DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic

• K Number: K173471
• Device Name: DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic
• Manufacturer: Shenzhen Mindray Bio-medical Electronics Co., LTD
• Date Cleared: 2018-01-08 ( 61 days)
• Product Code: IYN ITX IYO
• Regulation Number: 892.1550

Intended Use

The DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-raginal, musculo-skeletal (conventional, superficial), cardiac adult, cardiac pediatric, peripheral vessel, urology and transesophageal (Cardiac) exams.

Device Description

DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-mode, M-mode, PW-mode, CW mode, Color-mode, Color m-Mode, Power/Dirpower mode, TDI mode, 3D/4D mode, Elastography or the combined mode (i.e. B/M-mode).This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array.

Predicate Devices

K170277

Reference Devices

K171233, K163690, K171034

AI/ML (Artificial Intelligence / Machine Learning)

No
The document does not mention AI, ML, or any related terms, nor does it describe features or performance metrics typically associated with AI/ML applications in medical imaging.

Therapeutic

No
The device is described as a "Diagnostic Ultrasound System" intended to "acquire and display ultrasound images" for various exams. Its function is explicitly stated as diagnostic, not therapeutic.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states "DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic Ultrasound System is applicable..." and the "Device Description" also refers to it as an "ultrasound diagnostic system."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "Diagnostic Ultrasound System" and mentions employing "an array of probes," which are hardware components essential for ultrasound imaging. While it is software-controlled, it is not solely software.

IVD (In Vitro Diagnostic)

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

Here's why:

• IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
• This device is a diagnostic ultrasound system. Ultrasound systems use sound waves to create images of internal body structures. They are used for imaging within the body, not for analyzing samples taken from the body.

The intended use and device description clearly indicate that this is an imaging device used for visualizing anatomical structures and fluid flow directly within the patient's body. This is the core function of an ultrasound system, which 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-85 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-raginal, musculo-skeletal (conventional, superficial), cardiac adult, cardiac pediatric, peripheral vessel, urology and transesophageal (Cardiac) exams.

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

IYN, IYO, ITX

Device Description

DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-mode, M-mode, PW-mode, CW mode, Color-mode, Color m-Mode, Power/Dirpower mode, TDI mode, 3D/4D mode, Elastography or the combined mode (i.e. B/M-mode).This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

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

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)

Not Found

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.

K170277

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.

K171233, K163690, 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

0

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

Shenzhen Mindray Bio-medical Electronics Co., LTD. % Yang Zhaohui Engineer of Technical Regulation Mindray Building, Keji 12th Road South Hi-tech Industrial Park, Nanshan ShenZhen, GangDong 518057 P.R. CHINA

January 8, 2018

Re: K173471

Trade/Device Name: DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: November 1, 2017 Received: November 8, 2017

Dear Yang Zhaohui:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

1

Page 2 - Yang Zhaohui

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Michael D'Hara For

Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known)

K173471

Device Name

DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic Ultrasound System

Indications for Use (Describe)

The DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-raginal, musculo-skeletal (conventional, superficial), cardiac adult, cardiac pediatric, peripheral vessel, urology and transesophageal (Cardiac) exams.

Type of Use (Select one or both, as applicable)
✔ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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3

System:	DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 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 (specify)	Other (specify)
Ophthalmic	Ophthalmic
Fetal Imaging & Other	Fetal	P	P	P	P	P	P	P	Note 1, 2, 3, 4,6,7
	Abdominal	P	P	P	P	P	P	P	Note 1, 2, 3, 4, 6, 7, 10, 11, 12
	Intra-operative (Specify*)	P	P	P		P	P	P	Note 1,2,4
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P	Note 1, 2, 3,4,6,7
	Small Organ (Specify**)	P	P	P		P	P	P	Note 1,2, 4,7,8
	Neonatal Cephalic	P	P	P	P	P	P	P	Note 1,2, 4,6,7
	Adult Cephalic	P	P	P	P	P	P	P	Note 1, 2,4, 6,7
	Trans-rectal	P	P	P		P	P	P	Note 1, 2, 3,4,6,7,8
	Trans-vaginal	P	P	P		P	P	P	Note 1, 2, 3,4,6,7,8
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)	P	P	P	P	P	P	P	Note 1, 2, 4,6,7
	Musculo-skeletal (Superficial)	P	P	P		P	P	P	Note 1,2, 4,7
	Intravascular
Cardiac	Cardiac Adult	P	P	P	P	P	P	P	Note 1, 2,4,5,6,7,9
	Cardiac Pediatric	P	P	P	P	P	P	P	Note 1, 2,4,5,6,7
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)	P	P	P	P	P	P	P	Note 1, 5,6
	Intra-cardiac
Peripheral vessel	Peripheral vessel	P	P	P		P	P	P	Note 1, 2, 4,6,7
	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.
System:	DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 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
	Abdominal	P	P	P		P	P	P	Note 1, 2, 4, 6, 7,
10, 11, 12
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	Note 1, 2, 4,6,7
	Small Organ (Specify**)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)	P	P	P		P	P	P	Note 1, 2, 4,6,7
	Musculo-skeletal
(Superficial)
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
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(K171233); 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: Elastography
	Note 9: Contrast imaging(contrast agent for LVO)
	Note 10: Contrast imaging (Contrast agent for Liver)
	Note 11: STE
	Note 12: STQ
	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 Diagnostic Ultrasound System
Transducer:	L14-5WE
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)					Color	Amplitude		Combined Other (specify)
1 Only)		B	M	PWD	CWD	Doppler	Doppler	(specify)
Ophthalmic	Ophthalmic
Fetal Imaging	Fetal
& Other	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								Note 1,2, 4,7
	(Conventional)	P	P	P		P	P	P
	Musculo-skeletal								Note 1,2, 4,7
	(Superficial)	P	P	P		P	P	P
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral	Peripheral vessel	P	P	P		b	P	P	Note 1,2, 4,7
vessel	Other (Specify***)
	N=new indication; P=previously cleared by FDA(K171233); E=added under Appendix E
	Additional comments: Combined modes-B+M、PW+B、Color + B、PW +Color+B、PW +Color+B、Power + PW+B.
	*Intraoperative includes abdominal, thoracic, and vascular
	**Small organ-breast, thyroid, testes.
	*** * * * Other use includes Urology.
	Note 1: Tissue Harmonic Imaging. 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: Elastography
Note 9: Contrast imaging(contrast agent for LVO)
	Note 10: Contrast imaging (Contrast agent for Liver)
	Note 11: STE
	Note 12: STQ
	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 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
General (Track	Specific (Track 1 & 3)					Color	Amplitude		Combined Other (specify)
1 Only)		B	M	PWD	CWD	Doppler	Doppler	(specify)
Ophthalmic	Ophthalmic
Fetal Imaging	Fetal
& Other	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								Note 1, 2, 4,7
	(Conventional)	P	P	P		P	P	P
	Musculo-skeletal								Note 1, 2, 4,7
	(Superficial)	P	P	P		P	P	P
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral	Peripheral vessel	P	P	P		P	P	P	Note 1, 2, 4,7
vessel	Other (Specify***)
	N=new indication; P=previously cleared by FDA(K171233); E=added under Appendix E
	Additional comments: Combined modes-B+M、PW+B、Color + B、PW +Color+B、PW +Color+B、Power + PW+B.
	*Intraoperative includes abdominal, thoracic, and vascular
	**Small organ-breast, thyroid, testes.
	*** * * * Other use includes Urology.
	Note 1: Tissue Harmonic Imaging. 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: Elastography
	Note 9: Contrast imaging(contrast agent for LVO)
	Note 10: Contrast imaging (Contrast agent for Liver)
	Note 11: STE
	Note 12: STQ
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 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
	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(K171233); 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: Elastography
	Note 9: Contrast imaging(contrast agent for LVO)
	Note 10: Contrast imaging (Contrast agent for Liver)
	Note 11: STE
	Note 12: STQ
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 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
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	P	P	P		P	P	P	Note 1, 3, 4, 6,7
	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(K171233); 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: Elastography
	Note 9: Contrast imaging(contrast agent for LVO)
	Note 10: Contrast imaging (Contrast agent for Liver)
	Note 11: STE
	Note 12: STQ
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 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
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
	Abdominal	P	P	P		P	P	P	Note 1, 3, 4, 6
	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(K163690); 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: Elastography
	Note 9: Contrast imaging(contrast agent for LVO)
	Note 10: Contrast imaging (Contrast agent for Liver)
	Note 11: STE
	Note 12: STQ
System:	DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 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	Specific (Track 1 & 3)						Color	Amplitude		Combined (specify)	Other (specify)
1 Only)		B	M	PWD	CWD	Color Doppler	Amplitude Doppler	(specify)
Ophthalmic	Ophthalmic
Fetal Imaging	Fetal	P	P	P		P	P	P	Note 1, 2, 4,6,7
& Other	Abdominal	P	P	P		P	P	P	Note 1, 2, 4,6,7,10
	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	Peripheral vessel	P	P	P		P	P	P	Note 1, 2, 4,6,7
vessel	Other (Specify***)
	N=new indication; P=previously cleared by FDA(K170277); 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: Elastography
	Note 9: Contrast imaging(contrast agent for LVO)
	Note 10: Contrast imaging (Contrast agent for Liver)
	Note 11: STE
	Note 12: STQ
System:
	DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic Ultrasound System
Transducer:	L12-3E
Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:
Intended Use:
Clinical Application			Mode of Operation
General (Track	Specific (Track 1 & 3)	B	M	PWD	CWD	Color	Amplitude		Combined Other (specify)
1 Only)						Doppler	Doppler	(specify)
Ophthalmic	Ophthalmic
Fetal Imaging	Fetal
& Other	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	b	Note 1, 2, 4,7
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal								Note 1, 2, 4,7
	(Conventional)	P	P	P		P	P	P
	Musculo-skeletal								Note 1, 2, 4,7
		P	P	P		P	P	P
	(Superficial)
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral	Peripheral vessel	P	P	P		P	P	P	Note 1, 2, 4,7
vessel	Other (Specify***)
	N=new indication; P=previously cleared by FDA(K170277); E=added under Appendix E
	Additional comments: Combined modes-B+M、PW+B、Color + B、PW +Color+B、PW +Color+B、Power + PW+B.
	*Intraoperative includes abdominal, thoracic, and vascular
	** Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging. 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: Elastography
	Note 9: Contrast imaging(contrast agent for LVO)
	Note 10: Contrast imaging (Contrast agent for Liver)
	Note 11: STE
	Note 12: STQ
Concurrence of CDRH, Office of Device Evaluation(ODE)
System:	DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic Ultrasound System
Transducer:	DE11-3E
Intended Use:	Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application	Specific (Track 1 & 3)	Mode of Operation
General (Track
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, 3,4,6,7
	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
	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(K171233); 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: Elastography
	Note 9: Contrast imaging(contrast agent for LVO)
	Note 10: Contrast imaging (Contrast agent for Liver)
	Note 11: STE
	Note 12: STQ
	Concurrence of CDRH, Office of Device Evaluation(ODE)
System:	DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic Ultrasound System
Transducer:	SP5-1E
Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:
Intended Use:
Clinical Application			Mode of Operation
General (Track	Specific (Track 1 & 3)					Color	Amplitude		Combined Other (specify)
1 Only)		B	M	PWD	CWD	Doppler	Doppler	(specify)
Ophthalmic	Ophthalmic
Fetal Imaging	Fetal
& Other	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, 2,4,5,6,7,9
	Cardiac Pediatric	P	P	P	P	P	P	P	Note 1, 2,4,5,6,7
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral	Peripheral vessel
vessel	Other (Specify***)
	N=new indication; P=previously cleared by FDA(K170277); E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW +Color+B、PW +Color+B、Power + PW+B.
	*Intraoperative includes abdominal, thoracic, and vascular
	**Small organ-breast, thyroid, testes.
	*** Other use includes Urology.
	Note 1: Tissue Harmonic Imaging. 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: Elastography
	Note 9: Contrast imaging(contrast agent for LVO)
	Note 10: Contrast imaging (Contrast agent for Liver)
	Note 11: STE
	Note 12: STQ
Concurrence of CDRH, Office of Device Evaluation(ODE)
System:	DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 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	Specific (Track 1 & 3)					Color	Amplitude		Combined Other (specify)
1 Only)		B	M	PWD	CWD	Doppler	Doppler	(specify)
Ophthalmic	Ophthalmic
Fetal Imaging	Fetal	P	P	P		P	P	P	Note 1, 2, 4,6,7
& Other	Abdominal	P	P	P		P	P	P	Note 1, 2,
4,6,7,10,11,12
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	Note 1, 2, 4,6,7
	Small Organ (Specify**)
	Neonatal Cephalic
	Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)	P	P	P		P	P	P	Note 1, 2, 4,6,7
	Musculo-skeletal
(Superficial)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral	Peripheral vessel	P	P	P		P	P	P	Note 1, 2, 4,6,7
vessel	Other (Specify***)
	N=new indication; P=previously cleared by FDA(K170277); 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: Elastography
Note 9: Contrast imaging(contrast agent for LVO)
Note 10: Contrast imaging (Contrast agent for Liver)
Note 11: STE
Note 12: STQ
System:	DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 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	Specific (Track 1 & 3)					Color	Amplitude		Combined Other (specify)
1 Only)		B	M	PWD	CWD	Doppler	Doppler	(specify)
Ophthalmic	Ophthalmic
Fetal Imaging	Fetal	P	P	P		P	P	P	Note1,3, 4,6
& Other	Abdominal	P	P	P		P	P	P	Note1,3, 4,6
	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
	Peripheral vessel
Other (Specify***)
vessel
	N=new indication; P=previously cleared by FDA(K163690); E=added under Appendix E
	Additional comments: Combined modes-B+M、PW+B、Color + B、PW +Color+B、PW +Color+B、Power + PW+B.
*Intraoperative includes abdominal, thoracic, and vascular
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging. 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: Elastography
	Note 9: Contrast imaging(contrast agent for LVO)
	Note 10: Contrast imaging (Contrast agent for Liver)
	Note 11: STE
	Note 12: STQ
	Concurrence of CDRH, Office of Device Evaluation(ODE)

4

5

6

7

8

9

10

11

12

13

14

15

16

System:	DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 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							Other (specify)
	General (Track 1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color Doppler		Amplitude Doppler
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
	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(K171233); 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: Elastography
Note 9: Contrast imaging(contrast agent for LVO)
Note 10: Contrast imaging (Contrast agent for Liver)
Note 11: STE
Note 12: STQ
Concurrence of CDRH, Office of Device Evaluation(ODE)

17

System:	DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 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	Specific (Track 1 & 3)					Color	Amplitude		Combined Other (specify)
1 Only)		B	M	PWD	CWD	Doppler	Doppler	(specify)
Ophthalmic	Ophthalmic
Fetal Imaging	Fetal
& Other	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	b	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	Peripheral vessel	P	P	P		P	P	P	Note 1, 2, 4,6,7
vessel	Other (Specify***)
	N=new indication; P=previously cleared by FDA(K170277); E=added under Appendix E
	Additional comments: Combined modes-B+M、PW+B、Color + B、PW +Color+B、PW +Color+B、Power + PW+B.
	*Intraoperative includes abdominal, thoracic, and vascular
	**Small organ-breast, thyroid, testes.
	*** Other use includes Urology.
	Note 1: Tissue Harmonic Imaging. 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: Elastography
	Note 9: Contrast imaging(contrast agent for LVO)
	Note 10: Contrast imaging (Contrast agent for Liver)
	Note 11: STE
	Note 12: STQ
	Concurrence of CDRH, Office of Device Evaluation(ODE)

18

System:	DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 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(K170277); 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: Elastography
	Note 9: Contrast imaging(contrast agent for LVO)
	Note 10: Contrast imaging (Contrast agent for Liver)
	Note 11: STE
	Note 12: STQ
Concurrence of CDRH, Office of Device Evaluation(ODE)

19

System:	DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 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
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(K170277); 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: Elastography
	Note 9: Contrast imaging(contrast agent for LVO)
	Note 10: Contrast imaging (Contrast agent for Liver)
	Note 11: STE
	Note 12: STQ
Concurrence of CDRH, Office of Device Evaluation(ODE)

20

System:	DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 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
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
	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(K170277); 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: Elastography
	Note 9: Contrast imaging(contrast agent for LVO)
	Note 10: Contrast imaging (Contrast agent for Liver)
	Note 11: STE
Note 12: STQ
	Concurrence of CDRH, Office of Device Evaluation(ODE)

21

System:	DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic Ultrasound System
Transducer:	V11-3BE
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)						Color	Amplitude		Combined Other (specify)
1 Only)		B	M	PWD	CWD	Doppler	Doppler	(specify)
Ophthalmic	Ophthalmic
Fetal Imaging	Fetal	P	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	P	Note 1, 2, 4,6,7,8
	Trans-vaginal	P	P	P	P	P	P	P	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	Peripheral vessel
vessel	Other (Specify***)	P	P	P	P	P	P	P	Note 1, 2, 4,6,7
	N=new indication; P=previously cleared by FDA(K170277); 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: Elastography
	Note 9: Contrast imaging(contrast agent for LVO)
	Note 10: Contrast imaging (Contrast agent for Liver)
	Note 11: STE
	Note 12: STQ
	Concurrence of CDRH, Office of Device Evaluation(ODE)

22

System:	DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 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
	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(K170277); 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: Elastography
	Note 9: Contrast imaging(contrast agent for LVO)
	Note 10: Contrast imaging (Contrast agent for Liver)
	Note 11: STE
	Note 12: STQ
Concurrence of CDRH, Office of Device Evaluation(ODE)
System:	DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic Ultrasound System
Transducer:	P4-2NE
Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:
Intended Use:
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	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, 2,4,5,6,7,9
	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***)
System:	DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 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)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (specify)
1 Only)
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**)
	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(K170277); 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: Elastography
	Note 9: Contrast imaging(contrast agent for LVO)
	Note 10: Contrast imaging (Contrast agent for Liver)
	Note 11: STE
	Note 12: STQ
Concurrence of CDRH, Office of Device Evaluation(ODE)

23

24

25

System:	DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic Ultrasound 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
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	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)
	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***)
System:	DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 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
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	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	P	Note 1, 2, 4,6,7
	N=new indication; P=previously cleared by FDA(K170277); 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: Elastography
	Note 9: Contrast imaging(contrast agent for LVO)
	Note 10: Contrast imaging (Contrast agent for Liver)
	Note 11: STE
	Note 12: STQ
Concurrence of CDRH, Office of Device Evaluation(ODE)
System:	DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic Ultrasound System
Transducer:	L16-4HE
Intended Use:	Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application	Specific (Track 1 & 3)	Mode of Operation	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Combined (specify)	Other (specify)
		General (Track 1 Only)
Ophthalmic	Ophthalmic
Fetal Imaging & Other	Fetal
	Abdominal	P	P	P		P	P	P	Note1,2,4
	Intra-operative (Specify*)	P	P	P		P	P	P	Note1,2,4
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	Note1,2,4
	Small Organ (Specify**)	P	P	P		P	P	P	Note1,2,4
	Neonatal Cephalic	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	Note1,2,4
	Musculo-skeletal (Superficial)	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	Note1,2,4
vessel	Other (Specify***)
	N=new indication; P=previously cleared by FDA(K170277); 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: Elastography
	Note 9: Contrast imaging(contrast agent for LVO)
	Note 10: Contrast imaging (Contrast agent for Liver)
	Note 11: STE
Note 12: STQ
	Concurrence of CDRH, Office of Device Evaluation(ODE)
System:	DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 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	Ophthalmic
Fetal Imaging
& Other	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(K170277); 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: Elastography
Note 9: Contrast imaging(contrast agent for LVO)
Note 10: Contrast imaging (Contrast agent for Liver)
Note 11: STE
Note 12: STQ
Concurrence of CDRH, Office of Device Evaluation(ODE)
System:	DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic Ultrasound System
Transducer:	CW2s
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
	Other (Specify***)
	N=new indication; P=previously cleared by FDA(K170277); 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: Elastography
	Note 9: Contrast imaging(contrast agent for LVO)
	Note 10: Contrast imaging (Contrast agent for Liver)
	Note 11: STE
	Note 12: STQ
Concurrence of CDRH, Office of Device Evaluation(ODE)
System:	DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 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
	Other (Specify***)
	N=new indication; P=previously cleared by FDA(K170277); 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: Elastography
	Note 9: Contrast imaging(contrast agent for LVO)
	Note 10: Contrast imaging (Contrast agent for Liver)
	Note 11: STE
	Note 12: STQ
	Concurrence of CDRH, Office of Device Evaluation(ODE)

26

27

28

29

30

31

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.

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:

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

November 1, 2017 Date Prepared:

2. Device Name: DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 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)

3. Device Description:

32

DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-mode, M-mode, PW-mode, CW mode, Color-mode, Color m-Mode, Power/Dirpower mode, TDI mode, 3D/4D mode, Elastography or the combined mode (i.e. B/M-mode).This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array.

4. Intended Use:

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

6. Comparison with Predicate Devices:

DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 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-8	K170277
2. Reference device	Mindray	Resona 7	K171233
3. Reference device	Mindray	DC-70	K163690
4. Reference device	Mindray	M9	K171034

DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic Ultrasound System employs the same technology as the predicate devices. All systems transmit ultrasonic energy into patients, then perform 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. The subject device also has the same intended uses and basic operating modes as the predicate devices.

Subject device DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 has the same intended .

33

uses as the predicated device DC-8(K170277)

• . The materials of probes and Needle-guided brackets of DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 are the same to the probe of predicate device.
• . The acoustic power levels of DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 are below the limits of FDA, which is the same as the predicated device DC-8(K170277).
• DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 is designed in compliance with the FDA recognized electrical and physical safety standards, which are the same as the predicated device DC-8(K170277).

7. Non-clinical Tests:

DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 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 found to conform with applicable medical safety standards.

Non-clinical tests relied on in this premarket notification submission for a determination of substantial equivalence include testing showing compliance with the following standards:

• AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, c1:2009/(r)2012 and a2:2010/(r)2012 (consolidated text) medical electrical equipment - part 1: general requirements for basic safety and essential performance (iec 60601-1:2005, mod).
• IEC 60601-1-2 Edition 3: 2007-03, medical electrical equipment part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility - requirements and tests.
• . IEC 60601-2-37 Edition 2.0 2007, medical electrical equipment - part 2-37: particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment.
• . AAMI / ANSI / IEC 62304:2006, medical device software - software life cycle processes.
• ISO 14971 Second edition 2007-03-01, medical devices application of risk . management to medical devices.

34

• NEMA UD 2-2004 (R2009), acoustic output measurement standard for diagnostic . ultrasound equipment revision 3.
• AAMI / ANSI / ISO 10993-1:2009/(R)2013, biological evaluation of medical I devices - part 1: evaluation and testing within a risk management process.

8. Clinical Tests:

Not Applicable.

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 Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.