DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System

• K Number: K181637
• Device Name: DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System
• Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., LTD
• Date Cleared: 2019-01-09 ( 202 days)
• Product Code: IYN ITX IYO LLZ
• Regulation Number: 892.1550

Intended Use

The DC-70/ DC-70T / DC-70 Pro/ DC-70 Exp/ DC-75/ DC-78/ DC-70S Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), adult and pediatric cardiac, Trans-esoph. (Cardiac), peripheral vessel , intra-operative(abdominal, thoracic, and vascular) and urology exams.

Device Description

DC-70/ DC-70T /DC-70 Pro/ DC-70 Exp/ DC-75/ DC-78/ DC-70S is a software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, PW-Mode, P CW-Mode, Color-Mode , Power/Dirpower Mode, THI, Smart3D, 4D, iScape, TDI, Color M, Biopsy Guidance, Elastography, Contrast imaging (Contrast agent for Liver and LOV) or 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

K163690

Reference Devices

K171233, K173471, K171034, K171579

AI/ML (Artificial Intelligence / Machine Learning)

No
The 510(k) summary describes a standard ultrasound system with various imaging modes and probes. There is no mention of AI, ML, or related terms, nor any description of training or test sets which would be expected for an AI/ML device.

Therapeutic

No
The device is described as a "Diagnostic Ultrasound System" and its function is to "acquire and display ultrasound data," indicating its purpose is for diagnosis, not therapy.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the device is a "Diagnostic Ultrasound System" and lists various exams it is intended for, all of which are diagnostic in nature. Additionally, the "Device Description" calls it an "ultrasonic diagnostic system."

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 that include Linear array, Convex array, Phased array, Volume and Pencil probe." These probes are hardware components essential for acquiring ultrasound data, indicating it is not a software-only device.

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 Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health.
• Device Function: The description clearly states that this is an ultrasonic diagnostic system. It uses ultrasound waves to create images of internal structures within the body.
• Intended Use: The intended uses listed are all related to imaging various anatomical sites in vivo (within the living body).

Therefore, since the device operates by imaging structures within the body rather than analyzing specimens taken from the body, it does not fit the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The DC-70/ DC-70T / DC-70 Pro/ DC-70 Exp/ DC-78/ DC-70S Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), adult and pediatric cardiac, Trans-esoph. (Cardiac), peripheral vessel , intra-operative(abdominal, thoracic, and vascular) and urology exams.

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

IYN, IYO, ITX, LLZ

Device Description

DC-70/ DC-70T /DC-70 Pro/ DC-70 Exp/ DC-75/ DC-78/ DC-70S is a software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, PW-Mode, P CW-Mode, Color-Mode , Power/Dirpower Mode, THI, Smart3D, 4D, iScape, TDI, Color M, Biopsy Guidance, Elastography, Contrast imaging (Contrast agent for Liver and LOV) or 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, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), adult and pediatric cardiac, Trans-esoph. (Cardiac), peripheral vessel, intra-operative(abdominal, thoracic, and vascular) and urology.

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)

Non-clinical tests were performed. These include evaluation for acoustic output, biocompatibility, cleaning and disinfection effectiveness, and thermal, electrical, and mechanical safety. The device conforms to applicable medical safety standards. No clinical studies were required to support substantial equivalence.

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.

K163690

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, K173471, K171034, K171579

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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

January 9, 2019

Re: K181637

Trade/Device Name: DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX, LLZ Dated: December 25, 2018 Received: December 28, 2018

Dear Zhang Wei:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

1

requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Michael D.'Hara For

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K181637

Device Name

DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System

Indications for Use (Describe)

The DC-70/ DC-70T / DC-70 Pro/ DC-70 Exp/ DC-78/ DC-70S Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), adult and pediatric cardiac, Trans-esoph. (Cardiac), peripheral vessel , intra-operative(abdominal, thoracic, and vascular) and urology exams.

	Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)	Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Diagnostic Ultrasound Indications For Use Format

System: DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System Transducer: N/A

Intended

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use:

Clinical Application		Mode of Operation
General
(Track 1
Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P	P	P	P	P	Note 1, 2,3, 4,6,7
	Abdominal	P	P	P	P	P	P	P	Note 1, 2,3,4,6,7,9
	Intra-operative (Specify*)	P	P	P	P	P	P	P	Note 1, 2, 4
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P	Note 1, 2, 4,6,7
	Small Organ (Specify**)	P	P	P	P	P	P	P	Note 1,2, 4,7,8
Fetal
Imaging &
Other	Neonatal Cephalic	P	P	P	P	P	P	P	Note 1, 2,4,6,7
	Adult Cephalic	P	P	P	P	P	P	P	Note 1, 2,4,6,7
	Trans-rectal	P	P	P	P	P	P	P	Note 1, 2, 3,4,6,7
	Trans-vaginal	P	P	P	P	P	P	P	Note 1, 2, 3,4,6,7,8
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)	P	P	P	P	P	P	P	Note 1, 2, 4,6,7,8
	Musculo-skeletal (Superficial)	P	P	P	P	P	P	P	Note 1, 2, 4,7,8
	Intravascular								Note 1,
	Cardiac Adult	P	P	P	P	P	P	P	2,4,5,6,7,10
	Cardiac Pediatric	P	P	P	P	P	P	P	Note 1, 2,4,5,6,7
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)	N	N	N	N	N	N	N	Note 1, 5,6
	Intra-cardiac
Peripheral
vessel	Peripheral vessel	P	P	P	P	P	P	P	Note 1, 2, 4,6,7
	Other (Specify***)	P	P	P	P	P	P	P	Note 1, 2, 4,6,7
	N=new indication; P=previously cleared by FDA; E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+ B、Power + PW +B.
	*Intraoperative includes abdominal, thoracic, and vascular
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging.
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note5: TDI
	Note6: Color M
	Note7: Biopsy Guidance
	Note8: Elastography
	Note 9: Contrast imaging (Contrast agent for Liver)
	Note 10: Contrast imaging (Contrast agent for LVO)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Intended
Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Mode of Operation
	Clinical Application		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		P	P	P		P	P	P	Note 1, 2, 4,6,7
	Abdominal		P	P	P		P	P	P	Note 1, 2, 4,6,7,9
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric		P	P	P		P	P	P	Note 1, 2, 4,6,7
	Small Organ (Specify**)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)		P	P	P		P	P	P	Note 1, 2, 4,6,7
	Musculo-skeletal (Superficial)
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel		P	P	P		P	P	P	Note 1, 2, 4,6,7
	Other (Specify***)
N=new indication; P=previously cleared by FDA(K150204); E=added under Appendix E
Additional comments: Combined modes--B+M、PW+B、Color + B、Power+B、PW+Color+B、Power + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular etc.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
Note 1: Tissue Harmonic Imaging.
Note 2: Smart3D
Note 3:4D(Real-time 3D)
Note 4: iScape
Note5: TDI
Note6: Color M
Note7: Biopsy Guidance
Note8: Elastography
Note 9: Contrast imaging (Contrast agent for Liver)
Note 10: Contrast imaging (Contrast agent for LVO)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Intended
Use:	Clinical Application		Mode of Operation
	General
(Track 1
Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitud
e Doppler	Combined
(specify)	Other (specify)
Ophthalmic	Ophthalmic
		Fetal
		Abdominal	P	P	P	P	P	P	P	Note 1, 2, 4,6,7
		Intra-operative (Specify*)
		Intra-operative (Neuro)
		Laparoscopic
Fetal
Imaging &
Other		Pediatric	P	P	P	P	P	P	P	Note 1, 2, 4,6,7
		Small Organ (Specify**)
		Neonatal Cephalic	P	P	P	P	P	P	P	Note 1, 2, 4,6,7
		Adult Cephalic
		Trans-rectal
		Trans-vaginal
		Trans-urethral
		Trans-esoph. (non-Card.)
		Musculo-skeletal (Conventional)
		Musculo-skeletal (Superficial)
		Intravascular
Cardiac		Cardiac Adult
		Cardiac Pediatric	P	P	P	P	P	P	P	Note 1, 2, 4,6,7
		Intravascular (Cardiac)
		Trans-esoph. (Cardiac)
		Intra-cardiac
Peripheral
vessel		Peripheral vessel	P	P	P	P	P	P	P	Note 1, 2, 4,6,7
		Other (Specify***)
N=new indication; P=previously cleared by FDA(K150204); E=added under Appendix E
Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+ B、Power + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular etc.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
Note 1: Tissue Harmonic Imaging.
Note 2: Smart3D
Note 3:4D(Real-time 3D)
Note 4: iScape
Note5: TDI
Note6: Color M
Note7: Biopsy Guidance
Note8: Elastography
Note 9: Contrast imaging (Contrast agent for Liver)
Note 10: Contrast imaging (Contrast agent for LVO)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Intended
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	P	P	P	P	P	P	P	Note 1, 2, 4,6,7
	Abdominal	P	P	P	P	P	P	P	Note 1, 2, 4,6,7
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P	Note 1, 2, 4,6,7
	Small Organ (Specify**)
Fetal
Imaging &
Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel
	Other (Specify***)
	N=new indication; P=previously cleared by FDA(K150204); E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+ B、Power + PW +B.
	*Intraoperative includes abdominal, thoracic, and vascular etc.
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging.
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note5: TDI
	Note6: Color M
	Note7: Biopsy Guidance
	Note8: Elastography
	Note 9: Contrast imaging (Contrast agent for Liver)
	Note 10: Contrast imaging (Contrast agent for LVO)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Intended
Use:	Clinical Application		Mode of Operation
	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
e Doppler	Combined
(specify)	Other (specify)
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
Fetal
Imaging &
Other	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, 4,7
	Musculo-skeletal (Superficial)	P	P	P		P	P	P	Note 1, 2, 4,7
Cardiac	Intravascular
	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(K150204); E=added under Appendix E
Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular etc.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
Note 1: Tissue Harmonic Imaging.
Note 2: Smart3D
Note 3:4D(Real-time 3D)
Note 4: iScape
Note5: TDI
Note6: Color M
Note7: Biopsy Guidance
Note8: Elastography
Note 9: Contrast imaging (Contrast agent for Liver)
Note 10: Contrast imaging (Contrast agent for LVO)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Intended
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
	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
Fetal
Imaging &
Other	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, 4,7
	Musculo-skeletal (Superficial)	P	P	P		P	P	P	Note 1,2, 4,7
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	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(K150204); E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+ B、Power + PW +B.
	*Intraoperative includes abdominal, thoracic, and vascular etc.
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging.
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note5: TDI
	Note6: Color M
	Note7: Biopsy Guidance
	Note8: Elastography
	Note 9: Contrast imaging (Contrast agent for Liver)
	Note 10: Contrast imaging (Contrast agent for LVO)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Intended
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
	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
Fetal
Imaging &
Other	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, 4,7
	Musculo-skeletal (Superficial)	P	P	P		P	P	P	Note 1,2, 4,7
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	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(K150204); E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power + PW +B.
	*Intraoperative includes abdominal, thoracic, and vascular etc.
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging.
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note5: TDI
	Note6: Color M
	Note7: Biopsy Guidance
	Note8: Elastography
	Note 9: Contrast imaging (Contrast agent for Liver)
	Note 10: Contrast imaging (Contrast agent for LVO)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Intended
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	P	P	P	P	P	P	P	Note 1, 2, 4,6,7
	Abdominal
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)
Fetal
Imaging &
Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P	P	P	P	P	Note 1, 2, 4,6,7
	Trans-vaginal	P	P	P	P	P	P	N	Note 1, 2, 4,6,7,8
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
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(K150204); E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power + PW +B.
	*Intraoperative includes abdominal, thoracic, and vascular etc.
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging.
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note5: TDI
	Note6: Color M
	Note7: Biopsy Guidance
	Note8: Elastography
	Note 9: Contrast imaging (Contrast agent for Liver)
	Note 10: Contrast imaging (Contrast agent for LVO)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
	Clinical Application	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P	Note 1, 2, 4,6,7
	Abdominal
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
Fetal
Imaging &
Other	Small Organ (Specify**)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	P	P	Note 1, 2, 4,6,7
	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(K150204); E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+ B、Power + PW +B.
	*Intraoperative includes abdominal, thoracic, and vascular etc.
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging.
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note5: TDI
	Note6: Color M
	Note7: Biopsy Guidance
	Note8: Elastography
	Note 9: Contrast imaging (Contrast agent for Liver)
	Note 10: Contrast imaging (Contrast agent for LVO)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Intended
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	P	P	P		P	P	P	Note 1, 2, 4,6,7
	Abdominal
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)
Fetal
Imaging &
Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	P	P	Note 1, 2, 4,6,7
	Trans-vaginal	P	P	P		P	P	P	Note 1, 2, 4,6,7
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	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(K150204);						E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power + PW +B.
	*Intraoperative includes abdominal, thoracic, and vascular etc.
	** Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging.
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note5: TDI
	Note6: Color M
	Note7: Biopsy Guidance
	Note8: Elastography
	Note 9: Contrast imaging (Contrast agent for Liver)
	Note 10: Contrast imaging (Contrast agent for LVO)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Intended
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
	Abdominal	P	P	P	P	P	P	P	Note 1, 2,4,6,7
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P	Note 1, 2,4,6,7
	Small Organ (Specify**)
Fetal
Imaging &
Other	Neonatal Cephalic	P	P	P	P	P	P	P	Note 1, 2,4,6,7
	Adult Cephalic	P	P	P	P	P	P	P	Note 1, 2,4,6,7
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Cardiac Adult	P	P	P	P	P	P	P	Note 1,
2,4,5,6,7,10
	Cardiac Pediatric	P	P	P	P	P	P	P	Note 1, 2,4,5,6,7
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel
	Other (Specify***)
	N=new indication; P=previously cleared by FDA(K150204); E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+ B、Power + PW +B.
	*Intraoperative includes abdominal, thoracic, and vascular etc.
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging.
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note5: TDI
	Note6: Color M
	Note7: Biopsy Guidance
	Note8: Elastography
	Note 9: Contrast imaging (Contrast agent for Liver)
	Note 10: Contrast imaging (Contrast agent for LVO)
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
	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**)
Fetal
Imaging &
Other	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***)
	N=new indication; P=previously cleared by FDA(K150204); E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+ B、Power + PW +B.
	*Intraoperative includes abdominal, thoracic, and vascular etc.
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging.
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note5: TDI
	Note6: Color M
	Note7: Biopsy Guidance
	Note8: Elastography
	Note 9: Contrast imaging (Contrast agent for Liver)
	Note 10: Contrast imaging (Contrast agent for LVO)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Intended
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	Amplitud
e Doppler	Combined
(specify)	Other (specify)
Ophthalmic	Ophthalmic
	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
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)
Fetal
Imaging &
Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel
	Other (Specify***)
	N=new indication; P=previously cleared by FDA(K150204);						E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+ B、Power + PW +B.
	*Intraoperative includes abdominal, thoracic, and vascular etc.
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging.
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note5: TDI
	Note6: Color M
	Note7: Biopsy Guidance
	Note8: Elastography
	Note 9: Contrast imaging (Contrast agent for Liver)
	Note 10: Contrast imaging (Contrast agent for LVO)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
	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	P	P	P		P	P	P	Note 1, 3, 4, 6
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, 3, 4, 6
	Trans-vaginal	P	P	P		P	P	P	Note 1, 3, 4, 6
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel
	Other (Specify***)
	N=new indication; P=previously cleared by FDA(K150204); E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power + PW+B.
	*Intraoperative includes abdominal, thoracic, and vascular etc.
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging.
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note5: TDI
	Note6: Color M
	Note7: Biopsy Guidance
	Note8: Elastography
	Note 9: Contrast imaging (Contrast agent for Liver)
	Note 10: Contrast imaging (Contrast agent for LVO)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
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
	Abdominal
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)
Fetal
Imaging &
Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel				P
	Other (Specify***)
	N=new indication; P=previously cleared by FDA(K150204); E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power + PW +B.
	*Intraoperative includes abdominal, thoracic, and vascular etc.
	** Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging.
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note5: TDI
	Note6: Color M
	Note7: Biopsy Guidance
	Note8: Elastography
	Note 9: Contrast imaging (Contrast agent for Liver)
	Note 10: Contrast imaging (Contrast agent for LVO)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Intended
Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
General
(Track 1
Only)	Clinical Application	Mode of Operation						Other (specify)
		Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler		Amplitude
e Doppler	Combined
(specify)
Ophthalmic	Ophthalmic
Fetal
Imaging &
Other	Fetal		P	P	P		P	P	P	Note 1,2, 4,7
	Abdominal
	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
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)		P	P	P		P	P	P	Note 1,2, 4,7,8
	Musculo-skeletal (Superficial)		P	P	P		P	P	P	Note 1,2, 4,7,8
	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***)
Intended	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Use:	Mode of Operation
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	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
Fetal
Imaging &
Other	Adult Cephalic
	Trans-rectal	P	P	P		P	P	P	Note 1, 3, 4, 6, 7
	Trans-vaginal	P	P	P		P	P	P	Note 1, 3, 4, 6, 7
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
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 etc.
	** Small organ-breast, thyroid, testes.
	***()ther use includes Urology.
	Note 1: Tissue Harmonic Imaging.
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note5: TDI
	Note6: Color M
	Note7: Biopsy Guidance
	Note8: Elastography
	Note 9: Contrast imaging (Contrast agent for Liver)
	Note 10: Contrast imaging (Contrast agent for LVO)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application	Mode of Operation
	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (specify)
General
(Track 1
Only)	Ophthalmic
Fetal
Imaging &
Other	Ophthalmic	P	P	P		P	P	P	Note 1, 2, 4, 6, 7
	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	P	P	P		P	P	P	Note 1, 2, 4, 6, 7
	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(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 etc.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
Note 1: Tissue Harmonic Imaging.
Note 2: Smart3D
Note 3:4D(Real-time 3D)
Note 4: iScape
Note5: TDI
Note6: Color M
Note7: Biopsy Guidance
Note8: Elastography
Note 9: Contrast imaging (Contrast agent for Liver)
Note 10: Contrast imaging (Contrast agent for LVO)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIP)
Use:	Clinical Application						Mode of Operation
		Specific (Track 1 & 3)	B	M	PWD CWD	Color
Doppler	Amplitude
e Doppler	Combined
(specify)	Other (specify)
General
(Track 1
Only)	Ophthalmic	Ophthalmic
		Fetal	P	P	P	P	P	P	Note 1, 2, 4,6,7
		Abdominal	P	P	P	P	P	P	Note 1, 2, 4,6,7,9
		Intra-operative (Specify*)
		Intra-operative (Neuro)
		Laparoscopic
		Pediatric	P	P	P	P	P	P	Note 1, 2, 4,6,7
		Small Organ (Specify**)
Fetal
Imaging &
Other		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(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 etc.
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging.
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note5: TDI
	Note6: Color M
	Note7: Biopsy Guidance
	Note8: Elastography
	Note 9: Contrast imaging (Contrast agent for Liver)
	Note 10: Contrast imaging (Contrast agent for LVO)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

4

DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System System: Transducer: C5-2E

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follow

5

DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System System: Transducer: C11-3E

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follo Intended

6

System: DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System Transducer: C7-3E

Intended

7

DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System System: Transducer: L12-3E

8

DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System System: Transducer: L14-6NE

9

DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System System: Transducer: L14-6WE

10

DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System System: Transducer: V11-3E Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follo

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

11

DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System System: Transducer: V11-3BE

12

DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System System: Transducer: V V 1 - 3 W E

13

DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System System: Transducer: P4-2E Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

14

DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System System: Transducer: P7-3E

Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

15

System: DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System Transducer: D6-2E ded 1

16

DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System
DE10-3E System:
Transducer:

17

DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System System: CWS nsdu

18

DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System System: Transducer: L9-3E

19

DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System System: Transducer: DE11-3E

Transducer:

20

DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System System: Transducer: V V 1 - 3 HE

Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follow

21

DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System System: Transducer: C5-1E Intended

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

22

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
	Abdominal
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)
Fetal
Imaging &
Other	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 Adult
	Cardiac Pediatric
Cardiac	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(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 etc.
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging.
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note5: TDI
	Note6: Color M
	Note7: Biopsy Guidance
	Note8: Elastography
	Note 9: Contrast imaging (Contrast agent for Liver)
	Note 10: Contrast imaging (Contrast agent for LVO)

System: DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System Transducer: CB10-4E Intended

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

23

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

Use:
	Clinical Application	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (specify)
General
(Track 1
Only)	Specific (Track 1 & 3)
Ophthalmic	Ophthalmic
	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**)
Fetal
Imaging &
Other	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 Adult	P	P	P	P	P	P	P	Note 1, 2,4,5,6
	Cardiac Pediatric	P	P	P	P	P	P	P	Note 1, 2,4,5,6
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
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 etc.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
Note 1: Tissue Harmonic Imaging.
Note 2: Smart3D
Note 3:4D(Real-time 3D)
Note 4: iScape
Note5: TDI
Note6: Color M
Note7: Biopsy Guidance
Note8: Elastography
Note 9: Contrast imaging (Contrast agent for Liver)
Note 10: Contrast imaging (Contrast agent for LVO)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

System:	DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System
Transducer:	P10-4E

Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

24

| Intended

Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Clinical Application	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (specify)
General
(Track 1
Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P	P	P	P	P	Note 1, 2,4, 6,7
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P	Note 1, 2,4, 6,7
	Small Organ (Specify**)
Fetal
Imaging &
Other	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								Note 1,
	Cardiac Adult	P	P	P	P	P	P	P	Note 1,
2,4,5,6,7,10
	Cardiac Pediatric	P	P	P	P	P	P	P	Note 1, 2,4,5,6,7
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	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 etc.
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging.
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note5: TDI
	Note6: Color M
	Note7: Biopsy Guidance
	Note8: Elastography
	Note 9: Contrast imaging (Contrast agent for Liver)
	Note 10: Contrast imaging (Contrast agent for LVO)
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	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**)
Fetal
Imaging &
Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
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 etc.
	** Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging.
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note5: TDI
	Note6: Color M
	Note7: Biopsy Guidance
	Note8: Elastography
	Note 9: Contrast imaging (Contrast agent for Liver)
	Note 10: Contrast imaging (Contrast agent for LVO)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Intended
Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Clinical Application	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (specify)
General
(Track 1
Only)	Specific (Track 1 & 3)
Ophthalmic	Ophthalmic
	Fetal	P	P	P	P	P	P	P	Note 1, 3, 4, 6
	Abdominal	P	P	P	P	P	P	P	Note 1, 3, 4, 6
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)
Fetal
Imaging &
Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
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 etc.
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging.
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note5: TDI
	Note6: Color M
	Note7: Biopsy Guidance
	Note8: Elastography
	Note 9: Contrast imaging (Contrast agent for Liver)
	Note 10: Contrast imaging (Contrast agent for LVO)
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
	Abdominal
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)
Fetal
Imaging &
Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)	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(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 etc.
	** Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging.
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note5: TDI
	Note6: Color M
	Note7: Biopsy Guidance
	Note8: Elastography
	Note 9: Contrast imaging (Contrast agent for Liver)
	Note 10: Contrast imaging (Contrast agent for LVO)
Intended
Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Clinical Application	B	M	PWD	CWD	Color
Doppler	Amplitude Doppler	Combined
(specify)	Other (specify)
General
(Track 1
Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude Doppler	Combined
(specify)	Other (specify)
Ophthalmic	Ophthalmic
	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
Fetal
Imaging &
Other	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 Adult
	Cardiac Pediatric
Cardiac	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 etc.
	**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 Liver)
	Note 10: Contrast imaging (Contrast agent for LVO)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

System: DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System Transducer: SP5-1E Intended

25

DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System System: Transducer: D6-2NE

26

DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System System: Transducer: D7-2E Intended

tended
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

27

DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System System: Transducer: P7-3TE T ded

28

DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System System: Transducer: L14-5WE

Intended stic ultrasound imaging or fluid flow analysis of the human body as follo

29

System:	DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S 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
modes
(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)	N	N	N		N	N	N	Note 1, 2, 4
Fetal
Imaging &
Other	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 Adult
	Cardiac Pediatric
Cardiac	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 etc.
	**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 Liver)
	Note 10: Contrast imaging (Contrast agent for LVO)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
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	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	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 etc.
	**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 Liver)
	Note 10: Contrast imaging (Contrast agent for LVO)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

30

DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System System: Transducer: 6LB7E
Intended

31

System:	DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System
Transducer:	SC6-1E
Intended

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	N	N	N		N	N	N	Note 1, 2, 4, 6,7
	Abdominal	N	N	N		N	N	N	Note 1, 2, 4,6,7,9
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)
Fetal
Imaging &
Other	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 Adult
	Cardiac Pediatric
Cardiac	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.
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 Liver)
Note 10: Contrast imaging(contrast agent for LVO)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
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	N	N	N	N	N	N	N	Note 1, 3, 4, 6,7
	Abdominal	N	N	N	N	N	N	N	Note 1, 3, 4,6,7
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)
Fetal
Imaging &
Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel
	Other (Specify***)
	N=new indication; P=previously cleared by FDA; E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+ B、Power + PW +B.
	*Intraoperative includes abdominal, thoracic, and vascular.
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging.
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note 5: TDI
	Note 6: Color M
	Note 7: Biopsy Guidance
	Note 8: Elastography
	Note9: Contrast imaging (Contrast agent for Liver)
	Note 10: Contrast imaging(contrast agent for LVO)
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
	Abdominal	P	P	P	P	P	P	P	Note 1, 2, 4
	Intra-operative (Specify*)	P	P	P	P	P	P	P	Note 1, 2, 4
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P	Note 1, 2, 4
	Small Organ (Specify**)	P	P	P	P	P	P	P	Note 1, 2, 4
Fetal
Imaging &
Other	Neonatal Cephalic	P	P	P	P	P	P	P	Note 1, 2, 4
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)	P	P	P	P	P	P	P	Note 1, 2, 4
	Musculo-skeletal (Superficial)	P	P	P	P	P	P	P	Note 1, 2, 4
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel	P	P	P	P	P	P	P	Note 1, 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 etc.
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging.
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note5: TDI
	Note6: Color M
	Note7: Biopsy Guidance
	Note8: Elastography
	Note9: Contrast imaging (Contrast agent for Liver)
	Note 10: Contrast imaging(contrast agent for LVO)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System System: Transducer: SD8-1E

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DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System System: Transducer: L16-4HE Intended

intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

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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: K181637.

1. Submitter:

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

Date Prepared: May 25, 2018

2. Device Name: DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S 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)

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3. Device Description:

DC-70/ DC-70T /DC-70 Pro/ DC-70 Exp/ DC-75/ DC-78/ DC-70S is a software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, PW-Mode, P CW-Mode, Color-Mode , Power/Dirpower Mode, THI, Smart3D, 4D, iScape, TDI, Color M, Biopsy Guidance, Elastography, Contrast imaging (Contrast agent for Liver and LOV) or 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-70/ DC-70T / DC-70 Pro/ DC-70 Exp/ DC-78/ DC-78/ DC-70S Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), adult and pediatric cardiac, Trans-esoph. (Cardiac), peripheral vessel , intra-operative(abdominal, thoracic, and vascular) and urology exams.

5. Summary of Modifications

● New Added Transducers:

L14-5WE L20-5E 6LB7E SC6-IE SD8-1E L16-4HE

. New Added Needle-Guided Bracket:

NGB-035, NGB-039, NGB-009

● Main Added Features:

Add the contrast imaging(contrast agent for LVO) function to SP5-1E, P4-2E

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Add the contrast imaging(contrast agent for Liver) function to SC6-1E Add the elastography function to L14-5WE, L20-5E ,L9-3E

AutoEF

Smart face

Smart plane CNS

6. Comparison with Predicate Devices:

DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S 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	K163690
2. Reference device	Mindray	Resona 7	K171233
3. Reference device	Mindray	DC-80	K173471
4. Reference device	Mindray	M9	K171034
5. Reference device	Mindray	M6	K171579

DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S 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 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-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S has the same intended uses as the predicated device DC-70(K163690) and DC-80 K173471

Subject Device	Predicate device
DC-70/DC-70T /DC-70 PRO/DC-70 EXP	DC-70(K163690)
The DC-70/ DC-70T / DC-70 Pro/ DC-70
Exp/ DC-75/ DC-78/ DC-70S Diagnostic	The DC-70/ DC-70T / DC-70 Pro/ DC-70 Exp/
DC-75/ DC-78/ DC-70S Diagnostic Ultrasound

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| Ultrasound System is applicable for adults,
pregnant women, pediatric patients and
neonates. It is intended for use in fetal,
abdominal, pediatric, small organ(breast,
thyroid, testes), neonatal and adult cephalic,
trans-rectal, trans-vaginal,
musculo-skeletal(conventional, superficial),
adult and pediatric cardiac, Trans-esoph.
(Cardiac), peripheral vessel and urology
exams. | System is applicable for adults, pregnant
women, pediatric patients and neonates. It is
intended for use in fetal, abdominal, pediatric,
small organ(breast, thyroid, testes), neonatal and
adult cephalic, trans-rectal, trans-vaginal,
musculo-skeletal(conventional, superficial),
adult and pediatric cardiac, Trans-esoph.
(Cardiac), peripheral vessel and urology
exams. |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| intra-operative(abdominal, thoracic, and
vascular) | intra-operative(abdominal, thoracic, and
vascular)(DC-80 K173471) |

• The acoustic power levels of DC-70/ DC-70T/ DC-70 Pro/DC-70 Exp / DC-75/ ● DC-78/ DC-70S are below the limits of FDA, which is the same as the predicated device DC-70(K163690).
• . DC-70/ DC-70T/ DC-70 Pro/DC-70 Exp / DC-75/ DC-78/ DC-70S is designed in compliance with the FDA recognized electrical and physical safety standard, which is the same as the predicated device DC-70(K163690).
• DC-70/ DC-70T/ DC-70 Pro/DC-70 Exp / DC-75/ DC-78/ DC-70S has similar probes as the predicated device:

Subject device	Predicated device
DC-70/ DC-70T/ DC-70 Pro/DC-70 Exp /
DC-75/ DC-78/ DC-70S
L14-5WE	L14-5WE & DC-80 (K173471)
L20-5E	L20-5U& Resona 7 (K171233)
6LB7E	6LB7s& M6(K171579)
SC6-1E	SC6-1U& Resona 7 (K171233)
SD8-1E	D6-2E&DC-70(K163690)
L16-4HE	L16-4HE& DC-80 (K173471)

7. Non-clinical Tests:

DC-70/ DC-70T/ DC-70 Pro/DC-70 Exp/ DC-78/ DC-78/ DC-70S Diagnostic

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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
• AAMI/ANSI/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
• . UD 3 Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
• . ISO 10993-1 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process

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

8. Clinical Studies

Not applicable. The subject of this submission, DC-70/ DC-70T/ DC-70 Pro/ DC-70 Exp / DC-75/ DC-78/ DC-70S Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence.

Conclusion:

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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-70/ DC-70T/ DC-70 Pro/ DC-70 Exp / DC-75/ DC-78/ DC-70S Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.