Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other indication of AI/ML technology.

Therapeutic

No.
The device is described as a "Diagnostic Ultrasound System" and its intended use is for "ultrasound evaluations," which means it's used for diagnosis, not therapy.

Diagnostic

Yes

The "Device Description" explicitly states, "The Acclarix series contains the Acclarix AX8 and Acclarix LX8 Diagnostic Ultrasound Systems." The "Predicate Device(s)" also refers to "Acclarix LX8 Diagnostic Ultrasound System," clearly indicating its diagnostic nature.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the Acclarix series contains both a software platform and "the most parts of hardware platform from Edan Instruments," and describes the devices as "portable laptop diagnostic ultrasound system" and "cart based version," indicating significant hardware components.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or treatment.
Device Function: The description clearly states that this is an Ultrasound system. Ultrasound systems use sound waves to create images of internal body structures. They do not analyze specimens taken from the body.
Intended Use: The intended use describes various clinical applications for ultrasound evaluations of different anatomical sites within the body. This aligns with the function of an ultrasound machine, not an IVD.
Lack of IVD-related information: The document does not mention any analysis of biological samples, reagents, or laboratory procedures, which are characteristic of IVD devices.

Therefore, the Acclarix series Diagnostic Ultrasound System is a medical imaging device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Ultrasound system is intended for use by a qualified physician or allied health professional for ultrasound evaluations. Specific clinical applications include:

Abdominal
Gynecology (including endovaginal)
Obstetric
Cardiac
Small parts (Breast, Testes, Thyroid, etc.)
Urology
Musculoskeletal
Peripheral vascular
Intra-operative
Pediatric
Neonatal (including abdominal and cephalic)
Adult Cephalic

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

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

IYN, IYO, ITX

Device Description

The Acclarix series contains the Acclarix AX8 and Acclarix LX8 Diagnostic Ultrasound Systems sharing a software platform (Edan Ultrasound Software Platform, also abbreviated as EUP) and the most parts of hardware platform from Edan Instruments. The Acclarix AX8 is a portable laptop diagnostic ultrasound system. A simple way to summarize the difference is that the Acclarix LX8 is a cart based version of the Acclarix AX8.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Abdominal, Gynecology (including endovaginal), Obstetric, Cardiac, Small parts (Breast, Testes, Thyroid, etc.), Urology, Musculoskeletal, Peripheral vascular, Intra-operative, Pediatric, Neonatal (including abdominal and cephalic), Adult Cephalic

Indicated Patient Age Range

Pediatric, Neonatal, Adult

Intended User / Care Setting

qualified physician or allied health professional

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 testing is not required.
Non-clinical testing demonstrated compliance with IEC 60601-1 (Electrical Safety), IEC 60601-1-2 (Electromagnetic Compatibility), IEC 60601-2-37 (Requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment), NEMA UD 3 (Standard for real-time display of thermal and mechanical acoustic output indies on diagnostic ultrasound equipment), Acoustic output testing as per the guideline "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" dated September 9, 2008. Biocompatibility standards ISO 10993-1, ISO 10993-5 and ISO 10993-10 were also conducted. These tests were selected to show substantial equivalence between the subject device and the predicate.

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K171824

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K170277

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

Not Found

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

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

Summary

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). The logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. To the left of the FDA logo is a stylized image of human figures.

May 24, 2018

Edan Instruments, Inc % Ms. Alice Yang Regulatory Engineer Edan Medical 1200 Crossman Ave, Suite 200 SUNNYVALE CA 94089

Re: K180862

Trade/Device Name: Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: March 28, 2018 Received: April 2, 2018

Dear Ms. Yang:

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

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

1

Page 2 - Ms. Alice Yang

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

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jo. Delfino

for

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

Enclosure

2

Indications for Use

510(k) Number (if known) K180862

Device Name

Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound System

Indications for Use (Describe)

The Ultrasound system is intended for use by a qualified physician or allied health professional for ultrasound evaluations. Specific clinical applications include:

Abdominal
Gynecology (including endovaginal)
Obstetric
Cardiac
Small parts (Breast, Testes, Thyroid, etc.)
[" Urology
Musculoskeletal
Peripheral vascular
Intra-operative
Pediatric
Neonatal (including abdominal and cephalic)
Adult Cephalic

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)

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

Diagnostic Ultrasound Indications for Use Form Acclarix AX8 Diagnostic Ultrasound System

	Clinical Application		Mode of Operation
	General	Specific	B	M	PW	CW	Color	Combined
(Specify) [1]	Other
(Specify) [2]3
	Ophthalmic	Ophthalmic
		Fetal / Obstetrics	P	P	P		P	P	P
		Abdominal	P	P	P	P	P	P	P
		Intra-operative (Specify)	P	P	P		P	P	P
		Intra-operative (Neuro logical)
		Laparoscopic
		Pediatric	P	P	P		P	P	P
		Small Organ (Specify) *	P	P	P		P	P	P
Fetal
Imaging
& Other		Neonatal Cephalic	P	P	P		P	P	P
		Adult Cephalic	P	P	P		P	P	P
		Trans-rectal	P	P	P		P	P	P
		Trans-vaginal	P	P	P		P	P	P
		Trans-urethral
		Musculo-skeletal (Conventional)	P	P	P		P	P	P
		Musculo-skeletal (Superficial)	P	P	P		P	P	P
		Intravascular
		Other (Specify) **	P	P	P		P	P	P
		Adult Cardiac	P	P	P	P	P	P	N5
Cardiac		Pediatric Cardiac	P	P	P	P	P	P	N5
		Intravascular(Cardiac)
		Trans-esoph.(Cardiac)
		Intra- cardiac
Peripheral
vascular		Peripheral vascular	P	P	P		P	P	P
		Other (Specify)
	N = new indication; P = previously cleared by FDA; E = added under this appendix PDI= Power Doppler Imaging
Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW

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

Small Organ includes Thyroid, Testes, Breast, Lung Note

** Other use includes Urology, Gynecology

[1]: PDI: Power Doppler Imaging, DPDI: Directional Power Doppler Imaging

[2]: Biopsy Guidance

[3]: Harmonic Imaging, This feature does not use contrast agent.

4: 3D/4D 5: TDI

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Diagnostic Ultrasound Indications for Use Form Acclarix AX8 with C5-2Q Transducer

	Clinical Application	Mode of Operation
		B	M	PW	CW	Color	Combined
(Specify) [1]	Other
(Specify) [2][3]
General	Specific

Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal / Obstetrics	P	P	P		P	P	P
	Abdominal	P	P	P		P	P	P
	Intra-operative (Specify)
	Intra-operative (Neuro logical)
	Laparoscopic
	Pediatric
	Small Organ (Specify) *
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Musculo-skeletal(Conventional)	P	P	P		P	P	P
	Musculo-skeletal (Superficial)	P	P	P		P	P	P
	Intravascular
	Other (Specify) **	P	P	P		P	P	P
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 PDI= Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW * Small Organ includes Thyroid, Testes, Breast Note

** Other use includes Urology, Gynecology

[1]: PDI: Power Doppler Imaging, DPDI: Directional Power Doppler Imaging

[2]: Biopsy Guidance

[3]: Harmonic Imaging, This feature does not use contrast agent.

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Diagnostic Ultrasound Indications for Use Form Acclarix AX8 with L12-5Q Transducer

	Clinical Application	Mode of Operation
General	Specific	B	M	PW	CW	Color	Combined
(Specify) [1]	Other
(Specify) [2][3]
	Ophthalmic	Ophthalmic
	Fetal / Obstetrics
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro logical)
	Laparoscopic
	Pediatric
	Small Organ (Specify) *	N	N	N		N	N	N
Fetal Imaging
& Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Musculo-skeletal(Conventional)	P	P	P		P	P	P
	Musculo-skeletal (Superficial)	P	P	P		P	P	P
	Intravascular
	Other (Specify) **	P	P	P		P	P	P
	Adult Cardiac
	Pediatric Cardiac
Cardiac	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra- cardiac
Peripheral	Peripheral vascular	P	P	P		P	P	P
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 PDI=Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW * Small Organ includes Thyroid, Testes, Breast, Lung. Note

** Other use includes Urology.

[1]: PDI: Power Doppler Imaging, DPDI: Directional Power Doppler Imaging

[2]: Biopsy Guidance

[3]: Harmonic Imaging, This feature does not use contrast agent.

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Concurrence of Center for Devices and Radiological Health (CDRH)

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Diagnostic Ultrasound Indications for Use Form Acclarix AX8 with MC8-4Q Transducer

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

N = new indication; P = previously cleared by FDA; E = added under this appendix PDI=Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW * Small Organ includes Thyroid, Testes, Breast. Note

** Other use includes Neonatal abdominal.

[1]: PDI: Power Doppler Imaging, DPDI: Directional Power Doppler Imaging

[2]: Biopsy Guidance

[3]: Harmonic Imaging, This feature does not use contrast agent.

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Concurrence of Center for Devices and Radiological Health (CDRH)

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Diagnostic Ultrasound Indications for Use Form Acclarix AX8 with L10-4Q Transducer

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

N = new indication; P = previously cleared by FDA; E = added under this appendix PDI=Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW * Small Organ includes Thyroid, Testes, Breast. Note

** Other use includes Urology, Gynecology.

[1]: PDI: Power Doppler Imaging, DPDI: Directional Power Doppler Imaging

[2]: Biopsy Guidance

[3]: Harmonic Imaging, This feature does not use contrast agent.

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Concurrence of Center for Devices and Radiological Health (CDRH)

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Diagnostic Ultrasound Indications for Use Form Acclarix AX8 with E8-4Q Transducer

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

N = new indication; P = previously cleared by FDA; E = added under this appendix PDI=Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW * Small Organ includes Thyroid, Testes, Breast Note

** Other use includes Urology, Gynecology

[1]: PDI: Power Doppler Imaging ,DPDI: Directional Power Doppler Imaging

[2]: Biopsy Guidance

[3]: Harmonic Imaging, This feature does not use contrast agent.

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Concurrence of Center for Devices and Radiological Health (CDRH)

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Diagnostic Ultrasound Indications for Use Form Acclarix AX8 with L17-7HQ Transducer

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

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

N = new indication; P = previously cleared by FDA; E = added under this appendix PDI= Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW Note * Small Organ includes Thyroid, Testes, Breast

** Other use includes Urology, Gynecology

[1]: PDI: Power Doppler Imaging, DPDI: Directional Power Doppler Imaging

[2]: Biopsy Guidance

[3]: Harmonic Imaging, This feature does not use contrast agent.

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

Concurrence of Center for Devices and Radiological Health (CDRH)

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Diagnostic Ultrasound Indications for Use Form Acclarix AX8 with C5-2XQ Transducer

	Clinical Application	Mode of Operation
		B	M	PW	CW	Color	Combined
(Specify) [1]	Other
(Specify) [2][3]
Ophthalmic	Ophthalmic
	Fetal / Obstetrics	P	P	P		P	P	P
	Abdominal	P	P	P		P	P	P
	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	P	P
	Musculo-skeletal (Superficial)	P	P	P		P	P	P
	Intravascular
	Other (Specify) **	P	P	P		P	P	P
	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 PDI=Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW

Small Organ includes Thyroid, Testes, Breast Note

** Other use includes Urology, Gynecology

[1]: PDI: Power Doppler Imaging, DPDI: Directional Power Doppler Imaging

[2]: Biopsy Guidance

[3]: Harmonic Imaging, This feature does not use contrast agent.

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Concurrence of Center for Devices and Radiological Health (CDRH)

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Diagnostic Ultrasound Indications for Use Form Acclarix AX8 with P5-1XQ Transducer

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) [1]	Other
(Specify) [2][3]
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal / Obstetrics
	Abdominal	P	P	P	P	P	P	P
	Intra-operative (Specify)
	Intra-operative (Neuro logical)
	Laparoscopic
	Pediatric
	Small Organ (Specify) *
	Neonatal Cephalic
	Adult Cephalic	P	P	P		P	P	P
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Musculo-skeletal(Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Other (Specify) **
Cardiac	Adult Cardiac	P	P	P	P	P	P	N4
	Pediatric Cardiac	P	P	P	P	P	P	N4
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra- cardiac
Peripheral
vascular	Peripheral vascular
	Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix PDI=Power Doppler Imaging Additional comments: Combined mode: B+M,B+PW,B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW * Small Organ includes Thyroid, Testes, Breast Note

** Other use includes Urology, Gynecology

[1]: PDI: Power Doppler Imaging, DPDI: Directional Power Doppler Imaging _____________________________________________________________________________________________________

[2]: Biopsy Guidance

[3]: Harmonic Imaging, This feature does not use contrast agent.

4: TDI .

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Concurrence of Center for Devices and Radiological Health (CDRH)

12

Diagnostic Ultrasound Indications for Use Form Acclarix AX8 with L17-7SQ Transducer

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

N = new indication; P = previously cleared by FDA; E = added under this appendix PDI=Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW

Small Organ includes Thyroid, Testes, Breast Note

** Other use includes Urology, Gynecology

[1]: PDI: Power Doppler Imaging, DPDI: Directional Power Doppler Imaging ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[2]: Biopsy Guidance

[3]: Harmonic Imaging, This feature does not use contrast agent.

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		Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application		Mode of Operation
	Specific	B	M	PW	CW	Color	Combined (Specify) [1]	Other (Specify) [2]3
General	Ophthalmic
	Fetal / Obstetrics	P	P	P	P	P	P	P
	Abdominal	N	N	N	N	N	N	N
	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) **	N	N	N	N	N	N	N
	Adult Cardiac
	Pediatric Cardiac
Cardiac	Intravascular(Cardiac)
	Trans-esoph. (Cardiac)
	Intra- cardiac
	Peripheral vascular
Peripheral
vascular	Peripheral vascular
	Other (Specify)

Diagnostic Ultrasound Indications for Use Form Acclarix AX8 with C5-2MQ Transducer

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 PDI=Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW Note * Small Organ includes Thyroid, Testes, Breast

** Other use includes Urology, Gynecology

[1]: PDI: Power Doppler Imaging, DPDI: Directional Power Doppler Imaging

[2]: Biopsy Guidance

[3]: Harmonic Imaging, This feature does not use contrast agent. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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Diagnostic Ultrasound Indications for Use Form Acclarix AX8 with P5-1Q Transducer

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) [1]	Other
(Specify) [2][3]
Ophthalmic	Ophthalmic
	Fetal / Obstetrics
	Abdominal	N	N	N		N	N	N
	Intra-operative (Specify)
	Intra-operative (Neuro logical)
	Laparoscopic
	Pediatric
	Small Organ (Specify) *
Fetal Imaging
& Other	Neonatal Cephalic
	Adult Cephalic	N	N	N		N	N	N
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Musculo-skeletal(Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Other (Specify) **
Cardiac	Adult Cardiac	N	N	N	N	N	N	N4
	Pediatric Cardiac	N	N	N	N	N	N	N4
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra- cardiac
Peripheral	Peripheral vascular
vascular	Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix PDI=Power Doppler Imaging Additional comments: Combined mode: B+M,B+PW,B+CW,B+Color, B+Color+PW, B+Color+PW, B+PDI/DPDI +PW Note > Small Organ includes Thyroid, Testes, Breast

Comments of the

** Other use includes Urology, Gynecology

[1]: PDI: Power Doppler Imaging, DPDI: Directional Power Doppler Imaging

[2]: Biopsy Guidance

[3]: Harmonic Imaging, This feature does not use contrast agent.

4: TDI .

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Diagnostic Ultrasound Indications for Use Form Acclarix AX8 with P7-3Q Transducer

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) [1]	Other
(Specify) [2][3]
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal / Obstetrics
	Abdominal	N	N	N	N	N	N	N
	Intra-operative (Specify)
	Intra-operative (Neuro logical)
	Laparoscopic
	Pediatric	N	N	N	N	N	N	N
	Small Organ (Specify) *
	Neonatal Cephalic	N	N	N	N	N	N	N
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Musculo-skeletal(Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Other (Specify) **
Cardiac	Adult Cardiac	N	N	N	N	N	N	N4
	Pediatric Cardiac	N	N	N	N	N	N	N4
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra- cardiac
Peripheral
vascular	Peripheral vascular
	Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix PDI= Power Doppler Imaging Additional comments: Combined mode: B+M,B+CW,B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW * Small Organ includes Thyroid, Testes, Breast Note

** Other use includes Urology, Gynecology

[1]: PDI: Power Doppler Imaging, DPDI: Directional Power Doppler Imaging

[2]: Biopsy Guidance

[3]: Harmonic Imaging, This feature does not use contrast agent.

4: TDI .

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

Concurrence of Center for Devices and Radiological Health (CDRH)

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Diagnostic Ultrasound Indications for Use Form Acclarix AX8 with MC9-3TQ Transducer

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

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

N = new indication; P = previously cleared by FDA; E = added under this appendix PDI= Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW * Small Organ includes Thyroid, Testes, Breast. Note

** Other use includes Neonatal abdominal.

[1]: PDI: Power Doppler Imaging, DPDI: Directional Power Doppler Imaging

[2]: Biopsy Guidance

[3]: Harmonic Imaging, This feature does not use contrast agent.

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

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Diagnostic Ultrasound Indications for Use Form Acclarix LX8 Diagnostic Ultrasound System

ntended 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) [1]	Other
(Specify) [2]3
Ophthalmic	Ophthalmic
	Fetal / Obstetrics	P	P	P		P	P	P
	Abdominal	P	P	P	P	P	P	P
	Intra-operative (Specify)	P	P	P		P	P	P
	Intra-operative (Neuro logical)
	Laparoscopic
	Pediatric	P	P	P		P	P	P
Fetal Imaging
& Other	Small Organ (Specify) *	P	P	P		P	P	P
	Neonatal Cephalic	P	P	P		P	P	P
	Adult Cephalic	P	P	P		P	P	P
	Trans-rectal	P	P	P		P	P	P
	Trans-vaginal	P	P	P		P	P	P
	Trans-urethral
	Musculo-skeletal(Conventional)	P	P	P		P	P	P
	Musculo-skeletal (Superficial)	P	P	P		P	P	P
	Intravascular
	Other (Specify) **	P	P	P		P	P	P
	Adult Cardiac	P	P	P	P	P	P	N5
Cardiac	Pediatric Cardiac	P	P	P	P	P	P	N5
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra- cardiac
Peripheral	Peripheral vascular	P	P	P		P	P	P
vascular	Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix PDI= Power Doppler Imaging Additional comments: Combined mode: B+M, B+Color, B+PDV/DPDI, B+Color+PW, B+PDI/DPDI +PW, B+CW, B+Color+CW, B+PDI/DPDI +CW,

Small Organ includes Thyroid, Testes, Breast,Lung Note

** Other use includes Urology, Gynecology and Neonatal adbdominal

[1]: PDI: Power Doppler Imaging, DPDI: Directional Power Doppler Imaging

[2]: Biopsy Guidance .

[3]: Harmonic Imaging, This feature does not use contrast agent.

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Diagnostic Ultrasound Indications for Use Form Acclarix LX8 with L10-4D Transducer

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

N = new indication; P = previously cleared by FDA; E = added under this appendix PDI=Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW * Small Organ includes Thyroid, Testes, Breast. Note

** Other use includes Urology, Gynecology.

[1]: PDI: Power Doppler Imaging, DPDI: Directional Power Doppler Imaging ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[2]: Biopsy Guidance

[3]: Harmonic Imaging, This feature does not use contrast agent.

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Diagnostic Ultrasound Indications for Use Form Acclarix LX8 with E8-4D Transducer

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

N = new indication; P = previously cleared by FDA; E = added under this appendix PDI=Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW * Small Organ includes Thyroid, Testes, Breast Note

** Other use includes Urology, Gynecology

[1]: PDI: Power Doppler Imaging ,DPDI: Directional Power Doppler Imaging

[2]: Biopsy Guidance

[3]: Harmonic Imaging, This feature does not use contrast agent.

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

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Diagnostic Ultrasound Indications for Use Form Acclarix LX8 with L17-7HD Transducer

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

N = new indication; P = previously cleared by FDA; E = added under this appendix PDI= Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW * Small Organ includes Thyroid, Testes, Breast Note

** Other use includes Urology, Gynecology

[1]: PDI: Power Doppler Imaging, DPDI: Directional Power Doppler Imaging

[2]: Biopsy Guidance

[3]: Harmonic Imaging, This feature does not use contrast agent.

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

21

Diagnostic Ultrasound Indications for Use Form Acclarix LX8 with C5-2XD Transducer

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) [1]	Other
(Specify) [2][3]
Ophthalmic	Ophthalmic
	Fetal / Obstetrics	P	P	P		P	P	P
	Abdominal	P	P	P		P	P	P
	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	P	P
	Musculo-skeletal (Superficial)	P	P	P		P	P	P
	Intravascular
	Other (Specify) **	P	P	P		P	P	P
Cardiac	Adult Cardiac
	Pediatric Cardiac
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra- cardiac
Peripheral
vascular	Peripheral vascular
	Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix PDI= Power Doppler Imaging Additional comments: Combined mode: B+M, B+Color, B+Color, B+Color+PW, B+Color+PW, B+PDV/DPDI +PW Note > Small Organ includes Thyroid, Testes, Breast

** Other use includes Urology, Gynecology

[1]: PDI: Power Doppler Imaging, DPDI: Directional Power Doppler Imaging

[2]: Biopsy Guidance

[3]: Harmonic Imaging, This feature does not use contrast agent.

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

22

Diagnostic Ultrasound Indications for Use Form Acclarix LX8 with P5-1XD Transducer

	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) [1]	Other
(Specify) [2][3]
Ophthalmic	Ophthalmic
	Fetal / Obstetrics
	Abdominal	P	P	P	P	P	P	P
	Intra-operative (Specify)
	Intra-operative (Neuro logical)
	Laparoscopic
	Pediatric
	Small Organ (Specify) *
Fetal Imaging	Neonatal Cephalic
& Other	Adult Cephalic	P	P	P	P	P	P	P
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Musculo-skeletal(Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Other (Specify) **
	Adult Cardiac	P	P	P	P	P	P	N4
	Pediatric Cardiac	P	P	P	P	P	P	N4
Cardiac	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra- cardiac
Peripheral	Peripheral vascular
vascular	Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix PDI= Power Doppler Imaging Additional comments: Combined mode: B+M, B+CW, B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW, B+Color+CW, B+PDI/DPDI+CW

Note * Small Organ includes Thyroid, Testes, Breast

** Other use includes Urology, Gynecology

[1]: PDI: Power Doppler Imaging, DPDI: Directional Power Doppler Imaging

[2]: Biopsy Guidance

[3]: Harmonic Imaging, This feature does not use contrast agent.

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

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Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Clinical Application	Mode of Operation
		B	M	PW	CW	Color	Combined
(Specify) [1]	Other
(Specify) [2][3]
General	Specific
Ophthalmic	Ophthalmic
	Fetal / Obstetrics
	Abdominal
	Intra-operative (Specify)	P	P	P		P	P	P
	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	P	P
	Musculo-skeletal (Superficial)	P	P	P		P	P	P
	Intravascular
	Other (Specify) **
	Adult Cardiac
	Pediatric Cardiac
Cardiac	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra- cardiac

Peripheral
vascular	Peripheral vascular	N	N	N	N	N	N	N
	Other (Specify)

Diagnostic Ultrasound Indications for Use Form Acclarix LX8 with L17-7SD Transducer

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

N = new indication; P = previously cleared by FDA; E = added under this appendix PDI= Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW Note * Small Organ includes Thyroid, Testes, Breast

** Other use includes Urology, Gynecology

[1]: PDI: Power Doppler Imaging, DPDI: Directional Power Doppler Imaging

[2]: Biopsy Guidance

[3]: Harmonic Imaging, This feature does not use contrast agent.

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

24

Diagnostic Ultrasound Indications for Use Form Acclarix LX8 with C5-2MD Transducer

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) [1]	Other
(Specify)[2]3
Ophthalmic	Ophthalmic
	Fetal / Obstetrics	P	P	P		P	P	P
	Abdominal	N	N	N		N	N	N
	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) **	N	N	N		N	N	N
	Adult Cardiac
	Pediatric Cardiac
Cardiac	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra- cardiac
Peripheral
vascular	Peripheral vascular
	Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix PDI= Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW Note * Small Organ includes Thyroid, Testes, Breast

** Other use includes Urology, Gynecology

[1]: PDI: Power Doppler Imaging, DPDI: Directional Power Doppler Imaging

[2]: Biopsy Guidance

[3]: Harmonic Imaging, This feature does not use contrast agent.

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

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25

Diagnostic Ultrasound Indications for Use Form Acclarix LX8 with C5-2D Transducer

				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) [1]	Other
(Specify) [2][3]
Ophthalmic	Ophthalmic
	Fetal / Obstetrics	P	P	P		P	P	P
	Abdominal	P	P	P		P	P	P
	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	P	P
	Musculo-skeletal (Superficial)	P	P	P		P	P	P
	Intravascular
	Other (Specify) **	P	P	P		P	P	P
	Adult Cardiac
	Pediatric Cardiac
Cardiac	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra- cardiac
Peripheral
vascular	Peripheral vascular
	Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix PDI= Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW Note * Small Organ includes Thyroid, Testes, Breast

** Other use includes Urology, Gynecology

[1]: PDI: Power Doppler Imaging, DPDI: Directional Power Doppler Imaging

[2]: Biopsy Guidance

[3]: Harmonic Imaging, This feature does not use contrast agent.

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

Concurrence of Center for Devices and Radiological Health (CDRH)

26

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

Diagnostic Ultrasound Indications for Use Form Acclarix LX8 with L12-5D Transducer

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 PDI= Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW Note * Small Organ includes Thyroid, Testes, Breast, Lung.

** Other use includes Urology.

[1]: PDI: Power Doppler Imaging, DPDI: Directional Power Doppler Imaging

[2]: Biopsy Guidance

[3]: Harmonic Imaging, This feature does not use contrast agent.

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Diagnostic Ultrasound Indications for Use Form Acclarix LX8 with MC8-4D Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
		CHARACTERIAL CARRING REPORT REM CHIENE BER 1. 14 S

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

N = new indication; P = previously cleared by FDA; E = added under this appendix PDI= Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW Note * Small Organ includes Thyroid, Testes, Breast.

** Other use includes Neonatal abdominal_

[1]: PDI: Power Doppler Imaging, DPDI: Directional Power Doppler Imaging _____________________________________________________________________________________________________

[2]: Biopsy Guidance

[3]: Harmonic Imaging, This feature does not use contrast agent.

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Diagnostic Ultrasound Indications for Use Form Acclarix LX8 with P5-1D Transducer

		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) [1]	Other
(Specify) [2][3]
Ophthalmic	Ophthalmic
	Fetal / Obstetrics
	Abdominal	N	N	N		N	N	N
	Intra-operative (Specify)
	Intra-operative (Neuro logical)
	Laparoscopic
	Pediatric
	Small Organ (Specify) *
Fetal Imaging	Neonatal Cephalic
& Other	Adult Cephalic	N	N	N		N	N	N
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Musculo-skeletal(Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Other (Specify) **
	Adult Cardiac	N	N	N	N	N	N	N4
	Pediatric Cardiac	N	N	N	N	N	N	N4
Cardiac	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra- cardiac
Peripheral	Peripheral vascular
vascular	Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix PDI= Power Doppler Imaging Additional comments: Combined mode: B+M,B+PW,B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW Note * Small Organ includes Thyroid, Testes, Breast

** Other use includes Urology, Gynecology

[1]: PDI: Power Doppler Imaging, DPDI: Directional Power Doppler Imaging

[2]: Biopsy Guidance

[3]: Harmonic Imaging, This feature does not use contrast agent.

4: TDI .

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29

	Clinical Application	Mode of Operation
General	Specific	B	M	PW	CW	Color	Combined
(Specify) [1]	Other
(Specify) [2][3]

Ophthalmic	Ophthalmic
	Fetal / Obstetrics
	Abdominal	N	N	N	N	N	N	N
	Intra-operative (Specify)
	Intra-operative (Neuro logical)
	Laparoscopic
	Pediatric	N	N	N	N	N	N	N
	Small Organ (Specify) *
Fetal Imaging
& Other	Neonatal Cephalic	N	N	N	N	N	N	N
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Musculo-skeletal(Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Other (Specify) **
	Adult Cardiac	N	N	N	N	N	N	N4
	Pediatric Cardiac	N	N	N	N	N	N	N4
Cardiac	Intravascular(Cardiac)
	Trans-esoph. (Cardiac)
	Intra- cardiac
Peripheral	Peripheral vascular
vascular	Other (Specify)

Diagnostic Ultrasound Indications for Use Form Acclarix LX8 with P7-3D Transducer_

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 PDI= Power Doppler Imaging Additional comments: Combined mode: B+M,B+PW,B+CW,B+Color, B+Color+PW, B+Color+PW, B+PDI/DPDI +PW Note __ * Small Organ includes Thyroid, Testes, Breast

** Other use includes Urology, Gynecology

[1]: PDI: Power Doppler Imaging, DPDI: Directional Power Doppler Imaging

[2]: Biopsy Guidance

[3]: Harmonic Imaging, This feature does not use contrast agent.

4: TDI .

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Diagnostic Ultrasound Indications for Use Form Acclarix LX8 with MC9-3TD Transducer

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

N = new indication; P = previously cleared by FDA; E = added under this appendix PDI= Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW * Small Organ includes Thyroid, Testes, Breast. Note

** Other use includes Neonatal abdominal.

[1]: PDI: Power Doppler Imaging, DPDI: Directional Power Doppler Imaging

[2]: Biopsy Guidance

[3]: Harmonic Imaging, This feature does not use contrast agent.

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31

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, 518122 P.R.China.
Tel.: (0755) 26859216 Fax: +1 (408) 418-4059 |
|--------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Alice Yang |
| Date prepared: | March 28,2018 |
| 2. Device name
and
classification: | Device Name: Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8
Diagnostic Ultrasound System
Model: Acclarix AX8, Acclarix LX8
Classification Name:
892.1550 System, Imaging, Pulsed Doppler, Ultrasonic
Product code: IYN
892.1560 Ultrasonic, Pulsed echo, Imaging
Product code: IYO
892.1570 Transducer, Ultrasonic, Diagnostic
Product code: 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, Inc., Acclarix LX8 Diagnostic Ultrasound System
cleared under K171824 (Primary)
2. Shenzhen Mindray Bio-Medical Electronics Co., Ltd. DC-8 Diagnostic
Ultrasound System
cleared under K170277 (Reference) |
| 5. Reason for
Submission | By submission of the Traditional 510(k), Edan Instruments is requesting
clearance for an updated version of both the Acclarix AX8 and the Acclarix
LX8 Diagnostic Ultrasound Systems, known as the 1.4 release. |
| 6.
Pre-Submission,
IDE | Not applicable, there is no prior submission. |
| 7. Device
Description: | The Acclarix series contains the Acclarix AX8 and Acclarix LX8
Diagnostic Ultrasound Systems sharing a software platform (Edan
Ultrasound Software Platform, also abbreviated as EUP) and the most parts
of hardware platform from Edan Instruments. The Acclarix AX8 is a
portable laptop diagnostic ultrasound system. A simple way to summarize
the difference is that the Acclarix LX8 is a cart based version of the
Acclarix AX8. |
| 8. Intended Use: | The Acclarix AX8 Diagnostic Ultrasound system/Acclarix LX8 Diagnostic
Ultrasound system is intended for use by a qualified physician or allied
health professional for ultrasound evaluations. Specific clinical applications
include:
• Abdominal
• Gynecology (including endovaginal)
• Obstetric
• Cardiac
• Small parts (Breast, Testes, Thyroid, etc.)
• Urology
• Musculoskeletal
• Peripheral vascular
• Intra-operative
• Pediatric
• Neonatal (including abdominal and cephalic) |

32

Adult Cephalic

9. Predicate Device Comparison

Comparison to the predicate devices, the subject device has same intended use, similar product design, same performance effectiveness, performance safety as the predicate device as summarized in the following table:

| Item | Acclarix AX8 R1.4
Diagnostic
Ultrasound System
(Edan Instruments) | Acclarix LX8 R1.4
Diagnostic
Ultrasound System
(Edan Instruments) | Acclarix LX8
R1.3Diagnostic
Ultrasound System
(Edan Instruments) | Comparison
Result |
|---------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| 510(k)
Number | Current Submission | Current Submission | K171824 | - |
| Intended Use | Diagnostic ultrasound
imaging or fluid flow
analysis of the human
body | Diagnostic ultrasound
imaging or fluid flow
analysis of the human
body | Diagnostic ultrasound
imaging or fluid flow
analysis of the human
body | Same |
| Indications
for Use | The Acclarix AX8
Diagnostic Ultrasound
System is intended for
use by a qualified
physician or
sonographer for
ultrasound evaluation.
Clinical applications
include: Abdominal, | The Acclarix LX8
Diagnostic Ultrasound
System is intended for
use by a qualified
physician or
sonographer for
ultrasound evaluation.
Clinical applications
include: Abdominal, | The Acclarix LX8
Diagnostic Ultrasound
System is intended for
use by a qualified
physician or
sonographer for
ultrasound evaluation.
Clinical applications
include: Abdominal, | Same |
| | Gynecology (including
endovaginal), Obstetric,
Cardiac, Small parts
(Breast, Testes, Thyroid,
etc.), Urology,
Musculoskeletal,
Peripheral vascular,
Intra-operative, Pediatric
and Neonatal (including
abdominal and
cephalic), and Adult
cephalic. | Gynecology (including
endovaginal),
Obstetric, Cardiac,
Small parts (Breast,
Testes, Thyroid, etc.),
Urology,
Musculoskeletal,
Peripheral vascular,
Intra-operative,
Pediatric and Neonatal
(including abdominal
and cephalic), and
Adult cephalic. | Gynecology (including
endovaginal),
Obstetric, Cardiac,
Small parts (Breast,
Testes, Thyroid, etc.),
Urology,
Musculoskeletal,
Peripheral vascular,
Intra-operative,
Pediatric and Neonatal
(including abdominal
and cephalic), and
Adult cephalic. | |
| Installation
and Use | Portable
(laptop)Mobile
Equipment | Trolley Mobile
Equipment | Trolley Mobile
Equipment | Refer to
Table 2-2 |
| Safety
Standards | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-37
ISO 10993-1, -5, -10,
-12
AIUM, NEMA UD 2,
UD3 | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-37
ISO 10993-1, -5, -10,
-12
AIUM, NEMA UD 2,
UD3 | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-37
ISO 10993-1, -5, -10,
-12
AIUM, NEMA UD 2,
UD3 | Same |
| Patient
Contact
Materials | Complies with ISO
10993 | Complies with ISO
10993 | Complies with ISO
10993 | Same |
| Mode of
Operations | B-Mode, M-Mode,
Anatomical M
mode,Color,
PDI/DPDI, PW, CW,
3D/4D,TDI | B-Mode, M-Mode,
Anatomical M mode,
Color, PDI/DPDI, PW,
CW, 3D/4D,TDI | B-Mode, M-Mode,
Color, PDI/DPDI, PW,
CW, 3D/4D | Different |
| Measurements | B-Mode: Distance,
Circ/Area, Angle,
Volume, Stenosis ratio,
Dist Stenosis, Area
Stenosis.
M-Mode: Distance,
Time, Slope and Heart
Rate
D-Mode: Velocity, RI,
Time, PI, Heart Rate,
Auto Trace, PG1,PG2,
S/D, ΔV, Acceleration,
PHT, VTI, PGmax,
PGmean,TAMax,
AT,DT,PS,ED,MD, | B-Mode: Distance,
Circ/Area, Angle,
Volume, Stenosis ratio,
Dist Stenosis, Area
Stenosis.
M-Mode: Distance,
Time, Slope and Heart
Rate
D-Mode: Velocity, RI,
Time, PI, Heart Rate,
Auto Trace, PG1,PG2,
S/D, ΔV, Acceleration,
PHT, VTI, PGmax,
PGmean,TAMax,
AT,DT,PS,ED,MD, | B-Mode: Distance,
Circ/Area, Angle,
Volume, Stenosis ratio
M-Mode: Distance,
Time, Slope and Heart
Rate
D-Mode: Velocity, RI,
Time, PI, Heart Rate,
Auto Trace, PG, S/D,
ΔV, Acceleration,
PHT, VTI | Different |
| Principle of
Operation | Applying high voltage
burst to the
Piezoelectric material
in the transducer and | Applying high voltage
burst to the
Piezoelectric material
in the transducer and | Applying high voltage
burst to the
Piezoelectric material
in the transducer and | Same |
| | detect reflected echo to
construct diagnostic
image | detect reflected echo to
construct diagnostic
image | detect reflected echo to
construct diagnostic
image | |
| Acoustic
Output | Track 3: MI, TIS, TIC,
TIB (TI Range 0-6.0)
Derated ISPTA: 720
W/cm² maximum,
Mechanic Index ≤1.9
maximum or Derated
ISPPA 190 W/cm² max | Track 3: MI, TIS, TIC,
TIB (TI Range 0-6.0)
Derated ISPTA: 720
W/cm² maximum,
Mechanic Index ≤1.9
maximum or Derated
ISPPA 190 W/cm² max | Track 3: MI, TIS, TIC,
TIB (TI Range 0-6.0)
Derated ISPTA: 720
W/cm² maximum,
Mechanic Index ≤1.9
maximum or Derated
ISPPA 190 W/cm² max | Same |
| Transducer
Types | Convex Array
Linear Array
Endocavity-Micro
Convex Array
Phased Array
Micro Convex Array | Convex Array
Linear Array
Endocavity-Micro
Convex Array
Phased Array
Micro Convex Array | Convex Array
Linear Array
Endocavity-Micro
Convex Array
Phased Array
Micro Convex Array | Same |
| Transducer
Frequency | 1-17.0 MHz | 1-17.0 MHz | 1-17.0 MHz | Same |
| Primary
Display | Primary Screen:15.1
inch
(1920 x 1080) | Primary Screen: 21.5
inch
(1920 x 1080) | Primary Screen: 21.5
inch
(1920 x 1080) | Refer to
Table 2-2 |
| Transducer
Ports | Single -Transducer Port
(Extendable with
Multi-Transducer
Connector to Three
Ports) | Multi-Transducer Port
(Four) | Multi-Transducer Port
(Four) | Refer to
Table 2-2 |
| Dimensions/
Weight | 407mm(W)
x388mm(L) x77mm(H)
Weight: 8.2Kg
(With rechargeable
battery, without power
adaptor or transducers
or monitor glass.)
8.6Kg(with
rechargeable battery
and monitor glass,
without power adaptor
or transducers) | Height: 53 - 70
in(1355-1780mm)
Width: 23 in (585mm)
Depth: 36.6 in
(930mm)
Weight: 111 Kg (no
peripherals) | Height: 53 - 70 in
(1355-1780mm)
Width: 23 in (585mm)
Depth: 36.6 in
(930mm)
Weight: 111 Kg (no
peripherals) | Refer to
Table 2-2 |
| Power
Requirements | 00-240V, 50/60Hz,
2.5A max | 00-240V, 50/60Hz,
2.5A max | 100-240V, 50/60Hz,
2.5A max | Same |
| Features | 3D/4D, CW, HPRF,
Dual screen display,
Panorama, Spatial
Compounding
Imaging, Frequency
Compounding
Imaging,
Multi-Beam-Forming,
Speckle Resistance
Imaging(eSRI) | 3D/4D, CW, HPRF,
Dual screen display,
Panorama, Spatial
Compounding
Imaging, Frequency
Compounding
Imaging,
Multi-Beam-Forming,
Speckle Resistance
Imaging(eSRI) | 3D/4D, CW, HPRF,
Dual screen display,
Panorama, Spatial
Compounding
Imaging, Frequency
Compounding
Imaging,
Multi-Beam-Forming,
Speckle Resistance
Imaging(eSRI) | Different |
| One-Key-Optimization,
B-Steer, Digital Zoom,
Needle Visualization,
Auto IMT, Tissue
Doppler Imaging(TDI),
Anatomical M mode. | One-Key-Optimization,
B-Steer, Digital Zoom,
Needle Visualization,
Auto IMT, Tissue
Doppler Imaging(TDI),
Anatomical M mode. | One-Key-Optimization,
B-Steer, Digital Zoom,
Needle Visualization,
Auto IMT | | |

Table 2-1 Comparison between the subject Acclarix R1.4and Acclarix LX8 R1.3

33

34

35

Table 2-2 Comparison between the subject Acclarix AX8 R1.4 and Acclarix AX8 R1.3

| Item | Acclarix AX8 R1.4 Diagnostic
Ultrasound System (Edan
Instruments) | Acclarix AX8 R1.3Diagnostic
Ultrasound System (Edan
Instruments) | Comparison
Result |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| 510(k) Number | Current Submission | K171824
(Reference, as AX8 is portable
compared to LX8 and this AX8
submission is an SW update to
previous AX8.) | |
| Intended Use | Diagnostic ultrasound imaging or
fluid flow analysis of the human
body | Diagnostic ultrasound imaging or
fluid flow analysis of the human
body | Same |
| Indications for
Use | The Acclarix AX8 Diagnostic
Ultrasound System is intended
for use by a qualified physician
or sonographer for ultrasound
evaluation. Clinical applications
include: Abdominal, Gynecology
(including endovaginal),
Obstetric, Cardiac, Small parts
(Breast, Testes, Thyroid, etc.),
Urology, Musculoskeletal,
Peripheral vascular,
Intra-operative, Pediatric and
Neonatal (including abdominal
and cephalic), and Adult
cephalic. | The Acclarix AX8 Diagnostic
Ultrasound System is intended for
use by a qualified physician or
sonographer for ultrasound
evaluation. Clinical applications
include: Abdominal, Gynecology
(including endovaginal), Obstetric,
Cardiac, Small parts (Breast,
Testes, Thyroid, etc.), Urology,
Musculoskeletal, Peripheral
vascular, Intra-operative, Pediatric
and Neonatal (including abdominal
and cephalic), and Adult cephalic. | Same |
| Installation and
Use | Portable
(laptop)Mobile
Equipment | Portable (laptop)Mobile Equipment | Same |
| Design | 128 channel | 128 channel | Same |
| Safety
Standards | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-37
ISO 10993-1, -5, -10, -12
AIUM, NEMA UD 2, UD 3 | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-37
ISO 10993-1, -5, -10, -12
AIUM, NEMA UD 2, UD 3 | Same |
| Patient Contact
Materials | Complies with ISO 10993 | Complies with ISO 10993 | Same |
| Mode of
Operations | B-Mode, M-Mode, Color,
PDI/DPDI, PW, CW, 3D/4D,
Tissue Doppler Imaging(TDI),
Anatomical M mode. | B-Mode, M-Mode, Color,
PDI/DPDI, PW, CW, 3D/4D | Difference |
| Measurements | B-Mode: Distance, Circ/Area,
Angle, Volume, Stenosis ratio | B-Mode: Distance, Circ/Area,
Angle, Volume, Stenosis ratio | Different |

36

| Item | Acclarix AX8 R1.4 Diagnostic
Ultrasound System (Edan
Instruments) | Acclarix AX8 R1.3Diagnostic
Ultrasound System (Edan
Instruments) | Comparison
Result |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| | Dist Stenosis, Area Stenosis.
M-Mode: Distance, Time, Slope
and Heart Rate
D-Mode: Velocity, RI, Time, PI,
Heart Rate, Auto Trace,
PG1,PG2, S/D, ΔV, Acceleration,
PHT, VTI, PGmax,
PGmean,TAMax,
AT,DT,PS,ED,MD, | M-Mode: Distance, Time, Slope
and Heart Rate
D-Mode: Velocity, RI, Time, PI,
Heart Rate, Auto Trace
PG, S/D, AV, Acceleration, PHT,
VTI | |
| Principle of
Operation | Applying high voltage burst to
the Piezoelectric material in the
transducer and detect reflected
echo to construct diagnostic
image | Applying high voltage burst to the
Piezoelectric material in the
transducer and detect reflected echo
to construct diagnostic image | Same |
| Acoustic
Output | Track 3: MI, TIS, TIC, TIB (TI
Range 0-6.0)
Derated ISPTA: 720W/cm²
maximum,
Mechanic Index ≤ 1.9 maximum
or Derated ISPPA 190 W/cm2 max
Ophthalmic use:
TI = Max (TIS_as, TIC) ≤1;
ISPTA.3 ≤ 50m/W/cm2; and MI ≤
0.23 | Track 3: MI, TIS, TIC, TIB (TI
Range 0-6.0)
Derated ISPTA: 720W/cm²
maximum,
Mechanic Index ≤ 1.9 maximum or
Derated ISPPA 190 W/cm2 max
Ophthalmic use:
TI = Max (TIS_as, TIC) ≤1;
ISPTA.3 ≤ 50m/W/cm2; and MI ≤
0.23 | Same |
| Transducer
Frequency | 2.5-15.0 MHz | 2.5-15.0 MHz | Same |
| Dimensions/
Weight | 407mm(W) x388mm(L)
x77mm(H)
Weight: 8.2Kg
(With rechargeable battery,
without power adaptor or
transducers or monitor glass.)
8.6Kg(with rechargeable
battery and monitor glass,
without power adaptor or
transducers) | 407mm (W) x 388mm (L) x77mm
(H)
Weight: 9.1Kg
(With rechargeable battery, without
power adaptor or transducers.) | Different |
| Power
Requirements | 100-240V, 50/60Hz | 100-240V, 50/60Hz | Same |
| Rechargeable
Battery | Yes | Yes | Same |

Table 2-3Comparison between the subject Acclarix R1.4and DC-8(K170277)

| Item | Acclarix AX8
R1.4Diagnostic
Ultrasound System
(Edan Instruments) | Acclarix LX8
R1.4Diagnostic
Ultrasound System
(Edan Instruments) | DC-8 Diagnostic
Ultrasound System
(Shenzhen Mindray
Bio-Medical
Electronics) | Comparison
Result |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| 510(k)
Number | Current Submission | Current Submission | K170277
(Reference, for Color
1 Key optimization,
Anatomical M mode,
TDI) | -Same |
| Intended Use | Diagnostic ultrasound
imaging or fluid flow
analysis of the human
body | Diagnostic ultrasound
imaging or fluid flow
analysis of the human
body | Diagnostic Ultrasound
System applicable for
adults, pregnant
women, pediatric
patients and neonates. | Same |
| Indications
for Use | The Acclarix AX8
Diagnostic Ultrasound
System is intended for
use by a qualified
physician or
sonographer for
ultrasound evaluation.
Clinical applications
include: Abdominal,
Gynecology
(including
endovaginal),
Obstetric, Cardiac,
Small parts (Breast,
Testes, Thyroid, etc.),
Urology,
Musculoskeletal,
Peripheral vascular,
Intra-operative,
Pediatric and Neonatal
(including abdominal
and cephalic), and
Adult cephalic. | The Acclarix LX8
Diagnostic Ultrasound
System is intended for
use by a qualified
physician or
sonographer for
ultrasound evaluation.
Clinical applications
include: Abdominal,
Gynecology
(including
endovaginal),
Obstetric, Cardiac,
Small parts (Breast,
Testes, Thyroid, etc.),
Urology,
Musculoskeletal,
Peripheral vascular,
Intra-operative,
Pediatric and
Neonatal (including
abdominal and
cephalic), and Adult
cephalic. | The DC-8/DC-8
PRO/DC-8 CV/DC-8
EXP/DC-8S
Diagnostic Ultrasound
System is applicable
for adults, pregnant
women, pediatric
patients and neonates.
It is intended for use
in fetal, abdominal,
pediatric, small organ
(breast, thyroid.
testes), neonatal
cephalic, adult
cephalic, trans-rectal,
trans-vaginal,
musculo-skeletal
(conventional,
superficial), cardiac
adult, cardiac
pediatric, peripheral
vessel, urology and
transesophageal
(Cardiac) exams. | Same |
| Installation
and Use | Portable
(laptop)Mobile
Equipment | Trolley Mobile
Equipment | Trolley Mobile
Equipment | Refer to Table
2-2 |
| Safety
Standards | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-37
ISO 10993-1, -5, -10,
-12
AIUM, NEMA UD 2,
UD3 | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-37
ISO 10993-1, -5, -10,
-12
AIUM, NEMA UD 2,
UD3 | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-37
ISO 10993-1, -5, -10,
-12
AIUM, NEMA UD 2,
UD3 | Same |
| Patient
Contact
Materials | Complies with ISO
10993 | Complies with ISO
10993 | Complies with ISO
10993 | Same |

37

The subject device has same intended use, similar product design, same performance effectiveness, and

38

performance safety as the predicate device.

The differences between the subject device and predicate device do not affect the basic design principle, usage, effectiveness and safety of the subject device. And no question is raised regarding to effectiveness and safety.

10. Effectiveness and Safety Considerations:

Clinical test:

Clinical testing is not required.

Non-clinical test:

The Acclarix AX8 and Acclarix LX8 Diagnostic Ultrasound Systems comply with:

(1) IEC 60601-1 Electrical Safety

(2) IEC 60601-1-2 Electromagnetic Compatibility

(3) IEC 60601-2-37 Requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment

(4) NEMA UD 3 Standard for real-time display of thermal and mechanical acoustic output indies on diagnostic ultrasound equipment.

(5) Acoustic output testing as per the guideline "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" dated September 9, 2008.

The following biocompatibility standards are conducted on the subject device: (1) ISO 10993-1, ISO 10993-5 and ISO 10993-10

The tests were selected to show substantial equivalence between the subject device and the predicate.

11. Substantially Equivalent Determination

Verification and validation testing has been conducted on the Acclarix AX8 and Acclarix LX8 Diagnostic Ultrasound Systems. This premarket notification submission demonstrates that Acclarix AX8 and Acclarix LX8 Diagnostic Ultrasound Systems are substantially equivalent to the predicate devices.