Predicate Devices

Reference Devices

K171579, K103583, K171233, K163690, K122010

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary does not mention AI, ML, deep learning, or any related terms, and the description of the device's functionality is based on standard ultrasound imaging modes and post-processing.

Therapeutic

No
The device is described as a "Diagnostic Ultrasound System" for acquiring and displaying images of anatomical structures, which indicates diagnostic rather than therapeutic use.

Diagnostic

Yes

The device's name explicitly states "Diagnostic Ultrasound System" and its intended use is for various exams in different body parts for diagnostic purposes.

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 that include linear array, Phased array and convex array." This indicates the device includes hardware components (the ultrasound system and probes) in addition to software.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use clearly states that the device is a "Diagnostic Ultrasound System" used for imaging various anatomical sites in different patient populations. This involves using ultrasound waves to visualize structures within the body.
Device Description: The description details the system's function as acquiring and displaying ultrasound images in various modes. This is consistent with an imaging device, not a device that analyzes samples taken from the body.
Input Imaging Modality: The input modality is explicitly stated as "Ultrasound." IVD devices typically analyze biological samples (blood, urine, tissue, etc.).
No mention of analyzing biological samples: There is no indication in the provided text that this device interacts with or analyzes any biological samples.

In Vitro Diagnostic (IVD) devices are medical devices that are used to examine specimens, such as blood, urine, or tissue, that have been taken from the human body. They are used to provide information for diagnosis, monitoring, or screening.

This device, on the other hand, is an in vivo diagnostic imaging device, meaning it is used to visualize structures within the living body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The DC-40/DC-35/DC-40S/DC-40 Pro 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), musculo- skeletal (superficial), cardiac adult, cardiac pediatric, peripheral vessel and urology exams.

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

IYN, IYO, ITX

Device Description

The DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound images in B-Mode, M-Mode, PW-Mode, CW-mode, Color-Mode, Power/Dirpower mode, THI Mode, 3D/4D Mode, iScape mode, TDI mode, Color M mode, Biospy Guidance, Elastography, Contrast imaging (Liver) 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, Phased array and convex array.

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 cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional), musculo-skeletal (superficial), cardiac adult, cardiac pediatric, peripheral vessel, 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 relied on in this premarket notification submission for a determination of substantial equivalence include testing showing compliance with the following standards:

ANSI/AAMI ES60601-1 :2005/(R)2012 and A1:2012: Medical electrical equipment Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2 Edition 4.0 2014-02: 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 2.1 2015: Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
IEC 62304 Edition 1.1 2015-06: Medical device software - Software life cycle processes
IEC 62366-1 Edition 1.0 2015-02: Medical devices application of usability ■ engineering to medical devices
IEC 60601-1-6 Edition 3.1 2013-10: Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability.
ISO 14971 Second edition 2007-03-01: Medical devices Application of risk management to medical devices
NEMA UD 2-2004 (R2009): Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3
ISO 10993-1 Fourth edition 2009-10-15: Biological evaluation of medical devices --Part 1: Evaluation and testing within a risk management process, Fourth edition
These non-clinical tests relied on in this premarket notification submission can support the determination of substantial equivalence of the subject device.

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

Not Found

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

K162845

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.

K171579, K103583, K171233, K163690, K122010

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

April 9, 2019

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and full name on the right. The Department of Health & Human Services logo is a stylized human figure. The FDA acronym is in a blue square, and the full name "U.S. Food & Drug Administration" is in blue text.

Shenzhen Mindray Bio-Medical Electronics Co., LTD % Shi Jufang Engineer of Technical Regulation Keji 12th Road South, Hi-tech Industrial Park Shenzhen, Guangdong, 518057 P.R. CHINA

Re: K183377

Trade/Device Name: DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: March 19, 2019 Received: March 21, 2019

Dear Shi Jufang:

This letter corrects our substantially equivalent letter of April 4, 2019.

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

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

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

1

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

David Don

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

Enclosure

2

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K183377

Device Name

DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System

Indications for Use (Describe)

The DC-40/DC-35/DC-40S/DC-40 Pro 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), musculo- skeletal (superficial), cardiac adult, cardiac pediatric, peripheral vessel and urology exams.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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3

DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System System:

Transducer: N/A

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

Clinical Application						Mode of Operation
General	Specific	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other
(Specify)
(Track 1 Only)	(Track 1 & 3)
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, 9
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	N	P	P	P	Note 1, 2, 4,6,7
	Small Organ (Specify**)	P	P	P		P	P	P	Note 1,2, 4,6,7,8
	Neonatal Cephalic	P	P	P	N	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
	Trans-vaginal	P	P	P		P	P	P	Note 1, 2, 3,4,6,7
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)	P	P	P		P	P	P	Note 1, 2, 4,6,7,8
	Musculo-skeletal
(Superficial)	P	P	P		P	P	P	Note 1,2, 4,6,7,8
	Intravascular
Cardiac	Cardiac Adult	P	P	P	P	P	P	P	Note 1, 2,4,5,6,7
	Cardiac Pediatric	P	P	P	P	P	P	P	Note 1, 2,4,5,6,7
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel	P	P	P		P	P	P	Note 1, 2, 4,6,7
	Other (Specify***)	N	N	N		N	N	N	Note 1, 2, 4,6,7
	N=new indication; P=previously cleared by FDA (K162845);			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
	Note5: TDI
	Note6: Color M
	Note7: Biopsy Guidance
	Note8: Elastography
	Note9: Contrast imaging (Contrast agent for Liver)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
	Prescription USE (Per 21 CFR 801.109)

4

DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System System:

Transducer: 3C5A

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

Clinical Application						Mode of Operation
General	Specific			PWD	CWD	Color	Amplitude	Combined	Other
(Track 1 Only)	(Track 1 & 3)	B	M			Doppler	Doppler	(specify)	(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, 4,6,7,9
	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	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	P	P	P		P	P	P	Note 1, 2, 4,6,7
	(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 (K162845); 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.
	*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
	Note5: TDI
	Note6: Color M
	Note7: Biopsy Guidance
	Note8: Elastography
	Note9: Contrast imaging (Contrast agent for Liver)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
	Prescription USE (Per 21 CFR 801.109)

5

DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System System:

Transducer: 7L4A

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	Note 1,2, 4,6,7
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	Note 1,2, 4,6,7
	Small Organ (Specify**)	P	P	P		P	P	P	Note 1,2, 4,6,7,8
	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)	P	P	P		P	P	P	Note 1,2, 4,6,7,8
	Musculo-skeletal
(Superficial)	P	P	P		P	P	P	Note 1,2, 4,6,7,8
	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, 4,6,7
	Other (Specify***)
N=new indication; P=previously cleared by FDA (K162845); 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
Note5: TDI
Note6: Color M
Note7: Biopsy Guidance
Note8: Elastography
Note9: Contrast imaging (Contrast agent for Liver)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription USE (Per 21 CFR 801.109)

6

DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System System:

Transducer: L7-3

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

Clinical Application						Mode of Operation
General	Specific	B	M	PWD	CWD	Color	Amplitude	Combined	Other
(Track 1 Only)	(Track 1 & 3)					Doppler	Doppler	(specify)	(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	P	Note 1,2, 4,6,7
	Small Organ (Specify**)	P	P	P		P	P	P	Note 1,2, 4,6,7
	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	P	P	P		P	P	P	Note 1,2, 4,6,7
	(Conventional)
	Musculo-skeletal	P	P	P		P	P	P	Note 1,2, 4,6,7
	(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 (K162845); 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.
	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
	Note5: TDI
	Note6: Color M
	Note7: Biopsy Guidance
	Note8: Elastography
	Note9: Contrast imaging (Contrast agent for Liver)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
	Prescription USE (Per 21 CFR 801.109)

7

DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System System:

D7-2E 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	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 (K162845); 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
	Note5: TDI
	Note6: Color M
	Note7: Biopsy Guidance
	Note8: Elastography
	Note9: Contrast imaging (Contrast agent for Liver)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription USE (Per 21 CFR 801.109)
Clinical Application					Mode of Operation
General	Specific	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other
(Specify)
(Track 1 Only)	(Track 1 & 3)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal
	Abdominal
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P	Note 1,2, 4,7
	Small Organ (Specify**)	P	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	P	Note 1,2, 4,7,8
	Musculo-skeletal
(Superficial)	P	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	P	Note 1,2, 4,7
	Other (Specify***)
	N=new indication; P=previously cleared by FDA (K162845); 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
	Note5: TDI
	Note6: Color M
	Note7: Biopsy Guidance
	Note8: Elastography
	Note9: Contrast imaging (Contrast agent for Liver)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription USE (Per 21 CFR 801.109)

8

DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System System:

Transducer: L14-6NE

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

9

DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System System:

V11-3 Transducer:

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

Clinical Application	Mode of Operation
		B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Combined (specify)	Other (Specify)
General
(Track 1 Only)	Specific
(Track 1 & 3)
Ophthalmic	Ophthalmic
Fetal Imaging & Other	Fetal	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
	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***)
	N=new indication; P=previously cleared by FDA (K162845);			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
	Note5: TDI
	Note6: Color M
	Note7: Biopsy Guidance
	Note8: Elastography
	Note9: Contrast imaging (Contrast agent for Liver)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
	Prescription USE (Per 21 CFR 801.109)

10

DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System System:

P4-2 Transducer:

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

| Clinical Application | Specific
(Track 1 & 3) | 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 | P | Note 1, 2,4,6,7 |
| | Intra-operative (Specify*) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (Specify**) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | P | P | P | P | P | P | P | Note 1, 2,4,6,7 |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal
(Conventional) | | | | | | | | |
| | Musculo-skeletal
(Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| Cardiac | Cardiac Adult | P | P | P | P | P | P | P | Note 1, 2,4,5,6,7 |
| | Cardiac Pediatric | P | P | P | P | P | P | P | Note 1, 2,4,5,6,7 |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| Peripheral
vessel | Intra-cardiac | | | | | | | | |
| | Peripheral vessel | | | | | | | | |
| | Other (Specify***) | | | | | | | | |
| Clinical Application | Mode of Operation | | | | | | | | |
| General
(Track 1 Only) | Specific
(Track 1 & 3) | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Combined
(specify) | Other
(Specify) |
| Ophthalmic
& Other | Ophthalmic | | | | | | | | |
| | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative (Specify*) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (Specify**) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | N | N | N | | N | N | N | Note 1, 2, 4,6,7 |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal
(Conventional) | | | | | | | | |
| | Musculo-skeletal
(Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Peripheral vessel | | | | | | | | |
| Peripheral
vessel | Other (Specify***) | N | N | N | | N | N | N | Note 1, 2, 4,6,7 |
| | N=new indication; P=previously cleared by FDA (K162845); | | | 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 | | | | | | | | |
| | Note5: TDI | | | | | | | | |
| | Note6: Color M | | | | | | | | |
| | Note7: Biopsy Guidance | | | | | | | | |
| | Note8: Elastography | | | | | | | | |
| | Note9: Contrast imaging (Contrast agent for Liver) | | | | | | | | |
| | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | | | | | | | | |
| | Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) | | | | | | | | |
| | Prescription USE (Per 21 CFR 801.109) | | | | | | | | |

11

DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System System:

Transducer: CB10-4E

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

12

DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System System:

Transducer: DE11-3E

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

Clinical Application	Mode of Operation
General	Specific	B	M	PWD	CWD	Color	Amplitude	Combined	Other
(Track 1 Only)	(Track 1 & 3)					Doppler	Doppler	(specify)	(Specify)
Ophthalmic	Ophthalmic
Fetal Imaging	Fetal	N	N	N		N	N	N	Note 1, 3, 4, 6,7
& Other	Abdominal
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	N	N	N		N	N	N	Note 1, 3, 4, 6,7
	Trans-vaginal	N	N	N		N	N	N	Note 1, 3, 4, 6,7
	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***)
	N=new indication; P=previously cleared by FDA (K162845);								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
	Note5: TDI
	Note6: Color M
	Note7: Biopsy Guidance
	Note8: Elastography
	Note9: Contrast imaging (Contrast agent for Liver)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
	Prescription USE (Per 21 CFR 801.109)
Clinical Application	Mode of Operation
General
(Track 1 Only)	Specific
(Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other
(Specify)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal
	Abdominal
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	N	N	N		N	N	N	Note 1, 2, 4,6,7
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel
	Other (Specify***)	N	N	N		N	N	N	Note 1, 2, 4,6,7
N=new indication; P=previously cleared by FDA (K162845); 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
Note5: TDI
Note6: Color M
Note7: Biopsy Guidance
Note8: Elastography
Note9: Contrast imaging (Contrast agent for Liver)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription USE (Per 21 CFR 801.109)

Clinical Application		Mode of Operation							Other
(Specify)
General
(Track 1 Only)	Specific
(Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal
	Abdominal	N	N	N	N	N	N	N	Note 1, 2, 4,7
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N	N	N	N	N	Note 1, 2, 4,7
	Small Organ (Specify**)	N	N	N	N	N	N	N	Note 1,2, 4,7, 8
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)	N	N	N	N	N	N	N	Note 1, 2, 4,7,8
	Musculo-skeletal
(Superficial)	N	N	N	N	N	N	N	Note 1, 2, 4,7,8
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac

Peripheral
vessel	Peripheral vessel	N	N	N	N	N	N	N	Note 1, 2, 4,7
	Other (Specify***)
	N=new indication; P=previously cleared by FDA (K162845); 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
	Note5: TDI
	Note6: Color M
	Note7: Biopsy Guidance
	Note8: Elastography
	Note9: Contrast imaging (Contrast agent for Liver)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
	Prescription USE (Per 21 CFR 801.109)
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	N	N	N	N	N	N	N	Note 1, 2, 4,7
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N	N	N	N	N	Note 1, 2, 4,7
	Small Organ (Specify**)	N	N	N	N	N	N	N	Note 1, 2, 4,7,8
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)	N	N	N	N	N	N	N	Note 1, 2, 4,7,8
	Musculo-skeletal
(Superficial)	N	N	N	N	N	N	N	Note 1, 2, 4,7,8
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel	N	N	N	N	N	N	N	Note 1, 2, 4,7
	Other (Specify***)
N=new indication; P=previously cleared by FDA (K162845); 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
Note5: TDI
Note6: Color M
Note7: Biopsy Guidance
Note8: Elastography
Note9: Contrast imaging (Contrast agent for Liver)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription USE (Per 21 CFR 801.109)

13

DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System System:

Transducer: 6LB7

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

14

DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System System:

Transducer: L13-3

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

15

DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System System:

Transducer: 7L4B

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

16

DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System System:

Transducer: C6-2

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

Clinical Application		Mode of Operation
General
(Track 1 Only)	Specific
(Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other
(specify)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal	N	N	N	N	N	N	N	Note 1, 2, 4,6,7
	Abdominal	N	N	N	N	N	N	N	Note 1, 2, 4,6,7,9
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N	N	N	N	N	Note 1, 2, 4,6,7
	Small Organ (Specify**)
	Neonatal Cephalic	N	N	N	N	N	N	N	Note 1, 2, 4,6,7
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)	N	N	N	N	N	N	N	Note 1, 2, 4,6,7
	Musculo-skeletal
(Superficial)
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel	N	N	N	N	N	N	N	Note 1, 2, 4,6,7
	Other (Specify***)
	N=new indication; P=previously cleared by FDA (K162845); 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
	Note5: TDI
	Note6: Color M
	Note7: Biopsy Guidance
	Note8: Elastography
	Note9: Contrast imaging (Contrast agent for Liver)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
	Prescription USE (Per 21 CFR 801.109)

17

| Specific
Amplitude
Color
Combined
Other
CWD
B
M
PWD
(Track 1 & 3)
(specify)
Doppler
Doppler
(specify)
Ophthalmic
Fetal Imaging
Fetal
N
N
N
N
Note 1, 3, 4, 6
N
N
Abdominal
N
N
N
N
Note 1, 3, 4, 6
N
N
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
Other (Specify***)
vessel
N=new indication; P=previously cleared by FDA (K162845); 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
Note5: TDI
Note6: Color M
Note7: Biopsy Guidance
Note8: Elastography
Note9: Contrast imaging (Contrast agent for Liver)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription USE (Per 21 CFR 801.109) | 1110/1000 USD.
Clinical Application | Diagnostic attrasound maging of thats from and your and hamdn over as 1010WS. | | | Mode of Operation | | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | ----------------------------------------|-------------------------------------------------------------------------------|--|--|-------------------|--|--|
| General | | | | | | |
| (Track 1 Only) | | | | | | |
| Ophthalmic | | | | | | |
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| & Other | | | | | | |
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Transducer:

Intended Use: D7-2 Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

System:

DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System

18

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	N	N	N	N	N	N	N	Note 1, 2,4,6
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N	N	N	N	N	Note 1, 2,4,6
	Small Organ (Specify**)
	Neonatal Cephalic	N	N	N	N	N	N	N	Note 1, 2,4,6
	Adult Cephalic	N	N	N	N	N	N	N	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	N	N	N	N	N	N	N	Note 1, 2,4,5,6
	Cardiac Pediatric	N	N	N	N	N	N	N	Note 1, 2,4,5,6
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel
	Other (Specify***)

Transducer:

Intended Use: P10-4E Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

System:

DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System

19

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 8807.92(c).

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: +86 755 8188 6293 Fax: +86 755 2658 2680

Contact Person:

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

Date Prepared: November 28, 2018

2. Device Name:

DC-40/DC-35/DC-45/DC-40S/DC-40 Pro 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:

The DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound images in B-Mode, M-Mode, PW-Mode, CW-mode, Color-Mode, Power/Dirpower mode, THI Mode, 3D/4D Mode, iScape mode, TDI mode, Color M mode, Biospy Guidance, Elastography, Contrast imaging (Liver) or the combined mode (i.e. B/M-Mode, B/PW-mode, B/PW/Color). This

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system is a Track 3 device that employs an array of probes that include linear array, Phased array and convex array.

4. Intended Use:

The DC-40/DC-35/DC-45/DC-40S/DC-40 Pro 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), musculo- skeletal(superficial), cardiac adult, cardiac pediatric, peripheral vessel and urology exams.

5. Summary of Modifications and New Added Features

This submission device is a modifications to DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System previously cleared in K162845. The following is a brief overview of the modifications and new added features:

New added transducers ■ DE11-3E, 6LB7, L13-3, 7L4B, C6-2, D7-2, CB10-4E, P10-4E
New added needle-guided brackets ■ NGB-009, NGB-022, NGB-027

. New added features

Add Contrast imaging (contrast agent for Liver) Add the musculo-skeletal elastography function to transducers 7L4A、L14-6NE Smart Volume Smart FLC Smart Face Face+ ( subfunction of Smart Face) optional DVD recorder The other changes

. Change the size of LCD monitor Increase the MP4 format in the exported format list

6. Comparison with Predicate Devices:

The modified DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System is comparable with and substantially equivalent to these predicate devices:

	Predicate Device	Manufacturer	Model	510(k) Number
1.	Primary predicate	Mindray	DC-40	K162845

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device
2. Reference device	Mindray	M6	K171579
3. Reference device	Mindray	DC-7	K103583
4. Reference device	Mindray	Resona 7	K171233
5. Reference device	Mindray	DC-70	K163690
6. Reference device	Mindray	Z6	K122010

The modified DC-40/DC-35/DC-45/DC-40S/DC-40 Pro 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-40/DC-35/DC-45/DC- 40S/DC- 40 Pro has the same intended uses as the predicated device DC-40 (K162845).

| Items | Subject Device
DC-40/DC-35/DC-45/DC-40
S/DC-40 Pro | Predicate device
DC-40(K162845) |
|-----------------|----------------------------------------------------------|------------------------------------|
| Intended
Use | The DC-40/DC-35/DC-45/DC- | The DC-40/DC-35/DC-45/DC- |
| | 40S/DC- 40 Pro Diagnostic | 40S/DC- 40 Pro Diagnostic |
| | Ultrasound System is applicable | Ultrasound System is applicable |
| | for adults, pregnant women, | for adults, pregnant women, |
| | pediatric patients and neonates. | pediatric patients and neonates. |
| | It is intended for use in | It is intended for use in |
| | fetal, | fetal, |
| | abdominal, | abdominal, |
| | pediatric, | pediatric, |
| | small organ(breast, thyroid, | small organ(breast, thyroid, |
| | testes), | testes), |
| | neonatal cephalic, | neonatal cephalic, |
| | adult cephalic, | adult cephalic, |
| | trans-rectal, | trans-rectal, |
| | trans-vaginal, | trans-vaginal, |

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| musculo-skeletal (conventional),
musculo- skeletal(superficial),
cardiac adult, | musculo-skeletal (conventional),
musculo- skeletal(superficial),
cardiac adult, |
|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| cardiac pediatric,
peripheral vessel | cardiac pediatric
and peripheral vessel exams. |
| and urology exams. | urology exam |
| | M6 (K171579) |

The patient contact materials of the new added transducers and needle-guided brackets are tested under ISO 10993-1.
The acoustic power levels of modified DC-40/DC-35/DC-45/DC- 40S/DC- 40 Pro are below the limits of FDA, which are the same as the predicated device DC-40 (K162845).
The modified DC-40/DC-35/DC-45/DC- 40S/DC- 40 Pro is designed in compliance with the FDA recognized electrical and physical safety standards, which are the same as the predicated device DC-40 (K162845).
The modified DC-40/DC-35/DC-45/DC- 40S/DC- 40 Pro has the same imaging modes as the predicated devices.
The new added features of modified DC-40/DC-35/DC-45/DC- 40S/DC- 40 Pro are the same as the predicate devices.
The modified DC-40/DC-35/DC-45/DC- 40S/DC- 40 Pro has similar transducers with the predicate devices.

7. Non-clinical Tests:

DC-40/DC-35/DC-45/DC- 40S/DC- 40 Pro 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:

. ANSI/AAMI ES60601-1 :2005/(R)2012 and A1:2012: Medical electrical equipment
- Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2 Edition 4.0 2014-02: Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests

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. IEC 60601-2-37 Edition 2.1 2015: Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
. IEC 62304 Edition 1.1 2015-06: Medical device software - Software life cycle processes
IEC 62366-1 Edition 1.0 2015-02: Medical devices application of usability ■ engineering to medical devices
. IEC 60601-1-6 Edition 3.1 2013-10: Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability.
ISO 14971 Second edition 2007-03-01: Medical devices Application of risk management to medical devices
NEMA UD 2-2004 (R2009): Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3
ISO 10993-1 Fourth edition 2009-10-15: Biological evaluation of medical devices --Part 1: Evaluation and testing within a risk management process, Fourth edition These non-clinical tests relied on in this premarket notification submission can support the determination of substantial equivalence of the subject device.

8. Clinical Tests:

Not applicable. The subject of this submission, DC-40/DC-35/DC-45/DC-45/DC- 40 Pro Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence.

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-40/DC-35/DC-45/DC- 40S/DC- 40 Pro Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.