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

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.

AI/ML Overview

This FDA 510(k) K180862 document describes the Acclarix LX8 and Acclarix AX8 Diagnostic Ultrasound Systems, focusing on their intended use, clinical applications, and comparison to predicate devices to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and study information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly present a "table of acceptance criteria" in the format of specific thresholds for quantitative performance metrics (e.g., sensitivity, specificity, accuracy) and then report actual device performance against those thresholds. Instead, it relies on demonstrating substantial equivalence to legally marketed predicate devices.

The "acceptance criteria" can be inferred as meeting the safety and performance requirements of standards like IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, and ISO 10993 for biocompatibility, as well as adherence to FDA guidelines for acoustic output (NEMA UD 2, UD3). The reported device performance is that it complies with these standards and has similar performance effectiveness and safety to the predicate devices.

We can synthesize the comparison tables (Table 2-1, 2-2, 2-3) to show how the device's characteristics meet or are similar to the predicate devices, which implies meeting the established performance and safety profiles.

Inferred "Acceptance Criteria" and Reported Performance:

Acceptance Criteria (Inferred)	Reported Device Performance
Safety and Essential Performance Standards Compliance	The Acclarix AX8 and Acclarix LX8 Diagnostic Ultrasound Systems comply 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 indices on diagnostic ultrasound equipment.
Acoustic Output Compliance	Acoustic output testing performed as per FDA guidelines ("Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" dated September 9, 2008). - 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 - Ophthalmic use: TI = Max (TIS_as, TIC) ≤1; ISPTA.3 ≤ 50m/W/cm2; and MI ≤ 0.23
Biocompatibility of Patient Contact Materials	Complies with ISO 10993-1, ISO 10993-5, and ISO 10993-10.
Intended Use (Comparison to Predicate)	Same as predicate devices (Diagnostic ultrasound imaging or fluid flow analysis of the human body).
Indications for Use (Comparison to Predicate)	Same as predicate devices (extensive list including Abdominal, Gynecology, Obstetric, Cardiac, Small parts, Urology, Musculoskeletal, Peripheral vascular, Intra-operative, Pediatric, Neonatal cephalic, Adult cephalic).
General Product Design & Features (Comparison to Predicate)	Similar in product design, principle of operation, and transducer types/frequency range to predicate devices. Differences in modes of operation, measurements, display, and transducer ports are noted but do not raise questions of effectiveness and safety.
Performance Effectiveness (Comparison to Predicate)	Similar performance effectiveness to the predicate device. Differences are noted but deemed not to affect basic design principle, usage, effectiveness, and safety.
Performance Safety (Comparison to Predicate)	Similar performance safety to the predicate device. Differences are noted but deemed not to affect basic design principle, usage, effectiveness, and safety.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

The document does not specify any sample size for a test set in the context of clinical performance evaluation (e.g., number of patients/scans). This is because the submission primarily relies on non-clinical testing and comparison to predicate devices to establish substantial equivalence.

Similarly, there is no information provided regarding data provenance (country of origin, retrospective or prospective) for clinical data, as formal clinical testing with patient data was not a required component of this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

As no "test set" in the sense of clinical cases evaluated for ground truth is described in the document, there is no information regarding the number or qualifications of experts used to establish ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Since there is no described test set or expert evaluation of clinical cases, there is no adjudication method mentioned in the document.

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

The document does not mention any MRMC comparative effectiveness study, nor does it discuss AI assistance or its effect size on human reader performance. The device described is a diagnostic ultrasound system, not an AI-powered diagnostic tool.

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

The device is a diagnostic ultrasound system, not an algorithm, so a "standalone" algorithm performance study is not applicable and not mentioned.

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

As there were no clinical studies described, there is no mention of the type of ground truth used for performance evaluation. The "ground truth" for the non-clinical testing would be the engineering specifications and compliance with recognized standards.

8. The sample size for the training set:

The document describes a diagnostic ultrasound system, not an AI or machine learning algorithm that requires a training set. Therefore, there is no information regarding the sample size for a training set.

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

Since no training set for an algorithm is discussed, there is no information on how ground truth for a training set was established.

Summary

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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);

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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

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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)

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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
FetalImaging& 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
Peripheralvascular		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

(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 C5-2Q 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
Peripheralvascular	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)

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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.

(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 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
Peripheralvascular	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.

(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 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.

(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 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
Peripheralvascular	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 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
GeneralOphthalmic		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
Peripheralvascular	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
Peripheralvascular	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)

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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
Peripheralvascular	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
Peripheralvascular	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.

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

Concurrence of Center for Devices and Radiological Health (CDRH)

{13}------------------------------------------------

		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) *
FetalImaging& 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
Peripheralvascular	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. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

(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}------------------------------------------------

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 .

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

Concurrence of Center for Devices and Radiological Health (CDRH)

{15}------------------------------------------------

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
Peripheralvascular	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)

{16}------------------------------------------------

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

** 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)

Concurrence of Center for Devices and Radiological Health (CDRH)

{17}------------------------------------------------

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.

(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}------------------------------------------------

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
Peripheralvascular	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.

[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)

{19}------------------------------------------------

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)

{20}------------------------------------------------

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)

** 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
Peripheralvascular	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)

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

{23}------------------------------------------------

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

Peripheralvascular	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
Peripheralvascular	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)

{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
Peripheralvascular	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
Peripheralvascular	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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	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
Peripheralvascular	Peripheral vascular	N	N	N		N	N	N
	Other (Specify)

** 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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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 nameandclassification:	Device Name: Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8Diagnostic Ultrasound SystemModel: Acclarix AX8, Acclarix LX8Classification Name:892.1550 System, Imaging, Pulsed Doppler, UltrasonicProduct code: IYN892.1560 Ultrasonic, Pulsed echo, ImagingProduct code: IYO892.1570 Transducer, Ultrasonic, DiagnosticProduct code: ITXRegulatory Class: Class II
3.PremarketNotificationClass IIICertificationand Summary	Not applicable, the subject device is Class II.
4. PredicateDevice(s):	1. Edan Instruments, Inc., Acclarix LX8 Diagnostic Ultrasound Systemcleared under K171824 (Primary)2. Shenzhen Mindray Bio-Medical Electronics Co., Ltd. DC-8 DiagnosticUltrasound Systemcleared under K170277 (Reference)
5. Reason forSubmission	By submission of the Traditional 510(k), Edan Instruments is requestingclearance for an updated version of both the Acclarix AX8 and the AcclarixLX8 Diagnostic Ultrasound Systems, known as the 1.4 release.
6.Pre-Submission,IDE	Not applicable, there is no prior submission.
7. DeviceDescription:	The Acclarix series contains the Acclarix AX8 and Acclarix LX8Diagnostic Ultrasound Systems sharing a software platform (EdanUltrasound Software Platform, also abbreviated as EUP) and the most partsof hardware platform from Edan Instruments. The Acclarix AX8 is aportable laptop diagnostic ultrasound system. A simple way to summarizethe difference is that the Acclarix LX8 is a cart based version of theAcclarix AX8.
8. Intended Use:	The Acclarix AX8 Diagnostic Ultrasound system/Acclarix LX8 DiagnosticUltrasound system is intended for use by a qualified physician or alliedhealth professional for ultrasound evaluations. Specific clinical applicationsinclude:• Abdominal• Gynecology (including endovaginal)• Obstetric• Cardiac• Small parts (Breast, Testes, Thyroid, etc.)• Urology• Musculoskeletal• Peripheral vascular• Intra-operative• Pediatric• Neonatal (including abdominal and cephalic)

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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:

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

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

Item	Acclarix AX8 R1.4 DiagnosticUltrasound System (EdanInstruments)	Acclarix AX8 R1.3DiagnosticUltrasound System (EdanInstruments)	ComparisonResult
510(k) Number	Current Submission	K171824(Reference, as AX8 is portablecompared to LX8 and this AX8submission is an SW update toprevious AX8.)
Intended Use	Diagnostic ultrasound imaging orfluid flow analysis of the humanbody	Diagnostic ultrasound imaging orfluid flow analysis of the humanbody	Same
Indications forUse	The Acclarix AX8 DiagnosticUltrasound System is intendedfor use by a qualified physicianor sonographer for ultrasoundevaluation. Clinical applicationsinclude: Abdominal, Gynecology(including endovaginal),Obstetric, Cardiac, Small parts(Breast, Testes, Thyroid, etc.),Urology, Musculoskeletal,Peripheral vascular,Intra-operative, Pediatric andNeonatal (including abdominaland cephalic), and Adultcephalic.	The Acclarix AX8 DiagnosticUltrasound System is intended foruse by a qualified physician orsonographer for ultrasoundevaluation. Clinical applicationsinclude: Abdominal, Gynecology(including endovaginal), Obstetric,Cardiac, Small parts (Breast,Testes, Thyroid, etc.), Urology,Musculoskeletal, Peripheralvascular, Intra-operative, Pediatricand Neonatal (including abdominaland cephalic), and Adult cephalic.	Same
Installation andUse	Portable(laptop)MobileEquipment	Portable (laptop)Mobile Equipment	Same
Design	128 channel	128 channel	Same
SafetyStandards	IEC 60601-1IEC 60601-1-2IEC 60601-2-37ISO 10993-1, -5, -10, -12AIUM, NEMA UD 2, UD 3	IEC 60601-1IEC 60601-1-2IEC 60601-2-37ISO 10993-1, -5, -10, -12AIUM, NEMA UD 2, UD 3	Same
Patient ContactMaterials	Complies with ISO 10993	Complies with ISO 10993	Same
Mode ofOperations	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

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Item	Acclarix AX8 R1.4 DiagnosticUltrasound System (EdanInstruments)	Acclarix AX8 R1.3DiagnosticUltrasound System (EdanInstruments)	ComparisonResult
	Dist Stenosis, Area Stenosis.M-Mode: Distance, Time, Slopeand Heart RateD-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, Slopeand Heart RateD-Mode: Velocity, RI, Time, PI,Heart Rate, Auto TracePG, S/D, AV, Acceleration, PHT,VTI
Principle ofOperation	Applying high voltage burst tothe Piezoelectric material in thetransducer and detect reflectedecho to construct diagnosticimage	Applying high voltage burst to thePiezoelectric material in thetransducer and detect reflected echoto construct diagnostic image	Same
AcousticOutput	Track 3: MI, TIS, TIC, TIB (TIRange 0-6.0)Derated ISPTA: 720W/cm²maximum,Mechanic Index ≤ 1.9 maximumor Derated ISPPA 190 W/cm2 maxOphthalmic use:TI = Max (TIS_as, TIC) ≤1;ISPTA.3 ≤ 50m/W/cm2; and MI ≤0.23	Track 3: MI, TIS, TIC, TIB (TIRange 0-6.0)Derated ISPTA: 720W/cm²maximum,Mechanic Index ≤ 1.9 maximum orDerated ISPPA 190 W/cm2 maxOphthalmic use:TI = Max (TIS_as, TIC) ≤1;ISPTA.3 ≤ 50m/W/cm2; and MI ≤0.23	Same
TransducerFrequency	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 ortransducers or monitor glass.)8.6Kg(with rechargeablebattery and monitor glass,without power adaptor ortransducers)	407mm (W) x 388mm (L) x77mm(H)Weight: 9.1Kg(With rechargeable battery, withoutpower adaptor or transducers.)	Different
PowerRequirements	100-240V, 50/60Hz	100-240V, 50/60Hz	Same
RechargeableBattery	Yes	Yes	Same

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

Item	Acclarix AX8R1.4DiagnosticUltrasound System(Edan Instruments)	Acclarix LX8R1.4DiagnosticUltrasound System(Edan Instruments)	DC-8 DiagnosticUltrasound System(Shenzhen MindrayBio-MedicalElectronics)	ComparisonResult
510(k)Number	Current Submission	Current Submission	K170277(Reference, for Color1 Key optimization,Anatomical M mode,TDI)	-Same
Intended Use	Diagnostic ultrasoundimaging or fluid flowanalysis of the humanbody	Diagnostic ultrasoundimaging or fluid flowanalysis of the humanbody	Diagnostic UltrasoundSystem applicable foradults, pregnantwomen, pediatricpatients and neonates.	Same
Indicationsfor Use	The Acclarix AX8Diagnostic UltrasoundSystem is intended foruse by a qualifiedphysician orsonographer forultrasound evaluation.Clinical applicationsinclude: Abdominal,Gynecology(includingendovaginal),Obstetric, Cardiac,Small parts (Breast,Testes, Thyroid, etc.),Urology,Musculoskeletal,Peripheral vascular,Intra-operative,Pediatric and Neonatal(including abdominaland cephalic), andAdult cephalic.	The Acclarix LX8Diagnostic UltrasoundSystem is intended foruse by a qualifiedphysician orsonographer forultrasound evaluation.Clinical applicationsinclude: Abdominal,Gynecology(includingendovaginal),Obstetric, Cardiac,Small parts (Breast,Testes, Thyroid, etc.),Urology,Musculoskeletal,Peripheral vascular,Intra-operative,Pediatric andNeonatal (includingabdominal andcephalic), and Adultcephalic.	The DC-8/DC-8PRO/DC-8 CV/DC-8EXP/DC-8SDiagnostic UltrasoundSystem is applicablefor adults, pregnantwomen, pediatricpatients and neonates.It is intended for usein fetal, abdominal,pediatric, small organ(breast, thyroid.testes), neonatalcephalic, adultcephalic, trans-rectal,trans-vaginal,musculo-skeletal(conventional,superficial), cardiacadult, cardiacpediatric, peripheralvessel, urology andtransesophageal(Cardiac) exams.	Same
Installationand Use	Portable(laptop)MobileEquipment	Trolley MobileEquipment	Trolley MobileEquipment	Refer to Table2-2
SafetyStandards	IEC 60601-1IEC 60601-1-2IEC 60601-2-37ISO 10993-1, -5, -10,-12AIUM, NEMA UD 2,UD3	IEC 60601-1IEC 60601-1-2IEC 60601-2-37ISO 10993-1, -5, -10,-12AIUM, NEMA UD 2,UD3	IEC 60601-1IEC 60601-1-2IEC 60601-2-37ISO 10993-1, -5, -10,-12AIUM, NEMA UD 2,UD3	Same
PatientContactMaterials	Complies with ISO10993	Complies with ISO10993	Complies with ISO10993	Same

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

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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.

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.