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

• K Number: K162845
• Device Name: DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System
• Manufacturer: SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD
• Date Cleared: 2016-12-15 ( 65 days)
• Product Code: IYN ITX IYO
• Regulation Number: 892.1550

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(supertional), musculo-skeletal(superficial), cardiac adult, cardiac pediatric and peripheral vessel exams.

Device Description

DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-mode, PW-mode, PW-mode, CW mode, Color-mode, Power/Dirpower mode, THI mode, 3D/4D mode, iScape mode, TDI mode, Color M mode, Biopsy Guidance, Elastography, or the combined mode (i.e. B/M-Mode). This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array with a frequency range of approximately 3 MHz to 10.0MHz.

Predicate Devices

K140030, K152545, K162267

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The 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 typically associated with AI/ML development.

Therapeutic

No
The "Intended Use / Indications for Use" section explicitly states that the device is a "diagnostic ultrasound system," and the "Device Description" section reiterates that it is a "diagnostic system." There is no mention of therapeutic use.

Diagnostic

Yes
The "Intended Use / Indications for Use" and "Device Description" sections explicitly state that the device is a "diagnostic ultrasound system" and "ultrasound diagnostic system" respectively.

SaMD (Software as a Medical Device)

No

The device is described as a "diagnostic ultrasound system" which is a hardware device that is "software controlled". It also mentions employing "an array of probes" which are hardware components.

IVD (In Vitro Diagnostic)

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

Here's why:

• IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
• Device Function: The description clearly states that this is a "Diagnostic Ultrasound System." Ultrasound systems use sound waves to create images of internal body structures. They do not analyze samples taken from the body.
• Intended Use: The intended uses listed are all related to imaging various parts of the body (fetal, abdominal, cardiac, etc.) using ultrasound technology.
• Device Description: The description details the different ultrasound modes (B-mode, Color-mode, etc.) and the types of probes used, all of which are characteristic of an ultrasound imaging system.

The information provided consistently points to this device being an in vivo diagnostic imaging system, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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(supertional), musculo-skeletal(superficial), cardiac adult, cardiac pediatric and peripheral vessel exams.

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

IYN, IYO, ITX

Device Description

DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-mode, PW-mode, PW-mode, CW mode, Color-mode, Power/Dirpower mode, THI mode, 3D/4D mode, iScape mode, TDI mode, Color M mode, Biopsy Guidance, Elastography, or the combined mode (i.e. B/M-Mode). This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array with a frequency range of approximately 3 MHz to 10.0MHz.

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 were performed.
The acoustic power levels of the 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-N3 (K140030).
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-N3 (K140030).
The DC-40/DC-35/DC-45/DC-40S/DC-40 Pro has the same imaging modes as the predicated devices.
All of the functions of DC-40/DC-35/DC-45/DC-40S/DC-40 Pro are the same as the predicated devices.
The DC-40/DC-35/DC-45/DC-40S/DC-40 Pro has same tranducers with the predicated devices.
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-40S/DC-40 Pro Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

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.

K140030, K152545, K162267

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.

Not Found

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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird with three human profiles incorporated into its design.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 15, 2016

Shenzhen Mindray Bio-Medical Electronics Co., Ltd. % Zhai Pei Engineer of Technical Regulation Department Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan Shenzhen, Guangdong 518057 CHINA

Re: K162845

Trade/Device Name: DC-40/DC-35/DC-45/DC-40 Pro Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: September 28, 2016 Received: October 11, 2016

Dear Zhai Pei:

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

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

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

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forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael D'Hara

For

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

Enclosure

2

Indications for Use

510(k) Number (if known)

K162845

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-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(supertional), musculo-skeletal(superficial), cardiac adult, cardiac pediatric and peripheral vessel exams.

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

V Prescription Use (Part 21 CFR 801 Subpart D)

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

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	Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:
	Clinical Application	Mode of Operation
General
(Track 1)	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, 2,3, 4,6
	Abdominal	N	N	N	N	N	N	N	Note 1, 2,3, 4,6
	Intra-operative
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	N	N	Note 1, 2, 4,6,7
	Small Organ	N	N	N		N	N	N	Note 1,2, 4,6,7
	Neonatal Cephalic	N	N	N		N	N	N	Note 1, 2, 4,6,7
Fetal Imaging
& Other	Adult Cephalic	N	N	N	N	N	N	N	Note 1, 2,4,6,
	Trans-rectal	N	N	N		N	N	N	Note 1, 2, 4,6,
	Trans-vaginal	N	N	N		N	N	N	Note 1, 2, 4,6,
	Trans-urethral
	Trans-esoph. (non-
	Musculo-skeletal
(Conventional)	N	N	N		N	N	N	Note 1, 2, 4,6,7
	Musculo-skeletal
(Superficial)	N	N	N		N	N	N	Note 1,2, 4,6,7
	Intravascular
	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,
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 +1
	*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
Clinical Application		Mode of Operation
General
(Track 1	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	N	Note 1, 2, 4,6,7
	Abdominal	N	N	N	N	N	N	N	Note 1, 2, 4,6,7
	Intra-operative
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N	N	N	N	N	Note 1, 2, 4,6,7
	Small Organ
	Neonatal Cephalic	N	N	N	N	N	N	N	Note 1, 2, 4,6,7
Fetal Imaging
& Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-
	Musculo-skeletal
(Conventional)	N	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	N	Note 1, 2, 4,6,7
	Other (Specify***)
	N=new indication; P=previously cleared by FDA; E=added under Appendix E
	Additional comments: Combined modes--B+M, PW+B, Color + B, Power + B, PW +Color+ B,Power + PW +B
	*Intraoperative includes abdominal, thoracic, and vascular
**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
Note 4: iScape
	Note5: TDI
	Note6: Color M
	Note7: Biopsy Guidance
	Note8: Elastography
	(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		Mode of Operation
General
(Track 1	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	N	N	N		N	N	N	Note 1,2, 4,6,7
	Intra-operative
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	N	N	Note 1,2, 4,6,7
	Small Organ	N	N	N		N	N	N	Note 1,2, 4,6,7,8
	Neonatal Cephalic	N	N	N		N	N	N	Note 1,2, 4,6,7
Fetal Imaging
& Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.
(non-
	Musculo-skeletal
(Conventional)	N	N	N		N	N	N	Note 1,2, 4,6,7
	Musculo-skeletal
(Superficial)	N	N	N		N	N	N	Note 1,2, 4,6,7
	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. 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
(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		Mode of Operation
General
(Track 1	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	N	N	N	N	N	N	N	Note 1,2, 4,6,7
	Intra-operative
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N	N	N	N	N	Note 1,2, 4,6,7
	Small Organ	N	N	N	N	N	N	N	Note 1,2, 4,6,7
	Neonatal Cephalic	N	N	N	N	N	N	N	Note 1,2, 4,6,7
Fetal Imaging
& Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-
	Musculo-skeletal
(Conventional)	N	N	N	N	N	N	N	Note 1,2, 4,6,7
	Musculo-skeletal
(Superficial)	N	N	N	N	N	N	N	Note 1,2, 4,6,7
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	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; 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
(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		Mode of Operation
General
(Track 1	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Dopple	Amplitude
Doppler	Combined	Other (specify)
Ophthalmic	Ophthalmic
	Fetal	N	N	N		N	N	N	Note 1, 3, 4, 6
	Abdominal	N	N	N		N	N	N	Note 1, 3, 4, 6
	Intra-operative
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
Fetal Imaging
& Other	Small Organ
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-
	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. 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
	(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		Mode of Operation
General
(Track 1	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Dopple	Amplitude
Doppler	Combined	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	N	N	Note 1,2, 4,7
	Small Organ	N	N	N		N	N	N	Note 1,2, 4,7,8
	Neonatal Cephalic
Fetal Imaging
& Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-
	Musculo-skeletal
(Conventional)	N	N	N		N	N	N	Note 1,2, 4,7
	Musculo-skeletal
(Superficial)	N	N	N		N	N	N	Note 1,2, 4,7
	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, 4,7
	Other (Specify***)
	N=new indication; P=previously cleared by FDA; E=added under Appendix E
	Additional comments: Combined modes--B+M, PW+B, Color + B, Power + B, PW +Color+ B,Power + PW +B
	*Intraoperative includes abdominal, thoracic, and vascular
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note5: TDI
	Note6: Color M
	Note7: Biopsy Guidance
	Note8: Elastography
	(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		Mode of Operation
General
(Track 1	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined	Other (specify)
Ophthalmic	Ophthalmic
	Fetal	N	N	N		N	N	N	Note 1, 2, 4,6,7
	Abdominal
	Intra-operative
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ
	Neonatal Cephalic
Fetal Imaging
& Other	Adult Cephalic
	Trans-rectal	N	N	N		N	N	N	Note 1, 2, 4,6,7
	Trans-vaginal	N	N	N		N	N	N	Note 1, 2, 4,6,7
	Trans-urethral
	Trans-esoph. (non-
Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Peripheral vessel
	Other (Specify***)
	N=new indication; P=previously cleared by FDA; E=added under Appendix E
	Additional comments: Combined modes--B+M, PW+B, Color + B, Power + B, PW +Color+ B,Power + PW +B
	*Intraoperative includes abdominal, thoracic, and vascular
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Smart3D
Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note5: TDI
	Note6: Color M
	Note7: Biopsy Guidance
	Note8: Elastography
	(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:

Transducer:

N/A

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)

Note7: Biopsy Guidance Note8: Elastography

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3C5A Transducer:

5

Transducer: 7L4A

6

Transducer: L7-3

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

7

Transducer: D7-2E

8

Transducer: L14-6NE

9

Transducer: V11-3

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System:	DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System
Transducer:	P4-2

	Clinical Application	Mode of Operation
General
(Track 1	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Dopple	Amplitude
Doppler	Combined	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	N	N	N	N	N	N	N	Note 1, 2,4,6,7
	Intra-operative
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ
	Neonatal Cephalic
Fetal Imaging
& Other	Adult Cephalic	N	N	N	N	N	N	N	Note 1, 2,4,6,7
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Cardiac Adult	N	N	N	N	N	N	N	Note 1, 2,4,5,6,7
	Cardiac Pediatric	N	N	N	N	N	N	N	Note 1, 2,4,5,6,7
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel
	Other (Specify***)

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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: _____________________

1. Submitter:

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

Tel: [phone] Fax: [phone]

Contact Person:

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

September 28, 2016 Date Prepared:

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:

DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-mode, PW-mode, PW-mode, CW mode, Color-mode, Power/Dirpower mode, THI mode, 3D/4D mode, iScape mode, TDI mode,

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Color M mode, Biopsy Guidance, Elastography, or the combined mode (i.e. B/M-Mode). This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array with a frequency range of approximately 3 MHz to 10.0MHz.

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 and peripheral vessel exams.

5. Comparison with Predicate Devices:

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	Mindray	DC-N3	K140030
2	Mindray	DC-60	K152545
3	Mindray	Resona 7	K162267

The modified DC-40/DC-35/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-N3 (K140030).

| Items | Subject Device
DC-40/DC-35/DC-45/DC-40S/DC-40
Pro | Predicate device
DC-N3 (K140030) |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Intended
Use | DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System
is applicable for adults, pregnant women, pediatric patients and
neonates. | The DC-N3 diagnostic ultrasound system is applicable for adults, pregnant women, pediatric patients and neonates. |

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| 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
and peripheral vessel exams. | 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. |

----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

• . The patient contact materials of the transducers are tested under ISO 10993-1.
  . The acoustic power levels of the 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-N3 (K140030).

• 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-N3 (K140030).

• The DC-40/DC-35/DC-45/DC-40S/DC-40 Pro has the same imaging modes as the predicated devices.

• All of the functions of DC-40/DC-35/DC-45/DC-40S/DC-40 Pro are the same as the predicated devices.

• I The DC-40/DC-35/DC-45/DC-40S/DC-40 Pro has same tranducers with the predicated devices.

6. 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 designed 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:

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• 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
• 1 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.

7. Clinical Studies

Not applicable. The subject of this submission, DC-40/DC-35/DC-45/DC-40S/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-40S/DC-40 Pro Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.