | P | P | P | P | Note 1, 2, 4,6,7 | |
| | 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: Smart3D | | | | | | | | | |
| | Note 3:4D(Real-time 3D) | | | | | | | | | |
| | Note 4: iScape | | | | | | | | | |
| | Note5: TDI | | | | | | | | | |
| | Note6: Color M | | | | | | | | | |
| | Note7: Biopsy Guidance | | | | | | | | | |
| | Note8: Elastography | | | | | | | | | |
| | Note 9: Contrast imaging (Contrast agent for Liver) | | | | | | | | | |
| | Note 10: 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) | | | | | | | | | |
| Intended<br>Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | |
| | Mode of Operation | | | | | | | | | |
| | Clinical Application | | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) |
| General<br>(Track 1<br>Only) | Specific (Track 1 & 3) | | | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| Fetal<br>Imaging &<br>Other | Fetal | | P | P | P | | P | P | P | Note 1, 2, 4,6,7 |
| | Abdominal | | P | P | P | | P | P | P | Note 1, 2, 4,6,7,9 |
| | Intra-operative (Specify*) | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | | P | P | P | | P | P | P | Note 1, 2, 4,6,7 |
| | Small Organ (Specify**) | | | | | | | | | |
| | 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(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. | | | | | | | | | | |
| Note 2: Smart3D | | | | | | | | | | |
| Note 3:4D(Real-time 3D) | | | | | | | | | | |
| Note 4: iScape | | | | | | | | | | |
| Note5: TDI | | | | | | | | | | |
| Note6: Color M | | | | | | | | | | |
| Note7: Biopsy Guidance | | | | | | | | | | |
| Note8: Elastography | | | | | | | | | | |
| Note 9: Contrast imaging (Contrast agent for Liver) | | | | | | | | | | |
| Note 10: 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) | | | | | | | | | | |
| Intended<br>Use: | Clinical Application | | Mode of Operation | | | | | | | |
| | General<br>(Track 1<br>Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Amplitud<br>e Doppler | Combined<br>(specify) | Other (specify) |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| | | Fetal | | | | | | | | |
| | | Abdominal | P | P | P | P | P | P | P | Note 1, 2, 4,6,7 |
| | | Intra-operative (Specify*) | | | | | | | | |
| | | Intra-operative (Neuro) | | | | | | | | |
| | | Laparoscopic | | | | | | | | |
| Fetal<br>Imaging &<br>Other | | Pediatric | P | P | P | P | P | P | P | Note 1, 2, 4,6,7 |
| | | Small Organ (Specify**) | | | | | | | | |
| | | Neonatal Cephalic | P | 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) | | | | | | | | |
| | | Musculo-skeletal (Superficial) | | | | | | | | |
| | | Intravascular | | | | | | | | |
| Cardiac | | Cardiac Adult | | | | | | | | |
| | | Cardiac Pediatric | P | P | P | P | P | P | P | Note 1, 2, 4,6,7 |
| | | Intravascular (Cardiac) | | | | | | | | |
| | | Trans-esoph. (Cardiac) | | | | | | | | |
| | | Intra-cardiac | | | | | | | | |
| Peripheral<br>vessel | | Peripheral vessel | P | P | P | P | P | P | P | Note 1, 2, 4,6,7 |
| | | 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. | | | | | | | | | | |
| Note 2: Smart3D | | | | | | | | | | |
| Note 3:4D(Real-time 3D) | | | | | | | | | | |
| Note 4: iScape | | | | | | | | | | |
| Note5: TDI | | | | | | | | | | |
| Note6: Color M | | | | | | | | | | |
| Note7: Biopsy Guidance | | | | | | | | | | |
| Note8: Elastography | | | | | | | | | | |
| Note 9: Contrast imaging (Contrast agent for Liver) | | | | | | | | | | |
| Note 10: Contrast imaging (Contrast agent for LVO) | | | | | | | | | | |
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | | | | | | | | | | |
| Intended<br>Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | |
| | Clinical Application | | Mode of Operation | | | | | | | |
| General<br>(Track 1<br>Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>e 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<br>Imaging &<br>Other | Neonatal Cephalic | | | | | | | | | |
| | 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<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. | | | | | | | | | |
| | Note 2: Smart3D | | | | | | | | | |
| | Note 3:4D(Real-time 3D) | | | | | | | | | |
| | Note 4: iScape | | | | | | | | | |
| | Note5: TDI | | | | | | | | | |
| | Note6: Color M | | | | | | | | | |
| | Note7: Biopsy Guidance | | | | | | | | | |
| | Note8: Elastography | | | | | | | | | |
| | Note 9: Contrast imaging (Contrast agent for Liver) | | | | | | | | | |
| | Note 10: 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) | | | | | | | | | |
| Intended<br>Use: | Clinical Application | | Mode of Operation | | | | | | | |
| | Specific (Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>e Doppler | Combined<br>(specify) | Other (specify) | |
| General<br>(Track 1<br>Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>e Doppler | Combined<br>(specify) | Other (specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| Fetal<br>Imaging &<br>Other | 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 | |
|…
