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

• K Number: K200979
• Device Name: DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System
• Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., LTD.
• Date Cleared: 2020-05-28 ( 45 days)
• Product Code: IYN , ITX , IYO
• Regulation Number: 892.1550
• Type: Traditional
• Panel: Radiology
• Reference & Predicate Devices: K182603 , K171233 , K132779 , K090912 , K140030 , K111435
• Predicate For: N/A

Intended 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.

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.

AI/ML Overview

This is a 510(k) premarket notification for the Shenzhen Mindray Bio-medical Electronics Co., LTD DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System. The submission claims substantial equivalence to predicate devices, primarily the DP-50 Digital Ultrasonic Diagnostic Imaging System (K111435).

The document focuses on demonstrating substantial equivalence rather than presenting formal acceptance criteria with specific performance metrics for a new AI/algorithm. However, it implicitly defines acceptance based on the equivalence of its features and performance to predicate devices.

Here's an analysis of the provided information, focusing on aspects relevant to AI/algorithm performance if new features were indeed algorithm-driven. The new features such as "Smart 3D", "Smart Face", "Smart OB", "Smart Bladder", and "iNeedle" suggest the presence of algorithms or AI components.

Since this is a 510(k) premarket notification, formal "acceptance criteria" and detailed "study results" in the typical sense of a clinical trial for breakthrough devices demonstrating specific performance metrics are often replaced by comparisons to predicate devices and adherence to recognized standards.

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1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission primarily relying on substantial equivalence, explicit quantitative acceptance criteria for each individual "smart" feature (e.g., Smart Face, Smart OB) are not provided in the document in the format of a clinical study. Instead, acceptance is implied by demonstrating that the performance and technological characteristics of the new features are the same as or comparable to those already cleared in predicate devices. The "S/D" column indicates if the feature is "Same" or "Different" from the predicate. For those marked "S" (Same), the implied acceptance criterion is "performance identical to the predicate device."

Here's an interpretation based on the provided comparative tables for the "new added special functions":

Feature Category	Feature Name	Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Imaging Modes & Features	4D	Technological characteristics and function are the same as predicate (Resona 7, K171233).	Provides 4D function with real-time 3D image rendering, same as Resona 7.
	Smart 3D	Technological characteristics and function are the same as predicate (Resona 7, K171233).	Provides Smart 3D function with manual probe movement and automatic 3D rendering, same as Resona 7.
	Free Xros M	Technological characteristics and function are the same as predicate (Resona 7, K171233).	Allows manipulation of M-mark line at desired angles in 2D modes (B, Color, Power), same as Resona 7.
	iLive	Technological characteristics and function are the same as predicate (Resona 7, K171233).	Provides enhanced imaging experience with light rendering effect, global and partial scattering modes, same as Resona 7.
	iWorks	Technological characteristics and function are the same as predicate (Resona 7, K171233).	Provides step-by-step workflow protocols to reduce operations and keystrokes, same as Resona 7.
	iScape View	Technological characteristics and function are the same as predicate (Resona 7, K171233).	Provides panoramic imaging by piecing together B images for extended views, same as Resona 7.
	iNeedle	Technological characteristics and function are the same as predicate (Resona 7, K171233).	Makes needle display clearer during biopsy/anesthesia via additional deflection transmission, same as Resona 7.
	iPage	Technological characteristics and function are the same as predicate (Resona 7, K171233).	Provides a "Visualization" mode for displaying sectional images as parallel slices, same as Resona 7.
	HPRF	Technological characteristics and function are the same as predicate (Resona 7, K171233).	Enhances the range of detecting high-velocity flow when velocities exceed processing capabilities or depth for PW Doppler scale, same as Resona 7.
	Smart Face	Technological characteristics and function are the same as predicate (Resona 7, K171233).	Automatically recognizes fetal face and displays it at a recommended viewing angle, same as Resona 7.
	Smart OB	Technological characteristics and function are the same as predicate (Resona 7, K171233).	Provides obstetric measurement tools for calculating obstetric measurements, same as Resona 7.
	Smart Bladder	Technological characteristics and function are the same as predicate (DC-N3, K140030).	Measures the volume of urine in the bladder automatically, same as DC-N3.
New Imaging Modes (Transducers)	PW mode (all transducers)	Technological characteristics and function are the same as predicate (DC-N2, K132779).	Provides blood flow velocity and direction in real-time spectral display, same as DC-N2.
	Color mode (all transducers)	Technological characteristics and function are the same as predicate (DC-N2, K132779).	Detects color flow information to judge direction and speed of blood flow, same as DC-N2.
	Power mode (all transducers)	Technological characteristics and function are the same as predicate (DC-N2, K132779).	Provides non-directional display of blood flow intensity and DirPower for flow direction, same as DC-N2.
Acoustic Output	Ispta.3 < 720mW/cm2 and MI=1.9 or Isppa.3=190W/cm2	Acoustic output is below regulatory limits and measured according to 510(k) guidance.	All listed transducers (35C50EA, 65C15EA, 65EC10EA, 75L38EA, 75L53EA, 10L24EA, 65EB10EA, D6-2EA, 65EC10ED, 35C20EA, 75LT38EA) meet these criteria, as confirmed to be "yes" and "Same" as their respective predicates.
Inter-element Distance (75LT38EA)	No influence on diagnostic capabilities or safety/effectiveness.	Difference in distance (0.48mm vs 0.315mm) and array elements (80 vs 128) for 75LT38EA from predicate (7LT4P & Z6, K182603) does not impact intended use, safety, or efficacy.

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Study Details:

The document clearly states: "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."

This indicates that the submission relies entirely on non-clinical tests and comparisons to predicate devices previously cleared by the FDA. Therefore, detailed information regarding sample size, data provenance, expert ground truth, adjudication methods, or MRMC studies for performance evaluation of new AI/algorithm features is not provided within this document. The "studies" that prove the device meets acceptance criteria are explicitly non-clinical tests.

Here's an attempt to answer the remaining points based on the provided text, acknowledging the limitations for an AI/algorithm-specific evaluation:

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2. Sample Size Used for the Test Set and Data Provenance

• Sample Size (Test Set): Not applicable for clinical testing of algorithmic performance as no clinical studies were deemed necessary for this 510(k) submission.
• Data Provenance: Not applicable for clinical data. The submission relies on non-clinical tests which include evaluating the device's acoustic output, biocompatibility, cleaning and disinfection effectiveness, and electrical/mechanical safety based on recognized standards. The "data" proving performance for new features like Smart Face is the comparison of shared technological characteristics with existing cleared devices, rather than a dataset it was evaluated on.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. No clinical ground truth was established by experts for a test set to prove the performance of the "Smart" features within this 510(k) submission. The performance claim for these features is based on technological equivalence to predicate devices already cleared.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring expert adjudication for performance evaluation was conducted or submitted.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No. The document explicitly states "Not applicable" for clinical studies. Therefore, no MRMC comparative effectiveness study was conducted.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

This aspect is not explicitly addressed for the "Smart" features. Given the absence of clinical studies and a reliance on substantial equivalence, standalone performance data for algorithms would likely not have been presented in this type of submission. The features are described as integrated into the ultrasonic system, implying a human operator interaction.

7. The Type of Ground Truth Used

Not applicable in the context of clinical ground truth (e.g., pathology, outcomes data). For the non-clinical tests conducted (acoustic output, safety, etc.), the "ground truth" would be established by the specifications of the relevant international and national standards (e.g., AAMI/ANSI ES60601-1, IEC 60601-2-37). For the "Smart" features, the "ground truth" for showing acceptable performance is the assertion that their technological characteristics are the same as already-cleared predicate devices.

8. The Sample Size for the Training Set

Not applicable. The document does not provide any information about training sets for potential AI/algorithm components within the "Smart" features. The submission relies on demonstrating substantial equivalence to predicate devices, not on proving the performance of a newly developed, independently trained algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set information is provided.

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Summary of AI/Algorithm Information (Implied):

The listed "Smart" features (Smart 3D, Free Xros M, iLive, iWorks, iScape View, iNeedle, iPage, HPRF, Smart Face, Smart OB, Smart Bladder) suggest algorithmic processing and potentially AI components. However, this 510(k) submission primarily leverages the concept of substantial equivalence to predicate devices. For each of these features, the conclusion is that "The technological characteristics... are the same. So they are substantial equivalent." This means that the device's acceptability for these features rests on the assertion that they function identically to existing, cleared technology, rather than on new performance studies with specific acceptance criteria.

Summary

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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

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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 ([e-mail]) or phone [phone] 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

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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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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)

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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 ApplicationMode 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 GuidanceNote 3: iScape
	Note 4: TDI
	Note 5: Color M
	Note 6: Smart3DNote 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)

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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 (Track1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	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
Peripheralvessel	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 (Track1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	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
Peripheralvessel	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 (Track1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	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
Peripheralvessel	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)

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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).

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: [phone] Fax: [phone]

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

2. 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

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• 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;
  • 2. Add PW mode to all transducers;
  • 3. Add Color mode to all transducers;
  • 4. Add Power mode to all transducers;
  • 5. Add 4D and Smart 3D;
  • 6. Add Free Xros M;
  • 7. Add iScape View;
  • 8. Add iLive;
  • 9. Add iWorks;
  • 10. Add Smart Face;
  • 11. Add Smart OB;
  • 12. Add Smart Bladder;
  • 13. Add iNeedle;
  • 14. Add iPage;
  • 15. Add HPRF;
  • 16. Add mobile trolley UMT-160 and UMT-170;
  • 17. Change the probe board;
  • 18. 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:

Predicate Device	Manufacturer	Model	510(k) ControlNumber
------------------	--------------	-------	--------------------------

{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 DeviceDP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro	Predicate DeviceResona 7 (K171233)	S/D
4D	The probe performs the scanningautomatically. During the scanning,the system renders 3D images in realtime, and all 3D images are displayedin real time.	The probe performs the scanningautomatically. During the scanning,the system renders 3D images in realtime,and all 3D images are displayedin real time.	S
Conclusion	These two devices both provide 4D function. The technological characteristics ofthe 4D function are the same. So they are substantial equivalent.
Smart 3D	The operator manually moves theprobe to changes its position/anglewhen performing the scanning, thesystem carries out image renderingautomatically, and then displays aframe of 3D image.	The operator manually moves theprobe to changes its position/anglewhen performing the scanning, thesystem carries out image renderingautomatically, and then displays aframe of 3D image.	S
Conclusion	These two devices both provide Smart 3D function. The technologicalcharacteristics of the Smart 3D function are the same. So they are substantialequivalent.
Free Xros M	In the Anatomical M mode, you canmanipulate the M-mark line to moveto any position at desired angles. Thesystem supports anatomical Mscanning in 2D imaging modes(B,Color, Power mode)	In the Anatomical M mode, you canmanipulate the M-mark line to moveto any position at desired angles. Thesystem supports anatomical Mscanning in 2D imaging modes(B,Color, Power mode)	S
Conclusion	These two devices both provide Free Xros M function. The technologicalcharacteristics of the Free Xros M function are the same. So they are substantialequivalent.
	iLive brings a better imagingexperience by adding a lightrendering effect to the traditionalmethod. It supports the globallighting mode as well as the partialscattering mode, allowing humantissue texture to be revealed moreclearly.	iLive brings a better imagingexperience by adding a lightrendering effect to the traditionalmethod. It supports the globallighting mode as well as the partialscattering mode, allowing humantissue texture to be revealed moreclearly.
iLive			S
Conclusion	These two devices both provide iLive function. The technological characteristics ofthe iLive function are the same. So they are substantial equivalent.
	Provide several step by stepworkflow protocols according toclinical operation custom. User canactivate necessary display modes andimage parameters, measurements andcalculation items, add comments andpictograms as per the steps providedin the exam. This function reducesthe operations, especially reduces theexcessive number of control panelkey strokes.	Provide several step by stepworkflow protocols according toclinical operation custom. User canactivate necessary display modes andimage parameters, measurements andcalculation items, add comments andpictograms as per the steps providedin the exam. This function reducesthe operations, especially reduces theexcessive number of control panelkey strokes.
iWorks			S
Conclusion	These two devices both provide iWorks function. The technological characteristicsof the iWorks function are the same. So they are substantial equivalent.
	The iScape panoramic imagingfeature extends your field of view bypiecing together multiple B imagesinto a single, extended B image. Usethis feature, for example, to view acomplete hand or thyroid.	The iScape panoramic imagingfeature extends your field of view bypiecing together multiple B imagesinto a single, extended B image. Usethis feature, for example, to view acomplete hand or thyroid.
iScape View			S
Conclusion	These two devices both provide iScape function. The technological characteristics ofthe iScape function are the same. So they are substantial equivalent.
	iNeedle makes needle display clearerin the course of biopsy or anesthesiaby providing an additional deflectiontransmission.	iNeedle makes needle display clearerin the course of biopsy or anesthesiaby providing an additional deflectiontransmission.
iNeedle			S
Conclusion	These two devices both provide iNeedle function. The technological characteristicsof 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. Thedata is presented as slices through thedata set, which are parallel to eachother.iPage is an option and is not availablefor Smart 3D images.	for displaying sectional images. Thedata is presented as slices through thedata set, which are parallel to eachother.iPage is an option and is not availablefor Smart 3D images.
Conclusion	These two devices both provide iPage function. The technological characteristics ofthe iPage function are the same. So they are substantial equivalent.
	HPRF function is used when detectedvelocities exceed the processingcapabilities of the currently selectedPW Doppler scale, or when theselected anatomical site is too deepfor the selected PW Doppler scale.HPRF enhances the range ofdetecting high-velocity flow.	HPRF function is used when detectedvelocities exceed the processingcapabilities of the currently selectedPW Doppler scale, or when theselected anatomical site is too deepfor the selected PW Doppler scale.HPRF enhances the range ofdetecting high-velocity flow.	S
HPRF	These two devices both provide HPRF function. The technological characteristics ofthe HPRF function are the same. So they are substantial equivalent.
	This feature allows the system torecognize fetal face automaticallyand then display the face in arecommended viewing angle.	This feature allows the system torecognize fetal face automaticallyand then display the face in arecommended viewing angle.
Smart Face	These two devices both provide Smart Face function. The technologicalcharacteristics of the Smart Face function are the same. So they are substantialequivalent.		S
	The Smart OB is obstetricmeasurement tools. It is used tocalculate the obstetric measurements.	The Smart OB is obstetricmeasurement tools. It is used tocalculate the obstetric measurements.	S
Smart OB	These two devices both provide Smart OB function. The technologicalcharacteristics of the Smart OB function are the same. So they are substantialequivalent

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Items	Subject DeviceDP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro	Predicate DeviceDC-N3 (K140030)	S/D
Smart Bladder	The Smart Bladder is provided tomeasure the volume of the urine in	The Smart Bladder is provided tomeasure 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 DeviceDP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro	Predicate DeviceDC-N2(K132779)	S/D
PW mode to alltransducers	PW (Pulsed Wave Doppler) mode isused to provide blood flow velocityand direction utilizing a real-timespectral display. The horizontal axisrepresents time, while the verticalaxis represents Doppler frequencyshift.	PW (Pulsed Wave Doppler) mode isused to provide blood flow velocityand direction utilizing a real-timespectral display. The horizontal axisrepresents time, while the verticalaxis represents Doppler frequencyshift.	S
Conclusion	These two devices both provide PW mode. The technological characteristics of thePW mode are the same. So they are substantial equivalent.
Color mode to alltransducers	The Color mode is used to detectcolor flow information, and thecolor is designed to judge thedirection and speed of blood flow.	The Color mode is used to detectcolor flow information, and thecolor is designed to judge thedirection and speed of blood flow.	S
Conclusion	These two devices both provide Color mode. The technological characteristics ofthe Color mode are the same. So they are substantial equivalent.
Power mode toall transducers	Power mode provides anon-directional display of bloodflow in the form of intensity asopposed to flow velocity.DirPower (Directional Power mode)provides additional information offlow direction towards or awayfrom the probe.	Power mode provides anon-directional display of bloodflow in the form of intensity asopposed to flow velocity.DirPower (Directional Power mode)provides additional information offlow direction towards or awayfrom the probe.	S
Conclusion	These two devices both provide Power mode. The technological characteristics ofthe 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/DP-50S/DP-50Pro	35C50EA & DC-N2 (K132779)	S/D
Manufacturer	Shenzhen Mindray Bio-MedicalElectronics Co., Ltd.	Shenzhen Mindray Bio-MedicalElectronics Co., Ltd.	/
510(K) Number	/	K132779	/
Indication(s) for use	FetalAbdominalPediatricMusculo-skeletal(Conventional)	FetalAbdominalPediatricMusculo-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 outputbelow Ispta.3 =720mW/cm2 and eitherMI=1.9 or Isppa.3=190W/cm2?	yes	yes	S
Acoustic output ismeasured and recordedaccording to theprocedures 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	AbdominalPediatricNeonatal CephalicAdult CephalicCardiac Pediatric	AbdominalPediatricNeonatal CephalicAdult CephalicCleared 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 belowIspta.3 = 720mW/cm2 andeither MI=1.9 or Isppa.3=190W/cm2?	yes	yes	S
Acoustic output ismeasured and recordedaccording to the proceduresin 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-MedicalElectronics Co., Ltd.	Shenzhen Mindray Bio-MedicalElectronics Co., Ltd.	/
510(K) Number	/	K132779	/
Indication(s) for use	FetalTrans-rectalTrans-vaginal	FetalTrans-rectalTrans-vaginalUrology	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 belowIspta.3 = 720mW/cm2 andeither MI=1.9 or Isppa.3=190W/cm2?	yes	yes	S
Acoustic output ismeasured and recordedaccording to the proceduresin 510(k) guidance?	yes	yes	S
Geometrical shape	Convex	Convex	S

75L38EA

Model	75L38EA&DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro	75L38EA & DC-N2 (K132779)	S/D
Manufacturer	Shenzhen Mindray Bio-MedicalElectronics Co., Ltd.	Shenzhen Mindray Bio-MedicalElectronics Co., Ltd.	/
510(K) Number	/	K132779	/
Indication(s) for use	AbdominalPediatricSmall OrganNeonatal CephalicMusculo-skeletal(Conventional)Musculo-skeletal (Superficial)Peripheral vessel	AbdominalPediatricSmall OrganNeonatal CephalicMusculo-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 outputbelow Ispta.3 =720mW/cm2 and eitherMI=1.9 or Isppa.3=190W/cm2?	yes	yes
Acoustic output ismeasured and recordedaccording to theprocedures in 510(k)guidance?		yes	yes
	Geometrical shape	Linear	Linear

75L53EA

Model	75L53EA &DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro	75L38EA & DC-N2 (K132779)	S/D
Manufacturer	Shenzhen Mindray Bio-MedicalElectronics Co., Ltd.	Shenzhen Mindray Bio-MedicalElectronics Co., Ltd.	/
510(K) Number	/	K132779	/
Indication(s) for use	AbdominalPediatricSmall OrganNeonatal CephalicMusculo-skeletal(Conventional)Musculo-skeletal (Superficial)Peripheral vessel	AbdominalPediatricSmall OrganNeonatal CephalicMusculo-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 outputbelow Ispta.3 =720mW/cm2 and eitherMI=1.9 or Isppa.3=190W/cm2?	yes	yes
		Acoustic output ismeasured and recordedaccording to theprocedures in 510(k)guidance?	yes	yes
			Geometrical shape	Linear

10L24EA

Model	10L24EA &DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro	10L24EA & DC-N2 (K132779)	S/D
Manufacturer	Shenzhen Mindray Bio-MedicalElectronics Co., Ltd.	Shenzhen Mindray Bio-MedicalElectronics 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 outputbelow Ispta.3 =720mW/cm2 and eitherMI=1.9 or Isppa.3=190W/cm2?	yes	yes	S
		Acoustic output ismeasured and recordedaccording to theprocedures 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-MedicalElectronics Co., Ltd.	Shenzhen Mindray Bio-MedicalElectronics Co., Ltd.	/
510(K) Number	/	K132779	/
Indication(s) for use	Trans-rectal	FetalTrans-rectalTrans-vaginalUrology	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 belowIspta.3 = 720mW/cm2 andeither MI=1.9 or Isppa.3=190W/cm2?	yes	yes	S
Acoustic output ismeasured and recordedaccording to the proceduresin 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-MedicalElectronics Co., Ltd.	Shenzhen Mindray Bio-MedicalElectronics Co., Ltd.	/
510(K) Number	/	K182603	/
Indication(s) for use	FetalAbdominal	FetalAbdominal	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 belowIspta.3 = 720mW/cm2 andeither MI=1.9 or Isppa.3=190W/cm2?	yes	yes	S
Acoustic output ismeasured and recordedaccording to the proceduresin 510(k) guidance?	yes	yes	S
Distance between adjacentelements(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-MedicalElectronics Co., Ltd.	Shenzhen Mindray Bio-MedicalElectronics Co., Ltd.	/
510(K) Number	/	K132779	/
Indication(s) for use	FetalTrans-rectalTrans-vaginal	FetalTrans-rectalTrans-vaginalUrology	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 belowIspta.3 = 720mW/cm2 andeither MI=1.9 or Isppa.3=190W/cm2?	yes	yes	S
Acoustic output ismeasured and recordedaccording to the proceduresin 510(k) guidance?	yes	yes	S
Distance between adjacentelements(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-MedicalElectronics Co., Ltd.	Shenzhen Mindray Bio-MedicalElectronics Co., Ltd.	/
510(K) Number	/	K132779	/
Indication(s) for use	AbdominalPediatricCardiac Adult	AbdominalPediatricCardiac AdultCardiac Pediatric	S

B-16

Page 16 of 21

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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 belowIspta.3 = 720mW/cm2 andeither MI=1.9 or Isppa.3=190W/cm2?	yes	yes	S
Acoustic output ismeasured and recordedaccording to the proceduresin 510(k) guidance?	yes	yes	S
Distance between adjacentelements(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-MedicalElectronics Co., Ltd.	Shenzhen Mindray Bio-MedicalElectronics Co., Ltd.	/
510(K) Number	/	K182603	/
Indication(s) for use	AbdominalIntra-operativePediatricSmall OrganNeonatal CephalicMusculo-skeletal(Conventional)	AbdominalIntra-operativePediatricSmall OrganNeonatal CephalicMusculo-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 belowIspta.3 = 720mW/cm2 andeither MI=1.9 or Isppa.3=190W/cm2?	yes	yes	S
Acoustic output ismeasured and recordedaccording to the proceduresin 510(k) guidance?	yes	yes	S
Distance between adjacentelements(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

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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 isapplicable for adults, pregnant women, pediatric patientsand 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 Systemis applicable for adults, pregnant women, pediatricand 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, andvascular) ,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,

Page 20 of 21

{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.

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.