Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound System

K180862 · Edan Instruments, Inc. · IYN · May 24, 2018 · Radiology

Device Facts

• Record ID: K180862
• Device Name: Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound System
• Applicant: Edan Instruments, Inc.
• Product Code: IYN · Radiology
• Decision Date: May 24, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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

The Acclarix AX8 (portable laptop) and LX8 (cart-based) are diagnostic ultrasound systems sharing the Edan Ultrasound Software Platform (EUP). They utilize piezoelectric transducers to emit high-voltage bursts and detect reflected echoes to construct diagnostic images. Operated by physicians or allied health professionals in clinical settings, the systems provide real-time imaging and fluid flow analysis. Output is displayed on integrated monitors, assisting clinicians in diagnostic evaluations across various clinical applications. The systems support multiple modes including B-mode, M-mode, Color, PDI/DPDI, PW, CW, 3D/4D, and Tissue Doppler Imaging (TDI). Clinical benefits include non-invasive visualization of internal structures and blood flow, aiding in diagnosis and biopsy guidance.

Clinical Evidence

Bench testing only. No clinical data was required. Compliance with electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), acoustic output (NEMA UD 3), and biocompatibility (ISO 10993) standards was demonstrated.

Technological Characteristics

Systems utilize piezoelectric transducer technology for pulsed-echo imaging. Hardware includes convex, linear, phased, and micro-convex arrays (1-17 MHz). Connectivity includes multi-transducer ports. Software platform (EUP) supports B, M, PW, CW, Color, PDI/DPDI, 3D/4D, and TDI modes. Safety standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993. Form factors: portable laptop (AX8) and cart-based (LX8).

Indications for Use

Indicated for use by a qualified physician or allied health professional for ultrasound evaluations in abdominal, gynecological, obstetric, cardiac, small parts, urological, musculoskeletal, peripheral vascular, intra-operative, pediatric, neonatal, and adult cephalic clinical applications.

Regulatory Classification

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.

Predicate Devices

• Acclarix LX8 Diagnostic Ultrasound System (K171824)

Reference Devices

• DC-8 Diagnostic Ultrasound System (K170277)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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<br>(Specify) [1] | Other<br>(Specify) [2][3][4] |
| | Ophthalmic | Ophthalmic | | | | | | | |
| | | Fetal / Obstetrics | P | P | P | | P | P | P |
| | | Abdominal | P | P | P | P | P | P | P |
| | | Intra-operative (Specify) | P | P | P | | P | P | P |
| | | Intra-operative (Neuro logical) | | | | | | | |
| | | Laparoscopic | | | | | | | |
| | | Pediatric | P | P | P | | P | P | P |
| | | Small Organ (Specify) * | P | P | P | | P | P | P |
| Fetal<br>Imaging<br>& 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 | N[5] |
| Cardiac | | Pediatric Cardiac | P | P | P | P | P | P | N[5] |
| | | Intravascular(Cardiac) | | | | | | | |
| | | Trans-esoph.(Cardiac) | | | | | | | |
| | | Intra- cardiac | | | | | | | |
| Peripheral<br>vascular | | Peripheral vascular | P | P | P | | P | P | P |
| | | Other (Specify) | | | | | | | |
| | N = new indication; P = previously cleared by FDA; E = added under this appendix PDI= Power Doppler Imaging | | | | | | | | |
| Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW | | | | | | | | | |

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

* Small Organ includes Thyroid, Testes, Breast, Lung Note

** Other use includes Urology, Gynecology

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

[2]: Biopsy Guidance

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

[4]: 3D/4D [5]: TDI

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

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

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

** Other use includes Urology, Gynecology

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

[2]: Biopsy Guidance

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

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

Concurrence of Center for Devices and Radiological Health (CDRH)

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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<br>(Specify) [1] | Other<br>(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<br>& 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<br>(Specify) [1] | Other<br>(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<br>& Other | Neonatal Cephalic | P | P | P | P | P | P | P |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Musculo-skeletal(Conventional) | P | P | P | P | P | P | P |
| | Musculo-skeletal (Superficial) | P | P | P | P | P | P | P |
| | Intravascular | | | | | | | |
| | Other (Specify) ** | P | P | P | P | P | P | P |
| Cardiac | Adult Cardiac | | | | | | | |
| | Pediatric Cardiac | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra- cardiac | | | | | | | |
| Peripheral<br>vascular | Peripheral vascular | P | P | P | P | P | P | P |
| | Other (Specify) | | | | | | | |

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

** Other use includes Neonatal abdominal.

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

[2]: Biopsy Guidance

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

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

Concurrence of Center for Devices and Radiological Health (CDRH)

{7}------------------------------------------------

## 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<br>(Specify) [1] | Other<br>(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)

{8}------------------------------------------------

## 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<br>& Other | Fetal / Obstetrics | P | P | P | | P | P | P | |
| | Abdominal | | | | | | | | |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neuro logical) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (Specify) * | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | P | P | P | | P | P | P | |
| | Trans-vaginal | P | P | P | | P | P | P | |
| | Trans-urethral | | | | | | | | |
| | Musculo-skeletal(Conventional) | | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (Specify) ** | | | | | | | | |
| | Adult Cardiac | | | | | | | | |
| Cardiac | Pediatric Cardiac | | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | | |
| | Intra- cardiac | | | | | | | | |
| | Peripheral vascular | | | | | | | | |
| Peripheral<br>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)

{9}------------------------------------------------

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

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

| | Clinical Application | Mode of Operation | | | | | | |
|--------------------------|---------------------------------|-------------------|---|----|----|-------|---------------------------|---------------------------|
| General<br>Ophthalmic | | B | M | PW | CW | Color | Combined<br>(Specify) [1] | Other<br>(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<br>& Other | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Musculo-skeletal(Conventional) | P | P | P | | P | P | P |
| | Musculo-skeletal (Superficial) | P | P | P | | P | P | P |
| | Intravascular | | | | | | | |
| | Other (Specify) ** | | | | | | | |
| | Adult Cardiac | | | | | | | |
| | Pediatric Cardiac | | | | | | | |
| Cardiac | Intravascular(Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra- cardiac | | | | | | | |
| Peripheral<br>vascular | Peripheral vascular | P | P | P | | P | P | P |
| | Other (Specify) | | | | | | | |

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

** Other use includes Urology, Gynecology

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

[2]: Biopsy Guidance

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

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

Concurrence of Center for Devices and Radiological Health (CDRH)

{10}------------------------------------------------

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

| | Clinical Application | Mode of Operation | | | | | | |
|--------------------------|---------------------------------|-------------------|---|----|----|-------|---------------------------|---------------------------|
| | | B | M | PW | CW | Color | Combined<br>(Specify) [1] | Other<br>(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<br>& 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<br>vascular | Peripheral vascular | | | | | | | |
| | Other (Specify) | | | | | | | |

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

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

* Small Organ includes Thyroid, Testes, Breast Note

** Other use includes Urology, Gynecology

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

[2]: Biopsy Guidance

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

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

Concurrence of Center for Devices and Radiological Health (CDRH)

{11}------------------------------------------------

## 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<br>(Specify) [1] | Other<br>(Specify) [2][3] |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging<br>& 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 | N[4] |
| | Pediatric Cardiac | P | P | P | P | P | P | N[4] |
| | Intravascular(Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra- cardiac | | | | | | | |
| Peripheral<br>vascular | Peripheral vascular | | | | | | | |
| | Other (Specify) | | | | | | | |

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

** Other use includes Urology, Gynecology

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

[2]: Biopsy Guidance

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

[4]: TDI .

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

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

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

* Small Organ includes Thyroid, Testes, Breast Note

** Other use includes Urology, Gynecology

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

[2]: Biopsy Guidance

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

(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][4] |
| General | Ophthalmic | | | | | | | |
| | Fetal / Obstetrics | P | P | P | P | P | P | P |
| | Abdominal | N | N | N | N | N | N | N |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro logical) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify) * | | | | | | | |
| Fetal<br>Imaging<br>& Other | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Musculo-skeletal (Conventional) | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) ** | N | N | N | N | N | N | N |
| | Adult Cardiac | | | | | | | |
| | Pediatric Cardiac | | | | | | | |
| Cardiac | Intravascular(Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra- cardiac | | | | | | | |
| | Peripheral vascular | | | | | | | |
| Peripheral<br>vascular | Peripheral vascular | | | | | | | |
| | Other (Specify) | | | | | | | |

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

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

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

** Other use includes Urology, Gynecology

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

[2]: Biopsy Guidance

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

[4]: 3D/4D

(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<br>(Specify) [1] | Other<br>(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<br>& 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 | N[4] |
| | Pediatric Cardiac | N | N | N | N | N | N | N[4] |
| | 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<br>(Specify) [1] | Other<br>(Specify) [2][3] |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging<br>& 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 | | | | | |…