DC-90/DC-90S/DC-90Q/DC-95/DC-95/DC-88/DC-888/DC-80A Exp/DC-80A Pro/DC-80A Pro/DC-8X/DC-8Q/DC-81/ DC-82 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, thoracic, and vascular), pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-vaginal, musculo-skeletal(conventional, superficial), superficial), superficial), adult and pediatric cardiac, Trans-esoph. (Cardiac), peripheral vessel and urology exams.

This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic.

Modes of operation include: B, M, PWD, CWD, Color Doppler, Tissue Harmonic Imaging, Smart 3D, 4D, iScape, TDI, Color M, Biopsy Guidance, Elastography, Contrast agent for Liver), Contrast imaging (Contrast agent for LVO), STE, STQ, Ultrasound Fusion Imaging, GYN/Pelvic and Combined mode:B+M, PW +B, Color+B, Power+B, PW+Color+B, Power+PW+B.

Device Description

DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/ DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system.

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

AI/ML Overview

This document is a 510(k) summary for the Mindray DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System. It aims to demonstrate substantial equivalence to predicate devices, not to present a de novo clinical study with specific acceptance criteria related to a novel AI-driven diagnostic performance.

Therefore, many of the requested categories for describing acceptance criteria and study details are Not Applicable (NA) in the context of this 510(k) Pre-Market Notification. This document primarily focuses on demonstrating that the new device, with its added transducers, needle-guided brackets, and features, performs equivalently and safely to previously cleared devices.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria for Substantial Equivalence (General): The device must be as safe and effective as a legally marketed predicate device, and have the same intended use and technological characteristics, or if there are differences, the differences do not raise new questions of safety and effectiveness and are demonstrated to be safe and effective.

No specific quantitative acceptance criteria or reported device performance metrics in the format of "Accuracy > X%" or "Sensitivity > Y%" are presented in this 510(k) summary because it's for a general diagnostic ultrasound system, not an AI-enabled diagnostic device with specific performance claims for disease detection.

The document demonstrates equivalence through:

Intended Use: Identical to predicate.
Technological Characteristics: Employing the same fundamental ultrasonic imaging technology.
Performance: The new models are stated to have "the same performance and functions with the predicated device DC-80 (K192152)".
Electrical and Physical Safety: Compliance with recognized standards and acoustic power levels below FDA limits.
Biocompatibility: Materials for new transducers and needle-guided brackets are either the same as predicate or tested for biocompatibility.

Acceptance Criteria Category	Details from 510(k) Summary	Reported Device Performance
Intended Use	Same intended use as predicate device (DC-80 K192152). Applicable for adults, pregnant women, pediatric patients, and neonates for various exams (fetal, abdominal, small organ, cardiac, vascular, etc.).	The subject device's intended uses are "consistent with traditional clinical practices, FDA guidelines and established methods of patient examination," and are explicitly stated to be the same as the predicate device.
Technological Characteristics (Core)	Employs the same technology as predicate devices: "All systems transmit ultrasonic energy into patients, then perform post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body."	The document states the subject device "employs the same technology as the predicate devices," and has the "same intended uses and basic operating modes as the predicate devices."
Safety - Acoustic Power Levels	Acoustic power levels are to be "below the limits of FDA."	"The acoustic power levels of DC-90/DC-90S/... are below the limits of FDA, which is the same as the predicated device DC-80 (K192152)."
Safety - Electrical & Physical	Designed in compliance with FDA recognized electrical and physical safety standards.	"DC-90/DC-90S/... is designed in compliance with the FDA recognized electrical and physical safety standards, which are the same as the predicated device DC-80 (K192152)." Compliance with specific standards (ES60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, ISO 14971, NEMA UD 2-2004, ISO 10993-1, IEC 62366-1, IEC 60601-1-6) is stated.
Biocompatibility	Materials of new transducers and needle-guided brackets
are to be "the same as in the predicate device" or tested for biocompatibility.	"The materials of probes and Needle-guided brackets of DC-90/DC-90S/... are the same to the predicate device DC-80 (K192152)." Additionally, "the L13-3WE transducer was testing for biocompatibility."
Cleaning and Disinfection Effectiveness	Disinfection/sterilization methods for new transducers/brackets are to be provided to end-user.	"All the transducers and needle-guided brackets were provided non-sterile to the end user. And all the disinfection/sterilization methods for the new transducers and needle guide brackets were provided to the end user and the users are notified that disinfection /sterilizaiton are necessary in the Operation Manual."
Overall Safety and Effectiveness Profile	To be similar to the predicate device.	"Based on the performance data as documented in the study, the DC-90 Diagnostic Ultrasound system was found to have a safety and effectiveness profile that is similar to the predicate device."
Quality System Compliance	Design, development, and quality process to conform with 21 CFR 820, ISO 9001 and ISO 13485 quality systems.	"The design, development and quality process of the manufacturer confirms with 21 CFR 820, ISO 9001 and ISO 13485 quality systems."

2. Sample size used for the test set and the data provenance

NA. This 510(k) submission does not describe a clinical performance study with a "test set" in the context of an AI/ML algorithm for diagnostic performance. The non-clinical tests relate to engineering safety and performance standards (e.g., acoustic output, biocompatibility, electrical safety), not diagnostic accuracy derived from a patient dataset.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

NA. This is not a study assessing the diagnostic performance of an AI algorithm against expert-established ground truth.

4. Adjudication method for the test set

NA. See point 3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

NA. This 510(k) is for a general diagnostic ultrasound system, not an AI-assisted diagnostic tool requiring an MRMC study for human reader improvement. While the device does have "Smart" features (e.g., Smart 3D, Smart Pelvic, Smart Planes FH), the submission does not present a comparative effectiveness study demonstrating the incremental benefit of these features for human readers.

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

NA. This 510(k) is for a general diagnostic ultrasound system, not a standalone AI algorithm. It's an imaging device that produces images for human interpretation, potentially with some "smart" features that assist, but without a claim of standalone diagnostic performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

NA. In a 510(k) for a general ultrasound system, "ground truth" as it pertains to diagnostic accuracy of an AI algorithm is not typically established or required. The "ground truth" implied in this context would be the known physical and electrical properties of the device components and their adherence to engineering standards.

8. The sample size for the training set

NA. This submission does not describe an AI/ML algorithm with a "training set" for diagnostic performance.

9. How the ground truth for the training set was established

NA. See point 8.

Summary

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Shenzhen Mindray Bio-medical Electronics Co., Ltd. August 21, 2020 % Zhang Wei Engineer of Technical Regulation Mindray Building, Keji 12th Road South Hi-tech Industrial Park Nanshan, Shenzhen 518057 P.R. CHINA Re: K201693 Trade/Device Name: DC-90/DC-90S/DC-900/DC-95/DC-95S/DC-88/DC-88S/DC-80A/ DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX, LLZ Dated: May 20, 2020 Received: June 30, 2020

Dear Zhang Wei:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You 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

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting 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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K201693

Device Name

DC-90/DC-90S/DC-90Q/DC-95/DC-95/DC-88/DC-888/DC-80A/DC-80A Pro/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-81/DC-82 Diagnostic Ultrasound System

Indications for Use (Describe)

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

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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.

The assigned 510(k) number: K201693

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 5655 Fax: +86 755 2658 2680

Contact Person:

Zhang Wei 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: May 20, 2020

2. Device Name:

DC-90/DC-90S/DC-90Q/DC-95/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System Classification Regulatory Class: II Review Category: Tier II 21 CFR 892.1550 Ultrasonic Pulsed Doppler Imaging System (IYN) 21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System (IYO)

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21 CFR 892.1570 Diagnostic Ultrasound Transducer (ITX)

21 CFR 892.2050 Picture Archiving and Communications System(LLZ)

PredicateDevice	Manufacturer	Device Name	DevieClass	ProductCode	510(k)ControlNumber
1.Primarypredicatedevice	Mindray	DC-80/DC-80 PRO/DC-80EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ DiagnosticUltrasound System	II	IYN,IYO, ITXand LLZ	K192152
2.Referencedevice	Mindray	DC-80/DC-80 PRO/DC-80EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ DiagnosticUltrasound System	II	IYN,IYO, ITX	K173471
3.Referencedevice	Mindray	Resona 7/ Resona 7CV/ Resona7EXP/ Resona 7S/ Resona 7OBDiagnostic Ultrasound System	II	IYN, IYO,ITX	K171233

3. Predicate Device

Regulation name and code

21 CFR 892.1550 Ultrasonic Pulsed Doppler Imaging System (IYN)
21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System (IYO)
21 CFR 892.1570 Diagnostic Ultrasound Transducer (ITX)
21 CFR 892.2050 Picture Archiving and Communications System(LLZ)

4. Device Description:

DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/

DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system.

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

The new added transducers C5-1E, SC5-1E, C6-2GE, C7-3E, L14-6WE, L16-4HE, P10-4E, 6LB7E, CB10-4E, V11-3E, V11-3BE, DE10-3WE, D7-2E, P7-3TE, CW5s were cleared in FDA (K192152) and the CW2s were cleared in FDA (K173471);

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L13-3WE is equivalent with transducer L14-5WE, which was cleared in FDA (K192152).

The needle-guided brackets in this submission were cleared in FDA (K192152) and (K200001).

The materials used in the new transducers (except for L13-3WE) and needle-guided brackets were the same as in the predicate device. And the L13-3WE transducer was testing for biocompatibility.

All the transducers and needle-guided brackets were provided non-sterile to the end user. And all the disinfection/sterilization methods for the new transducers and needle guide brackets were provided to the end user and the users are notified that disinfection /sterilizaiton are necessary in the Operation Manual.

5. Intended Use:

The DC-80A /DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82/DC-88/DC-90/ DC-95/DC-88S/DC-90S/DC-95S/DC-90Q Diagnostic Ultrasound 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), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), adult and pediatric cardiac, Trans-esoph. (Cardiac), peripheral vessel and urology exams.

Modes of operation include: B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Tissue Harmonic Imaging, Smart 3D, 4D, iScape, TDI, Color M, Biopsy Guidance, Elastography, Contrast imaging (Contrast agent for Liver), Contrast imaging (Contrast agent for LVO), STE, STQ, Ultrasound Fusion Imaging, GYN/Pelvic and Combined mode:B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B.

6. Summary of Modifications

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New Added Transducers:

C5-1E, SC5-1E, C6-2GE, C7-3E, L14-6WE, L16-4HE, L13-3WE, P10-4E, 6LB7E, CB10-4E , V11-3E, V11-3BE, DE10-3WE, D7-2E, P7-3TE, CW5s, CW2s;

New Added Needle-Guided Bracket:

NGB-004、NGB-009、NGB-019、NGB-021、NGB-024、NGB-031、NGB-054;

Main Added Features:

1. Ultrasound Fusion Imaging to C5-1E, SP5-1E, SC5-1E, L14-5WE, SC6-1E;
1. Smart Pelvic to C5-1E, V11-3HE, D7-2E, DE11-3E, SC5-1E, C6-2GE, V11-3E, V11-3BE, SC6-1E, SD8-1E, DE10-3WE, C7-3E;
1. STE/STQ to L13-3WE, SC5-1E, C5-1E
1. Strain Elastography to L14-6WE、L13-3WE、V11-3E、V11-3BE
1. Add the Fetal to the Clinical Application of L9-3E;
1. Add the contrast imaging(Contrast imaging for Liver) function to SC5-1E . C5-1E, C6-2GE、C7-3E
1. RIMT;
1. Smart Planes FH;
1. Glazing Flow;
1. Fusion RESP;

The other New changes:

Reference device

1. STIC function to D7-2E;
1. Add Transducer Element Check;
1. OS Upgrade from win7 to win10;
1. Add Macfee anti-virus software.

7. Comparison with Predicate Devices:

DC-90/DC-90S/DC-900/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/

DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System is comparable

DC-80

Predicate Device	Manufacturer	Model	510(k) Control
1. Primary predicate device	Mindray	DC-80	K192152

Mindray

with and substantially equivalent to these predicate devices:

Number

K173471

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3. Reference device	Mindray	Resona 7	K171233
---------------------	---------	----------	---------

DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/

DC-80A Pro/DC-8X/DC-80/DC-81/DC-82 Diagnostic Ultrasound System employs the same technology as the predicate devices. All systems transmit ultrasonic energy into patients, then perform post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body. All systems allow for specialized measurements of structures and flow, and calculations. The subject device also has the same intended uses and basic operating modes as the predicate devices.

Subject device

DC-90/DC-90S/DC-900/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/ DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 has the same probes and indication for use and modes of operation with the predicated device DC-80 (K192152) , Reference device DC-80 (K173471)& Resona 7 ( K171233)

Subject	DC-80(predicate	DC-80(Reference	Resona 7(Reference
Device	device)	device)	device)
DC-90	(K192152)	(K173471)	(K171233)
C5-1E	C5-1E	/	/
SC5-1E	SC5-1E	/	/
C6-2GE	C6-2GE	/	/
C7-3E	C7-3E	/	/
L14-6WE	L14-6WE	/	/
L16-4HE	L16-4HE	/	/
L13-3WE	L14-5WE	/	/
P10-4E	P10-4E	/	/
6LB7E	6LB7E	/	/
CB10-4E	CB10-4E	/	/
V11-3E	V11-3E	/	/
V11-3BE	V11-3BE	/	/
DE10-3WE	DE10-3WE	/	/
D7-2E	D7-2E	/	/
P7-3TE	P7-3TE	/	/

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CW5s	CW5s	/	/
CW2s	/	CW2s	/
L9-3E	/	/	L9-3E

DC-90/DC-90S/DC-90Q/DC-95/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A

Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 has the same performance and functions with the predicated device DC-80 (K192152) .

Subject Device DC-90	Predicate device DC-80 (K192152)
Ultrasound Fusion Imaging	Ultrasound Fusion Imaging
Smart Pelvic	Smart Pelvic
STE/STQ	STE/STQ
Elastography	Elastography
Contrast imaging	Contrast imaging
Smart Planes FH	Smart Planes FH
Fusion RESP	Fusion RESP
Glazing Flow	Glazing Flow
Subject Device DC-90	Reference device Resona 7( K171233)
RIMT	RIMT

. The materials of probes and Needle-guided brackets of DC-90/DC-90S/DC-90Q/DC-95/DC-95/DC-95S/DC-88/DC-88S/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 are the same to the predicate device DC-80 (K192152).
. The acoustic power levels of DC-90/DC-90S/DC-90Q/DC-95/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 are below the limits of FDA, which is the same as the predicated device DC-80 (K192152).
DC-90/DC-90S/DC-90Q/DC-95/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A . Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 is designed in compliance with the FDA recognized electrical and physical safety standards, which are the same as the predicated device DC-80 (K192152).

8. Non-clinical Tests:

DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/

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DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety, and has been found to conform with applicable medical safety standards.

Non-clinical tests relied on in this premarket notification submission for a determination of substantial equivalence include testing showing compliance with the following standards:

AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012. c1:2009/(r)2012 and a2:2010/(r)2012 (consolidated text) medical electrical equipment - part 1: general requirements for basic safety and essential performance (iec 60601-1:2005, mod).
. IEC 60601-1-2 Edition 4.0 2014-02, medical electrical equipment - part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility - requirements and tests.
. IEC 60601-2-37 Edition 2.1 2015, medical electrical equipment - part 2-37: particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment.
. IEC 62304 Edition 1.1 2015-06, medical device software - software life cycle processes.
. ISO 14971 Second edition 2007-03-01, medical devices - application of risk management to medical devices.
. NEMA UD 2-2004 (R2009), acoustic output measurement standard for diagnostic ultrasound equipment revision 3.
. AAMI / ANSI / ISO 10993-1:2009/(R)2013, biological evaluation of medical devices - part 1: evaluation and testing within a risk management process.
. IEC 62366-1 Edition 1.0 2015-02 Medical devices - Part 1: Application of usability engineering to medical devices [Including CORRIGENDUM 1 (2016)]
IEC 60601-1-6 Edition 3.1 2013-10 Medical electrical equipment Part 1-6: General . requirements for basic safety and essential performance - Collateral standard: Usability

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9. Clinical Tests:

Not Applicable.

10. Summary

Based on the performance data as documented in the study, the DC-90 Diagnostic Ultrasound system was found to have a safety and effectiveness profile that is similar to the predicate device.

Conclusion:

Intended uses and other key features are consistent with traditional clinical practices, FDA guidelines and established methods of patient examination. The design, development and quality process of the manufacturer confirms with 21 CFR 820, ISO 9001 and ISO 13485 quality systems. The device conforms to applicable medical device safety standards. Therefore, the DC-90/DC-90S/DC-90S/DC-95/DC-95S/DC-88/ DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound 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.