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" clearly states it is for "ultrasound evaluations," which are diagnostic in nature, not therapeutic.

Diagnostic

Yes
The device is explicitly named "Acclarix AX8 Diagnostic Ultrasound system" and "Acclarix LX8 Diagnostic Ultrasound system" in the "Intended Use / Indications for Use" and "Device Description" sections, indicating its diagnostic purpose. It is also mentioned that it is intended for "ultrasound evaluations."

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". It also describes the AX8 as a "portable laptop diagnostic ultrasound system" and the LX8 as a "cart based version", both of which are hardware systems. The performance studies also include testing related to electrical safety, electromagnetic compatibility, and acoustic output, which are hardware-related tests.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is performed outside of the body.
Device Function: The Acclarix AX8 and LX8 are diagnostic ultrasound systems. They use sound waves to create images of internal body structures. This is a form of in vivo (within the living body) diagnostic imaging.
Intended Use: The intended use clearly states the system is for "ultrasound evaluations" of various anatomical sites within the body. There is no mention of analyzing specimens or performing tests on samples taken from the patient.

Therefore, the Acclarix AX8 and LX8 Diagnostic Ultrasound Systems are diagnostic imaging devices, not IVDs.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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)
Adult Cephalic

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

IYO, ITX, IYN

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

Adult, Pediatric, Neonatal (including abdominal and cephalic), Fetal.

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)

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. Clinical testing is not required. Non-clinical tests comply with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 3, Acoustic output testing as per the guideline "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers'' dated September 9, 2008, and biocompatibility standards ISO 10993-1, ISO 10993-5 and ISO 10993-10.

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.

K162055, K161300, K152545, K152543

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.

K161300, K152545, K152543

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

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Summary

0

Public Health Service

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus, with three human profiles forming the staff of the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 18, 2017

Edan Instruments Inc % Mr. Doug Worth Sr. Dir. US RA/QA Edan Medical 1200 Crossman Avenue, Suite 200 SUNNYVALE CA 94089

Re: K171824

Trade/Device Name: Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, ITX, IYN Dated: June 12, 2017 Received: June 19, 2017

Dear Mr. Worth:

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. Iisting 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

1

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Michael D. O'Hara
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)

K171824

Device Name

Acclarix AX8 Diagnostic Ultrasound System/Acclarix LX8 Diagnostic Ultrasound System

Indications for Use (Describe)

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)
· Adult Cephalic

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.

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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."

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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	N	N	N		N	N	N
	Small Organ (Specify) *	P	P	P		P	P	P
Fetal
Imaging
& Other	Neonatal Cephalic	N	N	N		N	N	N
	Adult Cephalic	N	N	N	N	N	N	N
	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	P
	Pediatric Cardiac	P	P	P	P	P	P	P
Cardiac	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra- cardiac
Peripheral
vascular	Peripheral vascular	P	P	P		P	P	P
	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+PD/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: 3D/4D

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Acclarix AX8 with C5-2Q Transducer

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

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

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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
Fetal
Imaging
	Ophthalmic
	Fetal / Obstetrics
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro logical)
	Laparoscopic
	Pediatric
	Small Organ (Specify) *	P	P	P	P	P	P	P
	Neonatal Cephalic
	Adult Cephalic
& Other	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
	Adult Cardiac
	Pediatric Cardiac
Cardiac	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra- cardiac
Peripheral	Peripheral vascular	P	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. 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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Acclarix AX8 with MC8-4Q 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	N	N	N		N	N	N
	Small Organ (Specify) *
Fetal	Neonatal Cephalic	N	N	N		N	N	N
Imaging
& 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) **	N	N	N		N	N	N
	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. 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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Acclarix AX8 with L10-4Q Transducer

	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)
	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)

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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Acclarix AX8 with E8-4Q Transducer

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	Neonatal Cephalic
Imaging	Adult Cephalic
& Other	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)

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+PD/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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Acclarix AX8 with L17-7HQ 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) *	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)

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+PD/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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Acclarix AX8 with C5-2XQ Transducer

	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	P
	Abdominal	P	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)	N	N	N	N	N	N	N
	Musculo-skeletal (Superficial)	N	N	N	N	N	N	N
	Intravascular
	Other (Specify) **	P	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+PD/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

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

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Acclarix AX8 with P5-1XQ 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	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	N	N	N	N	N	N	N
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Musculo-skeletal(Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Other (Specify) **
	Adult Cardiac	P	P	P	P	P	P	P
	Pediatric Cardiac	P	P	P	P	P	P	P
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 PDI= Power Doppler Imaging Additional comments: Combined mode: B+M,B+CW,B+Color, B+PDI/DPDI, B+Color+PW, B+PD/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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Acclarix AX8 with L17-7SQ Transducer

	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
	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) **
Cardiac	Adult Cardiac
	Pediatric Cardiac
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra- cardiac
	Peripheral
vascular	Peripheral vascular	N	N	N		N	N
		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)

13

Acclarix AX8 with C5-2MQ 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	N	N	N	N	N	N	N
	Abdominal
	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)
	Musculo-skeletal (Superficial)
	Intravascular
	Other (Specify) **
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+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)

14

Acclarix LX8 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
Imaging
& Other	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
	Neonatal Cephalic	P	P	P		P	P	P
	Adult Cephalic	N	N	N	N	N	N	N
	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
Cardiac	Adult Cardiac	P	P	P	P	P	P	P
	Pediatric Cardiac	P	P	P	P	P	P	P
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra- cardiac
Peripheral
vascular	Peripheral vascular	P	P	P		P	P	P
	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+PDVDPDI, B+Color+PW, B+PDI/DPDI +PW, B+CW, B+Color+CW, B+PDI/DPDI+CW,

Note * Small Organ includes Thyroid, Testes, Breast

** 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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Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) Prescription Use (Per 21 CFR 801.109)

15

Acclarix LX8 with L10-4D 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) *	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)

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

16

Acclarix LX8 with E8-4D Transducer

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

17

Acclarix LX8 with L17-7HD Transducer

	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
	Intra-operative (Specify)
	Intra-operative (Neuro logical)
	Laparoscopic
	Pediatric
	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)

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.

(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)

18

Acclarix LX8 with C5-2XD Transducer

	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)

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

19

Acclarix LX8 with P5-1XD Transducer

	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	N	N	N	N	N	N	N
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Musculo-skeletal(Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Other (Specify) **
Cardiac	Adult Cardiac	P	P	P	P	P	P	P
	Pediatric Cardiac	P	P	P	P	P	P	P
	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+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)

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

20

Acclarix LX8 with L17-7SD 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)	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)

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.

(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

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]
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
	Trans-vaginal
	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+PDV/DPDI, B+Color+PW, B+PDV/DPDI +PW Note * Small Organ includes Thyroid, Testes, Breast

** Other use includes Urology Gynecology

** 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

Acclarix LX8 with C5-2D Transducer

	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)

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.

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

Concurrence of Center for Devices and Radiological Health (CDRH)

23

Acclarix LX8 with L12-5D Transducer

	Clinical Application	Mode of Operation
General	Specific	B	M	PW	CW	Color	Combined	Other
							(Specify) [1]	(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	P
Fetal	Neonatal Cephalic
Imaging	Adult Cephalic
& Other	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	Peripheral vascular	P	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. 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)

24

Acclarix LX8 with MC8-4D Transducer

	Clinical Application	Mode of Operation
	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
Fetal
Imaging
& Other	Pediatric	P	P	P	P	P	P	P
	Small Organ (Specify) *
	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	Peripheral vascular	P	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. 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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25

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:	June 12,2017
2. Device name
and
classification:	Device Name: 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 K162055 (Primary)
	2. Edan Instruments, Inc., Acclarix AX8 Diagnostic Ultrasound System
cleared under K161300 (Reference)
	3. Shenzhen Mindray Bio-Medical Electronics Co., Ltd. DC60
Diagnostic Ultrasound System cleared under K152545 (Reference)
	4. Shenzhen Mindray Bio-Medical Electronics Co., Ltd., M9 Diagnostic
Ultrasound System cleared under K152543 (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 1.3 release.

26

| 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)
• 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 R1.3
Diagnostic Ultrasound
System
(Edan Instruments) | Acclarix LX8 R1.3
Diagnostic Ultrasound
System
(Edan Instruments) | Acclarix LX8 R1.21
Diagnostic Ultrasound
System
(Edan Instruments) | Comparison
Result |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| 510(k)
Number | Current Submission | Current Submission | (K160790 &) K162055 | - |
| 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 | The Acclarix LX8
Diagnostic Ultrasound
System is intended for
use by a qualified
physician or sonographer | The Acclarix LX8
Diagnostic Ultrasound
System is intended for
use by a qualified
physician or sonographer | Difference |
| | 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. | 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. | 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). | |
| Installation
and Use | Portable (laptop)Mobile
Equipment | Trolley Mobile
Equipment | Trolley Mobile
Equipment | Refer to
Table 9-2 |
| | IEC 60601-1 | IEC 60601-1 | IEC 60601-1 | |
| | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | |
| | IEC 60601-2-37 | IEC 60601-2-37 | IEC 60601-2-37 | |
| Safety
Standards | ISO 10993-1, -5, -10,
-12 | ISO 10993-1, -5, -10,
-12 | ISO 10993-1, -5, -10,
-12 | Same |
| | AIUM, NEMA UD 2,
UD3 | AIUM, NEMA UD 2,
UD3 | AIUM, NEMA UD 2,
UD3 | |
| Patient
Contact
Materials | Complies with ISO
10993 | Complies with ISO
10993 | Complies with ISO
10993 | Same |
| | B-Mode, M-Mode,
Color, PDI/DPDI, PW,
CW, 3D/4D | B-Mode, M-Mode,
Color, PDI/DPDI, PW,
CW, 3D/4D | B-Mode, M-Mode,
Color, PDI/DPDI, PW,
CW, 3D/4D | |
| Mode of
Operations | | | | Same |
| | 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 | 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 | 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 | |
| Measurements | | | | Same |
| | 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 | Applying high voltage
burst to the Piezoelectric
material in the
transducer and detect
reflected echo to
construct diagnostic
image | |
| Principle of
Operation | | | | Same |
| Acoustic
Output | Track 3: MI, TIS, TIC,
TIB (TI Range 0-6.0) | Track 3: MI, TIS, TIC,
TIB (TI Range 0-6.0) | Track 3: MI, TIS, TIC,
TIB (TI Range 0-6.0) | Same |
| | W/cm² maximum,
Mechanic Index ≤1.9
maximum or Derated
ISPPA 190 W/cm² max | W/cm² maximum,
Mechanic Index ≤1.9
maximum or Derated
ISPPA 190 W/cm² max | W/cm² maximum,
Mechanic Index ≤1.9
maximum or Derated
ISPPA 190 W/cm² max | |
| 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 9-2 |
| Transducer
Ports | Single -Transducer Port
(Extendable with
Multi-Transducer
Connector to Three
Ports) | Multi-Transducer Port
(Four) | Multi-Transducer Port
(Four) | Refer to
Table 9-2 |
| Dimensions/
Weight | 407mm(W) x388mm(L)
x77mm(H)
Weight: 9.1Kg
(With rechargeable
battery, 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 9-2 |
| Power
Requirements | 100-240V, 50/60Hz, 2.5A max | 100-240V, 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),
One-Key-Optimization,
B-Steer, Digital Zoom,
Needle Visualization,
Auto IMT | 3D/4D, CW, HPRF, Dual
screen display,
Panorama, Spatial
Compounding Imaging,
Frequency
Compounding Imaging,
Multi-Beam-Forming,
Speckle Resistance
Imaging(eSRI),
One-Key-Optimization,
B-Steer, Digital Zoom,
Needle Visualization,
Auto IMT | 3D/4D, CW, HPRF, Dual
screen display,
Panorama, Spatial
Compounding Imaging,
Frequency
Compounding Imaging,
Multi-Beam-Forming,
Speckle Resistance
Imaging(eSRI),
One-Key-Optimization,
B-Steer, Digital Zoom,
Needle Visualization,
Auto IMT | Same |

Table 9-1 Comparison between the subject Acclarix R1.3 and Acclarix LX8 R1.21

27

28

Table 9-2 Comparison between the subject Acclarix AX8 R1.3 and Acclarix AX8 R1.2

| Item | Acclarix AX8 R1.3 Diagnostic
Ultrasound System (Edan
Instruments) | Acclarix AX8 R1.2 Diagnostic
Ultrasound System (Edan
Instruments) | Comparison
Result |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| 510(k) Number | Current Submission | K161300
(Reference, as AX8 is portable
compared to LX8 and this AX8
submission is an SW update to | - |
| Item | Acclarix AX8 R1.3 Diagnostic
Ultrasound System (Edan
Instruments) | Acclarix AX8 R1.2 Diagnostic
Ultrasound System (Edan
Instruments)
previous AX8.) | Comparison
Result |
| 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 Edan Acclarix AX8
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, and Intra-operative. | Difference |
| Installation and
Use | Portable (laptop)Mobile
Equipment | Portable (laptop)Mobile
Equipment | Same |
| Design | 128 channels | 128 channels | 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 | B-Mode, M-Mode, Color,
PDI/DPDI, PW, CW | Difference |
| Measurements | 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, $Δ$ V, Acceleration, PHT,
VTI | 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, $Δ$ V, Acceleration, PHT,
VTI | Same |
| 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 | Track 3: MI, TIS, TIC, TIB (TI
Range 0-6.0)
Derated ISPTA: 720W/cm² | Same |
| Item | Acclarix AX8 R1.3 Diagnostic
Ultrasound System (Edan Instruments) | Acclarix AX8 R1.2 Diagnostic
Ultrasound System (Edan Instruments) | Comparison
Result |
| | Mechanic Index $\leq$ 1.9 maximum
or Derated ISPPA 190 W/cm2 max
Ophthalmic use:
TI = Max (TIS_as, TIC) $\leq$ 1;
ISPTA.3 $\leq$ 50m/W/cm2; and MI $\leq$ 0.23 | Mechanic Index $\leq$ 1.9 maximum
or Derated ISPPA 190 W/cm2 max
Ophthalmic use:
TI = Max (TIS_as, TIC) $\leq$ 1;
ISPTA.3 $\leq$ 50m/W/cm2; and MI $\leq$ 0.23 | |
| Transducer
Frequency | 2.5-15.0 MHz | 2.5-15.0 MHz | Same |
| Dimensions/
Weight | 407mm (W) x 388mm (L) x77mm (H)
Weight: 9.1Kg
(With rechargeable battery, without power adaptor or transducers.) | 407mm (W) x 388mm (L) x77mm (H)
Weight: 9.1Kg
(With rechargeable battery, without power adaptor or transducers.) | Same |
| Power
Requirements | 100-240V, 50/60Hz | 100-240V, 50/60Hz | Same |
| Rechargeable
Battery | Yes | Yes | Same |

29

30

Table 9-3 Comparison between the subject Acclarix R1.3and DC60 (K152545)

| | Acclarix AX8 R1.3
Diagnostic
Ultrasound System
(Edan Instruments) | Acclarix LX8 R1.3
Diagnostic
Ultrasound System
(Edan Instruments) | DC-60 Diagnostic
Ultrasound System
(Shenzhen Mindray
Bio-Medical Electronics) | Comparison
Result |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| Item | | | | |
| 510(k)
Number | Current Submission | Current Submission | K152545
(Reference, for Adult
Cephalic) | - |
| 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. | 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. | The
DC-60DiagnosticUltrasound
System is intended for use
in fetal, abdominal,
pediatric, small organ
(breast, thyroid, testes),
neonatal and adult cephalic,
trans-rectal, trans-vaginal,
muscular-skeletal
(conventional, superficial),
adult and pediatric cardiac,
peripheral vessel and
urology exams. | Same (for
Adult
Cephalic) |

31

| | Small parts (Breast,
Testes, Thyroid,
etc.), Urology,
Musculoskeletal,
Peripheral vascular,
Intra-operative,
Pediatric and
Neonatal (including
abdominal and
cephalic), and Adult
cephalic. | Small parts (Breast,
Testes, Thyroid,
etc.), Urology,
Musculoskeletal,
Peripheral vascular,
Intra-operative,
Pediatric and
Neonatal (including
abdominal and
cephalic), and Adult
cephalic. | Trolley Mobile Equipment | | |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|------|
| Installation
and Use | Portable
(laptop)Mobile
Equipment | Trolley Mobile
Equipment | Trolley Mobile Equipment | Refer to
Table 9-2 | |
| | 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 | |

Table 9-4 Comparison between the subject Acclarix R1.3 and M9 (K152543)

| Item | Acclarix AX8 R1.3
Diagnostic
Ultrasound System
(Edan Instruments) | Acclarix LX8
R1.3 Diagnostic
Ultrasound
System
(Edan
Instruments) | M9 Diagnostic
Ultrasound System
(Shenzhen
MindrayBio-Medical
Electronics) | Comparison
Result |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| 510(k)
Number | Current Submission | Current
Submission | K152543
(Reference, for
Measurement in
Panorama, PW one-key
optimization, Acoustic
Power Control and
Wireless network
connection) | - |
| 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 | The Acclarix
LX8 Diagnostic
Ultrasound
System is
intended for use | The M9Diagnostic
Ultrasound System is
intended for use in fetal,
abdominal, pediatric, small
organ (breast, thyroid, | |
| | 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. | 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. | testes), neonatal and adult
cephalic, trans-rectal,
trans-vaginal,
muscular-skeletal
(conventional, superficial),
adult and pediatric cardiac,
trans-esoph. (Cardiac),
peripheral vessel, urology
exams. | |
| Installation
and Use | Portable
(laptop)Mobile
Equipment | Trolley Mobile
Equipment | Portable Mobile
Equipment | Refer
to
Table 9-2 |
| 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 |
| Features | PW one-key
optimization with a
continuous adjustment
on PW gain, DR,
baseline and PRF scale
Acoustic Power
Control based on
previous power
management | PW one-key
optimization with
a continuous
adjustment on
PW gain, DR,
baseline and PRF
scale
Acoustic Power
Control based on | iTouch auto adjusts PW
mode image with gain,
scale, PRF and wall filter.
Acoustic Power Setting
and Acoustic Power
Control | Difference
(PW one-key
optimization
and Acoustic
Power
Control) |
| | | previous power
management | | |
| Measurements | 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 | 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 | B-Mode, M-Mode,
PW-Mode, Color-Mode,
Power/Dirpower Mode,
THI, iScape mode, Color
M, Elastography, LVO or
the combined mode (i.e.
B/M-Mode, B/PW-mode,
B/PW/Color). | Same (for
Measurement
in Panorama) |
| Wireless
network
connection | Complies with FCC
Rules Part 15 (FCC
ID: SMQAX8EDAN)
Frequency Range:
2.400-2.483 GHz
(2.4GHz IMS band)
Module Type: OFDM,
CCK
Output Power:
≤17dbm | Complies with
FCC Rules Part
15
(FCC ID:
SMQLX8EDAN)
Frequency
Range:
2.412-2.472
GHz, (2.4GHz
IMS band)
Module Type:
OFDM, CCK
Output Power:
≤17dbm | Complies with FCC Rules
Part 15
Operating Frequency:
2.412-2.472 GHz, 2.484
GHz (2.4GHz& 5GHz
IMS band)
Module Type: DSSS,
OFDM
Output Power: ≤17dbm | Difference
(for
Wireless) |

32

33

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

34

(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.