Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and does not describe any features or performance metrics indicative of AI/ML.

Therapeutic

No
The device is described as a "Diagnostic Ultrasound System" and its intended use is for "ultrasound evaluations." Its function is to "acquire and display ultrasound data," which is a diagnostic rather than therapeutic purpose.

Diagnostic

Yes

The "Intended Use / Indications for Use" and "Device Description" explicitly state that it is a "Diagnostic Ultrasound System" and is "intended for use by a qualified physician or allied health professional for ultrasound evaluations".

SaMD (Software as a Medical Device)

No

The device description explicitly states it consists of a "main unit along with associated transducers," indicating it includes hardware components beyond just software.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use clearly states the system is for "ultrasound evaluations" by a qualified physician or allied health professional for various clinical applications. This describes a diagnostic imaging system used on the patient, not a device used to test samples from the patient (which is the core of IVD).
Device Description: The description reinforces that it's a "Diagnostic Ultrasound System" that acquires and displays ultrasound data.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any of the typical components or processes associated with in vitro diagnostics.

The device is a diagnostic ultrasound system, which is a different category of medical device than an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Acclarix AX3 series/Acclarix LX3 series Diagnostic Ultrasound System is intended for use by a qualified physician or allied health professional for ultrasound evaluations in hospitals and clinical applications include:Abdominal. Gynecology, Obstetric. Cardiac, Small parts. Urology, Musculoskeletal . Peripheral vascular. Intraoperative, Pediatric, Neonatal , Adult Cephalic.
The modes of operation for Acclarix AX3 series include B mode, M mode, M mode, Doppler mode, Harmonic Imaging, and their combination modes.

Product codes

IYN, IYO, ITX

Device Description

Acclarix AX3 Series/ Acclarix LX3 Series is a software controlled Diagnostic Ultrasound System, which consists of a main unit along with associated transducers. It is intended for use by a qualified physician or allied health professional for ultrasound evaluations. This system is a Track 3 device to acquire and display ultrasound data in various imaging modes.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Abdominal, Obstetrics, Musculoskeletal, Peripheral vascular, Intra-operative, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Small Organ (Thyroid, Testes, Breast), Urology, Gynecology. Cardiac (Adult Cardiac, Pediatric Cardiac).

Indicated Patient Age Range

Pediatric, Neonatal, Adult

Intended User / Care Setting

Qualified physician or allied health professional for ultrasound evaluations in hospitals and clinics.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Clinical test: Clinical testing is not required.
Non-clinical test: The Acclarix AX3 Series and Acclarix LX3 Series Diagnostic Ultrasound Systems comply with:
(1) ANSVAAMI ES 60601-1:2005/(R) 2012 and A1:2012, C1:2009(R)2012 and A2:2010/(R)2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
(2) 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 disturbances - Requirements and tests
(3) 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
(4) Acoustic output testing as per the guideline "Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" dated June 27, 2019
The following biocompatibility standards are conducted on the subject device:
(5) ISO 10993-1: 2018, ISO 10993-5:2009 and ISO 10993-10:2010
The tests were selected to show substantial equivalence between the subject device and the predicate.
The non-clinical performance testing showed that the subject devices are as safe and as effective as the predicate devices.

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

Not Found

Predicate Device(s)

K192791, K192879, K200232, K201693

Reference Device(s)

K192879, K200232, K201693

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

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

Summary

0

Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration. The logo consists of a blue square on the left side, followed by the text "ADMINISTRATION" in blue. The text is in a sans-serif font and is aligned to the right of the blue square.

January 25, 2021

Edan Instruments, Inc. % Ying Dai Regulatory Engineer #15 Jinhui Road, Jinsha Community, Kengzi Sub-District, Pingshan District Shenzhen, Guangdong 518122 P R CHINA

Re: K202856

Trade/Device Name: Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3 Super, Acclarix AX25, Acclarix AX28, Acclarix AX2, Acclarix AX2 Exp, Acclarix AX2 Super, Acclarix AX15, Acclarix AX18, Acclarix LX3, Acclarix LX3 Exp, Acclarix LX3 Super, Acclarix LX25 and Acclarix LX28 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: December 25, 2020 Received: December 28, 2020

Dear Ying Dai:

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

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

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

1

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

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

Sincerely,

For

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

Enclosure

2

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known) K202856

Device Name

Diagnostic Ultrasound System; Models: Acclarix AX3 Exp. Acclarix AX3 Super, Acclarix AX25, Acclarix AX28, Acclarix AX2, Acclarix AX2 Exp, Acclarix AX2 Super, Acclarix AX18; Acclarix LX3, Acclarix LX3, Acclarix LX3 Super, Acclarix LX25, Acclarix LX28

Indications for Use (Describe)

The Acclarix AX3 series/Acclarix LX3 series Diagnostic Ultrasound System is intended for use by a qualified physician or allied health professional for ultrasound evaluations in hospitals and clinical applications include:Abdominal. Gvnecology, Obstetric. Cardiac, Small parts. Urology, Musculosketal . Peripheral vascular. Intraoperative, Pediatric, Neonatal , Adult Cephalic.

The modes of operation for Acclarix AX3 series include B mode, M mode, M mode, Doppler mode, Harmonic Imaging, and their combination modes.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response. including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

Acclarix AX3 Series/Acclarix LX3 Series Diagnostic Ultrasound System

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

	Clinical Application	Mode of Operation
General	Specific	B	M	PW	CW	Color*	Combined
(Specify)	Other (Specify)
Ophthalmic	Ophthalmic
	Fetal / Obstetrics	P	P	P		P	Note[1]	Note[2] [3] [4]
	Abdominal****	P	P	P	P	P	Note[1]	Note[2] [3]
	Intra-operative (Specify)	N	N	N	N	N	Note[1]	Note[2] [3]
	Intra-operative (Neuro logical)
	Laparoscopic
	Pediatric	N	N	N	N	N	Note[1]	Note[2] [3]
	Small Organ (Specify) **	P	P	P		P	Note[1]	Note[2] [3]
Fetal
Imaging
& Other	Neonatal Cephalic	N	N	N	N	N	Note[1]	Note[2] [3]
	Adult Cephalic	P	P	P	P	P	Note[1]	Note[2] [3]
	Trans-rectal	P	P	P		P	Note[1]	Note[2] [3]
	Trans-vaginal	P	P	P		P	Note[1]	Note[2] [3]
	Trans-urethral
	Musculo-skeletal(Conventional)	P	P	P		P	Note[1]	Note[2] [3]
	Musculo-skeletal (Superficial)	P	P	P		P	Note[1]	Note[2] [3]
	Intravascular
	Other (Specify) ***	P	P	P		P	Note[1]	Note[2] [3]
Cardiac	Adult Cardiac	P	P	P	P	P	Note[1]	Note[2] [3] [5] [6]
	Pediatric Cardiac	N	N	N	N	N	Note[1]	Note[2] [3] [5] [6]
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra- cardiac
Peripheral	Peripheral vascular	P	P	P		P	Note[1]	Note[2] [3]
vascular	Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Note: * Color Doppler includes Color imaging, PDI(Power Doppler Imaging) and DPDI(Directional Power Doppler Imaging)

** Small Organ Thyroid, Testes, Breast. ***Other use includes Urology Gynecology. ****Abdominal includes ABD and lung scanning.

| [1]: Combined mode: B+M, B+PW, B+Color,
B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW | [2]: Biopsy
Guidance | [3]: Harmonic Imaging. This
feature does not use contrast agent. | [4]: 3D/4D |
|-----------------------------------------------------------------------------------|-------------------------|---------------------------------------------------------------------|------------|
| [5]: TDI. | [6]: Anatomic M | | |

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

4

C5-2Q Transducer on Acclarix AX3 Series/Acclarix LX3 Series

	Clinical Application	Mode of Operation
General	Specific	B	M	PW	CW	Color*	Combined	Other
							(Specify)	(Specify)
Ophthalmic	Ophthalmic
	Fetal / Obstetrics	P	P	P		P	Note[1]	Note[2] [3]
	Abdominal ****	P	P	P		P	Note[1]	Note[2] [3]
	Intra-operative (Specify)
	Intra-operative (Neuro logical)
	Laparoscopic
	Pediatric
	Small Organ (Specify) **
Fetal Imaging	Neonatal Cephalic
& Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Musculo-skeletal(Conventional)	P	P	P		P	Note[1]	Note[2] [3]
	Musculo-skeletal (Superficial)	P	P	P		P	Note[1]	Note[2] [3]
	Intravascular
	Other (Specify) ***	P	P	P		P	Note[1]	Note[2] [3]
Cardiac	Adult Cardiac
	Pediatric Cardiac
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra- cardiac
Peripheral	Peripheral vascular
vascular	Other (Specify)

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

N = new indication; P = previously cleared by FDA; E = added under this appendix

Note: * Color Doppler includes Color imaging, PDI(Power Doppler Imaging) and DPDI(Directional Power Doppler Imaging)

** Small Organ includes Thyroid, Testes, Breast. ***Other use includes Urology and Gynecology.

****Abdominal includes ABD and lung scanning.

| [1]: Combined mode: B+M, B+PW,
B+Color, B+PDI/DPDI, B+Color+PW,
B+PDI/DPDI +PW | [2]: Biopsy Guidance | [3]: Harmonic Imaging.
This feature does not use
contrast agent. | [4]: 3D/4D |
|--------------------------------------------------------------------------------------|----------------------|------------------------------------------------------------------------|------------|
| [5]: TDI. | [6]: Anatomic M | | |

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

5

C7-2XQ Transducer on Acclarix AX3 Series/Acclarix LX3 Series

	Clinical Application	Mode of Operation
General	Specific	B	M	PW	CW	Color*	Combined (Specify)	Other (Specify)

Ophthalmic	Ophthalmic
	Fetal / Obstetrics	P	P	P		P	Note[1]	Note[2] [3]
	Abdominal ****	P	P	P		P	Note[1]	Note[2] [3]
	Intra-operative (Specify)
	Intra-operative (Neuro logical)
	Laparoscopic
	Pediatric
	Small Organ (Specify) **
Fetal Imaging & Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Musculo-skeletal(Conventional)	P	P	P		P	Note[1]	Note[2] [3]
	Musculo-skeletal (Superficial)	P	P	P		P	Note[1]	Note[2] [3]
	Intravascular
	Other (Specify) ***	P	P	P		P	Note[1]	Note[2] [3]
Cardiac	Adult Cardiac
	Pediatric Cardiac
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra- cardiac
Peripheral vascular	Peripheral vascular
vascular	Other (Specify)

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

N = new indication; P = previously cleared by FDA; E = added under this appendix

Note: * Color Doppler includes Color imaging, PDI(Power Doppler Imaging) and DPDI(Directional Power Doppler Imaging)

** Small Organ includes Thyroid, Testes, Breast. ***Other use includes Urology and Gynecology.

****Abdominal includes ABD and lung scanning.

| [1]: Combined mode: B+M, B+PW, B+Color,
B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW | [2]: Biopsy
Guidance | [3]: Harmonic Imaging.This feature
does not use contrast agent. | [4]: 3D/4D |
|-----------------------------------------------------------------------------------|-------------------------|--------------------------------------------------------------------|------------|
| [5]: TDI. | [6]: Anatomic M | | |

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

6

C5-1Q Transducer on Acclarix AX3 Series/Acclarix LX3 Series

	Clinical Application	Mode of Operation
General	Specific	B	M	PW	CW	Color*
(Specify)	Combined
(Specify)	Other
(Specify)

Ophthalmic	Ophthalmic
	Fetal / Obstetrics	P	P	P		P	Note[1]	Note[2] [3]
	Abdominal ****	P	P	P		P	Note[1]	Note[2] [3]
	Intra-operative (Specify)
	Intra-operative (Neuro logical)
	Laparoscopic
	Pediatric
	Small Organ (Specify) **
Fetal Imaging
& Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Musculo-skeletal(Conventional)	P	P	P		P	Note[1]	Note[2] [3]
	Musculo-skeletal (Superficial)	P	P	P		P	Note[1]	Note[2] [3]
	Intravascular
	Other (Specify) ***	P	P	P		P	Note[1]	Note[2] [3]
	Adult Cardiac
	Pediatric Cardiac
Cardiac	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra- cardiac
Peripheral
vascular	Peripheral vascular
	Other (Specify)

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

N = new indication; P = previously cleared by FDA; E = added under this appendix

Note: * Color Doppler includes Color imaging, PDI(Power Doppler Imaging) and DPDI(Directional Power Doppler Imaging)

** Small Organ includes Thyroid, Testes, Breast. ***Other use includes Urology and Gynecology.

****Abdominal includes ABD and lung scanning.

| [1]: Combined mode: B+M, B+PW, B+Color,
B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW | [2]: Biopsy
Guidance | [3]: Harmonic Imaging. This feature
does not use contrast agent. | [4]: 3D/4D |
|-----------------------------------------------------------------------------------|-------------------------|---------------------------------------------------------------------|------------|
| [5]: TDI. | [6]: Anatomic
M | | |

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

7

C6-2MQ Transducer on Acclarix AX3 Series/Acclarix LX3 Series

	Clinical Application		Mode of Operation
General	Specific	B	M	PW	CW	Color*
(Specify)	Combined
(Specify)	Other
(Specify)
		Ophthalmic	Ophthalmic
	Fetal / Obstetrics	P	P	P		P	Note[1]	Note[2] [3] [4]
	Abdominal	P	P	P		P	Note[1]	Note[2] [3]
	Intra-operative (Specify)
	Intra-operative (Neuro logical)
	Laparoscopic
	Pediatric
	Small Organ (Specify) **
Fetal Imaging
& Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Musculo-skeletal(Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Other (Specify) ***	P	P	P		P	Note[1]	Note[2] [3]
	Adult Cardiac
Cardiac	Pediatric Cardiac
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra- cardiac
Peripheral
vascular	Peripheral vascular
	Other (Specify)

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

N = new indication; P = previously cleared by FDA; E = added under this appendix Note:

Color Doppler includes Color imaging, PDI(Power Doppler Imaging) and DPDI(Directional Power Doppler Imaging)

***Other use includes Gynecology. ** Small Organ includes Thyroid, Testes, Breast.

| [1]: Combined mode: B+M, B+PW,
B+Color, B+PDI/DPDI, B+Color+PW,
B+PDI/DPDI +PW | [2]: Biopsy Guidance | [3]: Harmonic Imaging.
This feature does not use
contrast agent. | [4]: 3D/4D |
|--------------------------------------------------------------------------------------|----------------------|------------------------------------------------------------------------|------------|
| [5]: TDI. | [6]: Anatomic M | | |

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

8

L12-5Q Transducer on Acclarix AX3 Series/Acclarix LX3 Series

	Clinical Application	Mode of Operation
	Specific	B	M	PW	CW	Color*	Combined
(Specify)	Other
(Specify)
General	Specific
Ophthalmic	Ophthalmic
	Fetal / Obstetrics
	Abdominal ****	P	P	P		P	Note[1]	Note[2] [3]
	Intra-operative (Specify)
	Intra-operative (Neuro logical)
	Laparoscopic
	Pediatric
	Small Organ (Specify) **	P	P	P		P	Note[1]	Note[2] [3]
Fetal Imaging
& Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Musculo-skeletal(Conventional)	P	P	P		P	Note[1]	Note[2] [3]
	Musculo-skeletal (Superficial)	P	P	P		P	Note[1]	Note[2] [3]
	Intravascular
	Other (Specify) ***
	Adult Cardiac
Cardiac	Pediatric Cardiac
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra- cardiac
Peripheral	Peripheral vascular	P	P	P		P	Note[1]	Note[2] [3]
vascular	Other (Specify)

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

N = new indication; P = previously cleared by FDA; E = added under this appendix

Note: * Color Doppler includes Color imaging, PDI(Power Doppler Imaging) and DPDI(Directional Power Doppler Imaging)

** Small Organ includes Thyroid, Testes, Breast. ***Other use includes Urology and Gynecology.

****Abdominal includes lung scanning.

| [1]: Combined mode: B+M, B+PW,
B+Color, B+PDI/DPDI, B+Color+PW,
B+PDI/DPDI +PW | [2]: Biopsy Guidance | [3]: Harmonic Imaging.
This feature does not use
contrast agent. | [4]: 3D/4D |
|--------------------------------------------------------------------------------------|----------------------|------------------------------------------------------------------------|------------|
| [5]: TDI. | [6]: Anatomic M | | |

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

9

L17-7HQ Transducer on Acclarix AX3 Series/Acclarix LX3 Series

Clinical Application		Mode of Operation
General	Specific	B	M	PW	CW	Color*	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal / Obstetrics
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro logical)
	Laparoscopic
	Pediatric
	Small Organ (Specify) **	P	P	P		P	Note[1]	Note[2] [3]
Fetal Imaging
& Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Musculo-skeletal(Conventional)	P	P	P		P	Note[1]	Note[2] [3]
	Musculo-skeletal (Superficial)	P	P	P		P	Note[1]	Note[2] [3]
	Intravascular
	Other (Specify) ***
	Adult Cardiac
Cardiac	Pediatric Cardiac
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra- cardiac
Peripheral
vascular	Peripheral vascular	P	P	P		P	Note[1]	Note[2] [3]
	Other (Specify)

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

N = new indication; P = previously cleared by FDA; E = added under this appendix

Note: * Color Doppler includes Color imaging, PDI(Power Doppler Imaging) and DPDI(Directional Power Doppler Imaging)

** Small Organ includes Thyroid, Testes, Breast. ***Other use includes Urology and Gynecology.

| [1]: Combined mode: B+M, B+PW,
B+Color, B+PDI/DPDI, B+Color+PW,
B+PDI/DPDI +PW | [2]: Biopsy Guidance | [3]: Harmonic Imaging.This
feature does not use contrast
agent. | [4]: 3D/4D |
|--------------------------------------------------------------------------------------|----------------------|-----------------------------------------------------------------------|------------|
| [5]: TDI. | [6]: Anatomic M | | |

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

10

L17-7SQ Transducer on Acclarix AX3 Series/Acclarix LX3 Series

	Clinical Application	Mode of Operation
General	Specific	B	M	PW	CW	Color*	Combined
(Specify)	Other
(Specify)

Ophthalmic	Ophthalmic
	Fetal / Obstetrics
	Abdominal
	Intra-operative (Specify)	P	P	P		P	Note[1]	Note[2] [3]
	Intra-operative (Neuro logical)
	Laparoscopic
	Pediatric
	Small Organ (Specify) **
Fetal Imaging	Neonatal Cephalic
& Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Musculo-skeletal(Conventional)	P	P	P		P	Note[1]	Note[2] [3]
	Musculo-skeletal (Superficial)	P	P	P		P	Note[1]	Note[2] [3]
	Intravascular
	Other (Specify) ***
	Adult Cardiac
Cardiac	Pediatric Cardiac
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra- cardiac
Peripheral	Peripheral vascular	P	P	P		P	Note[1]	Note[2] [3]
vascular	Other (Specify)

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

N = new indication; P = previously cleared by FDA; E = added under this appendix

Note:

Color Doppler includes Color imaging, PDI(Power Doppler Imaging) and DPDI(Directional Power Doppler Imaging)

** Small Organ includes Thyroid, Testes, Breast.	***Other use includes Urology and Gynecology.
--------------------------------------------------	-----------------------------------------------

[1]: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW	[2]: Biopsy Guidance	[3]: Harmonic Imaging. This feature does not use contrast agent.	[4]: 3D/4D
[5]: TDI.	[6]: Anatomic M

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11

E8-4Q Transducer on Acclarix AX3 Series/Acclarix LX3 Series

	Clinical Application		Mode of Operation
	General	Specific	B	M	PW	CW	Color*	Combined (Specify)	Other (Specify)
Ophthalmic	Ophthalmic
Fetal Imaging & Other	Fetal / Obstetrics		P	P	P		P	Note[1]	Note[2] [3]
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro logical)
	Laparoscopic
	Pediatric
	Small Organ (Specify) **
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal		P	P	P		P	Note[1]	Note[2] [3]
	Trans-vaginal		P	P	P		P	Note[1]	Note[2] [3]
	Trans-urethral
	Musculo-skeletal(Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Other (Specify) ***		P	P	P		P	Note[1]	Note[2] [3]
Cardiac	Adult Cardiac
	Pediatric Cardiac
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra- cardiac
Peripheral vascular	Peripheral vascular
	Other (Specify)

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

N = new indication; P = previously cleared by FDA; E = added under this appendix

Note:

Color Doppler includes Color imaging, PDI(Power Doppler Imaging) and DPDI(Directional Power Doppler Imaging)

** Small Organ includes Thyroid, Testes, Breast.
***Other use includes Urology and Gynecology.

[1]: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW	[2]: Biopsy Guidance	[3]: Harmonic Imaging. This feature does not use contrast agent.	[4]: 3D/4D
[5]: TDI.	[6]: Anatomic M

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12

E10-3BQ Transducer on Acclarix AX3 Series/Acclarix LX3 Series

	Clinical Application	Mode of Operation
General	Specific	B	M	PW	CW	Color*
(Specify)	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal / Obstetrics	P	P	P		P	Note[1]	Note[2] [3]
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro logical)
	Laparoscopic
	Pediatric
	Small Organ (Specify) **
Fetal Imaging
& Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	Note[1]	Note[2] [3]
	Trans-vaginal	P	P	P		P	Note[1]	Note[2] [3]
	Trans-urethral
	Musculo-skeletal(Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Other (Specify) ***	P	P	P		P	Note[1]	Note[2] [3]
Cardiac	Adult Cardiac
	Pediatric Cardiac
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra- cardiac
Peripheral
vascular	Peripheral vascular
	Other (Specify)

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

N = new indication; P = previously cleared by FDA; E = added under this appendix

Note:

Color Doppler includes Color imaging, PDI(Power Doppler Imaging) and DPDI(Directional Power Doppler Imaging)

** Small Organ includes Thyroid, Testes, Breast.	***Other use includes Urology and Gynecology.
--------------------------------------------------	-----------------------------------------------

| [1]: Combined mode: B+M, B+PW,
B+Color, B+PDI/DPDI, B+Color+PW,
B+PDI/DPDI +PW | [2]: Biopsy Guidance | [3]: Harmonic Imaging.
This feature does not use
contrast agent. | [4]: 3D/4D |
|--------------------------------------------------------------------------------------|----------------------|------------------------------------------------------------------------|------------|
| [5]: TDI. | [6]: Anatomic M | | |

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13

E10-3HQ Transducer on Acclarix AX3 Series/Acclarix LX3 Series

	Clinical Application		Mode of Operation
	General	Specific	B	M	PW	CW	Color*	Combined (Specify)	Other (Specify)
	Ophthalmic	Ophthalmic
	Fetal Imaging
& Other	Fetal / Obstetrics	P	P	P		P	Note[1]	Note[2] [3]
		Abdominal
		Intra-operative (Specify)
		Intra-operative (Neuro logical)
		Laparoscopic
		Pediatric
		Small Organ (Specify) **
		Neonatal Cephalic
		Adult Cephalic
		Trans-rectal	P	P	P		P	Note[1]	Note[2] [3]
		Trans-vaginal	P	P	P		P	Note[1]	Note[2] [3]
		Trans-urethral
		Musculo-skeletal(Conventional)
		Musculo-skeletal (Superficial)
		Intravascular
		Other (Specify) ***	P	P	P		P	Note[1]	Note[2] [3]
	Cardiac	Adult Cardiac
		Pediatric Cardiac
		Intravascular(Cardiac)
		Trans-esoph.(Cardiac)
		Intra- cardiac
Peripheral
vascular	Peripheral vascular
	Other (Specify)

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

N = new indication; P = previously cleared by FDA; E = added under this appendix

Note: * Color Doppler includes Color imaging, PDI(Power Doppler Imaging) and DPDI(Directional Power Doppler Imaging)

** Small Organ includes Thyroid, Testes, Breast. ***Other use includes Urology and Gynecology.

| [1]: Combined mode: B+M, B+PW,
B+Color, B+PDI/DPDI, B+Color+PW,
B+PDI/DPDI +PW | [2]: Biopsy Guidance | [3]: Harmonic Imaging.
This feature does not use
contrast agent. | [4]: 3D/4D |
|--------------------------------------------------------------------------------------|----------------------|------------------------------------------------------------------------|------------|
| [5]: TDI. | [6]: Anatomic M | | |

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14

MC8-4Q Transducer on Acclarix AX3 Series/Acclarix LX3 Series

	Clinical Application		Mode of Operation
	General	Specific	B	M	PW	CW	Color*	Combined (Specify)	Other (Specify)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other		Fetal / Obstetrics
		Abdominal	P	P	P		P	Note[1]	Note[2] [3]
		Intra-operative (Specify)
		Intra-operative (Neuro logical)
		Laparoscopic
		Pediatric	P	P	P		P	Note[1]	Note[2] [3]
		Small Organ (Specify) **
		Neonatal Cephalic	N	N	N	N	N	Note[1]	Note[2] [3]
		Adult Cephalic
		Trans-rectal
		Trans-vaginal
		Trans-urethral
		Musculo-skeletal (Conventional)	P	P	P		P	Note[1]	Note[2] [3]
		Musculo-skeletal (Superficial)	P	P	P		P	Note[1]	Note[2] [3]
		Intravascular
		Other (Specify) ***
Cardiac		Adult Cardiac
		Pediatric Cardiac
		Intravascular(Cardiac)
		Trans-esoph.(Cardiac)
		Intra- cardiac
Peripheral
vascular		Peripheral vascular	N	N	N	N	N	Note[1]	Note[2] [3]
		Other (Specify)

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

N = new indication; P = previously cleared by FDA; E = added under this appendix

Note:

Color Doppler includes Color imaging, PDI(Power Doppler Imaging) and DPDI(Directional Power Doppler Imaging)

***Other use includes Gynecology. ** Small Organ includes Thyroid, Testes, Breast.

| [1]: Combined mode: B+M, B+PW,
B+Color, B+PDI/DPDI, B+Color+PW,
B+PDI/DPDI +PW | [2]: Biopsy Guidance | [3]: Harmonic Imaging.
This feature does not use
contrast agent. | [4]: 3D/4D |
|--------------------------------------------------------------------------------------|----------------------|------------------------------------------------------------------------|------------|
| [5]: TDI. | [6]: Anatomic M | | |

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15

MC9-3TQ Transducer on Acclarix AX3 Series/Acclarix LX3 Series

	Clinical Application		Mode of Operation
	Specific	B	M	PW	CW	Color*	Combined (Specify)	Other (Specify)
General	Ophthalmic
	Fetal / Obstetrics
	Abdominal	P	P	P		P	Note[1]	Note[2] [3]
	Intra-operative (Specify)
	Intra-operative (Neuro logical)
	Laparoscopic
	Pediatric	P	P	P		P	Note[1]	Note[2] [3]
	Small Organ (Specify) **
Fetal Imaging & Other	Neonatal Cephalic	P	P	P		P	Note[1]	Note[2] [3]
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Musculo-skeletal(Conventional)	P	P	P		P	Note[1]	Note[2] [3]
	Musculo-skeletal (Superficial)	P	P	P		P	Note[1]	Note[2] [3]
	Intravascular
	Other (Specify) ***
Cardiac	Adult Cardiac
	Pediatric Cardiac
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra- cardiac
Peripheral vascular	Peripheral vascular	P	P	P		P	Note[1]	Note[2] [3]
vascular	Other (Specify)

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

N = new indication; P = previously cleared by FDA; E = added under this appendix

Note:

Color Doppler includes Color imaging, PDI(Power Doppler Imaging) and DPDI(Directional Power Doppler Imaging)

| [1]: Combined mode: B+M, B+PW,
B+Color, B+PDI/DPDI, B+Color+PW,
B+PDI/DPDI +PW | [2]: Biopsy Guidance | [3]: Harmonic Imaging.
This feature does not use
contrast agent. | [4]: 3D/4D |
|--------------------------------------------------------------------------------------|----------------------|------------------------------------------------------------------------|------------|
| [5]: TDI. | [6]: Anatomic M | | |

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16

P5-1Q Transducer on Acclarix AX3 Series/Acclarix LX3 Series

	Clinical Application		Mode of Operation
	General	Specific	B	M	PW	CW	Color*	Combined
(Specify)	Other
(Specify)
	Ophthalmic	Ophthalmic
Fetal Imaging
& Other		Fetal / Obstetrics
		Abdominal	P	P	P	P	P	Note[1]	Note[2] [3]
		Intra-operative (Specify)
		Intra-operative (Neuro logical)
		Laparoscopic
		Pediatric
		Small Organ (Specify) **
		Neonatal Cephalic
		Adult Cephalic	P	P	P	P	P	Note[1]	Note[2] [3]
		Trans-rectal
		Trans-vaginal
		Trans-urethral
		Musculo-skeletal (Conventional)
		Musculo-skeletal (Superficial)
		Intravascular
		Other (Specify) ***
Cardiac		Adult Cardiac	P	P	P	P	P	Note[1]	Note[2] [3] [5][6]
		Pediatric Cardiac	P	P	P	P	P	Note[1]	Note[2] [3] [5][6]
		Intravascular(Cardiac)
		Trans-esoph.(Cardiac)
		Intra- cardiac
Peripheral
vascular		Peripheral vascular
		Other (Specify)

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

N = new indication; P = previously cleared by FDA; E = added under this appendix

Note:

Color Doppler includes Color imaging, PDI(Power Doppler Imaging) and DPDI(Directional Power Doppler Imaging)

| [1]: Combined mode: B+M, B+PW,
B+Color, B+PDI/DPDI, B+Color+PW,
B+PDI/DPDI +PW | [2]: Biopsy Guidance | [3]: Harmonic Imaging.
This feature does not use
contrast agent. | [4]: 3D/4D |
|--------------------------------------------------------------------------------------|----------------------|------------------------------------------------------------------------|------------|
| [5]: TDI. | [6]: Anatomic M | | |

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17

P7-3Q Transducer on Acclarix AX3 Series/Acclarix LX3 Series

	Clinical Application		Mode of Operation
General	Specific	B	M	PW	CW	Color*	Combined (Specify)	Other (Specify)
Ophthalmic	Ophthalmic
Fetal Imaging & Other	Fetal / Obstetrics
	Abdominal	P	P	P	P	P	Note[1]	Note[2] [3]
	Intra-operative (Specify)
	Intra-operative (Neuro logical)
	Laparoscopic
	Pediatric	P	P	P	P	P	Note[1]	Note[2] [3]
	Small Organ (Specify) **
	Neonatal Cephalic	P	P	P	P	P	Note[1]	Note[2] [3]
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Musculo-skeletal(Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Other (Specify) ***
Cardiac	Adult Cardiac	P	P	P	P	P	Note[1]	Note[2] [3] [5] [6]
	Pediatric Cardiac	P	P	P	P	P	Note[1]	Note[2] [3] [5] [6]
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra- cardiac
Peripheral vascular	Peripheral vascular
	Other (Specify)

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

N = new indication; P = previously cleared by FDA; E = added under this appendix

Note:

Color Doppler includes Color imaging, PDI(Power Doppler Imaging) and DPDI(Directional Power Doppler Imaging)

** Small Organ includes Thyroid, Testes, Breast.	***Other use includes Urology and Gynecology.
--------------------------------------------------	-----------------------------------------------

| [1]: Combined mode: B+M, B+PW,
B+Color, B+PDI/DPDI, B+Color+PW,
B+PDI/DPDI +PW | [2]: Biopsy Guidance | [3]: Harmonic Imaging.
This feature does not use
contrast agent. | [4]: 3D/4D |
|--------------------------------------------------------------------------------------|----------------------|------------------------------------------------------------------------|------------|
| [5]: TDI. | [6]: Anatomic M | | |

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18

L17-7Q Transducer on Acclarix AX3 Series

Clinical Application		Mode of Operation
	Specific	B	M	PW	CW	Color*	Combined
(Specify)	Other
(Specify)
General	Ophthalmic
Fetal Imaging
& Other	Fetal / Obstetrics
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro logical)
	Laparoscopic
	Pediatric
	Small Organ (Specify) **	P	P	P		P	Note[1]	Note[2] [3]
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Musculo-skeletal(Conventional)	P	P	P		P	Note[1]	Note[2] [3]
	Musculo-skeletal (Superficial)	P	P	P		P	Note[1]	Note[2] [3]
	Intravascular
	Other (Specify) ***
Cardiac	Adult Cardiac
	Pediatric Cardiac
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra- cardiac
Peripheral
vascular	Peripheral vascular	P	P	P		P	Note[1]	Note[2] [3]
	Other (Specify)

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

N = new indication; P = previously cleared by FDA; E = added under this appendix

Note: * Color Doppler includes Color imaging, PDI(Power Doppler Imaging) and DPDI(Directional Power Doppler Imaging)

** Small Organ includes Thyroid, Testes, Breast. ***Other use includes Urology and Gynecology.

| [1]: Combined mode: B+M, B+PW,
B+Color, B+PDI/DPDI,
B+Color+PW, B+PDI/DPDI +PW | [2]: Biopsy Guidance | [3]: Harmonic Imaging.
This feature does not use
contrast agent. | [4]: 3D/4D |
|--------------------------------------------------------------------------------------|----------------------|------------------------------------------------------------------------|------------|
| [5]: TDI. | [6]: Anatomic M | | |

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19

510(k) Summary

Prepared in accordance with the requirements of 21 CFR Part 807.92

1. Submitter:	Edan Instruments, Inc.
	#15 Jinhui Road, Jinsha Community, Kengzi Sub-District, Pingshan District,
	Shenzhen, Guangdong, 518122 P.R.China.
	Tel: +86-755-2685 6469 Fax: +86-755-2689 8330
Contact person:	Ying DAI
Preparing date:	Sep 25th, 2020
2. Device name and
classification:	Device Name: Diagnostic Ultrasound System
Model: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3 Super, Acclarix
AX25, Acclarix AX28, Acclarix AX2, Acclarix AX2 Exp, Acclarix AX2
Super, Acclarix AX15, Acclarix AX18; Acclarix LX3, Acclarix LX3 Exp,
Acclarix LX3 Super, Acclarix LX25 and Acclarix LX28
Classification Name/ Product code:
21 CFR 892.1550 System, Imaging, Pulsed Doppler, Ultrasonic / IYN
21 CFR 892.1560, System, Imaging, Pulsed Echo, Ultrasonic/IYO
21 CFR 892.1570, Transducer, Ultrasonic, Diagnostic / ITX
Regulatory Class: Class II
3.Premarket Notification
Class III Certification and
Summary	Not applicable, the subject device is Class II.
4. Predicate Device(s):	1) Edan Instruments, Acclarix AX3 series Diagnostic Ultrasound System,
cleared under K192791 (Primary)
	2) Edan Instruments, Acclarix LX9 series Diagnostic Ultrasound System,
cleared under K192879 (reference)
	3) George J. Hattub, LVivo Software Application, cleared under K200232
(reference)
	4) Shenzhen Mindray Bio-Medical Electronics Co., Ltd, DC-90
Diagnostic Ultrasound System cleared under K201693 (reference)
5. Reason for
Submission	By submission of the Traditional 510(k), Edan Instruments is requesting
clearance for an updated version of Acclarix AX3 series Diagnostic
Ultrasound System and new models of Acclarix LX3 series Diagnostic

20

Ultrasound System. 6.Pre-Submission, Not applicable, there is no pre-submission. IDE 7. Device Description: Acclarix AX3 Series/ Acclarix LX3 Series is a software controlled Diagnostic Ultrasound System, which consists of a main unit along with associated transducers. It is intended for use by a qualified physician or allied health professional for ultrasound evaluations. This system is a Track 3 device to acquire and display ultrasound data in various imaging modes. 8. Indication for Use The Acclarix AX3 series/Acclarix LX3 series Diagnostic Ultrasound System is intended for use by a qualified physician or allied health professional for ultrasound evaluations in hospitals and clinics. General clinical applications include: Abdominal, Gynecology, Obstetric, Cardiac, Small parts, Urology, Musculoskeletal, Peripheral vascular, Intra-operative, Pediatric, Neonatal , Adult Cephalic. The modes of operation for Acclarix AX3 series/Acclarix LX3 series include B mode, M mode, Doppler mode, Harmonic Imaging, and their combination modes.

9. Predicate Device Comparison

The subject devices Acclarix AX3 series are the same as the primary predicated devices Acclarix AX3 series (K192791) in items such as:

Intended Use/ Indications for Use; 1)
1. Mode of Operations;
1. Design principles:
Hardware and software platforms; 4)
1. Transducer types;
1. Acoustic Output, which are below the limits of FDA;
1. The materials of transducers and needle guide brackets.

The differences of subject devices Acclarix AX3 series with the primary predicated device Acclarix AX3 series (K192791) are described as below:

1. Addition of clinical applications: Pediatrics, Neonatal and Intra-operative, which are cleared by Acclarix LX9 series via K192879.

21

1. Addition of new transducers: MC8-4Q, MC9-3TQ, L17-7SQ, P7-3Q, C7-2XQ, C5-1Q, E10-3HQ, C6-2MQ, which are cleared by Acclarix LX9 series via K192879.
1. Addition of imaging modes: Anatomic M mode, TDI mode, 3D/4D mode, which are cleared by Acclarix LX9 series via K192879.
1. Addition of measurement function: Auto IMT, which is cleared by Acclarix LX9 series via K192879.
1. Addition of new needle guide brackets: BGK-004, BGK-006, BGK-007 and BGK-009, which are cleared by Acclarix LX9 series via K192879 except for the BGK-009 bracket. BGK-009 bracket uses the same material as the BGK-005 bracket previously cleared under LX9 series (K192879).
1. Addition of measurement function: Auto EF measurement, which is cleared by K200232.

The subject and predicate devices have similar design features and performance specifications. The technological differences between the subject and predicate devices do not raise different questions of safety or effectiveness.

10. Performance Data:

Clinical test:

Clinical testing is not required.

Non-clinical test:

The Acclarix AX3 Series and Acclarix LX3 Series Diagnostic Ultrasound Systems comply with:

(1) ANSVAAMI ES 60601-1:2005/(R) 2012 and A1:2012, C1:2009(R)2012 and A2:2010/(R)2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
(2) 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 disturbances - Requirements and tests
(3) 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
(4) Acoustic output testing as per the guideline "Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" dated June 27, 2019

The following biocompatibility standards are conducted on the subject device:

(5) ISO 10993-1: 2018, ISO 10993-5:2009 and ISO 10993-10:2010
The tests were selected to show substantial equivalence between the subject device and the predicate.

The non-clinical performance testing showed that the subject devices are as safe and as effective as the predicate devices.

11. Conclusion

Verification and validation testing has been conducted on the Acclarix AX3 Series and Acclarix LX3 Series Diagnostic

510(k)_Summary

22

Ultrasound Systems. This premarket notification submission demonstrates that Acclarix AX3 Series and Acclarix LX3 Series Diagnostic Ultrasound Systems are substantially equivalent to the predicate devices.