Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound System

• K Number: K171824
• Device Name: Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound System
• Manufacturer: Edan Instruments Inc
• Date Cleared: 2017-07-18 ( 29 days)
• Product Code: IYO , ITX , IYN
• Regulation Number: 892.1560
• Type: Traditional
• Panel: Radiology
• Reference & Predicate Devices: K161300 , K152545 , K152543 , K162055
• Predicate For: K171900 , K180862

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

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

The provided text describes the Acclarix AX8 and Acclarix LX8 Diagnostic Ultrasound Systems. However, it does not explicitly state acceptance criteria in the typical sense of quantitative thresholds for performance metrics. Instead, it outlines the scope of the device's intended use and compares its features and compliance with standards to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

As noted above, explicit quantitative acceptance criteria are not presented. The document focuses on demonstrating substantial equivalence to predicate devices by comparing intended use, design features, safety standards compliance, and modes of operation.

Feature/Criterion	Acceptance Standard (Implied, based on predicate device comparison)	Reported Device Performance (Acclarix AX8/LX8)
Intended Use	Diagnostic ultrasound imaging or fluid flow analysis of the human body for various clinical applications.	Same as predicate devices, with some expanded clinical applications (e.g., Adult Cephalic for LX8, Neonatal Cephalic/Pediatric for AX8 with specific transducers).
Safety Standards Compliance	IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993 (various parts), AIUM, NEMA UD 2, UD 3.	Complies with all listed safety standards.
Patient Contact Materials	Complies with ISO 10993.	Complies with ISO 10993.
Acoustic Output	Track 3: MI, TIS, TIC, TIB (TI Range 0-6.0), Mechanic Index ≤1.9 max or Derated ISPPA 190 W/cm² max, Ophthalmic use: TI = Max (TIS_as, TIC) ≤ 1; ISPTA.3 ≤ 50m/W/cm²; and MI ≤ 0.23.	Same as predicate devices.
Transducer Frequency	1-17.0 MHz (for AX8/LX8 overall, specific ranges vary by transducer)	1-17.0 MHz (overall), specific ranges as listed for each transducer.
Modes of Operation	B-Mode, M-Mode, Color, PDI/DPDI, PW, CW, 3D/4D (for AX8 R1.3 and LX8 R1.3).	Same as or improved over predicate devices (e.g., AX8 R1.3 adds 3D/4D, CW compared to AX8 R1.2).
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.	Same as predicate devices.

2. Sample Size Used for the Test Set and Data Provenance:

The document states: "Clinical testing is not required." This implies that the device's performance was not evaluated through a clinical study with a "test set" of patient data in the typical sense that would involve a sample size and data provenance (country of origin, retrospective/prospective). The assessment is based on non-clinical tests (e.g., engineering benchmarks, compliance with standards) and comparison to legally marketed predicate devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable, as "Clinical testing is not required." Therefore, there was no "ground truth" for a test set established by experts in this context.

4. Adjudication Method:

Not applicable, as "Clinical testing is not required."

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. The document does not describe any MRMC studies or the use of AI. The devices are diagnostic ultrasound systems, not AI-powered diagnostic aids, and the submission is for an updated version of existing devices, primarily focusing on hardware and software updates and expanded indications.

6. Standalone (Algorithm Only) Performance:

Not applicable. The device is an ultrasound system, not an AI algorithm intended for standalone performance evaluation without human-in-the-loop.

7. Type of Ground Truth Used:

Not directly applicable in the context of clinical performance evaluation (e.g., pathology, outcomes data). For the purpose of regulatory submission, the "ground truth" for demonstrating substantial equivalence is compliance with established safety and performance standards for diagnostic ultrasound equipment (e.g., acoustic output, electrical safety, biocompatibility) and functional equivalence to predicate devices.

8. Sample Size for the Training Set:

Not applicable. This document is for a medical device regulatory submission for an ultrasound system, not for an AI/machine learning algorithm that would require a "training set."

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no "training set" for this device in the context of an AI algorithm.

Summary

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Public Health Service

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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

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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)

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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
FetalImaging& 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
Peripheralvascular	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]
OphthalmicFetalImaging
	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
FetalImaging& 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)

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
FetalImaging& 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)

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) *
FetalImaging& 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
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+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) *
FetalImaging	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
FetalImaging& 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
	Peripheralvascular	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
FetalImaging& 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
Peripheralvascular	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.

(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) 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
FetalImaging	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.

(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)

{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
FetalImaging& 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
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 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)

{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
FetalImaging& 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
Peripheralvascular	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) *
FetalImaging& 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 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
FetalImaging& 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
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+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) *
FetalImaging& 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)

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
FetalImaging& 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) *
FetalImaging& 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)

{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
FetalImaging& 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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Concurrence of Center for Devices and Radiological Health (CDRH)

{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.: [phone] Fax: [phone]
Contact Person:	Alice Yang
Date prepared:	June 12,2017
2. Device nameandclassification:	Device Name: Diagnostic Ultrasound System
	Model: Acclarix AX8, Acclarix LX8
	Classification Name:
	892.1550 System, Imaging, Pulsed Doppler, UltrasonicProduct code: IYN
	892.1560 Ultrasonic, Pulsed echo, ImagingProduct code: IYO
	892.1570 Transducer, Ultrasonic, DiagnosticProduct code: ITX
	Regulatory 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 K162055 (Primary)
	2. Edan Instruments, Inc., Acclarix AX8 Diagnostic Ultrasound Systemcleared under K161300 (Reference)
	3. Shenzhen Mindray Bio-Medical Electronics Co., Ltd. DC60Diagnostic Ultrasound System cleared under K152545 (Reference)
	4. Shenzhen Mindray Bio-Medical Electronics Co., Ltd., M9 DiagnosticUltrasound System cleared under K152543 (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 1.3 release.

{26}------------------------------------------------

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)• 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 R1.3Diagnostic UltrasoundSystem(Edan Instruments)	Acclarix LX8 R1.3Diagnostic UltrasoundSystem(Edan Instruments)	Acclarix LX8 R1.21Diagnostic UltrasoundSystem(Edan Instruments)	ComparisonResult
510(k)Number	Current Submission	Current Submission	(K160790 &) K162055	-
Intended Use	Diagnostic ultrasoundimaging or fluid flowanalysis of the humanbody	Diagnostic ultrasoundimaging or fluid flowanalysis of the humanbody	Diagnostic ultrasoundimaging or fluid flowanalysis of the humanbody	Same
Indicationsfor Use	The Acclarix AX8Diagnostic UltrasoundSystem is intended for useby a qualified physicianor sonographer for	The Acclarix LX8Diagnostic UltrasoundSystem is intended foruse by a qualifiedphysician or sonographer	The Acclarix LX8Diagnostic UltrasoundSystem is intended foruse by a qualifiedphysician or sonographer	Difference
	ultrasound evaluation.Clinical applicationsinclude: Abdominal,Gynecology (includingendovaginal), Obstetric,Cardiac, Small parts(Breast, Testes, Thyroid,etc.), Urology,Musculoskeletal,Peripheral vascular,Intra-operative, Pediatricand Neonatal (includingabdominal and cephalic),and Adult cephalic.	for ultrasoundevaluation. Clinicalapplications include:Abdominal, Gynecology(including endovaginal),Obstetric, Cardiac, Smallparts (Breast, Testes,Thyroid, etc.), Urology,Musculoskeletal,Peripheral vascular,Intra-operative, Pediatricand Neonatal (includingabdominal and cephalic),and Adult cephalic.	for ultrasoundevaluation. Clinicalapplications include:Abdominal, Gynecology(including endovaginal),Obstetric, Cardiac, Smallparts (Breast, Testes,Thyroid, etc.), Urology,Musculoskeletal,Peripheral vascular,Intra-operative, Pediatricand Neonatal (includingabdominal and cephalic).
Installationand Use	Portable (laptop)MobileEquipment	Trolley MobileEquipment	Trolley MobileEquipment	Refer toTable 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
SafetyStandards	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
PatientContactMaterials	Complies with ISO10993	Complies with ISO10993	Complies with ISO10993	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 ofOperations				Same
	B-Mode: Distance,Circ/Area, Angle,Volume, Stenosis ratioM-Mode: Distance,Time, Slope and HeartRateD-Mode: Velocity, RI,Time, PI, Heart Rate,Auto Trace, PG, S/D,ΔV, Acceleration, PHT,VTI	B-Mode: Distance,Circ/Area, Angle,Volume, Stenosis ratioM-Mode: Distance,Time, Slope and HeartRateD-Mode: Velocity, RI,Time, PI, Heart Rate,Auto Trace, PG, S/D,ΔV, Acceleration, PHT,VTI	B-Mode: Distance,Circ/Area, Angle,Volume, Stenosis ratioM-Mode: Distance,Time, Slope and HeartRateD-Mode: Velocity, RI,Time, PI, Heart Rate,Auto Trace, PG, S/D,ΔV, Acceleration, PHT,VTI
Measurements				Same
	Applying high voltageburst to the Piezoelectricmaterial in thetransducer and detectreflected echo toconstruct diagnosticimage	Applying high voltageburst to the Piezoelectricmaterial in thetransducer and detectreflected echo toconstruct diagnosticimage	Applying high voltageburst to the Piezoelectricmaterial in thetransducer and detectreflected echo toconstruct diagnosticimage
Principle ofOperation				Same
AcousticOutput	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 ≤1.9maximum or DeratedISPPA 190 W/cm² max	W/cm² maximum,Mechanic Index ≤1.9maximum or DeratedISPPA 190 W/cm² max	W/cm² maximum,Mechanic Index ≤1.9maximum or DeratedISPPA 190 W/cm² max
TransducerTypes	Convex ArrayLinear ArrayEndocavity-MicroConvex ArrayPhased ArrayMicro Convex Array	Convex ArrayLinear ArrayEndocavity-MicroConvex ArrayPhased ArrayMicro Convex Array	Convex ArrayLinear ArrayEndocavity-MicroConvex ArrayPhased ArrayMicro Convex Array	Same
TransducerFrequency	1-17.0 MHz	1-17.0 MHz	1-17.0 MHz	Same
PrimaryDisplay	Primary Screen:15.1inch(1920 x 1080)	Primary Screen: 21.5inch(1920 x 1080)	Primary Screen: 21.5inch(1920 x 1080)	Refer toTable 9-2
TransducerPorts	Single -Transducer Port(Extendable withMulti-TransducerConnector to ThreePorts)	Multi-Transducer Port(Four)	Multi-Transducer Port(Four)	Refer toTable 9-2
Dimensions/Weight	407mm(W) x388mm(L)x77mm(H)Weight: 9.1Kg(With rechargeablebattery, without poweradaptor or transducers.)	Height: 53 - 70in(1355-1780mm)Width: 23 in (585mm)Depth: 36.6 in (930mm)Weight: 111 Kg (noperipherals)	Height: 53 - 70 in(1355-1780mm)Width: 23 in (585mm)Depth: 36.6 in (930mm)Weight: 111 Kg (noperipherals)	Refer toTable 9-2
PowerRequirements	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, Dualscreen display,Panorama, SpatialCompounding Imaging,FrequencyCompounding Imaging,Multi-Beam-Forming,Speckle ResistanceImaging(eSRI),One-Key-Optimization,B-Steer, Digital Zoom,Needle Visualization,Auto IMT	3D/4D, CW, HPRF, Dualscreen display,Panorama, SpatialCompounding Imaging,FrequencyCompounding Imaging,Multi-Beam-Forming,Speckle ResistanceImaging(eSRI),One-Key-Optimization,B-Steer, Digital Zoom,Needle Visualization,Auto IMT	3D/4D, CW, HPRF, Dualscreen display,Panorama, SpatialCompounding Imaging,FrequencyCompounding Imaging,Multi-Beam-Forming,Speckle ResistanceImaging(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

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

Item	Acclarix AX8 R1.3 DiagnosticUltrasound System (EdanInstruments)	Acclarix AX8 R1.2 DiagnosticUltrasound System (EdanInstruments)	ComparisonResult
510(k) Number	Current Submission	K161300(Reference, as AX8 is portablecompared to LX8 and this AX8submission is an SW update to	-
Item	Acclarix AX8 R1.3 DiagnosticUltrasound System (EdanInstruments)	Acclarix AX8 R1.2 DiagnosticUltrasound System (EdanInstruments)previous AX8.)	ComparisonResult
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 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,Peripheral vascular,Intra-operative, Pediatric andNeonatal (including abdominaland cephalic), and Adult cephalic.	The Edan Acclarix AX8Ultrasound System is intended foruse by a qualified physician orallied health professional forultrasound evaluations. Specificclinical applications include:Abdominal, Gynecology(including endovaginal), Obstetric,Cardiac, Small parts (Breast,Testes, Thyroid, etc.), Urology,Musculoskeletal, Peripheralvascular, and Intra-operative.	Difference
Installation andUse	Portable (laptop)MobileEquipment	Portable (laptop)MobileEquipment	Same
Design	128 channels	128 channels	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	B-Mode, M-Mode, Color,PDI/DPDI, PW, CW	Difference
Measurements	B-Mode: Distance, Circ/Area,Angle, Volume, Stenosis ratioM-Mode: Distance, Time, Slopeand Heart RateD-Mode: Velocity, RI, Time, PI,Heart Rate, Auto TracePG, S/D, $Δ$ V, Acceleration, PHT,VTI	B-Mode: Distance, Circ/Area,Angle, Volume, Stenosis ratioM-Mode: Distance, Time, Slopeand Heart RateD-Mode: Velocity, RI, Time, PI,Heart Rate, Auto TracePG, S/D, $Δ$ V, Acceleration, PHT,VTI	Same
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 reflectedecho to construct diagnostic image	Same
AcousticOutput	Track 3: MI, TIS, TIC, TIB (TIRange 0-6.0)Derated ISPTA: 720W/cm²	Track 3: MI, TIS, TIC, TIB (TIRange 0-6.0)Derated ISPTA: 720W/cm²	Same
Item	Acclarix AX8 R1.3 DiagnosticUltrasound System (Edan Instruments)	Acclarix AX8 R1.2 DiagnosticUltrasound System (Edan Instruments)	ComparisonResult
	Mechanic Index $\leq$ 1.9 maximumor Derated ISPPA 190 W/cm2 maxOphthalmic use:TI = Max (TIS_as, TIC) $\leq$ 1;ISPTA.3 $\leq$ 50m/W/cm2; and MI $\leq$ 0.23	Mechanic Index $\leq$ 1.9 maximumor Derated ISPPA 190 W/cm2 maxOphthalmic use:TI = Max (TIS_as, TIC) $\leq$ 1;ISPTA.3 $\leq$ 50m/W/cm2; and MI $\leq$ 0.23
TransducerFrequency	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
PowerRequirements	100-240V, 50/60Hz	100-240V, 50/60Hz	Same
RechargeableBattery	Yes	Yes	Same

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

	Acclarix AX8 R1.3DiagnosticUltrasound System(Edan Instruments)	Acclarix LX8 R1.3DiagnosticUltrasound System(Edan Instruments)	DC-60 DiagnosticUltrasound System(Shenzhen MindrayBio-Medical Electronics)	ComparisonResult
Item
510(k)Number	Current Submission	Current Submission	K152545(Reference, for AdultCephalic)	-
IntendedUse	Diagnosticultrasound imagingor fluid flow analysisof the human body	Diagnosticultrasound imagingor fluid flow analysisof the human body	Diagnostic UltrasoundSystem applicable foradults, pregnant women,pediatric patients andneonates.	Same
Indicationsfor Use	The Acclarix AX8DiagnosticUltrasound Systemis intended for useby a qualifiedphysician orsonographer forultrasoundevaluation. Clinicalapplications include:Abdominal,Gynecology(includingendovaginal),Obstetric. Cardiac.	The Acclarix LX8DiagnosticUltrasound Systemis intended for useby a qualifiedphysician orsonographer forultrasoundevaluation. Clinicalapplications include:Abdominal,Gynecology(includingendovaginal),Obstetric. Cardiac.	TheDC-60DiagnosticUltrasoundSystem is intended for usein 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 andurology exams.	Same (forAdultCephalic)

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	Small parts (Breast,Testes, Thyroid,etc.), Urology,Musculoskeletal,Peripheral vascular,Intra-operative,Pediatric andNeonatal (includingabdominal andcephalic), and Adultcephalic.	Small parts (Breast,Testes, Thyroid,etc.), Urology,Musculoskeletal,Peripheral vascular,Intra-operative,Pediatric andNeonatal (includingabdominal andcephalic), and Adultcephalic.	Trolley Mobile Equipment
Installationand Use	Portable(laptop)MobileEquipment	Trolley MobileEquipment	Trolley Mobile Equipment	Refer toTable 9-2
	SafetyStandards	IEC 60601-1IEC 60601-1-2IEC 60601-2-37ISO 10993-1, -5,-10, -12AIUM, NEMA UD2, UD3	IEC 60601-1IEC 60601-1-2IEC 60601-2-37ISO 10993-1, -5,-10, -12AIUM, NEMA UD2, 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 ISO 10993

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

Item	Acclarix AX8 R1.3DiagnosticUltrasound System(Edan Instruments)	Acclarix LX8R1.3 DiagnosticUltrasoundSystem(EdanInstruments)	M9 DiagnosticUltrasound System(ShenzhenMindrayBio-MedicalElectronics)	ComparisonResult
510(k)Number	Current Submission	CurrentSubmission	K152543(Reference, forMeasurement inPanorama, PW one-keyoptimization, AcousticPower Control andWireless networkconnection)	-
Intended Use	Diagnostic ultrasoundimaging or fluid flowanalysis of the humanbody	Diagnosticultrasoundimaging or fluidflow analysis ofthe human body	Diagnostic UltrasoundSystem applicable foradults, pregnant women,pediatric patients andneonates.	Same
Indicationsfor Use	The Acclarix AX8Diagnostic UltrasoundSystem is intended foruse by a qualifiedphysician or	The AcclarixLX8 DiagnosticUltrasoundSystem isintended for use	The M9DiagnosticUltrasound System isintended for use in fetal,abdominal, pediatric, smallorgan (breast, thyroid,
	sonographer 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.	by a qualifiedphysician orsonographer forultrasoundevaluation.Clinicalapplicationsinclude:Abdominal,Gynecology(includingendovaginal),Obstetric,Cardiac, Smallparts (Breast,Testes, Thyroid,etc.), Urology,Musculoskeletal,Peripheralvascular,Intra-operative,Pediatric andNeonatal(includingabdominal andcephalic), andAdult cephalic.	testes), neonatal and adultcephalic, trans-rectal,trans-vaginal,muscular-skeletal(conventional, superficial),adult and pediatric cardiac,trans-esoph. (Cardiac),peripheral vessel, urologyexams.
Installationand Use	Portable(laptop)MobileEquipment	Trolley MobileEquipment	Portable MobileEquipment	RefertoTable 9-2
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, NEMAUD 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 withISO 10993	Complies with ISO 10993	Same
Features	PW one-keyoptimization with acontinuous adjustmenton PW gain, DR,baseline and PRF scaleAcoustic PowerControl based onprevious powermanagement	PW one-keyoptimization witha continuousadjustment onPW gain, DR,baseline and PRFscaleAcoustic PowerControl based on	iTouch auto adjusts PWmode image with gain,scale, PRF and wall filter.Acoustic Power Settingand Acoustic PowerControl	Difference(PW one-keyoptimizationand AcousticPowerControl)
		previous powermanagement
Measurements	B-Mode: Distance,Circ/Area, Angle,Volume, Stenosis ratioM-Mode: Distance,Time, Slope and HeartRateD-Mode: Velocity, RI,Time, PI, Heart Rate,Auto Trace, PG, S/D,ΔV, Acceleration,PHT, VTI	B-Mode:Distance,Circ/Area,Angle, Volume,Stenosis ratioM-Mode:Distance, Time,Slope and HeartRateD-Mode:Velocity, RI,Time, PI, HeartRate, Auto Trace,PG, S/D, ΔV,Acceleration,PHT, VTI	B-Mode, M-Mode,PW-Mode, Color-Mode,Power/Dirpower Mode,THI, iScape mode, ColorM, Elastography, LVO orthe combined mode (i.e.B/M-Mode, B/PW-mode,B/PW/Color).	Same (forMeasurementin Panorama)
Wirelessnetworkconnection	Complies with FCCRules Part 15 (FCCID: SMQAX8EDAN)Frequency Range:2.400-2.483 GHz(2.4GHz IMS band)Module Type: OFDM,CCKOutput Power:≤17dbm	Complies withFCC Rules Part15(FCC ID:SMQLX8EDAN)FrequencyRange:2.412-2.472GHz, (2.4GHzIMS band)Module Type:OFDM, CCKOutput Power:≤17dbm	Complies with FCC RulesPart 15Operating Frequency:2.412-2.472 GHz, 2.484GHz (2.4GHz& 5GHzIMS band)Module Type: DSSS,OFDMOutput Power: ≤17dbm	Difference(forWireless)

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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:

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(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

§ 892.1560 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.