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

• K Number: K192152
• Device Name: 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
• Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., LTD
• Date Cleared: 2019-12-13 ( 126 days)
• Product Code: IYN ITX IYO LLZ
• Regulation Number: 892.1550

Intended Use

The DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic Ultrasound System is applicable for adults, pregnant woments and neonates. It is intended for use in fetal, abdominal. intra-operative (abdominal, thoracic, and vascular), pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, cardiac(adult, pediatric), trans-soph. (Cardiac), peripheral vessel, and urology exams.

Device Description

DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/ DC-TQ is a software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, PW-Mode, CCW-Mode, Color-Mode , Power/Dirpower Mode, THI, Smart3D, 4D, iScape, TDI, Color M, Biopsy Guidance, Strsin Elastography, Contrast imaging (Contrast agent for Liver and LVO), STE, STQ, Ultrasound Fusion Imaging, GYN/Pelvic and the combined mode (i.e. B/M-Mode, B/PW-mode, B/PW/Color). This system is a Track 3 device that employs an array of probes that include Linear array, Convex array, Phased array, Volume and Pencil probe.

Predicate Devices

K181637

Reference Devices

K181985, K171233, K190206, K173471, K171034

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard ultrasound imaging modes and features, not AI/ML capabilities.

Therapeutic

No
The device is described as a "Diagnostic Ultrasound System" intended to "acquire and display ultrasound data," indicating its purpose is for diagnosis rather than treatment.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states "The DC-80/DC-80 PRO/... Diagnostic Ultrasound System is applicable for adults, pregnant woments and neonates."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "software controlled, ultrasonic diagnostic system" and mentions employing "an array of probes," which are hardware components essential for acquiring ultrasound data. The performance studies also include testing for electrical safety, EMC, acoustic power, thermal, electrical, and mechanical safety, all related to hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
• Device Function: The description clearly states that this is an ultrasonic diagnostic system. It acquires and displays ultrasound data by sending sound waves into the body and processing the returning echoes to create images of internal structures and fluid flow.
• No Mention of Samples: There is no mention of the device analyzing samples taken from the body. Its function is based on non-invasive imaging using ultrasound.

Therefore, this device falls under the category of medical imaging devices, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic Ultrasound System is applicable for adults, pregnant woments and neonates. It is intended for use in fetal, abdominal. intra-operative (abdominal, thoracic, and vascular), pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, cardiac(adult, pediatric), trans-soph. (Cardiac), peripheral vessel, and urology exams.

Product codes (comma separated list FDA assigned to the subject device)

IYN, IYO, ITX, LLZ

Device Description

DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/ DC-TQ is a software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, PW-Mode, CCW-Mode, Color-Mode , Power/Dirpower Mode, THI, Smart3D, 4D, iScape, TDI, Color M, Biopsy Guidance, Strsin Elastography, Contrast imaging (Contrast agent for Liver and LVO), STE, STQ, Ultrasound Fusion Imaging, GYN/Pelvic and the combined mode (i.e. B/M-Mode, B/PW-mode, B/PW/Color).

This system is a Track 3 device that employs an array of probes that include Linear array, Convex array, Phased array, Volume and Pencil probe.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal, abdominal, intra-operative (abdominal, thoracic, and vascular), pediatric, small organ (breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), cardiac (adult, pediatric), trans-esoph. (Cardiac), peripheral vessel, and urology.

Indicated Patient Age Range

Adults, pregnant women, pediatric patients and neonates.

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Performance data provided included biocompatibility testing, electrical safety and electromagnetic compatibility (EMC), acoustic power testing, and software verification and validation testing. Clinical studies were not required to support substantial equivalence. The device was found to have a safety and effectiveness profile similar to the predicate device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K181637

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K181985, K171233, K190206, K173471, K171034

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
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.(b)
Classification. Class II.

Summary

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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, with the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below that.

December 13, 2019

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

Re: K192152

Trade/Device Name: 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 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX and LLZ Dated: October 30, 2019 Received: November 21, 2019

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 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

1

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 (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 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,

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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Indications for Use

510(k) Number (if known) K192152

Device Name

DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-86/DC-865/DC-89/DC-TV/DC-TQ Diagnostic Ultrasound System

Indications for Use (Describe)

The DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic Ultrasound System is applicable for adults, pregnant woments and neonates. It is intended for use in fetal, abdominal. intra-operative (abdominal, thoracic, and vascular), pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, cardiac(adult, pediatric), trans-soph. (Cardiac), peripheral vessel, and urology 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)

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| System: | 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 | | | | | | | | | | | | | | | | | | |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------|------------------------|-------------------------------------------------------------------------------------------------------|-----|------------------|-------------------|-----------------------|-----------------------|--------------------------------------|------------------------------------|--|--|--|--|--|--|--|--|--|
| Transducer: | | | | | | | | | | | | | | | | | | | |
| Intended Use: | Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | | | | | | | | | | |
| Clinical Application | Mode of Operation | | | | | | | | | | | | | | | | | | |
| General (Track 1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined | Other (specify) | | | | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | | | | | | | | | | | | |
| Fetal Imaging
& Other | Fetal | P | P | P | | P | P | P | Note 1, 2,3, 4,6,7,13 | | | | | | | | | | |
| | Abdominal | P | P | P | P | P | P | P | Note 1, 2,
3,4,6,7,10,11,12,13,14 | | | | | | | | | | |
| | Intra-operative (Specify*) | P | P | P | | P | P | P | Note1,2,4 | | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | | | | | | | | | |
| | Pediatric | P | P | P | | P | P | P | Note 1, 2,3, 4,6,7,13 | | | | | | | | | | |
| | Small Organ (Specify**) | P | P | P | | P | P | P | Note 1,2,
4,7,8,11,12,13 | | | | | | | | | | |
| | Neonatal Cephalic | P | P | P | | P | P | P | Note 1,2, 4,6,7,13 | | | | | | | | | | |
| | Adult Cephalic | P | P | P | | P | P | P | Note 1, 2,4, 6,7,13 | | | | | | | | | | |
| | Trans-rectal | P | P | P | | P | P | P | Note 1, 2,3, 4,6,7,8 | | | | | | | | | | |
| | Trans-vaginal | P | P | P | | P | P | P | Note 1, 2,3, 4,6,7,8,14 | | | | | | | | | | |
| | Trans-urethral | | | | | | | | | | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | | | | | | | | | | |
| | Musculo-skeletal
(Conventional) | P | P | P | | P | P | P | Note 1, 2,
4,6,7,8,11,12,13 | | | | | | | | | | |
| | Musculo-skeletal
(Superficial) | P | P | P | | P | P | | Note 1,2,
4,7,8,11,12,13 | | | | | | | | | | |
| | Intravascular | | | | | | | | | | | | | | | | | | |
| Cardiac | Cardiac Adult | P | P | P | | P | P | P | Note 1, 2,4,5,6,7,9,13 | | | | | | | | | | |
| | Cardiac Pediatric | P | P | P | | P | P | P | Note 1, 2,4,5,6,7,13 | | | | | | | | | | |
| | Intravascular (Cardiac)
Trans-esoph. (Cardiac) | P | P | P | | P | P | P | Note 1, 5,6 | | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | | | | | | | | | | |
| Peripheral
vessel | Peripheral vessel | P | P | P | N | P | P | P | Note 1, 2, 4,6,7,13 | | | | | | | | | | |
| | Other (Specify***) | 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. The feature does not use contrast agents. | | | | | | | | | | | | | | | | | | |
| | 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: Strain Elastography | | | | | | | | | | | | | | | | | | |
| | Note 9: Contrast imaging(contrast agent for LVO) | | | | | | | | | | | | | | | | | | |
| | Note 10: Contrast imaging (Contrast agent for Liver) | | | | | | | | | | | | | | | | | | |
| | Note 11: STE | | | | | | | | | | | | | | | | | | |
| | Note 12: STQ | | | | | | | | | | | | | | | | | | |
| | Note 13: Ultrasound Fusion Imaging | | | | | | | | | | | | | | | | | | |
| | Note 14: GYN/Pelvic | | | | | | | | | | | | | | | | | | |
| | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | | | | | | | | | | | | | | | | | | |
| | Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) | | | | | | | | | | | | | | | | | | |
| System: | 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 | | | | | | | | | | | | | | | | | | |
| Transducer: | C5-1E | | | | | | | | | | | | | | | | | | |
| Intended Use: | Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | | | | | | | | | | |
| Clinical Application | Mode of Operation | | | | | | | | | | | | | | | | | | |
| | General (Track 1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color
Doppler | Amplitude Doppler | Combined
(specify) | Other (specify) | | | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | | | | | | | | | | | | |
| Fetal Imaging
& Other | Fetal | | P | P | P | | P | P | P | Note 1, 2, 4,6,7,13 | | | | | | | | | |
| | Abdominal | | P | P | P | | P | P | P | Note 1, 2,
4,6,7,10,11,12,13,14 | | | | | | | | | |
| | Intra-operative (Specify) | | | | | | | | | | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | | | | | | | | | |
| | Pediatric | | P | P | P | | P | P | P | Note 1, 2, 4,6,7,13 | | | | | | | | | |
| | 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, 4,6,7,13 | | | | | | | | | |
| | Musculo-skeletal
(Superficial) | | | | | | | | | | | | | | | | | | |
| | Intravascular | | | | | | | | | | | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | | | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | | | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | | | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | | | | | | | | | | |
| Peripheral
vessel | Peripheral vessel | | P | P | P | | P | P | P | Note 1, 2, 4,6,7,13 | | | | | | | | | |
| | Other (Specify) | | | | | | | | | | | | | | | | | | |
| | N=new indication; P=previously cleared by FDA(K173471); E=added under Appendix E | | | | | | | | | | | | | | | | | | |
| | Additional comments: Combined modes--B+M\PW+B\Color + B\Power + B\PW +Color+B\Power + PW +B. | | | | | | | | | | | | | | | | | | |
| | Intraoperative includes abdominal, thoracic, and vascular | | | | | | | | | | | | | | | | | | |
| | Small organ-breast, thyroid, testes. | | | | | | | | | | | | | | | | | | |
| | Other use includes Urology. | | | | | | | | | | | | | | | | | | |
| | Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | | | | | | | | | | | | | | | | | | |
| | Note 2: Smart3D | | | | | | | | | | | | | | | | | | |
| | Note 3:4D(Real-time 3D) | | | | | | | | | | | | | | | | | | |
| | Note 4: iScape | | | | | | | | | | | | | | | | | | |
| | Note 5: TDI | | | | | | | | | | | | | | | | | | |
| | Note 6: Color M | | | | | | | | | | | | | | | | | | |
| | Note 7: Biopsy Guidance | | | | | | | | | | | | | | | | | | |
| | Note 8: Strain Elastography | | | | | | | | | | | | | | | | | | |
| | Note 9: Contrast imaging(contrast agent for LVO) | | | | | | | | | | | | | | | | | | |
| | Note 10: Contrast imaging (Contrast agent for Liver) | | | | | | | | | | | | | | | | | | |
| | Note 11: STE | | | | | | | | | | | | | | | | | | |
| | Note 12: STQ | | | | | | | | | | | | | | | | | | |
| | Note 13: Ultrasound Fusion Imaging | | | | | | | | | | | | | | | | | | |
| | Note 14: GYN/Pelvic | | | | | | | | | | | | | | | | | | |
| | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | | | | | | | | | | | | | | | | | | |
| System: | 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 | | | | | | | | | | | | | | | | | | |
| | System | | | | | | | | | | | | | | | | | | |
| Transducer: | L14-5WE | | | | | | | | | | | | | | | | | | |
| Intended Use: | Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | | | | | | | | | | |
| Clinical Application | | | | | | | | | | | | | | | | | | | |
| | General (Track 1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Combined
(specify) | Other (specify) | | | | | | | | | |
| | Ophthalmic | Ophthalmic | | | | | | | | | | | | | | | | | |
| Fetal Imaging
& Other | Fetal | | | | | | | | | | | | | | | | | | |
| | Abdominal | | P | P | P | | P | P | P | Note 1,2, 4,7,13 | | | | | | | | | |
| | Intra-operative (Specify) | | | | | | | | | | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | | | | | | | | | |
| | Pediatric | | P | P | P | | P | P | P | Note 1,2, 4,7,13 | | | | | | | | | |
| | Small Organ (Specify) | | P | P | P | | P | P | P | Note 1,2,
4,7,8,11,12,13 | | | | | | | | | |
| | Neonatal Cephalic | | P | P | P | | P | P | P | Note 1,2, 4,7,13 | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | | | | | | | | | | |
| | Trans-rectal
Trans-vaginal | | | | | | | | | | | | | | | | | | |
| | Trans-urethral | | | | | | | | | | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | | | | | | | | | | |
| | Musculo-skeletal
(Conventional) | | P | P | P | | P | P | P | Note 1,2,4,7,11,12,13 | | | | | | | | | |
| | Musculo-skeletal
(Superficial) | | P | P | P | | P | P | P | Note 1,2,4,7,11,12,13 | | | | | | | | | |
| | Intravascular | | | | | | | | | | | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | | | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | | | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | | | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | | | | | | | | | | |
| Peripheral
vessel | Peripheral vessel | | P | P | P | | P | P | P | Note 1,2, 4,7,13 | | | | | | | | | |
| | Other (Specify) | | | | | | | | | | | | | | | | | | |
| | N=new indication; P=previously cleared by FDA(K173471); E=added under Appendix E | | | | | | | | | | | | | | | | | | |
| | Additional comments: Combined modes--B+M, PW+B, Color + B, Power + B, PW+Color+B, Power + PW +B. | | | | | | | | | | | | | | | | | | |
| | Intraoperative includes abdominal, thoracic, and vascular | | | | | | | | | | | | | | | | | | |
| | Small organ-breast, thyroid, testes. | | | | | | | | | | | | | | | | | | |
| | Other use includes Urology. | | | | | | | | | | | | | | | | | | |
| | Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | | | | | | | | | | | | | | | | | | |
| | Note 2: Smart3D | | | | | | | | | | | | | | | | | | |
| | Note 3:4D(Real-time 3D) | | | | | | | | | | | | | | | | | | |
| | Note 4: iScape | | | | | | | | | | | | | | | | | | |
| | Note 5: TDI | | | | | | | | | | | | | | | | | | |
| | Note 6: Color M | | | | | | | | | | | | | | | | | | |
| | Note 7: Biopsy Guidance | | | | | | | | | | | | | | | | | | |
| | Note 8: Strain Elastography | | | | | | | | | | | | | | | | | | |
| | Note 9: Contrast imaging(contrast agent for LVO) | | | | | | | | | | | | | | | | | | |
| | Note 10: Contrast imaging (Contrast agent for Liver) | | | | | | | | | | | | | | | | | | |
| | Note 11: STE | | | | | | | | | | | | | | | | | | |
| | Note 12: STQ | | | | | | | | | | | | | | | | | | |
| | Note 13: Ultrasound Fusion Imaging | | | | | | | | | | | | | | | | | | |
| | Note 14: GYN/Pelvic | | | | | | | | | | | | | | | | | | |
| | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | | | | | | | | | | | | | | | | | | |
| System: | 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 | | | | | | | | | | | | | | | | | | |
| Transducer: | L9-3E | | | | | | | | | | | | | | | | | | |
| Intended Use: | Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | | | | | | | | | | |
| Clinical Application | Mode of Operation | | | | | | | | | | | | | | | | | | |
| | B | M | PWD | CWD | Color
Doppler | Amplitude Doppler | Combined
(specify) | Other (specify) | | | | | | | | | | | |
| General (Track 1 Only) | Specific (Track 1 & 3) | | | | | | | | | | | | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | | | | | | | | | | | | |
| Fetal Imaging
& Other | Fetal | | | | | | | | | | | | | | | | | | |
| | Abdominal | P | P | P | | P | P | P | Note 1, 2, 4,7,10 | | | | | | | | | | |
| | Intra-operative (Specify) | | | | | | | | | | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | | | | | | | | | |
| | Pediatric | P | P | P | | P | P | P | Note 1, 2, 4,7 | | | | | | | | | | |
| | Small Organ (Specify) | P | P | P | | P | P | P | Note 1,2, 4,7,8,11,12 | | | | | | | | | | |
| | Neonatal Cephalic | P | P | P | | P | P | P | Note 1, 2, 4,7 | | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | | | | | | | | | | |
| | Trans-rectal | | | | | | | | | | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | | | | | | | | | | |
| | Trans-urethral | | | | | | | | | | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | | | | | | | | | | |
| | Musculo-skeletal
(Conventional) | P | P | P | | P | P | P | Note 1, 2, 4,7,11,12 | | | | | | | | | | |
| | Musculo-skeletal
(Superficial) | P | P | P | | P | P | P | Note 1, 2, 4,7,11,12 | | | | | | | | | | |
| | Intravascular | | | | | | | | | | | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | | | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | | | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | | | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | | | | | | | | | | |
| Peripheral
vessel | Peripheral vessel | P | P | P | | P | P | P | Note 1, 2, 4,7 | | | | | | | | | | |
| | Other (Specify) | | | | | | | | | | | | | | | | | | |
| | N=new indication; P=previously cleared by FDA(K173471); E=added under Appendix E | | | | | | | | | | | | | | | | | | |
| | Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power + PW +B | | | | | | | | | | | | | | | | | | |
| | Intraoperative includes abdominal, thoracic, and vascular | | | | | | | | | | | | | | | | | | |
| | Small organ-breast, thyroid, testes. | | | | | | | | | | | | | | | | | | |
| | Other use includes Urology. | | | | | | | | | | | | | | | | | | |
| | Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | | | | | | | | | | | | | | | | | | |
| | Note 2: Smart3D | | | | | | | | | | | | | | | | | | |
| | Note 3:4D(Real-time 3D) | | | | | | | | | | | | | | | | | | |
| | Note 4: iScape | | | | | | | | | | | | | | | | | | |
| | Note 5: TDI | | | | | | | | | | | | | | | | | | |
| | Note 6: Color M | | | | | | | | | | | | | | | | | | |
| | Note 7: Biopsy Guidance | | | | | | | | | | | | | | | | | | |
| | Note 8: Strain Elastography | | | | | | | | | | | | | | | | | | |
| | Note 9: Contrast imaging(contrast agent for LVO) | | | | | | | | | | | | | | | | | | |
| | Note 10: Contrast imaging (Contrast agent for Liver) | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | |
| | Note 11: STE | | | | | | | | | | | | | | | | | | |
| | Note 12: STQ | | | | | | | | | | | | | | | | | | |
| | Note 13: Ultrasound Fusion Imaging | | | | | | | | | | | | | | | | | | |
| | Note 14: GYN/Pelvic | | | | | | | | | | | | | | | | | | |
| System: | 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 | | | | | | | | | | | | | | | | | | |
| Transducer: | V11-3HE | | | | | | | | | | | | | | | | | | |
| Intended Use: | Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | | | | | | | | | | |
| Clinical Application | Mode of Operation | | | | | | | | | | | | | | | | | | |
| | General (Track 1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined (specify) | Other (specify) | | | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | | | | | | | | | | | | |
| Fetal Imaging & Other | Fetal | P | P | P | | P | P | P | Note 1, 2, 4,6,7 | | | | | | | | | | |
| | Abdominal | | | | | | | | | | | | | | | | | | |
| | Intra-operative (Specify) | | | | | | | | | | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | | | | | | | | | |
| | Pediatric | | | | | | | | | | | | | | | | | | |
| | Small Organ (Specify) | | | | | | | | | | | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | | | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | | | | | | | | | | |
| | Trans-rectal | P | P | P | | P | P | P | Note 1, 2, 4,6,7,8 | | | | | | | | | | |
| | Trans-vaginal | P | P | P | | P | P | P | Note 1, 2, 4,6,7,8,14 | | | | | | | | | | |
| | Trans-urethral | | | | | | | | | | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | | | | | | | | | | |
| | Musculo-skeletal
(Conventional) | | | | | | | | | | | | | | | | | | |
| | Musculo-skeletal
(Superficial) | | | | | | | | | | | | | | | | | | |
| | Intravascular | | | | | | | | | | | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | | | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | | | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | | | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | | | | | | | | | | |
| Peripheral
vessel | Peripheral vessel | | | | | | | | | | | | | | | | | | |
| | Other (Specify) | P | P | P | | P | P | P | Note 1, 2, 4,6,7 | | | | | | | | | | |
| | N=new indication; P=previously cleared by FDA(K173471); E=added under Appendix E | | | | | | | | | | | | | | | | | | |
| | Additional comments: Combined modes--B+M\、PW+B\、Color + B\、Power + B\、PW+Color+B\、Power + PW +B. | | | | | | | | | | | | | | | | | | |
| | Intraoperative includes abdominal, thoracic, and vascular | | | | | | | | | | | | | | | | | | |
| | Small organ-breast, thyroid, testes. | | | | | | | | | | | | | | | | | | |
| | Other use includes Urology. | | | | | | | | | | | | | | | | | | |
| | Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | | | | | | | | | | | | | | | | | | |
| | Note 2: Smart3D | | | | | | | | | | | | | | | | | | |
| | Note 3:4D(Real-time 3D) | | | | | | | | | | | | | | | | | | |
| | Note 4: iScape | | | | | | | | | | | | | | | | | | |
| | Note 5: TDI | | | | | | | | | | | | | | | | | | |
| | Note 6: Color M | | | | | | | | | | | | | | | | | | |
| | Note 7: Biopsy Guidance | | | | | | | | | | | | | | | | | | |
| Note 8: Strain Elastography | | | | | | | | | | | | | | | | | | | |
| | Note 9: Contrast imaging(contrast agent for LVO) | | | | | | | | | | | | | | | | | | |
| | Note 10: Contrast imaging (Contrast agent for Liver) | | | | | | | | | | | | | | | | | | |
| | Note 11: STE | | | | | | | | | | | | | | | | | | |
| | Note 12: STQ | | | | | | | | | | | | | | | | | | |
| | Note 13: Ultrasound Fusion Imaging | | | | | | | | | | | | | | | | | | |
| | Note 14: GYN/Pelvic | | | | | | | | | | | | | | | | | | |
| | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | | | | | | | | | | | | | | | | | | |
| System: | 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 | | | | | | | | | | | | | | | | | | |
| Transducer: | D8-2E | | | | | | | | | | | | | | | | | | |
| 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
Doppler | Amplitude Doppler | Combined
(specify) | Other (specify) | | | | | | | | | | |
| 1 Only) | | | | | | | | | | | | | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | | | | | | | | | | | | |
| Fetal Imaging
& Other | Fetal | P | P | P | P | P | P | P | Note 1, 3, 4, 6,7 | | | | | | | | | | |
| | Abdominal | P | P | P | P | P | P | P | Note 1, 3, 4, 6,7,14 | | | | | | | | | | |
| | Intra-operative (Specify) | | | | | | | | | | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | | | | | | | | | |
| | Pediatric | | | | | | | | | | | | | | | | | | |
| | Small Organ (Specify) | | | | | | | | | | | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | | | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | | | | | | | | | | |
| | Trans-rectal | | | | | | | | | | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | | | | | | | | | | |
| | Trans-urethral | | | | | | | | | | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | | | | | | | | | | |
| | Musculo-skeletal
(Conventional) | | | | | | | | | | | | | | | | | | |
| | Musculo-skeletal
(Superficial) | | | | | | | | | | | | | | | | | | |
| | Intravascular | | | | | | | | | | | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | | | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | | | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | | | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | | | | | | | | | | |
| Peripheral
vessel | Peripheral vessel | | | | | | | | | | | | | | | | | | |
| | Other (Specify) | | | | | | | | | | | | | | | | | | |
| | N=new indication; P=previously cleared by FDA(K173471); E=added under Appendix E | | | | | | | | | | | | | | | | | | |
| | Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW +Color+B、Power + PW +B. | | | | | | | | | | | | | | | | | | |
| | Intraoperative includes abdominal, thoracic, and vascular | | | | | | | | | | | | | | | | | | |
| | Small organ-breast, thyroid, testes. | | | | | | | | | | | | | | | | | | |
| | Other use includes Urology. | | | | | | | | | | | | | | | | | | |
| | Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | | | | | | | | | | | | | | | | | | |
| | Note 2: Smart3D | | | | | | | | | | | | | | | | | | |
| | Note 3:4D(Real-time 3D) | | | | | | | | | | | | | | | | | | |
| | Note 4: iScape | | | | | | | | | | | | | | | | | | |
| | Note 5: TDI | | | | | | | | | | | | | | | | | | |
| | Note 6: Color M | | | | | | | | | | | | | | | | | | |
| | Note 7: Biopsy Guidance | | | | | | | | | | | | | | | | | | |
| | Note 8: Strain Elastography | | | | | | | | | | | | | | | | | | |
| | Note 9: Contrast imaging(contrast agent for LVO) | | | | | | | | | | | | | | | | | | |
| | Note 10: Contrast imaging (Contrast agent for Liver) | | | | | | | | | | | | | | | | | | |
| | Note 11: STE | | | | | | | | | | | | | | | | | | |
| | Note 12: STQ | | | | | | | | | | | | | | | | | | |
| | Note 13: Ultrasound Fusion Imaging | | | | | | | | | | | | | | | | | | |
| | Note 14: GYN/Pelvic | | | | | | | | | | | | | | | | | | |
| | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | | | | | | | | | | | | | | | | | | |
| System: | 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 | | | | | | | | | | | | | | | | | | |
| Transducer: | D7-2E | | | | | | | | | | | | | | | | | | |
| 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) 1 Only) | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined (specify) | Other (specify) | | | | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | | | | | | | | | | | | |
| Fetal Imaging & Other | Fetal | P | P | P | | P | P | P | Note 1, 3, 4, 6 | | | | | | | | | | |
| | Abdominal | P | P | P | | P | P | P | Note 1, 3, 4, 6,14 | | | | | | | | | | |
| | Intra-operative (Specify) | | | | | | | | | | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | | | | | | | | | |
| | Pediatric | | | | | | | | | | | | | | | | | | |
| | Small Organ (Specify) | | | | | | | | | | | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | | | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | | | | | | | | | | |
| | Trans-rectal | | | | | | | | | | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | | | | | | | | | | |
| | Trans-urethral | | | | | | | | | | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | | | | | | | | | | |
| | Musculo-skeletal
(Conventional) | | | | | | | | | | | | | | | | | | |
| | Musculo-skeletal
(Superficial) | | | | | | | | | | | | | | | | | | |
| | Intravascular | | | | | | | | | | | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | | | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | | | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | | | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | | | | | | | | | | |
| Peripheral vessel | Peripheral vessel | | | | | | | | | | | | | | | | | | |
| | Other (Specify) | | | | | | | | | | | | | | | | | | |
| | N=new indication; P=previously cleared by FDA(K173471); E=added under Appendix E | | | | | | | | | | | | | | | | | | |
| | Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW +Color+B、Power + PW +B | | | | | | | | | | | | | | | | | | |
| | Intraoperative includes abdominal, thoracic, and vascular | | | | | | | | | | | | | | | | | | |
| | Small organ-breast, thyroid, testes. | | | | | | | | | | | | | | | | | | |
| | Other use includes Urology. | | | | | | | | | | | | | | | | | | |
| | Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | | | | | | | | | | | | | | | | | | |
| | Note 2: Smart3D | | | | | | | | | | | | | | | | | | |
| | Note 3:4D(Real-time 3D) | | | | | | | | | | | | | | | | | | |
| | Note 4: iScape | | | | | | | | | | | | | | | | | | |
| | Note 5: TDI | | | | | | | | | | | | | | | | | | |
| | Note 6: Color M | | | | | | | | | | | | | | | | | | |
| | Note 7: Biopsy Guidance | | | | | | | | | | | | | | | | | | |
| | Note 8: Strain Elastography | | | | | | | | | | | | | | | | | | |
| | Note 9: Contrast imaging(contrast agent for LVO) | | | | | | | | | | | | | | | | | | |
| | Note 10: Contrast imaging (Contrast agent for Liver) | | | | | | | | | | | | | | | | | | |
| | Note 11: STE | | | | | | | | | | | | | | | | | | |
| | Note 12: STQ | | | | | | | | | | | | | | | | | | |
| | Note 13: Ultrasound Fusion Imaging | | | | | | | | | | | | | | | | | | |
| | Note 14: GYN/Pelvic | | | | | | | | | | | | | | | | | | |
| | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | | | | | | | | | | | | | | | | | | |
| System: | 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 | | | | | | | | | | | | | | | | | | |
| Transducer: | C7-3E | | | | | | | | | | | | | | | | | | |
| Intended Use: | Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | | | | | | | | | | |
| Clinical Application | Mode of Operation | | | | | | | | | | | | | | | | | | |
| General (Track
1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color
Doppler | Amplitude Doppler | Combined
(specify) | Other (specify) | | | | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | | | | | | | | | | | | |
| Fetal Imaging
& Other | Fetal | P | P | P | | P | P | P | Note 1, 2, 4.6.7 | | | | | | | | | | |
| | Abdominal | P | P | P | | P | P | P | Note 1, 2, 4,6,7,10,14 | | | | | | | | | | |
| | 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) | | | | | | | | | | | | | | | | | | |
| | Musculo-skeletal
(Superficial) | | | | | | | | | | | | | | | | | | |
| | Intravascular | | | | | | | | | | | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | | | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | | | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | | | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | | | | | | | | | | |
| Peripheral
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(K173471); E=added under Appendix E | | | | | | | | | | | | | | | | | | |
| | Additional comments: Combined modes--B+M\、PW+B\、Color + B\、Power + B\、PW +Color+B\、Power + PW +B. | | | | | | | | | | | | | | | | | | |
| | Intraoperative includes abdominal, thoracic, and vascular | | | | | | | | | | | | | | | | | | |
| | Small organ-breast, thyroid, testes. | | | | | | | | | | | | | | | | | | |
| | Other use includes Urology. | | | | | | | | | | | | | | | | | | |
| | Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | | | | | | | | | | | | | | | | | | |
| | Note 2: Smart3D | | | | | | | | | | | | | | | | | | |
| | Note 3:4D(Real-time 3D) | | | | | | | | | | | | | | | | | | |
| | Note 4: iScape | | | | | | | | | | | | | | | | | | |
| | Note 5: TDI | | | | | | | | | | | | | | | | | | |
| | Note 6: Color M | | | | | | | | | | | | | | | | | | |
| | Note 7: Biopsy Guidance | | | | | | | | | | | | | | | | | | |
| | Note 8: Strain Elastography | | | | | | | | | | | | | | | | | | |
| | Note 9: Contrast imaging(contrast agent for LVO) | | | | | | | | | | | | | | | | | | |
| | Note 10: Contrast imaging (Contrast agent for Liver) | | | | | | | | | | | | | | | | | | |
| | Note 11: STE | | | | | | | | | | | | | | | | | | |
| | Note 12: STQ | | | | | | | | | | | | | | | | | | |
| | Note 13: Ultrasound Fusion Imaging | | | | | | | | | | | | | | | | | | |
| | Note 14: GYN/Pelvic | | | | | | | | | | | | | | | | | | |
| | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | | | | | | | | | | | | | | | | | | |
| System: | 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 | | | | | | | | | | | | | | | | | | |
| Transducer: | | | | | | | | | | L12-3E | | | | | | | | | |
| 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
Doppler | Amplitude Doppler | Combined
(specify) | Other (specify) | | | | | | | | | | |
| 1 Only) | | | | | | | e Doppler | | | | | | | | | | | | |
| | | | | | | | | (specify) | | | | | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | | | | | | | | | | | | |
| Fetal Imaging
& 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 | | | | | | | | | | |
| | Small Organ (Specify) | P | P | P | | P | P | P | Note 1,2, 4,7,8,11,12 | | | | | | | | | | |
| | Neonatal Cephalic | P | P | P | | P | P | P | Note 1, 2, 4,7 | | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | | | | | | | | | | |
| | Trans-rectal | | | | | | | | | | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | | | | | | | | | | |
| | Trans-urethral | | | | | | | | | | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | | | | | | | | | | |
| | Musculo-skeletal
(Conventional) | P | P | P | | P | P | P | Note 1, 2, 4,7,11,12 | | | | | | | | | | |
| | Musculo-skeletal
(Superficial) | P | P | P | | P | P | P | Note 1, 2, 4,7,11,12 | | | | | | | | | | |
| | Intravascular | | | | | | | | | | | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | | | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | | | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | | | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | | | | | | | | | | |
| Peripheral
vessel | Peripheral vessel | P | P | P | | P | P | P | Note 1, 2, 4,7 | | | | | | | | | | |
| | Other (Specify) | | | | | | | | | | | | | | | | | | |
| | N=new indication; P=previously cleared by FDA(K173471); E=added under Appendix E | | | | | | | | | | | | | | | | | | |
| | Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW +Color+B、Power + PW +B. | | | | | | | | | | | | | | | | | | |
| | Intraoperative includes abdominal, thoracic, and vascular | | | | | | | | | | | | | | | | | | |
| | Small organ-breast, thyroid, testes. | | | | | | | | | | | | | | | | | | |
| | Other use includes Urology. | | | | | | | | | | | | | | | | | | |
| | Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | | | | | | | | | | | | | | | | | | |
| | Note 2: Smart3D | | | | | | | | | | | | | | | | | | |
| | Note 3:4D(Real-time 3D) | | | | | | | | | | | | | | | | | | |
| | Note 4: iScape | | | | | | | | | | | | | | | | | | |
| | Note 5: TDI | | | | | | | | | | | | | | | | | | |
| | Note 6: Color M | | | | | | | | | | | | | | | | | | |
| | Note 7: Biopsy Guidance | | | | | | | | | | | | | | | | | | |
| | Note 8: Strain Elastography | | | | | | | | | | | | | | | | | | |
| | Note 9: Contrast imaging(contrast agent for LVO) | | | | | | | | | | | | | | | | | | |
| | Note 10: Contrast imaging (Contrast agent for Liver) | | | | | | | | | | | | | | | | | | |
| | Note 11: STE | | | | | | | | | | | | | | | | | | |
| | Note 12: STQ | | | | | | | | | | | | | | | | | | |
| | Note 13: Ultrasound Fusion Imaging | | | | | | | | | | | | | | | | | | |
| | System: | Note 14: GYN/Pelvic | 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 | | | | | | | | | | | | | | | | |
| Transducer: | DE11-3E | | | | | | | | | | | | | | | | | | |
| Intended Use: | Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | | | | | | | | | | |
| Clinical Application | Mode of Operation | | | | | | | | | | | | | | | | | | |
| | General (Track
1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color
Doppler | Amplitude Doppler | Combined
(specify) | Other (specify) | | | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | | | | | | | | | | | | |
| Fetal Imaging
& Other | Fetal | | P | P | P | | P | P | P | Note 1, 3,4,6,7 | | | | | | | | | |
| | 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, 3,4,6,7,8 | | | | | | | | | |
| | Trans-vaginal | | P | P | P | | P | P | P | Note 1, 3,4,6,7,8,14 | | | | | | | | | |
| | Trans-urethral | | | | | | | | | | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | | | | | | | | | | |
| | Musculo-skeletal
(Conventional) | | | | | | | | | | | | | | | | | | |
| | Musculo-skeletal
(Superficial) | | | | | | | | | | | | | | | | | | |
| | Intravascular | | | | | | | | | | | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | | | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | | | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | | | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | | | | | | | | | | |
| Peripheral
vessel | Peripheral vessel
Other (Specify) | | | | | | | | | | | | | | | | | | |
| | N=new indication; P=previously cleared by FDA(K173471); E=added under Appendix E | | | | | | | | | | | | | | | | | | |
| | Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power + PW +B. | | | | | | | | | | | | | | | | | | |
| | *Intraoperative includes abdominal, thoracic, and vascular | | | | | | | | | | | | | | | | | | |
| | **Small organ-breast, thyroid, testes. | | | | | | | | | | | | | | | | | | |
| | ***Other use includes Urology. | | | | | | | | | | | | | | | | | | |
| | Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | | | | | | | | | | | | | | | | | | |
| | Note 2: Smart3D | | | | | | | | | | | | | | | | | | |
| | Note 3:4D(Real-time 3D) | | | | | | | | | | | | | | | | | | |
| | Note 4: iScape | | | | | | | | | | | | | | | | | | |
| | Note 5: TDI | | | | | | | | | | | | | | | | | | |
| | Note 6: Color M | | | | | | | | | | | | | | | | | | |
| | Note 7: Biopsy Guidance | | | | | | | | | | | | | | | | | | |
| | Note 8: Strain Elastography | | | | | | | | | | | | | | | | | | |
| | Note 9: Contrast imaging(contrast agent for LVO) | | | | | | | | | | | | | | | | | | |
| | Note 10: Contrast imaging (Contrast agent for Liver) | | | | | | | | | | | | | | | | | | |
| | Note 11: STE | | | | | | | | | | | | | | | | | | |
| | Note 12: STQ | | | | | | | | | | | | | | | | | | |
| | Note 13: Ultrasound Fusion Imaging | | | | | | | | | | | | | | | | | | |
| | Note 14: GYN/Pelvic | | | | | | | | | | | | | | | | | | |
| | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE) | | | | | | | | | | | | | | | | | | |

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13

System:	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
Transducer:	SP5-1E
Intended Use:	Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application				Mode of Operation
	General (Track
1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
e Doppler	Combined
(specify)	Other (specify)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal
	Abdominal	P	P	P	P	P	P	P	Note 1, 2,4, 6,7,13
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P	Note 1, 2,4, 6,7,13
	Small Organ (Specify**)
	Neonatal Cephalic
	Adult Cephalic	P	P	P	P	P	P	P	Note 1, 2,4, 6,7,13
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
Cardiac	Cardiac Adult	P	P	P	P	P	P	P	Note 1, 2,4,5,6,7,9,13
	Cardiac Pediatric	P	P	P	P	P	P	P	Note 1, 2,4,5,6,7,13
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel
	Other (Specify***)
	N=new indication; P=previously cleared by FDA(K173471);					E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、Power + B、PW+Color+B、Power + PW +B.
	*Intraoperative includes abdominal, thoracic, and vascular
	**Small organ-breast, thyroid, testes.
	Other use includes Urology.
	Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note 5: TDI
	Note 6: Color M
	Note 7: Biopsy Guidance
	Note 8: Strain Elastography
	Note 9: Contrast imaging(contrast agent for LVO)
	Note 10: Contrast imaging (Contrast agent for Liver)
	Note 11: STE
	Note 12: STQ
	Note 13: Ultrasound Fusion Imaging
	Note 14: GYN/Pelvic
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of Device Evaluation(ODE)
System:	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
Transducer:	SC5-1E
Intended Use:	Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application	Mode of Operation
General (Track 1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude Doppler	Combin ed
(specify)	Other (specify)
Ophthalmic	Ophthalmic
Fetal Imaging & Other	Fetal	P	P	P		P	P	P	Note 1, 2, 4,6,7,13
	Abdominal	P	P	P		P	P	P	Note 1, 2,
4,6,7,10,11,12,13,14
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	Note 1, 2, 4,6,7,13
	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, 4,6,7,13
	Musculo-skeletal
(Superficial)
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral vessel	Peripheral vessel	P	P	P		P	P	P	Note 1, 2, 4,6,7,13
	Other (Specify***)
	N=new indication; P=previously cleared by FDA(K173471); E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power + PW +B
	*Intraoperative includes abdominal, thoracic, and vascular
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note 5: TDI
	Note 6: Color M
Note 7: Biopsy Guidance
Note 8: Strain Elastography
Note 9: Contrast imaging(contrast agent for LVO)
Note 10: Contrast imaging (Contrast agent for Liver)
Note 11: STE
Note 12: STQ
Note 13: Ultrasound Fusion Imaging
Note 14: GYN/Pelvic
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)
System:	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
Transducer:	D6-2NE
Intended Use:	Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application	Mode of Operation
	General (Track
1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude Doppler	Combined (specify)	Other (specify)
Ophthalmic
Fetal Imaging
& Other	Ophthalmic
	Fetal		P	P	P		P	P	P	Note1,3, 4,6
	Abdominal		P	P	P		P	P	P	Note1,3, 4,6,14
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric		P	P	P		P	P	P	Note1,3, 4,6
	Small Organ (Specify**)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel
	Other (Specify***)
	N=new indication; P=previously cleared by FDA(K173471); E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW +Color+B、Power + PW +B.
	*Intraoperative includes abdominal, thoracic, and vascular
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note 5: TDI
	Note 6: Color M
	Note 7: Biopsy Guidance
	Note 8: Strain Elastography
	Note 9: Contrast imaging(contrast agent for LVO)
	Note 10: Contrast imaging (Contrast agent for Liver)
	Note 11: STE
	Note 12: STQ
	Note 13: Ultrasound Fusion Imaging
	Note 14: GYN/Pelvic
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of Device Evaluation(ODE)
System:	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
Transducer:	C6-2GE
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) 1 Only)	B	M	PWD	CWD	Color
Doppler	Amplitude Doppler	Combined
(specify)	Other (specify)
Ophthalmic	Ophthalmic
Fetal Imaging & Other	Fetal	P	P	P		P	P	P	Note1,2,4,6,7
	Abdominal	P	P	P		P	P	P	Note1,2,4,6,7, 10 , 14
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	Note1,2,4,6,7
	Small Organ (Specify**)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel
	Other (Specify***)
	N=new indication; P=previously cleared by FDA(K173471); E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power + PW +B.
	*Intraoperative includes abdominal, thoracic, and vascular
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note 5: TDI
	Note 6: Color M
Note 7: Biopsy Guidance
Note 8: Strain Elastography
	Note 9: Contrast imaging(contrast agent for LVO)
	Note 10: Contrast imaging (Contrast agent for Liver)
	Note 11: STE
	Note 12: STQ
	Note 13: Ultrasound Fusion Imaging
	Note 14: GYN/Pelvic
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of Device Evaluation(ODE)
System:	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
Transducer:	C11-3E
Intended Use:	Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application	Mode of Operation
	General (Track 1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (specify)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	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**)
	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)
	Musculo-skeletal
(Superficial)
	Intravascular
Cardiac	Cardiac Adult		P	P	P		P	P	P	Note 1, 2, 4,6,7
	Cardiac Pediatric		P	P	P		P	P	P	Note 1, 2, 4,6,7
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
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(K173471); E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power + PW +B.
	*Intraoperative includes abdominal, thoracic, and vascular
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note 5: TDI
	Note 6: Color M
	Note 7: Biopsy Guidance
	Note 8: Strain Elastography
	Note 9: Contrast imaging(contrast agent for LVO)
	Note 10: Contrast imaging (Contrast agent for Liver)
	Note 11: STE
	Note 12: STQ
	Note 13: Ultrasound Fusion Imaging
	Note 14: GYN/Pelvic
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of Device Evaluation(ODE)
System:	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
Transducer:	L14-6NE
Intended Use:	Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application	Mode of Operation
	General (Track 1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Combined (specify)	Other (specify)
Ophthalmic	Ophthalmic
Fetal Imaging & 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
	Small Organ (Specify**)		P	P	P		P	P	P	Note 1,2, 4,7,8
	Neonatal Cephalic		P	P	P		P	P	P	Note 1,2, 4,7
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)		P	P	P		P	P	P	Note 1,2, 4,7
	Musculo-skeletal (Superficial)		P	P	P		P	P	P	Note 1,2, 4,7
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral vessel	Peripheral vessel		P	P	P		P	P	P	Note 1,2, 4,7
	Other (Specify***)
	N=new indication; P=previously cleared by FDA(K173471);						E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW +Color+B、Power + PW +B.
	*Intraoperative includes abdominal, thoracic, and vascular
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note 5: TDI
	Note 6: Color M
	Note 7: Biopsy Guidance
	Note 8: Strain Elastography
	Note 9: Contrast imaging(contrast agent for LVO)
	Note 10: Contrast imaging (Contrast agent for Liver)
	Note 11: STE
	Note 12: STQ
	Note 13: Ultrasound Fusion Imaging
	Note 14: GYN/Pelvic
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
System:	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
Transducer:	L14-6WE
Intended Use:	Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:
	Clinical Application	Mode of Operation
	General (Track 1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
e Doppler	Combined
(specify)	Other (specify)
	Ophthalmic	Ophthalmic
Fetal Imaging
& 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
	Small Organ (Specify**)	P	P	P		P	P	P	Note 1,2, 4,7,8
	Neonatal Cephalic	P	P	P		P	P	P	Note 1,2, 4,7
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)	P	P	P		P	P	P	Note 1,2, 4,7
	Musculo-skeletal
(Superficial)	P	P	P		P	P	P	Note 1,2, 4,7
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel	P	P	P		P	P	P	Note 1,2, 4,7
	Other (Specify***)
	N=new indication; P=previously cleared by FDA(K173471); E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power + PW +B.
	*Intraoperative includes abdominal, thoracic, and vascular
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note 5: TDI
	Note 6: Color M
	Note 7: Biopsy Guidance
	Note 8: Strain Elastography
	Note 9: Contrast imaging(contrast agent for LVO)
	Note 10: Contrast imaging (Contrast agent for Liver)
	Note 11: STE
	Note 12: STQ
	Note 13: Ultrasound Fusion Imaging
	Note 14: GYN/Pelvic
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
System:	DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-86/DC-86/DC-865/DC-89/DC-TV/DC-TQ Diagnostic Ultrasound
	System
Transducer:	V11-3E
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		Amplitud	Combin	Other (specify)
1 Only)						Doppler	e Doppler	ed
								(specify)
Ophthalmic	Ophthalmic
Fetal Imaging	Fetal	P	P	P		P	P	P	Note 1, 2, 4,6,7
& Other	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, 4,6,7,8
	Trans-vaginal	P	P	P		P	P	P	Note 1, 2, 4,6,7,8,14
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
	(Conventional)
	Musculo-skeletal
	(Superficial)
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral	Peripheral vessel
vessel	Other (Specify***)	P	P	P		P	P	P	Note 1, 2, 4,6,7
	N=new indication; P=previously cleared by FDA(K173471);					E=added under Appendix E
	Additional comments: Combined modes-B+M、PW+B、Color + B、PW +Color+B、PW +Color+B、PW+B.
	*Intraoperative includes abdominal, thoracic, and vascular
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note 5: TDI
	Note 6: Color M
	Note 7: Biopsy Guidance
	Note 8: Strain Elastography
Note 9: Contrast imaging(contrast agent for LVO)
	Note 10: Contrast imaging (Contrast agent for Liver)
	Note 11: STE
	Note 12: STQ
	Note 13: Ultrasound Fusion Imaging
	Note 14: GYN/Pelvic
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of Device Evaluation(ODE)

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15

16

17

18

19

20

21

| System: | 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 | | | | | | | | | |
|-----------------------------|----------------------------------------------------------------------------------------------------------------|---|---|-----|-----|--------------------------|------------------------|---------------------------|-----------------------|--|
| Transducer: | V11-3BE | | | | | | | | | |
| Intended Use: | Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | |
| Clinical Application | General (Track Specific (Track 1 & 3)
1 Only) | B | M | PWD | CWD | Color
Doppler | Amplitude Doppler | Combined
(specify) | Other (specify) | |
| | | | | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| Fetal Imaging
& Other | Fetal | P | P | P | | P | P | P | Note 1, 2, 4,6,7 | |
| | Abdominal | | | | | | | | | |
| | Intra-operative (Specify*) | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | | | | | | | | | |
| | Small Organ (Specify**) | | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | P | P | P | | P | P | P | Note 1, 2, 4,6,7,8 | |
| | Trans-vaginal | P | P | P | | P | P | P | Note 1, 2, 4,6,7,8,14 | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | |
| | Musculo-skeletal
(Conventional) | | | | | | | | | |
| | Musculo-skeletal
(Superficial) | | | | | | | | | |
| | Intravascular | | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| Peripheral
vessel | Peripheral vessel | | | | | | | | | |
| | Other (Specify***) | P | P | P | | P | P | P | Note 1, 2, 4,6,7 | |
| | N=new indication; P=previously cleared by FDA(K173471); E=added under Appendix E | | | | | | | | | |
| | Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power + PW +B. | | | | | | | | | |
| | Intraoperative includes abdominal, thoracic, and vascular | | | | | | | | | |
| | Small organ-breast, thyroid, testes. | | | | | | | | | |
| | Other use includes Urology. | | | | | | | | | |
| | Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | | | | | | | | | |
| | Note 2: Smart3D | | | | | | | | | |
| | Note 3:4D(Real-time 3D) | | | | | | | | | |
| | Note 4: iScape | | | | | | | | | |
| | Note 5: TDI | | | | | | | | | |
| | Note 6: Color M | | | | | | | | | |
| | Note 7: Biopsy Guidance | | | | | | | | | |
| | Note 8: Strain Elastography | | | | | | | | | |
| | Note 9: Contrast imaging(contrast agent for LVO) | | | | | | | | | |
| | Note 10: Contrast imaging (Contrast agent for Liver) | | | | | | | | | |
| | Note 11: STE | | | | | | | | | |
| | Note 12: STQ | | | | | | | | | |
| | Note 13: Ultrasound Fusion Imaging | | | | | | | | | |
| | Note 14: GYN/Pelvic | | | | | | | | | |
| | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | | | | | | | | | |
| | Concurrence of CDRH, Office of Device Evaluation(ODE) | | | | | | | | | |
| System: | 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 | | | | | | | | | |
| Transducer: | DE10-3E | | | | | | | | | |
| Intended Use: | Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | |
| Clinical Application | Mode of Operation | | | | | | | | | |
| General (Track 1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color
Doppler | Amplitude Doppler | Combined (specify) | Other (specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| Fetal Imaging
& Other | Fetal | P | P | P | | P | P | P | Note 1, 3,4,6,7 | |
| | 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, 3,4,6,7,8 | |
| | Trans-vaginal | P | P | P | | P | P | P | Note 1, 3,4,6,7,8,14 | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | |
| | Musculo-skeletal
(Conventional) | | | | | | | | | |
| | Musculo-skeletal
(Superficial) | | | | | | | | | |
| | Intravascular | | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| Peripheral
vessel | Peripheral vessel | | | | | | | | | |
| | Other (Specify) | | | | | | | | | |
| | N=new indication; P=previously cleared by FDA(K173471); E=added under Appendix E | | | | | | | | | |
| | Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power + PW +B. | | | | | | | | | |
| | Intraoperative includes abdominal, thoracic, and vascular | | | | | | | | | |
| | Small organ-breast, thyroid, testes. | | | | | | | | | |
| | Other use includes Urology. | | | | | | | | | |
| | Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | | | | | | | | | |
| | Note 2: Smart3D | | | | | | | | | |
| | Note 3:4D(Real-time 3D) | | | | | | | | | |
| | Note 4: iScape | | | | | | | | | |
| | Note 5: TDI | | | | | | | | | |
| | Note 6: Color M | | | | | | | | | |
| | Note 7: Biopsy Guidance | | | | | | | | | |
| | Note 8: Strain Elastography | | | | | | | | | |
| | Note 9: Contrast imaging(contrast agent for LVO) | | | | | | | | | |
| | Note 10: Contrast imaging (Contrast agent for Liver) | | | | | | | | | |
| | Note 11: STE | | | | | | | | | |
| | Note 12: STQ | | | | | | | | | |
| | Note 13: Ultrasound Fusion Imaging | | | | | | | | | |
| | Note 14: GYN/Pelvic | | | | | | | | | |
| | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | | | | | | | | | |
| | Concurrence of CDRH, Office of Device Evaluation(ODE) | | | | | | | | | |
| System: | 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 | | | | | | | | | |
| Transducer: | P4-2NE | | | | | | | | | |
| 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)
1 Only) | B | M | PWD | CWD | Color
Doppler | Amplitude
e Doppler | Combined
(specify) | Other (specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| Fetal Imaging
& Other | Fetal | | | | | | | | | |
| | 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) | | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | | |
| | Adult Cephalic | P | P | P | P | P | P | P | Note 1, 2,4,6,7 | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | |
| | Musculo-skeletal
(Conventional) | | | | | | | | | |
| | Musculo-skeletal
(Superficial) | | | | | | | | | |
| | Intravascular | | | | | | | | | |
| Cardiac | Cardiac Adult | P | P | P | P | P | P | P | Note 1, 2,4,5,6,7 | |
| | Cardiac Pediatric | P | P | P | P | P | P | P | Note 1, 2,4,5,6,7 | |
| | Intravascular (Cardiac) | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| Peripheral
vessel | Peripheral vessel | | | | | | | | | |
| | Other (Specify) | | | | | | | | | |
| | N=new indication; P=previously cleared by FDA(K173471); E=added under Appendix E | | | | | | | | | |
| | Additional comments: Combined modes--B+M, PW+B, Color + B, Power + B, PW+Color+B, Power + PW+B. | | | | | | | | | |
| | Intraoperative includes abdominal, thoracic, and vascular | | | | | | | | | |
| | Small organ-breast, thyroid, testes. | | | | | | | | | |
| | Other use includes Urology.) | | | | | | | | | |
| | Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | | | | | | | | | |
| | Note 2: Smart3D | | | | | | | | | |
| | Note 3:4D(Real-time 3D) | | | | | | | | | |
| | Note 4: iScape | | | | | | | | | |
| | Note 5: TDI | | | | | | | | | |
| | Note 6: Color M | | | | | | | | | |
| | Note 7: Biopsy Guidance | | | | | | | | | |
| Note 8: Strain Elastography | | | | | | | | | | |
| | Note 9: Contrast imaging(contrast agent for LVO) | | | | | | | | | |
| | Note 10: Contrast imaging (Contrast agent for Liver) | | | | | | | | | |
| | Note 11: STE | | | | | | | | | |
| | Note 12: STQ | | | | | | | | | |
| | Note 13: Ultrasound Fusion Imaging | | | | | | | | | |
| | Note 14: GYN/Pelvic | | | | | | | | | |
| | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | | | | | | | | | |
| | | | | | | | | | | |
| | Concurrence of CDRH, Office of Device Evaluation(ODE) | | | | | | | | | |
| System: | 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 | | | | | | | | | |
| Transducer: | P7-3E | | | | | | | | | |
| 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) 1 Only) | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Combin
ed
(specify) | Other (specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| Fetal Imaging
& Other | Fetal | | | | | | | | | |
| | Abdominal | P | P | P | P | P | P | P | Note 1, 2,4,6 | |
| | Intra-operative (Specify) | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | P | P | P | P | P | P | P | Note 1, 2.4.6 | |
| | Small Organ (Specify) | | | | | | | | | |
| | Neonatal Cephalic | P | P | P | P | P | P | P | Note 1, 2,4,6 | |
| | Adult Cephalic | P | P | P | P | P | P | P | Note 1, 2,4,6 | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | |
| | Musculo-skeletal
(Conventional) | P | P | P | P | P | P | P | Note 1, 2,4,6 | |
| | Musculo-skeletal
(Superficial) | | | | | | | | | |
| | Intravascular | | | | | | | | | |
| Cardiac | 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 | |
| | Intravascular (Cardiac) | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| Peripheral
vessel | Peripheral vessel | | | | | | | | | |
| | Other (Specify) | | | | | | | | | |
| | N=new indication; P=previously cleared by FDA(K173471); E=added under Appendix E | | | | | | | | | |
| | Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power + PW +B. | | | | | | | | | |
| | Intraoperative includes abdominal, thoracic, and vascular | | | | | | | | | |
| | Small organ-breast, thyroid, testes. | | | | | | | | | |
| | Other use includes Urology. | | | | | | | | | |
| | Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | | | | | | | | | |
| | Note 2: Smart3D | | | | | | | | | |
| | Note 3:4D(Real-time 3D) | | | | | | | | | |
| | Note 4: iScape | | | | | | | | | |
| | Note 5: TDI | | | | | | | | | |
| | Note 6: Color M | | | | | | | | | |
| | Note 7: Biopsy Guidance | | | | | | | | | |
| | Note 8: Strain Elastography | | | | | | | | | |
| | Note 9: Contrast imaging(contrast agent for LVO) | | | | | | | | | |
| | Note 10: Contrast imaging (Contrast agent for Liver) | | | | | | | | | |
| | Note 11: STE | | | | | | | | | |
| | Note 12: STQ | | | | | | | | | |
| | Note 13: Ultrasound Fusion Imaging | | | | | | | | | |
| | Note 14: GYN/Pelvic | | | | | | | | | |
| | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | | | | | | | | | |
| | Concurrence of CDRH, Office of Device Evaluation(ODE) | | | | | | | | | |
| System: | 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 | | | | | | | | | |
| | System | | | | | | | | | |
| Transducer: | P10-4E | | | | | | | | | |
| 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 Doppler | Combined (specify) | Other (specify) | |
| 1 Only) | | | | | | Doppler | e Doppler | ed | | |
| | | | | | | | | (specify) | | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| Fetal Imaging | Fetal | | | | | | | | | |
| & Other | Abdominal | P | P | P | P | P | P | P | Note 1, 2,4,6 | |
| | Intra-operative (Specify) | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | P | P | P | P | P | P | P | Note 1, 2,4,6 | |
| | Small Organ (Specify) | | | | | | | | | |
| | | | | | P | | | | | |
| | Neonatal Cephalic | P | P | P | P | P | P | P | Note 1, 2,4,6 | |
| | Adult Cephalic | P | P | P | P | P | P | P | Note 1, 2,4,6 | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | |
| | Musculo-skeletal | | | | | | | | | |
| | (Conventional) | | | | | | | | | |
| | Musculo-skeletal | | | | | | | | | |
| | (Superficial) | | | | | | | | | |
| | Intravascular | | | | | | | | | |
| Cardiac | 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 | |
| | Intravascular (Cardiac) | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| Peripheral | Peripheral vessel | | | | | | | | | |
| vessel | Other (Specify) | | | | | | | | | |
| | N=new indication; P=previously cleared by FDA(K173471); | | | | | E=added under Appendix E | | | | |
| | Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power + PW +B. | | | | | | | | | |
| | *Intraoperative includes abdominal, thoracic, and vascular | | | | | | | | | |
| | **Small organ-breast, thyroid, testes. | | | | | | | | | |
| | ***Other use includes Urology. | | | | | | | | | |
| | Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | | | | | | | | | |
| | Note 2: Smart3D | | | | | | | | | |
| | Note 3:4D(Real-time 3D) | | | | | | | | | |
| | Note 4: iScape | | | | | | | | | |
| | Note 5: TDI | | | | | | | | | |
| | Note 6: Color M | | | | | | | | | |
| | Note 7: Biopsy Guidance | | | | | | | | | |
| Note 8: Strain Elastography | | | | | | | | | | |
| | Note 9: Contrast imaging(contrast agent for LVO) | | | | | | | | | |
| | Note 10: Contrast imaging (Contrast agent for Liver) | | | | | | | | | |
| | Note 11: STE | | | | | | | | | |
| | Note 12: STQ | | | | | | | | | |
| | Note 13: Ultrasound Fusion Imaging | | | | | | | | | |
| | Note 14: GYN/Pelvic | | | | | | | | | |
| | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | | | | | | | | | |
| | Concurrence of CDRH, Office of Device Evaluation(ODE) | | | | | | | | | |

22

23

24

25

26

System:	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
Transducer:	CB10-4E
Intended Use:	Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application	Mode of Operation
	General (Track
1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
e Doppler	Combined
(specify)	Other (specify)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal
	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, 4,6,7
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel
	Other (Specify***)	P	P	P		P	P	P	Note 1, 2, 4,6,7
	N=new indication; P=previously cleared by FDA(K173471); E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power + PW +B.
	*Intraoperative includes abdominal, thoracic, and vascular
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note 5: TDI
	Note 6: Color M
	Note 7: Biopsy Guidance
	Note 8: Strain Elastography
	Note 9: Contrast imaging(contrast agent for LVO)
	Note 10: Contrast imaging (Contrast agent for Liver)
	Note 11: STE
	Note 12: STQ
	Note 13: Ultrasound Fusion Imaging
	Note 14: GYN/Pelvic
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
System:	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
Transducer:	L16-4HE
Intended Use:	Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application	Mode of Operation
	General (Track 1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Combined (specify)	Other (specify)
Ophthalmic	Ophthalmic
Fetal Imaging & Other	Fetal
	Abdominal	P	P	P	P	P	P	P	Note1,2,4
	Intra-operative (Specify*)	P	P	P	P	P	P	P	Note1,2,4
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P	Note1,2,4
	Small Organ (Specify**)	P	P	P	P	P	P	P	Note1,2,4
	Neonatal Cephalic	P	P	P	P	P	P	P	Note1,2,4
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)	P	P	P	P	P	P	P	Note1,2,4
	Musculo-skeletal (Superficial)	P	P	P	P	P	P	P	Note1,2,4
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral vessel	Peripheral vessel	P	P	P	P	P	P	P	Note1,2,4
	Other (Specify***)
	N=new indication; P=previously cleared by FDA(K173471); E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power + PW +B.
	*Intraoperative includes abdominal, thoracic, and vascular
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note 5: TDI
	Note 6: Color M
Note 7: Biopsy Guidance
Note 8: Strain Elastography
	Note 9: Contrast imaging(contrast agent for LVO)
	Note 10: Contrast imaging (Contrast agent for Liver)
	Note 11: STE
	Note 12: STQ
	Note 13: Ultrasound Fusion Imaging
	Note 14: GYN/Pelvic
System:	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
Transducer:	P7-3TE
Intended Use:	Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application			Mode of Operation
	General (Track
1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude Doppler	Combined
(specify)	Other (specify)
Ophthalmic
& Other	Ophthalmic
	Fetal Imaging	Fetal
		Abdominal
		Intra-operative (Specify*)
		Intra-operative (Neuro)
		Laparoscopic
		Pediatric
		Small Organ (Specify**)
		Neonatal Cephalic
		Adult Cephalic
		Trans-rectal
		Trans-vaginal
		Trans-urethral
		Trans-esoph. (non-Card.)
		Musculo-skeletal
(Conventional)
		Musculo-skeletal
(Superficial)
		Intravascular
Cardiac		Cardiac Adult
		Cardiac Pediatric
		Intravascular (Cardiac)
		Trans-esoph. (Cardiac)	P	P	P	P	P	P	P	Note 1, 5,6
		Intra-cardiac
Peripheral
vessel		Peripheral vessel
		Other (Specify***)
	N=new indication; P=previously cleared by FDA(K173471); E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power + PW +B.
	*Intraoperative includes abdominal, thoracic, and vascular
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note 5: TDI
	Note 6: Color M
	Note 7: Biopsy Guidance
Note 8: Strain Elastography
	Note 9: Contrast imaging(contrast agent for LVO)
	Note 10: Contrast imaging (Contrast agent for Liver)
	Note 11: STE
	Note 12: STQ
	Note 13: Ultrasound Fusion Imaging
	Note 14: GYN/Pelvic
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
System:	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
Transducer:	CW5s
Intended Use:	Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application		Mode of Operation
	General (Track 1 Only) Specific (Track 1 & 3)	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Combined (specify)	Other (specify)
Ophthalmic	Ophthalmic
Fetal Imaging & Other	Fetal
	Abdominal
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric				P
	Small Organ (Specify**)
	Neonatal Cephalic
	Adult Cephalic				P
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
Cardiac	Cardiac Adult				P
	Cardiac Pediatric				P
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral vessel	Peripheral vessel					N
	Other (Specify***)
	N=new indication; P=previously cleared by FDA(K173471); E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW +Color+B、Power + PW +B.
	*Intraoperative includes abdominal, thoracic, and vascular
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note 5: TDI
	Note 6: Color M
		Note 7: Biopsy Guidance
		Note 8: Strain Elastography
		Note 9: Contrast imaging(contrast agent for LVO)
	Note 10: Contrast imaging (Contrast agent for Liver)
	Note 11: STE
	Note 12: STQ
	Note 13: Ultrasound Fusion Imaging
	Note 14: GYN/Pelvic
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
System:	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
Transducer:	C5-2E
Intended Use:	Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application			Mode of Operation
	General (Track 1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Combined (specify)	Other (specify)
Ophthalmic		Ophthalmic
Fetal Imaging & Other		Fetal	N	N	N		N	N	N	Note 1, 2, 4,6,7
		Abdominal	N	N	N		N	N	N	Note 1, 2, 4,6,7,14
		Intra-operative (Specify*)
		Intra-operative (Neuro)
		Laparoscopic
		Pediatric	N	N	N		N	N	N	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)	N	N	N		N	N	N	Note 1, 2, 4,6,7
		Musculo-skeletal (Superficial)
		Intravascular
Cardiac		Cardiac Adult
		Cardiac Pediatric
		Intravascular (Cardiac)
		Trans-esoph. (Cardiac)
		Intra-cardiac
Peripheral vessel		Peripheral vessel	N	N	N		N	N	N	Note 1, 2, 4,6,7
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. The feature does not use contrast agents.
	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: Strain Elastography
	Note 9: Contrast imaging(contrast agent for LVO)
	Note 10: Contrast imaging (Contrast agent for Liver)
	Note 11: STE
	Note 12: STQ
	Note 13: Ultrasound Fusion Imaging
	Note 14: GYN/Pelvic
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of Device Evaluation(ODE)

27

28

29

30

31

System:	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
Transducer:	P4-2E
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
Doppler	Amplitude Doppler	Combined
(specify)	Other (specify)
1 Only)							e
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal
	Abdominal	N	N	N	N	N	N	N	Note 1,2,4,6,7
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N	N	N	N	N	Note 1,2,4,6,7
	Small Organ (Specify**)
	Neonatal Cephalic	N	N	N	N	N	N	N	Note 1,2,4,6,7
	Adult Cephalic	N	N	N	N	N	N	N	Note 1,2,4,6,7
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
Cardiac	Cardiac Adult	N	N	N	N	N	N	N	Note 1,2,4,5,6,7
	Cardiac Pediatric	N	N	N	N	N	N	N	Note 1,2,4,5,6,7
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
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. The feature does not use contrast agents.
	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: Strain Elastography
	Note 9: Contrast imaging(contrast agent for LVO)
	Note 10: Contrast imaging (Contrast agent for Liver)
	Note 11: STE
	Note 12: STQ
	Note 13: Ultrasound Fusion Imaging
	Note 14: GYN/Pelvic
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of Device Evaluation(ODE)
System:	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
Transducer:	D6-2E
Intended Use:	Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application	Mode of Operation
	General (Track 1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude Doppler	Combined
(specify)	Other (specify)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal		N	N	N		N	N	N	Note 1,3,4,6,7
	Abdominal		N	N	N		N	N	N	Note 1,3,4,6,7,14
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric		N	N	N		N	N	N	Note 1,3,4,6,7
	Small Organ (Specify**)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
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. The feature does not use contrast agents.
	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: Strain Elastography
	Note 9: Contrast imaging(contrast agent for LVO)
	Note 10: Contrast imaging (Contrast agent for Liver)
	Note 11: STE
	Note 12: STQ
	Note 13: Ultrasound Fusion Imaging
	Note 14: GYN/Pelvic
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of Device Evaluation(ODE)
System:	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
Transducer:	SC6-1E
Intended Use:	Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application	Mode of Operation
	General (Track 1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (specify)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal		N	N	N		N	N	N	Note 1,2,4,6,7,13
	Abdominal		N	N	N		N	N	N	Note1,2,4,6,7,10,11
,12,13,14
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric		N	N	N		N	N	N	Note 1,2,4,6,7,13
	Small Organ (Specify**)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)		N	N	N		N	N	N	Note 1,2,4,6,7,13
	Musculo-skeletal
(Superficial)
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel		N	N	N		N	N	N	Note 1,2,4,6,7,13
	Other (Specify***)
System:	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
Transducer:	L20-5E
Intended Use:	Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application	Mode of Operation
	General (Track
1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude Doppler	Combined
(specify)	Other (specify)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal
	Abdominal
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)	N	N	N		N	N	N	Note 1,2,4
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)	N	N	N		N	N	N	Note 1,2,4,8
	Musculo-skeletal
(Superficial)	N	N	N		N	N	N	Note 1,2,4,8
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel	N	N	N		N	N	N	Note 1,2,4
	Other (Specify***)
	N=new indication; P=previously cleared by FDA; E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power + PW +B.
	*Intraoperative includes abdominal, thoracic, and vascular
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note 5: TDI
	Note 6: Color M
	Note 7: Biopsy Guidance
	Note 8: Strain Elastography
	Note 9: Contrast imaging(contrast agent for LVO)
	Note 10: Contrast imaging (Contrast agent for Liver)
	Note 11: STE
	Note 12: STQ
	Note 13: Ultrasound Fusion Imaging
	Note 14: GYN/Pelvic
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of Device Evaluation(ODE)
System:	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
Transducer:	SD8-1E
Intended Use:	Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application	Mode of Operation
	General (Track
1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude Doppler	Combined
(specify)	Other (specify)
	Ophthalmic	Ophthalmic
Fetal Imaging
& Other		Fetal	N	N	N		N	N	N	Note 1, 3, 4, 6,7
		Abdominal	N	N	N		N	N	N	Note 1, 3, 4, 6,7,14
		Intra-operative (Specify*)
		Intra-operative (Neuro)
		Laparoscopic
		Pediatric
		Small Organ (Specify**)
		Neonatal Cephalic
		Adult Cephalic
		Trans-rectal
		Trans-vaginal
		Trans-urethral
		Trans-esoph. (non-Card.)
		Musculo-skeletal
(Conventional)
		Musculo-skeletal
(Superficial)
		Intravascular
Cardiac		Cardiac Adult
		Cardiac Pediatric
		Intravascular (Cardiac)
		Trans-esoph. (Cardiac)
		Intra-cardiac
Peripheral
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. The feature does not use contrast agents.
	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: Strain Elastography
	Note 9: Contrast imaging(contrast agent for LVO)
	Note 10: Contrast imaging (Contrast agent for Liver)
	Note 11: STE
	Note 12: STQ
	Note 13: Ultrasound Fusion Imaging
	Note 14: GYN/Pelvic
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of Device Evaluation(ODE)
System:	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
Transducer:	DE10-3WE
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
Doppler	Amplitude Doppler	Combined
(specify)	Other (specify)
1 Only)
								(specify)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal	N	N	N		N	N	N	Note 1, 3, 4, 6,7
	Abdominal
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	N	N	N		N	N	N	Note 1, 3, 4, 6,7
	Trans-vaginal	N	N	N		N	N	N	Note 1, 3, 4, 6,7,14
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
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. The feature does not use contrast agents.
	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: Strain Elastography
	Note 9: Contrast imaging(contrast agent for LVO)
	Note 10: Contrast imaging (Contrast agent for Liver)
	Note 11: STE
	Note 12: STQ
	Note 13: Ultrasound Fusion Imaging
	Note 14: GYN/Pelvic
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
System:	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
Transducer:	V11-3WE
Intended Use:	Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:
Mode of Operation
	General (Track 1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude Doppler	Combined
(specify)	Other (specify)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal		N	N	N		N	N	N	Note 1,2,4,6,7
	Abdominal
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal		N	N	N		N	N	N	Note 1,2,4,6,7,8
	Trans-vaginal		N	N	N		N	N	N	Note 1,2,4,6,7,8
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel
	Other (Specify***)		N	N	N		N	N	N	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. The feature does not use contrast agents.
	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: Strain Elastography
	Note 9: Contrast imaging(contrast agent for LVO)
	Note 10: Contrast imaging (Contrast agent for Liver)
	Note 11: STE
	Note 12: STQ
	Note 13: Ultrasound Fusion Imaging
	Note 14: GYN/Pelvic
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of Device Evaluation(ODE)
System:	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
Transducer:	SC5-1NE
Intended Use:	Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application	Mode of Operation
General (Track 1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude Doppler	Combined
(specify)	Other (specify)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal	N	N	N		N	N	N	Note 1,2,4,6,7
	Abdominal	N	N	N		N	N	N	Note 1,2,4,6,7,14
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	N	N	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)	N	N	N		N	N	N	Note 1,2,4,6,7
	Musculo-skeletal
(Superficial)
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel	N	N	N		N	N	N	Note 1,2,4,6,7
	Other (Specify***)
	N=new indication; P=previously cleared by FDA; E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW +Color+B、Power + PW +B.
	*Intraoperative includes abdominal, thoracic, and vascular
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
Note 5: TDI
	Note 6: Color M
	Note 7: Biopsy Guidance
	Note 8: Strain Elastography
	Note 9: Contrast imaging(contrast agent for LVO)
	Note 10: Contrast imaging (Contrast agent for Liver)
	Note 11: STE
	Note 12: STQ
	Note 13: Ultrasound Fusion Imaging
	Note 14: GYN/Pelvic
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of Device Evaluation(ODE)
System:	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
Transducer:	6LB7E
Intended Use:	Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application	Mode of Operation
	General (Track
1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (specify)
Ophthalmic		Ophthalmic
Fetal Imaging
& Other		Fetal
		Abdominal
		Intra-operative (Specify*)
		Intra-operative (Neuro)
		Laparoscopic
		Pediatric
		Small Organ (Specify**)
		Neonatal Cephalic
		Adult Cephalic
		Trans-rectal	N	N	N		N	N	N	Note 1,2,4,6,7
		Trans-vaginal
		Trans-urethral
		Trans-esoph. (non-Card.)
		Musculo-skeletal
(Conventional)
		Musculo-skeletal
(Superficial)
		Intravascular
Cardiac		Cardiac Adult
		Cardiac Pediatric
		Intravascular (Cardiac)
		Trans-esoph. (Cardiac)
		Intra-cardiac
Peripheral
vessel		Peripheral vessel
		Other (Specify***)	N	N	N		N	N	N	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、Power +Color+B、Power + PW +B.
	*Intraoperative includes abdominal, thoracic, and vascular
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note 5: TDI
	Note 6: Color M
	Note 7: Biopsy Guidance
	Note 8: Strain Elastography
	Note 9: Contrast imaging(contrast agent for LVO)
	Note 10: Contrast imaging (Contrast agent for Liver)
	Note 11: STE
	Note 12: STQ
	Note 13: Ultrasound Fusion Imaging
	Note 14: GYN/Pelvic
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of Device Evaluation(ODE)

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510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92(c).

The assigned 510(k) number is: K192152

1. Submitter:

Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China Tel: [phone] Fax: [phone]

Contact Person:

Zhang Wei Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China

Date Prepared: July 25, 2019

2. Device Name: DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-865/ DC-89/DC-TV/DC-TQ Diagnostic Ultrasound System

Classification

Regulatory Class: II Review Category: Tier II 21 CFR 892.1550 Ultrasonic Pulsed Doppler Imaging System (IYN) 21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System (IYO) 21 CFR 892.1570 Diagnostic Ultrasound Transducer (ITX) 21 CFR 892.2050 Picture Archiving and Communications System(LLZ)

41

3. Device Description:

DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/

DC-TQ is a software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, PW-Mode, CCW-Mode, Color-Mode , Power/Dirpower Mode, THI, Smart3D, 4D, iScape, TDI, Color M, Biopsy Guidance, Strsin Elastography, Contrast imaging (Contrast agent for Liver and LVO), STE, STQ, Ultrasound Fusion Imaging, GYN/Pelvic and the combined mode (i.e. B/M-Mode, B/PW-mode, B/PW/Color).

This system is a Track 3 device that employs an array of probes that include Linear array, Convex array, Phased array, Volume and Pencil probe.

4. Intended Use:

The DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/ DC-TO Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, intra-operative (abdominal, thoracic, and vascular), pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), cardiac(adult, pediatric) , trans-esoph. (Cardiac), peripheral vessel, and urology exams.

5. Summary of Modifications

• . New Added Transducers: C5-2E, P4-2E, D6-2E, SC6-1E, L20-5E, SD8-1E, DE10-3WE, V11-3WE, SC51-NE, 6LB7E;
• . New Added Needle-Guided Bracket: NGB-009, NGB-015, NGB-020, NGB-027, NGB-035, NGB-039;
• Main Added Features:
  • 1. Ultrasound Fusion Imaging to C5-1E, SP5-1E, SC5-1E, L14-5WE, SC6-1E;
  • 2. Smart Pelvic Floor to C5-1E, V11-3HE, D8-2E, D7-2E, DE11-3E, SC5-1E, D6-2NE, C6-2GE, V11-3E, V11-3BE, DE10-3E, C5-2E, D6-2E, SC6-1E, SD8-1E, DE10-3WE, SC5-1NE, C7-3E;
  • 3. STE/STQ to L12-3E, L14-5WE, L9-3E, SC6-1E;

42

• 4. Strain Elastography to L20-5E, V11-3WE;
• 5. Add the peripheral vessel to the Clinical Application of CW5s ;;
• 6. Smart Face;
• 7. Smart Planes FH;
• 8. Glazing Flow;
• 9. Fusion RESP;
• 10. The DC-80 series has two had disks (128G SSD+1T HDD);
• 11. The battery can provide power supply when scanning;
• 12. DC-80 series can support four or five transducer ports configuration;
• 13. The signal channel between the probe and the main host is 128.

6. Comparison with Predicate Devices:

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 is comparable with and substantially equivalent to these predicate devices:

| Predicate Device | Manufacturer | Model | 510(k)
Control
Number |
|-----------------------------|--------------|------------|-----------------------------|
| 1. Primary predicate device | Mindray | DC-70 | K181637 |
| 2. Reference device | GE | Voluson E8 | K181985 |
| 3. Reference device | Mindray | Resona 7 | K171233 |
| 4. Reference device | Mindray | DC-90 | K190206 |
| 5. Reference device | Mindray | DC-80 | K173471 |
| 6. Reference device | Mindray | M9 | K171034 |

DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/

DC-TQ has the same technological characteristics, is comparable in key safety and effectiveness features, and has the same intended uses and basic operating modes as the predicate devices. All systems transmit ultrasonic energy into patients and perform

43

post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body. All systems allow for specialized measurements of structures and flow, and calculations.

• Subject device
  DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-86S/DC-89 /DC-TV/DC-TQ has the samilar intended uses and transduer as the predicated device DC-70 (K181637),DC-90 (K190206) , DC-80 (K173471 ) , M9 (K171034)

| Subject
Device
DC-80 | DC-70(predicate
device) | DC-80(Reference
device) | Resona
7(Reference
device) | M9(Reference
device) |
|----------------------------|----------------------------|----------------------------|----------------------------------|-------------------------|
| C5-2E | C5-2E | / | / | / |
| P4-2E | P4-2E | / | / | / |
| L20-5E | L20-5E | / | / | / |
| 6LB7E | 6LB7E | / | / | / |
| SD8-1E | SD8-1E | / | / | / |
| SC5-1NE | C5-2E | / | / | / |
| D6-2E | / | D6-2NE | / | / |
| SC6-1E | / | C5-1E | / | / |
| DE10-3WE | / | / | DE10-3WU | / |
| V11-3WE | / | V11-3WE | / | / |
| CW5s | / | / | / | CW2s |

DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/

DC-TQ has the same function as the predicated device Resona 7 (K171233)

Subject Device DC-80	Predicate device Resona7 (171233)
Ultrasound Fusion Imaging	Ultrasound Fusion Imaging
Smart Pelvic	Smart Pelvic
STE/STQ	STE/STQ
elastography	elastography
Smart Face	Smart Face

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Smart Planes FH	Smart Planes FH
Fusion RESP	Fusion RESP

DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/

DC-TQ has the samilar function as the Reference device Voluson™ E8 K181985

Subject Device DC-80	Predicate device( Voluson TM E8 K181985)
Glazing Flow	Glazing Flow

7. PERFORMANCE DATA

• . Biocompatibility testing
  The biocompatibility evaluation for the DC-80 device was conducted in accordance with International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA.

• . Electrical safety and electromagnetic compatibility (EMC) DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/ DC-TV/DC-TQ is Electrical safety and electromagnetic compatibility (EMC) Electrical safety and EMC testing were conducted on the DC-80 Diagnostic Ultrasound. The system complies with the IEC 60601-1, and IEC 60601-2-37 standards for safety and the IEC 60601-1-2 standard for EMC.

• . DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/ DC-TV/DC-TQ is designed in compliance with the FDA recognized electrical and physical safety standard, which is the same as the predicated device DC-70 (K181637), DC-90(K190206), DC-80(K173471), M9(K171034)

• . Acoustic Power Testing

The acoustic power levels of DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85

/DC-86/DC-86S/DC-89/DC-TV/DC-TQ are below the limits of FDA, as recommended by FDA's Guidance for Industry and FDA Staff "Marketing Clearance of Diagnostic Ultrasound Systems and Transducers - Guidance for Industry and Food and Drug Administration Staff".

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Software Verification and Validation Testing ●

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."

8. Non-clinical Tests:

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 has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety, and has been designed to conform with applicable medical safety standards. This device has been tested and evaluated under the following standards:

• AAMI/ANSI ES60601-1: Medical electrical equipment Part 1: General requirements for basic safety and essential performance
• . IEC 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (Edition 3)
• . IEC 60601-2-37: Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
• IEC 62304: Medical device software Software life cycle processes ●
• IEC:62366:Medical devices - application of usability engineering to medical devices
• IEC 60601-1-6: medical electrical equipment - part 1-6: general requirements for basic safety and essential performance - collateral standard: usability.
• ISO14971: Medical devices - Application of risk management to medical devices
• UD 2: Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment ● Revision 3
• ISO 10993-1 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process

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These non-clinical tests relied on in this premarket notification submission can support the determination of substantial equivalence of the subject device.

9. Clinical Studies

Not applicable. The subject of this submission, 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, does not require clinical studies to support substantial equivalence.

10. Summary

Based on the performance data as documented in the study, the DC-80 Diagnostic Ultrasound system was found to have a safety and effectiveness profile that is similar to the predicate device.

Conclusion:

Intended uses and other key features are consistent with traditional clinical practices, FDA guidelines and established methods of patient examination. The design, development and quality process of the manufacturer confirms with 21 CFR 820, ISO 9001 and ISO 13485 quality systems. The device conforms to applicable medical device safety standards. Therefore, the 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 is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.