Predicate Devices

Reference Devices

K182603, K171233, K132779, K090912, K140030

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary does not mention AI, ML, or any related terms, and the device description focuses on standard ultrasound imaging modes and features.

Therapeutic

No.
The device is described as a "Digital Ultrasonic Diagnostic Imaging System," and its function is to "acquire and display ultrasound data," indicating a diagnostic rather than therapeutic purpose.

Diagnostic

Yes.

The device's name explicitly states "Digital Ultrasonic Diagnostic Imaging System" and its intended use is for "diagnostic imaging."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "Digital Ultrasonic Diagnostic Imaging System" and employs "an array of probes that include Linear array, Convex array probe," indicating it includes hardware components for image acquisition.

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. This testing is done outside of the body.
Device Function: The DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System is an ultrasonic imaging system. It uses sound waves to create images of internal structures within the body.
Intended Use: The intended use clearly describes imaging various anatomical sites within the body (fetal, abdominal, cardiac, etc.). It does not mention analyzing samples taken from the body.

Therefore, this device falls under the category of medical imaging devices, not In Vitro Diagnostic devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, Intra-operative (abdominal, thoracic, and vascular),pediatric, small organ(breast, thyroid, testes, etc.), neonatal and adult cephalic, transvaginal, musculo-skeletal(conventional, superficial), cardiac(adult, pediatric), peripheral vascular . The system is designed to be used by a trained operator in a clinical setting.

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

IYN, IYO, ITX

Device Description

The DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System is a general purpose, portable, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, PW-Mode, Color-Mode, Power/Dirpower Mode, THI, Smart3D, 4D, iScape, Biopsy Guidance 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 probe.

The software of DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System is based on the main predicate DP-50, and it has a Moderate level of concern.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal, abdominal, Intra-operative (abdominal, thoracic, and vascular), pediatric, small organ (breast, thyroid, testes, etc.), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), cardiac (adult, pediatric), peripheral vascular, Urology

Indicated Patient Age Range

adults, pregnant women, pediatric patients and neonates

Intended User / Care Setting

A trained operator in a clinical setting.

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 conducted for acoustic output, biocompatibility, cleaning and disinfection effectiveness, thermal, electrical and mechanical safety. The device was designed to conform with applicable medical safety standards: AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, IEC 62366, IEC 60601-1-6, ISO14971, and ISO 10993-1. Clinical studies were not required. The overall conclusion states that the device is substantially equivalent to currently cleared devices with respect to safety and effectiveness.

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.

K111435

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.

K182603, K171233, K132779, K090912, K140030

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

Not Found

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.

Summary

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 28, 2020

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

Re: K200979

Trade/Device Name: DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: April 3, 2020 Received: April 13, 2020

Dear Shi Jufang:

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

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

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

1

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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K200979

Device Name

DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System

Indications for Use (Describe)

DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, Intra-operative (abdominal, thoracic, and vascular),pediatric, small organ(breast, thyroid, testes, etc.), neonatal and adult cephalic, transvaginal, musculo-skeletal(conventional, superficial), cardiac(adult, pediatric), peripheral vascular . The system is designed to be used by a trained operator in a clinical setting.

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

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3

Digital Ultrasonic Diagnostic Imaging System Indications For Use Format
System:	DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System
Transducer:	N/A
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application	Specific (Track 1 & 3)	Mode of Operation					Combined (specify)	Other (Specify)
General
(Track 1 Only)		B	M	PWD	CWD	Color Doppler			Amplitude Doppler
Ophthalmic	Ophthalmic
Fetal Imaging &
Other	Fetal	P	P	N	N	N	N	P	Note 1,2,6,7
	Abdominal	P	P	N	N	N	N	P	Note 1,2,3,6,7
	Intra-operative (Specify*)	N	N	N	N	N	N	N	Note 1,2,3,6
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	N	N	N	N	P	Note 1,2,3,6
	Small Organ (Specify**)	P	P	N	N	N	N	P	Note 1,2,3,6
	Neonatal Cephalic	P	P	N	N	N	N	P	Note 1,2,3,6
	Adult Cephalic	P	P	N	N	N	N	P	Note 1,2,6
	Trans-rectal	P	P	N	N	N	N	P	Note 1,2,6
	Trans-vaginal	P	P	N	N	N	N	P	Note 1,2,6
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)	P	P	N	N	N	N	P	Note 1,2,3,6
	Musculo-skeletal (Superficial)	P	P	N	N	N	N	P	Note 1,2,3,6
	Intravascular
Cardiac	Cardiac Adult	N	N	N	N	N	N	N	Note 1,2,6
	Cardiac Pediatric	P	P	N	N	N	N	P	Note 1,2,6
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral vessel	Peripheral vessel	P	P	N	N	N	N	P	Note 1,2,3,6
	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: Biopsy Guidance
	Note 3: iScape
	Note 4: TDI
	Note 5: Color M
	Note 6: Smart3D
	Note 7:4D(Real-time 3D)
	(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

Digital Ultrasonic Diagnostic Imaging System Indications For Use Format
System:	DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System
Transducer:	35C50EA
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
	Ophthalmic	Ophthalmic
Fetal Imaging & Other	Fetal			P	P	N		N	N	P	Note 1,2,6
	Abdominal			P	P	N		N	N	P	Note 1,2,6
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric			P	P	N		N	N	P	Note 1,2,6
	Small Organ (Specify**)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)			P	P	N		N	N	P	Note 1,2,6
	Musculo-skeletal (Superficial)
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac

Peripheral vessel	Peripheral vessel			P	P	N		N	N	P	Note 1,2,6
	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: Biopsy Guidance
	Note 3: iScape
	Note 4: TDI
	Note 5: Color M
	Note 6: Smart3D
	Note 7:4D(Real-time 3D)
	(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)
Digital Ultrasonic Diagnostic Imaging System Indications For Use Format
System:	DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System
Transducer:	65EC10EA
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)					Color	Amplitude	Combined
Only)		B	M	PWD	CWD	Doppler	Doppler	(specify)	Other (Specify)
Ophthalmic	Ophthalmic
Fetal Imaging &	Fetal	P	P	N		N	N	P	Note 1,2,6
Other	Abdominal
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	N		N	N	P	Note 1,2,6
	Trans-vaginal	P	P	N		N	N	P	Note 1,2,6
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral vessel	Peripheral vessel
	Other (Specify***)
	N=new indication; P=previously cleared by FDA;
E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power + PW +B.
	*Intraoperative includes abdominal, thoracic, and vascular.
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging.
Note 2: Biopsy Guidance
Note 3: iScape
Note 4: TDI
	Note 5: Color M
	Note 6: Smart3D
	Note 7:4D(Real-time 3D)
(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)
Digital Ultrasonic Diagnostic Imaging System Indications For Use Format
System:	DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System
Transducer:	75L38EA
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application	Mode of Operation
General (Track 1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Combined (specify)	Other (Specify)
Ophthalmic	Ophthalmic
Fetal Imaging & Other	Fetal
	Abdominal	P	P	N		N	N	P	Note 1,2,3,6
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	N		N	N	P	Note 1,2,3,6
	Small Organ (Specify**)	P	P	N		N	N	P	Note 1,2,3,6
	Neonatal Cephalic	P	P	N		N	N	P	Note 1,2,3,6
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)	P	P	N		N	N	P	Note 1,2,3,6
	Musculo-skeletal (Superficial)	P	P	N		N	N	P	Note 1,2,3,6
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral vessel	Peripheral vessel	P	P	N		N	N	P	Note 1,2,3,6
	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: Biopsy Guidance
Note 3: iScape
	Note 4: TDI
	Note 5: Color M
	Note 6: Smart3D
Note 7:4D(Real-time 3D)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

5

6

7

Digital Ultrasonic Diagnostic Imaging System Indications For Use Format
System:	DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System
Transducer:	65C15EA
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application	Mode of Operation
General (Track
1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (Specify)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal
	Abdominal	P	P	N		N	N	P	Note 1,2,6
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	N		N	N	P	Note 1,2,6
	Small Organ (Specify**)
	Neonatal Cephalic	P	P	N		N	N	P	Note 1,2,6
	Adult Cephalic	P	P	N		N	N	P	Note 1,2,6
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric	P	P	N		N	N	P	Note 1,2,6
	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: Biopsy Guidance
Note 3: iScape
	Note 4: TDI
	Note 5: Color M
	Note 6: Smart3D
	Note 7:4D(Real-time 3D)
(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)
Digital Ultrasonic Diagnostic Imaging System Indications For Use Format
System:	DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System
Transducer:	35C20EA
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application	Specific (Track 1 & 3)	Mode of Operation						Other (Specify)
		B	M	PWD	CWD	Color Doppler	Amplitude Doppler		Combined (specify)
Ophthalmic	Ophthalmic
Fetal Imaging & Other	Fetal
	Abdominal	N	N	N		N	N	N	Note 1,2,6
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	N	N	Note 1,2,6
	Small Organ (Specify**)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
Cardiac	Cardiac Adult	N	N	N		N	N	N	Note 1,2,6
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral vessel	Peripheral vessel
	Other (Specify***)
	N=new indication; P=previously cleared by FDA; E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power + PW +B.
	*Intraoperative includes abdominal, thoracic, and vascular.
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging.
	Note 2: Biopsy Guidance
	Note 3: iScape
	Note 4: TDI
	Note 5: Color M
	Note 6: Smart3D
	Note 7:4D(Real-time 3D)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Digital Ultrasonic Diagnostic Imaging System Indications For Use Format
System:	DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System
Transducer:	10L24EA
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application	Mode of Operation
General (Track
1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (Specify)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal
	Abdominal	P	P	N		N	N	P	Note 1,2,3,6
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	N		N	N	P	Note 1,2,3,6
	Small Organ (Specify**)	P	P	N		N	N	P	Note 1,2,3,6
	Neonatal Cephalic	P	P	N		N	N	P	Note 1,2,3,6
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)	P	P	N		N	N	P	Note 1,2,3,6
	Musculo-skeletal (Superficial)	P	P	N		N	N	P	Note 1,2,3,6
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel	P	P	N		N	N	P	Note 1,2,3,6
	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: Biopsy Guidance
	Note 3: iScape
	Note 4: TDI
	Note 5: Color M
	Note 6: Smart3D
	Note 7:4D(Real-time 3D)
	(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)
Digital Ultrasonic Diagnostic Imaging System Indications For Use Format
System:	DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System
Transducer:	65EB10EA
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application				Mode of Operation
General (Track	Specific (Track 1 & 3)					Color	Amplitude	Combined
1 Only)		B	M	PWD	CWD	Doppler	Doppler	(specify)	Other (Specify)
Ophthalmic	Ophthalmic
Fetal Imaging & Other	Fetal
	Abdominal
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	N		N	N	P	Note 1,2,6
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral vessel	Peripheral vessel
	Other (Specify***)
	N=new indication; P=previously cleared by FDA;			E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power + PW +B.
	*Intraoperative includes abdominal, thoracic, and vascular.
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging.
	Note 2: Biopsy Guidance
Note 3: iScape
	Note 4: TDI
	Note 5: Color M
Note 6: Smart3D
	Note 7:4D(Real-time 3D)
	(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)
Digital Ultrasonic Diagnostic Imaging System Indications For Use Format
System:	DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System
Transducer:	65EC10ED
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application	Mode of Operation
General (Track 1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Combined (specify)	Other (Specify)
Ophthalmic	Ophthalmic
Fetal Imaging & Other	Fetal	N	N	N		N	N	N	Note 1,2,6
	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 1,2,6
	Trans-vaginal	N	N	N		N	N	N	Note 1,2,6
	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
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: Biopsy Guidance
	Note 3: iScape
	Note 4: TDI
	Note 5: Color M
	Note 6: Smart3D
	Note 7:4D(Real-time 3D)
	(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)
Digital Ultrasonic Diagnostic Imaging System Indications For Use Format
System:	DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System
Transducer:	75LT38EA
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	N	N	N		N	N	N	Note 1,2,3,6
	Intra-operative (Specify*)	N	N	N		N	N	N	Note 1,2,3,6
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	N	N	Note 1,2,3,6
	Small Organ (Specify**)	N	N	N		N	N	N	Note 1,2,3,6
	Neonatal Cephalic	N	N	N		N	N	N	Note 1,2,3,6
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)	N	N	N		N	N	N	Note 1,2,3,6
	Musculo-skeletal (Superficial)	N	N	N		N	N	N	Note 1,2,3,6
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac

Peripheral vessel	Peripheral vessel	N	N	N		N	N	N	Note 1,2,3,6
	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: Biopsy Guidance
Note 3: iScape
Note 4: TDI
Note 5: Color M
Note 6: Smart3D
Note 7:4D(Real-time 3D)
(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)
Digital Ultrasonic Diagnostic Imaging System Indications For Use Format
System:	DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System
Transducer:	75L53EA
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)
Ophthalmic	Ophthalmic
Fetal Imaging & Other	Fetal
	Abdominal	P	P	N		N	N	P	Note 1,2,3,6
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	N		N	N	P	Note 1,2,3,6
	Small Organ (Specify**)	P	P	N		N	N	P	Note 1,2,3,6
	Neonatal Cephalic	P	P	N		N	N	P	Note 1,2,3,6
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)	P	P	N		N	N	P	Note 1,2,3,6
	Musculo-skeletal (Superficial)	P	P	N		N	N	P	Note 1,2,3,6
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral vessel	Peripheral vessel	P	P	N		N	N	P	Note 1,2,3,6
	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: Biopsy Guidance
	Note 3: iScape
	Note 4: TDI
	Note 5: Color M
	Note 6: Smart3D
	Note 7:4D(Real-time 3D)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Digital Ultrasonic Diagnostic Imaging System Indications For Use Format
System:	DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System
Transducer:	D6-2EA
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application	Mode of Operation
General (Track
1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (Specify)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal	N	N	N		N	N	N	Note 1,2,7
	Abdominal	N	N	N		N	N	N	Note 1,2,7
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel
	Other (Specify***)
	N=new indication; P=previously cleared by FDA;					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: Biopsy Guidance
	Note 3: iScape
	Note 4: TDI
	Note 5: Color M
	Note 6: Smart3D
	Note 7:4D(Real-time 3D)
	(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

9

10

11

12

13

14

15

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).

K200979 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: +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: April 3, 2020

Device Name: DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging 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)

Page 1 of 21

16

3. Main Predicate Device: DP-50 Digital Ultrasonic Diagnostic Imaging System Classification

Regulatory Class: II Review Category: Tier II 21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System (IYO) 21 CFR 892.1570 Diagnostic Ultrasound Transducer (ITX)

4. Device Description:

The DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System is a general purpose, portable, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, PW-Mode, Color-Mode, Power/Dirpower Mode, THI, Smart3D, 4D, iScape, Biopsy Guidance 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 probe.

The software of DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System is based on the main predicate DP-50, and it has a Moderate level of concern.

5. Indications for Use:

The DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, Intra-operative (abdominal, thoracic, and vascular), pediatric, small organ (breast, thyroid, testes, etc.), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), cardiac(adult, pediatric), peripheral vascular. The system is designed to be used by a trained operator in a clinical setting.

6. Summary of Modifications

Page 2 of 21

17

Newly Added Models: . DP-50T,DP-50Expert,DP-50S,DP-50Pro;
Newly Added Transducers: D6-2EA,65EC10ED,35C20EA,75LT38EA;
Newly Added Needle-guided Brackets: NGB-003,NGB-010;
Main Added Features and Modifications: ●
- 1. Appearance change;
- 1. Add PW mode to all transducers;
- 1. Add Color mode to all transducers;
- 1. Add Power mode to all transducers;
- 1. Add 4D and Smart 3D;
- 1. Add Free Xros M;
- 1. Add iScape View;
- 1. Add iLive;
- 1. Add iWorks;
- 1. Add Smart Face;
- 1. Add Smart OB;
- 1. Add Smart Bladder;
- 1. Add iNeedle;
- 1. Add iPage;
- 1. Add HPRF;
- 1. Add mobile trolley UMT-160 and UMT-170;
- 1. Change the probe board;
- 1. Add function of transducer element check.

7. Comparison with Predicate Devices:

The DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System is comparable with and substantially equivalent to these predicate devices:

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

18

1. Primary predicate device	Mindray	DP-50	K111435
2. Reference device	Mindray	Z6	K182603
3. Reference device	Mindray	Resona 7	K171233
4. Reference device	Mindray	DC-N2	K132779
5. Reference device	Mindray	DP-6900	K090912
6. Reference device	Mindray	DC-N3	K140030

Below is comparative tables of new added special functions: >

| Items | Subject Device
DP-50/DP-50T/DP-50Expert/DP-50
S/DP-50Pro | Predicate Device
Resona 7 (K171233) | S/
D |
|-------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| 4D | The probe performs the scanning
automatically. During the scanning,
the system renders 3D images in real
time, and all 3D images are displayed
in real time. | The probe performs the scanning
automatically. During the scanning,
the system renders 3D images in real
time,and all 3D images are displayed
in real time. | S |
| Conclusion | These two devices both provide 4D function. The technological characteristics of
the 4D function are the same. So they are substantial equivalent. | | |
| Smart 3D | The operator manually moves the
probe to changes its position/angle
when performing the scanning, the
system carries out image rendering
automatically, and then displays a
frame of 3D image. | The operator manually moves the
probe to changes its position/angle
when performing the scanning, the
system carries out image rendering
automatically, and then displays a
frame of 3D image. | S |
| Conclusion | These two devices both provide Smart 3D function. The technological
characteristics of the Smart 3D function are the same. So they are substantial
equivalent. | | |
| Free Xros M | In the Anatomical M mode, you can
manipulate the M-mark line to move
to any position at desired angles. The
system supports anatomical M
scanning in 2D imaging modes(B,
Color, Power mode) | In the Anatomical M mode, you can
manipulate the M-mark line to move
to any position at desired angles. The
system supports anatomical M
scanning in 2D imaging modes(B,
Color, Power mode) | S |
| Conclusion | These two devices both provide Free Xros M function. The technological
characteristics of the Free Xros M function are the same. So they are substantial
equivalent. | | |
| | iLive brings a better imaging
experience by adding a light
rendering effect to the traditional
method. It supports the global
lighting mode as well as the partial
scattering mode, allowing human
tissue texture to be revealed more
clearly. | iLive brings a better imaging
experience by adding a light
rendering effect to the traditional
method. It supports the global
lighting mode as well as the partial
scattering mode, allowing human
tissue texture to be revealed more
clearly. | |
| iLive | | | S |
| | | | |
| Conclusion | These two devices both provide iLive function. The technological characteristics of
the iLive function are the same. So they are substantial equivalent. | | |
| | Provide several step by step
workflow protocols according to
clinical operation custom. User can
activate necessary display modes and
image parameters, measurements and
calculation items, add comments and
pictograms as per the steps provided
in the exam. This function reduces
the operations, especially reduces the
excessive number of control panel
key strokes. | Provide several step by step
workflow protocols according to
clinical operation custom. User can
activate necessary display modes and
image parameters, measurements and
calculation items, add comments and
pictograms as per the steps provided
in the exam. This function reduces
the operations, especially reduces the
excessive number of control panel
key strokes. | |
| iWorks | | | S |
| | | | |
| Conclusion | These two devices both provide iWorks function. The technological characteristics
of the iWorks function are the same. So they are substantial equivalent. | | |
| | The iScape panoramic imaging
feature extends your field of view by
piecing together multiple B images
into a single, extended B image. Use
this feature, for example, to view a
complete hand or thyroid. | The iScape panoramic imaging
feature extends your field of view by
piecing together multiple B images
into a single, extended B image. Use
this feature, for example, to view a
complete hand or thyroid. | |
| iScape View | | | S |
| | | | |
| Conclusion | These two devices both provide iScape function. The technological characteristics of
the iScape function are the same. So they are substantial equivalent. | | |
| | iNeedle makes needle display clearer
in the course of biopsy or anesthesia
by providing an additional deflection
transmission. | iNeedle makes needle display clearer
in the course of biopsy or anesthesia
by providing an additional deflection
transmission. | |
| iNeedle | | | S |
| | | | |
| Conclusion | These two devices both provide iNeedle function. The technological characteristics
of the iNeedle function are the same. So they are substantial equivalent. | | |
| iPage | iPage is a new "Visualization" mode | iPage is a new "Visualization" mode | S |
| | for displaying sectional images. The
data is presented as slices through the
data set, which are parallel to each
other.
iPage is an option and is not available
for Smart 3D images. | for displaying sectional images. The
data is presented as slices through the
data set, which are parallel to each
other.
iPage is an option and is not available
for Smart 3D images. | |
| Conclusion | These two devices both provide iPage function. The technological characteristics of
the iPage function are the same. So they are substantial equivalent. | | |
| | HPRF function is used when detected
velocities exceed the processing
capabilities of the currently selected
PW Doppler scale, or when the
selected anatomical site is too deep
for the selected PW Doppler scale.
HPRF enhances the range of
detecting high-velocity flow. | HPRF function is used when detected
velocities exceed the processing
capabilities of the currently selected
PW Doppler scale, or when the
selected anatomical site is too deep
for the selected PW Doppler scale.
HPRF enhances the range of
detecting high-velocity flow. | S |
| HPRF | These two devices both provide HPRF function. The technological characteristics of
the HPRF function are the same. So they are substantial equivalent. | | |
| | This feature allows the system to
recognize fetal face automatically
and then display the face in a
recommended viewing angle. | This feature allows the system to
recognize fetal face automatically
and then display the face in a
recommended viewing angle. | |
| Smart Face | These two devices both provide Smart Face function. The technological
characteristics of the Smart Face function are the same. So they are substantial
equivalent. | | S |
| | The Smart OB is obstetric
measurement tools. It is used to
calculate the obstetric measurements. | The Smart OB is obstetric
measurement tools. It is used to
calculate the obstetric measurements. | S |
| Smart OB | These two devices both provide Smart OB function. The technological
characteristics of the Smart OB function are the same. So they are substantial
equivalent | | |

19

20

| Items | Subject Device
DP-50/DP-50T/DP-50Expert/DP-50
S/DP-50Pro | Predicate Device
DC-N3 (K140030) | S/D |
|---------------|------------------------------------------------------------------------|------------------------------------------------------------------------|-----|
| Smart Bladder | The Smart Bladder is provided to
measure the volume of the urine in | The Smart Bladder is provided to
measure the volume of the urine in | S |

21

	the bladder automatically.	the bladder automatically.
Conclusion	These two devices both provide Smart Bladder function. The technological characteristics of the Smart Bladder function are the same. So they are substantial equivalent.

Below is comparative tables of new added imaging modes:

| Items | Subject Device
DP-50/DP-50T/DP-50Expert/DP-
50S/DP-50Pro | Predicate Device
DC-N2(K132779) | S/D |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|
| PW mode to all
transducers | PW (Pulsed Wave Doppler) mode is
used to provide blood flow velocity
and direction utilizing a real-time
spectral display. The horizontal axis
represents time, while the vertical
axis represents Doppler frequency
shift. | PW (Pulsed Wave Doppler) mode is
used to provide blood flow velocity
and direction utilizing a real-time
spectral display. The horizontal axis
represents time, while the vertical
axis represents Doppler frequency
shift. | S |
| Conclusion | These two devices both provide PW mode. The technological characteristics of the
PW mode are the same. So they are substantial equivalent. | | |
| Color mode to all
transducers | The Color mode is used to detect
color flow information, and the
color is designed to judge the
direction and speed of blood flow. | The Color mode is used to detect
color flow information, and the
color is designed to judge the
direction and speed of blood flow. | S |
| Conclusion | These two devices both provide Color mode. The technological characteristics of
the Color mode are the same. So they are substantial equivalent. | | |
| Power mode to
all transducers | Power mode provides a
non-directional display of blood
flow in the form of intensity as
opposed to flow velocity.
DirPower (Directional Power mode)
provides additional information of
flow direction towards or away
from the probe. | Power mode provides a
non-directional display of blood
flow in the form of intensity as
opposed to flow velocity.
DirPower (Directional Power mode)
provides additional information of
flow direction towards or away
from the probe. | S |
| Conclusion | These two devices both provide Power mode. The technological characteristics of
the Power mode are the same. So they are substantial equivalent. | | |

Detailed information of newly added imaging modes to these transducers are as follows:

22

35C50EA

| Model | 35C50EA&
DP-50/DP-50T/DP-50Expert/D
P-50S/DP-50Pro | 35C50EA & DC-N2 (K132779) | S/D |
|------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|
| Manufacturer | Shenzhen Mindray Bio-Medical
Electronics Co., Ltd. | Shenzhen Mindray Bio-Medical
Electronics Co., Ltd. | / |
| 510(K) Number | / | K132779 | / |
| Indication(s) for use | Fetal
Abdominal
Pediatric
Musculo-skeletal(Conventional) | Fetal
Abdominal
Pediatric
Musculo-skeletal(Conventional)
Peripheral vessel | S |
| Modes of operation | B/M/PWD/Color Doppler
/ Amplitude Doppler
/ B+M/PW+B
/Color+B/ Power+B
/PW+Color+B
/Power+PW+B
/THI/ Biopsy Guidance
/Smart3D | B/M/PWD/Color Doppler
/ Amplitude Doppler
/ B+M/PW+B
/Color+B/ Power+B
/PW+Color+B
/Power+PW+B
/THI/ Biopsy Guidance /iScape
/Smart3D | S |
| Is the acoustic output
below Ispta.3 =
720mW/cm2 and either
MI=1.9 or Isppa.3
=190W/cm2? | yes | yes | S |
| Acoustic output is
measured and recorded
according to the
procedures in 510(k)
guidance? | yes | yes | S |
| Geometrical shape | Convex | Convex | S |

65C15EA

| Model | 65C15EA &
DP-50/DP-50T/DP-50Expert/
DP-50S/DP-50Pro | 65C15EA & DC-N2 (K132779) | S/D |
|--------------|-----------------------------------------------------------|------------------------------|-----|
| Manufacturer | Shenzhen Mindray Bio-Medical | Shenzhen Mindray Bio-Medical | / |

23

	Electronics Co., Ltd.	Electronics Co., Ltd.
510(K) Number	/	K132779	/
Indication(s) for use	Abdominal
Pediatric
Neonatal Cephalic
Adult Cephalic
Cardiac Pediatric	Abdominal
Pediatric
Neonatal Cephalic
Adult Cephalic
Cleared in K111435 already.	S
Modes of operation	B/M/PWD/Color Doppler
/ Amplitude Doppler
/ B+M/PW+B
/Color+B/ Power+B
/PW+Color+B
/Power+PW+B
/THI/ Biopsy Guidance
/Smart3D	B/M/PWD/Color Doppler
/ Amplitude Doppler
/ B+M/PW+B
/Color+B/ Power+B
/PW+Color+B
/Power+PW+B
/THI/ Biopsy Guidance/iScape
/Smart3D	S
Is the acoustic output below
Ispta.3 = 720mW/cm2 and
either MI=1.9 or Isppa.3
=190W/cm2?	yes	yes	S
Acoustic output is
measured and recorded
according to the procedures
in 510(k) guidance?	yes	yes	S
Geometrical shape	Convex	Convex	S

65EC10EA

| Model | 65EC10EA&
DP-50/DP-50T/DP-50Expert/
DP-50S/DP-50Pro | D6-2P& DC-N2 (K132779) | S/D |
|-----------------------|-----------------------------------------------------------|-------------------------------------------------------|-----|
| Manufacturer | Shenzhen Mindray Bio-Medical
Electronics Co., Ltd. | Shenzhen Mindray Bio-Medical
Electronics Co., Ltd. | / |
| 510(K) Number | / | K132779 | / |
| Indication(s) for use | Fetal
Trans-rectal
Trans-vaginal | Fetal
Trans-rectal
Trans-vaginal
Urology | S |

24

| Modes of operation | B/M/PWD/Color Doppler
/ Amplitude Doppler
/ B+M/PW+B
/Color+B/ Power+B
/PW+Color+B
/Power+PW+B
/THI/ Biopsy Guidance
/Smart3D | B/M/PWD/Color Doppler
/ Amplitude Doppler
/ B+M/PW+B
/Color+B/ Power+B
/PW+Color+B
/Power+PW+B
/THI/ Biopsy Guidance/iScape
/Smart3D | S |
|---------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|---|
| Is the acoustic output below
Ispta.3 = 720mW/cm2 and
either MI=1.9 or Isppa.3
=190W/cm2? | yes | yes | S |
| Acoustic output is
measured and recorded
according to the procedures
in 510(k) guidance? | yes | yes | S |
| Geometrical shape | Convex | Convex | S |

75L38EA

| Model | 75L38EA&
DP-50/DP-50T/DP-50Expert/D
P-50S/DP-50Pro | 75L38EA & DC-N2 (K132779) | S/D |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|-----|
| Manufacturer | Shenzhen Mindray Bio-Medical
Electronics Co., Ltd. | Shenzhen Mindray Bio-Medical
Electronics Co., Ltd. | / |
| 510(K) Number | / | K132779 | / |
| Indication(s) for use | Abdominal
Pediatric
Small Organ
Neonatal Cephalic
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Peripheral vessel | Abdominal
Pediatric
Small Organ
Neonatal Cephalic
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Peripheral vessel | S |

25

| Modes of operation | B/M/PWD/Color Doppler
/ Amplitude Doppler
/ B+M/PW+B
/Color+B/ Power+B
/PW+Color+B
/Power+PW+B
/THI/ Biopsy Guidance/iScape
/Smart3D | B/M/PWD/Color Doppler
/ Amplitude Doppler
/ B+M/PW+B
/Color+B/ Power+B
/PW+Color+B
/Power+PW+B
/THI/ Biopsy Guidance/iScape
/Smart3D | S |
|------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| | Is the acoustic output
below Ispta.3 =
720mW/cm2 and either
MI=1.9 or Isppa.3
=190W/cm2? | yes | yes |
| Acoustic output is
measured and recorded
according to the
procedures in 510(k)
guidance? | | yes | yes |
| | Geometrical shape | Linear | Linear |

75L53EA

| Model | 75L53EA &
DP-50/DP-50T/DP-50Expert/D
P-50S/DP-50Pro | 75L38EA & DC-N2 (K132779) | S/D |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|-----|
| Manufacturer | Shenzhen Mindray Bio-Medical
Electronics Co., Ltd. | Shenzhen Mindray Bio-Medical
Electronics Co., Ltd. | / |
| 510(K) Number | / | K132779 | / |
| Indication(s) for use | Abdominal
Pediatric
Small Organ
Neonatal Cephalic
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Peripheral vessel | Abdominal
Pediatric
Small Organ
Neonatal Cephalic
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Peripheral vessel | S |

26

| Modes of operation | B/M/PWD/Color Doppler
/ Amplitude Doppler
/ B+M/PW+B
/Color+B/ Power+B
/PW+Color+B
/Power+PW+B
/THI/ Biopsy Guidance/iScape
/Smart3D | B/M/PWD/Color Doppler
/ Amplitude Doppler
/ B+M/PW+B
/Color+B/ Power+B
/PW+Color+B
/Power+PW+B
/THI/ Biopsy Guidance/iScape
/Smart3D | S | |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|--------|
| | Is the acoustic output
below Ispta.3 =
720mW/cm2 and either
MI=1.9 or Isppa.3
=190W/cm2? | yes | yes | |
| | | Acoustic output is
measured and recorded
according to the
procedures in 510(k)
guidance? | yes | yes |
| | | | Geometrical shape | Linear |

10L24EA

| Model | 10L24EA &
DP-50/DP-50T/DP-50Expert/D
P-50S/DP-50Pro | 10L24EA & DC-N2 (K132779) | S/D |
|-----------------------|-----------------------------------------------------------|-------------------------------------------------------|-----|
| Manufacturer | Shenzhen Mindray Bio-Medical
Electronics Co., Ltd. | Shenzhen Mindray Bio-Medical
Electronics Co., Ltd. | / |
| 510(K) Number | / | K132779 | / |
| Indication(s) for use | Abdominal | Abdominal | S |
| | Pediatric | Pediatric | |
| | Small Organ | Small Organ | |
| | Neonatal Cephalic | Neonatal Cephalic | |
| | Musculo-skeletal(Conventional) | Musculo-skeletal(Conventional) | |
| | Musculo-skeletal (Superficial) | Musculo-skeletal (Superficial) | |
| | Peripheral vessel | Peripheral vessel | |

27

| Modes of operation | B/M/PWD/Color Doppler
/ Amplitude Doppler
/ B+M/PW+B
/Color+B/ Power+B
/PW+Color+B
/Power+PW+B
/THI/ Biopsy Guidance/iScape
/Smart3D | B/M/PWD/Color Doppler
/ Amplitude Doppler
/ B+M/PW+B
/Color+B/ Power+B
/PW+Color+B
/Power+PW+B
/THI/ Biopsy Guidance/iScape
/Smart3D | S | | | |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|--------|--------|---|
| | Is the acoustic output
below Ispta.3 =
720mW/cm2 and either
MI=1.9 or Isppa.3
=190W/cm2? | yes | yes | S | | |
| | | Acoustic output is
measured and recorded
according to the
procedures in 510(k)
guidance? | yes | yes | S | |
| | | | Geometrical shape | Linear | Linear | S |

65EB10EA

| Model | 65EB10EA&
DP-50/DP-50T/DP-50Expert/
DP-50S/DP-50Pro | 65EB10EA & DC-N2
(K132779) | S/D |
|-----------------------|-----------------------------------------------------------|-------------------------------------------------------|-----|
| Manufacturer | Shenzhen Mindray Bio-Medical
Electronics Co., Ltd. | Shenzhen Mindray Bio-Medical
Electronics Co., Ltd. | / |
| 510(K) Number | / | K132779 | / |
| Indication(s) for use | Trans-rectal | Fetal
Trans-rectal
Trans-vaginal
Urology | S |

28

| Modes of operation | B/M/PWD/Color Doppler
/ Amplitude Doppler
/ B+M/PW+B
/Color+B/ Power+B
/PW+Color+B
/Power+PW+B
/THI/ Biopsy Guidance
/Smart3D | B/M/PWD/Color Doppler
/ Amplitude Doppler
/ B+M/PW+B
/Color+B/ Power+B
/PW+Color+B
/Power+PW+B
/THI/ Biopsy Guidance/iScape
/Smart3D | |
|---------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|---|
| Is the acoustic output below
Ispta.3 = 720mW/cm2 and
either MI=1.9 or Isppa.3
=190W/cm2? | yes | yes | S |
| Acoustic output is
measured and recorded
according to the procedures
in 510(k) guidance? | yes | yes | S |
| Geometrical shape | Convex | Convex | S |

Below is comparative tables of new added transducers:

D6-2EA

| Model | D6-2EA &
DP-50/DP-50T/DP-50Expert/
DP-50S/DP-50Pro | D6-2P&Z6 (K182603) | S/D |
|-----------------------|----------------------------------------------------------|-------------------------------------------------------|-----|
| Manufacturer | Shenzhen Mindray Bio-Medical
Electronics Co., Ltd. | Shenzhen Mindray Bio-Medical
Electronics Co., Ltd. | / |
| 510(K) Number | / | K182603 | / |
| Indication(s) for use | Fetal
Abdominal | Fetal
Abdominal | S |

29

| Modes of operation | B/M/PWD/Color Doppler
/ Amplitude Doppler
/ B+M/PW+B
/Color+B/ Power+B
/PW+Color+B
/Power+PW+B
/THI/Smart3D/4D | B/M/PWD/Color Doppler
/ Amplitude Doppler
/ B+M/PW+B
/Color+B/ Power+B
/PW+Color+B
/Power+PW+B
/THI/Smart3D/4D | S |
|---------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|---|
| Is the acoustic output below
Ispta.3 = 720mW/cm2 and
either MI=1.9 or Isppa.3
=190W/cm2? | yes | yes | S |
| Acoustic output is
measured and recorded
according to the procedures
in 510(k) guidance? | yes | yes | S |
| Distance between adjacent
elements(mm) | 0.6048 | 0.6048 | S |
| Geometrical shape | Convex | Convex | S |
| Array elements | 128 | 128 | S |
| Radius/Width(mm) | 40 | 40 | S |
| Axis size(mm) | 11 | 11 | S |
| Nominal frequency(MHz) | 4.0 | 4.0 | S |

65EC10ED

| Model | 65EC10ED&
DP-50/DP-50T/DP-50Expert/
DP-50S/DP-50Pro | 65EC10ED &DC-N2
(K132779) | S/D |
|-----------------------|-----------------------------------------------------------|-------------------------------------------------------|-----|
| Manufacturer | Shenzhen Mindray Bio-Medical
Electronics Co., Ltd. | Shenzhen Mindray Bio-Medical
Electronics Co., Ltd. | / |
| 510(K) Number | / | K132779 | / |
| Indication(s) for use | Fetal
Trans-rectal
Trans-vaginal | Fetal
Trans-rectal
Trans-vaginal
Urology | S |

30

| Modes of operation | B/M/PWD/Color Doppler
/ Amplitude Doppler
/ B+M/PW+B
/Color+B/ Power+B
/PW+Color+B
/Power+PW+B
/THI/ Biopsy Guidance
/Smart3D | B/M/PWD/Color Doppler
/ Amplitude Doppler
/ B+M/PW+B
/Color+B/ Power+B
/PW+Color+B
/Power+PW+B
/THI/ Biopsy Guidance
/Smart3D/iScape | S |
|---------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|---|
| Is the acoustic output below
Ispta.3 = 720mW/cm2 and
either MI=1.9 or Isppa.3
=190W/cm2? | yes | yes | S |
| Acoustic output is
measured and recorded
according to the procedures
in 510(k) guidance? | yes | yes | S |
| Distance between adjacent
elements(mm) | 0.312 | 0.312 | S |
| Geometrical shape | Convex | Convex | S |
| Array elements | 80 | 80 | S |
| Radius/Width(mm) | 10 | 10 | S |
| Axis size(mm) | 5 | 5 | S |
| Nominal frequency(MHz) | 6.5 | 6.5 | S |

35C20EA

| Model | 35C20EA&
DP-50/DP-50T/DP-50Expert/
DP-50S/DP-50Pro | 35C20EA & DC-N2
(K132779) | S/D |
|-----------------------|----------------------------------------------------------|--------------------------------------------------------------|-----|
| Manufacturer | Shenzhen Mindray Bio-Medical
Electronics Co., Ltd. | Shenzhen Mindray Bio-Medical
Electronics Co., Ltd. | / |
| 510(K) Number | / | K132779 | / |
| Indication(s) for use | Abdominal
Pediatric
Cardiac Adult | Abdominal
Pediatric
Cardiac Adult
Cardiac Pediatric | S |

B-16

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31

| Modes of operation | B/M/PWD/Color Doppler
/ Amplitude Doppler
/ B+M/PW+B
/Color+B/ Power+B
/PW+Color+B
/Power+PW+B
/THI/ Biopsy Guidance
/Smart3D | B/M/PWD/Color Doppler
/ Amplitude Doppler
/ B+M/PW+B
/Color+B/ Power+B
/PW+Color+B
/Power+PW+B
/THI/ Biopsy Guidance
/Smart3D/iScape | S |
|---------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|---|
| | | | |
| Is the acoustic output below
Ispta.3 = 720mW/cm2 and
either MI=1.9 or Isppa.3
=190W/cm2? | yes | yes | S |
| Acoustic output is
measured and recorded
according to the procedures
in 510(k) guidance? | yes | yes | S |
| Distance between adjacent
elements(mm) | 0.4 | 0.4 | S |
| Geometrical shape | Convex | Convex | S |
| Array elements | 80 | 80 | S |
| Radius/Width(mm) | 20 | 20 | S |
| Axis size(mm) | 12.4 | 12.4 | S |
| Nominal frequency(MHz) | 3.5 | 3.5 | S |

75LT38EA

| Model | 75LT38EA&
DP-50/DP-50T/DP-50Expert/
DP-50S/DP-50Pro | 7LT4P & Z6 (K182603) | S/D |
|-----------------------|-----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|-----|
| Manufacturer | Shenzhen Mindray Bio-Medical
Electronics Co., Ltd. | Shenzhen Mindray Bio-Medical
Electronics Co., Ltd. | / |
| 510(K) Number | / | K182603 | / |
| Indication(s) for use | Abdominal
Intra-operative
Pediatric
Small Organ
Neonatal Cephalic
Musculo-skeletal(Conventional) | Abdominal
Intra-operative
Pediatric
Small Organ
Neonatal Cephalic
Musculo-skeletal(Conventional) | S |

32

| Modes of operation | Musculo-skeletal (Superficial)
Peripheral vessel | Musculo-skeletal (Superficial)
Peripheral vessel | |
|---------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|---|
| | B/M/PWD/Color Doppler
/ Amplitude Doppler
/ B+M/PW+B
/Color+B/ Power+B
/PW+Color+B
/Power+PW+B
/THI/ Biopsy Guidance /iScape
/Smart3D | B/M/PWD/Color Doppler
/ Amplitude Doppler
/ B+M/PW+B
/Color+B/ Power+B
/PW+Color+B
/Power+PW+B
/THI/ Biopsy Guidance /iScape
/Smart3D | S |
| Is the acoustic output below
Ispta.3 = 720mW/cm2 and
either MI=1.9 or Isppa.3
=190W/cm2? | yes | yes | S |
| Acoustic output is
measured and recorded
according to the procedures
in 510(k) guidance? | yes | yes | S |
| Distance between adjacent
elements(mm) | 0.48 | 0.315 | D |
| Geometrical shape | Linear | Linear | S |
| Array elements | 80 | 128 | D |
| Radius/Width(mm) | / | / | S |
| Axis size(mm) | 4 | 4 | S |
| Nominal frequency(MHz) | 7.5 | 7.5 | S |

Note:

Due to new design, the distance between adjacent elements and array elements of 75LT38EA is different from 7LT4P. This difference does not influence the diagnostic, and use of the device. The added 75LT38EA has been tested under the IEC60601-1, IEC60601-1-2 etc. This difference does not influence the safety and effectiveness of this transducers.

Meaning of symbols used in the above table: S: Same D: Different

The DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System has the same technological characteristics, is comparable in key

Page 18 of 21

33

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
The DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System has the similar intended uses as the predicated device DP-50 (K111435)

Subject Device	Predicate device
DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro	DP-50 (K111435)
The Digital Ultrasonic Diagnostic Imaging 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, etc.),
neonatal and adult cephalic, trans-rectal, trans-vaginal,
musculo-skeletal(conventional, superficial),
cardiac(pediatric), peripheral vascular .	The Digital Ultrasonic Diagnostic Imaging System
is applicable for adults, pregnant women, pediatric
and neonates. It is intended for use in fetal,
abdominal, pediatric, small organ (breast, thyroid,
testes, etc.), neonatal and adult cephalic,
trans-rectal, trans-vaginal,
musculo-skeletal(conventional, superficial),
cardiac(pediatric), peripheral vascular .
Intra-operative (abdominal, thoracic, and
vascular) ,cardiac(adult)	Cleared in Z6 (K182603)

The acoustic power levels of DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro are ● below the limits of FDA, which is the same as the predicated device DP-50 (K111435)
The DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro is designed in compliance with ● the FDA recognized electrical and physical safety standard, which is the same as the predicated device DP-50 (K111435)

The DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro has similar probes as the predicated device.

8. Non-clinical Tests:

34

The DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety, and has been designed to conform with applicable medical safety standards. This device has been tested and evaluated under the following standards:

AAMI/ANSI ES60601-1: Medical electrical equipment Part 1: General requirements for basic safety and essential performance
. IEC 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (Edition 3)
. IEC 60601-2-37: Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
IEC 62304: Medical device software Software life cycle processes ●
IEC 62366:Medical devices - application of usability engineering to medical devices
IEC 60601-1-6: medical electrical equipment part 1-6: general requirements for ● basic safety and essential performance - collateral standard: usability.
ISO14971: Medical devices - Application of risk management to medical devices
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.

9. Clinical Studies

Not applicable. The subject of this submission,

DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System, does not require clinical studies to support substantial equivalence.

Conclusion:

Intended uses and other key features are consistent with traditional clinical practices,

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35

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 DP-50/DP-50T/DP-50Expert/DP-50S /DP-50Pro Digital Ultrasonic Diagnostic Imaging System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.