LinkQuest Diagnostic Ultrasound System model SQ860

K172059 · Linkquest, Inc. · IYN · Oct 5, 2017 · Radiology

Device Facts

• Record ID: K172059
• Device Name: LinkQuest Diagnostic Ultrasound System model SQ860
• Applicant: Linkquest, Inc.
• Product Code: IYN · Radiology
• Decision Date: Oct 5, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The LinkQuest Diagnostic Ultrasound SQ860 is intended for diagnostic ultrasound imaging analysis of adults, pregnant women, pediatric patients and neonates. It is intended for use by or on the order of a physician or similarly qualified health care professional in fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, musculo-skeletal (conventional, superficial), cardiac adult, cardiac pediatric, peripheral vessel and urology exams.

Device Story

Mobile, software-controlled diagnostic ultrasound system; acquires/displays images via linear, convex, intracavity, phased, and 4D array probes (2-10 MHz). Operates in B-Mode, M-Mode, Color-Mode, PW/CW-Mode, TDI, 3D/4D, and Elastography. Used in clinical settings by physicians or qualified healthcare professionals for diagnostic imaging and fluid flow analysis. Provides real-time visual output for clinical assessment; aids in biopsy guidance, nerve block injections, and general diagnostic evaluation. Benefits include non-invasive visualization of internal structures and blood flow to support clinical decision-making.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical bench testing, including compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 14971, ISO 10993, NEMA UD-2, and AIUM/NEMA UD-3 standards.

Technological Characteristics

Mobile ultrasound system; frequency range 2-10 MHz. Probes: linear, convex, intracavity, phased, 4D arrays. Modes: B, M, Color, PW/CW Doppler, TDI, 3D/4D, Elastography. Compliance: IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-2-37 (ultrasound), ISO 14971 (risk management), ISO 10993 (biocompatibility), NEMA UD-2/UD-3 (acoustic output).

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid flow analysis in adults, pregnant women, pediatric patients, and neonates. Clinical applications include fetal, abdominal, small organ (breast, thyroid, testes), neonatal/adult cephalic, pediatric, trans-rectal, trans-vaginal, musculoskeletal, cardiac, peripheral vessel, and urology exams.

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

• Ultrasonics Touch (K083095)
• SonoSite maxx (K130173)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.

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

October 5, 2017

Linkquest Inc. C/0 Dr. Xiaolong Yu President 6749 Top Gun Street #100 San Diego CA 92121

Re: K172059

Trade/Device Name: LinkQuest Diagnostic Ultrasound System model SO860 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: June 28, 2017 Received: July 7, 2017

Dear Dr. Yu:

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 (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.

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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/Resourcesfor You/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 yours.

Michael D. O'Hara For

Robert Ochs 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) k172059

Device Name

LinkQuest Diagnostic Ultrasound System model SQ860

Indications for Use (Describe)

The LinkQuest Diagnostic Ultrasound SQ860 is intended for diagnostic ultrasound imaging analysis of adults, pregnant women, pediatric patients and neonates. It is intended for use by or on the order of a physician or similarly qualified health care professional in fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, musculo-skeletal (conventional, superficial), cardiac adult, cardiac pediatric, peripheral vessel and urology exams.

Type of Use (Select one or both, as applicable)

| <div> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> |
|---------------------------------------------------------------------------------------------------------------|
| <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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## Indications for Use Form

#### SQ 860 Diagnostic Ultrasound Systems System:

Transducer: N/A

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

| Clinical Application | Mode of Operation | | | | | | |
|----------------------------|-------------------|---|-----|-----|---------------|--------------------|------------------|
| Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color Doppler | Combined (Specify) | Other* (Specify) |
| Fetal | N | N | N | | N | N(*1) | N(*2) |
| Abdominal | N | N | N | N | N | N(*1) | N(*2) |
| Small Organ (Specify) | N | N | N | | N | N(*1) | N(*2) |
| Neonatal Cephalic | N | N | N | | N | N(*1) | N(*2)` |
| Adult Cephalic | N | N | N | | N | N(*1) | N(*2) |
| Pediatric | N | N | N | | N | N(*1) | N(*2) |
| Trans-rectal | N | N | N | | N | N(*1) | N(*2) |
| Trans-vaginal | N | N | N | | N | N(*1) | N(*2) |
| Cardiac | N | N | N | N | N | N(*1) | N(*2) |
| Peripheral Vessel | N | N | N | | N | N(*1) | N(*2) |
| MSK Conventional | N | N | N | | N | N(*1) | N(*2) |
| MSK Superficial | N | N | N | | N | N(*1) | N(*2) |
| Vascular Access | N | N | N | | N | N(*1) | N(*2,*4) |
| Nerve Block | N | N | N | | N | N(*1) | N(*2,*3) |
| Other (Specify) | | | | | | | |

N = New indication; P = Previously cleared

Additional Comments:

Small Organ: Breast, Thyroid, Testicle

*1. B/M, B/PWD, B/CF/PWD, (B includes Simple B (SB) imaging, Harmonic Imaging (HI) , SB/HI ) *2. Elastography, Power Doppler (DPD). Biopsy Guidance Imaging, Panoramic Imaging, Tissue Doppler Imaging, Compound Imaging, Freehand 3D Imaging, Live 3D/4D Imaging.

*3. Imaging for guidance of nerve block injections

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Transducer: A8L1

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

| Clinical Application | Mode of Operation | | | | | | |
|----------------------------|-------------------|---|-----|-----|------------------|-----------------------|---------------------|
| Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Fetal | N | N | N | N | N | N(*1) | N(*2) |
| Abdominal | N | N | N | N | N | N(*1) | N(*2) |
| Small Organ (Specify) | N | N | N | N | N | N(*1) | N(*2) |
| Neonatal Cephalic | N | N | N | N | N | N(*1) | N(*2)` |
| Adult Cephalic | N | N | N | N | N | N(*1) | N(*2) |
| Pediatric | N | N | N | N | N | N(*1) | N(*2) |
| Trans-rectal | | | | | | | |
| Trans-vaginal | | | | | | | |
| Cardiac | | | | | | | |
| Peripheral Vessel | N | N | N | N | N | N(*1) | N(*2) |
| MSK Conventional | N | N | N | N | N | N(*1) | N(*2) |
| MSK Superficial | N | N | N | N | N | N(*1) | N(*2) |
| Vascular Access | N | N | N | N | N | N(*1) | N(*2,*4) |
| Nerve Block | N | N | N | N | N | N(*1) | N(*2,*3) |
| Other (Specify) | | | | | | | |

N = New indication; P = Previously cleared

Additional Comments:

Small Organ: Breast, Thyroid, Testicle

*1. B/M, B/PWD, B/CF/PWD, (B includes Simple B (SB) imaging, Harmonic Imaging (HI) , SB/H )

*2. Elastography, Power Doppler (DPD). Biopsy Guidance Imaging, Tissue Doppler Imaging, Tissue Doppler Imaging, Compound Imaging, Freehand 3D Imaging, Live 3D/4D Imaging.

*3. Imaging for guidance of nerve block injections

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Transducer: A3C1 Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | Mode of Operation | | | | | | |
|----------------------------|-------------------|---|-----|-----|------------------|-----------------------|---------------------|
| Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Fetal | N | N | N | N | N | N(*1) | N(*2) |
| Abdominal | N | N | N | N | N | N(*1) | N(*2) |
| Small Organ (Specify) | N | N | N | N | N | N(*1) | N(*2) |
| Neonatal Cephalic | | | | | | | |
| Adult Cephalic | | | | | | | |
| Pediatric | N | N | N | N | N | N(*1) | N(*2) |
| Trans-rectal | | | | | | | |
| Trans-vaginal | | | | | | | |
| Cardiac | | | | | | | |
| Peripheral Vessel | N | N | N | N | N | N(*1) | N(*2) |
| MSK Conventional | N | N | N | N | N | N(*1) | N(*2) |
| MSK Superficial | N | N | N | N | N | N(*1) | N(*2) |
| Vascular Access | | | | | | | |
| Nerve Block | | | | | | | |
| Other (Specify) | | | | | | | |

N = New indication; P = Previously cleared

Additional Comments:

Small Organ: Breast, Thyroid, Testicle

*1. B/M, B/PWD, B/CF/PWD, (B includes Simple B (SB) imaging, Harmonic Imaging (HI) , SB/H )

*2. Elastography, Power Doppler (DPD). Biopsy Guidance Imaging, Tissue Doppler Imaging, Tissue Doppler Imaging, Compound Imaging, Freehand 3D Imaging, Live 3D/4D Imaging.

*3. Imaging for guidance of nerve block injections

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Transducer: A3S1

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

| Clinical Application | Mode of Operation | | | | | | |
|----------------------------|-------------------|---|-----|-----|------------------|-----------------------|---------------------|
| Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Fetal<br>Abdominal | N | N | N | N | N | N(*1) | N(*2) |
| Small Organ (Specify) | | | | | | | |
| Neonatal Cephalic | N | N | N | | N | N(*1) | N(*2) |
| Adult Cephalic | N | N | N | | N | N(*1) | N(*2) |
| Pediatric | N | N | N | N | N | N(*1) | N(*2) |
| Trans-rectal | | | | | | | |
| Trans-vaginal | | | | | | | |
| Cardiac | N | N | N | N | N | N(*1) | N(*2) |
| Peripheral Vessel | | | | | | | |
| MSK Conventional | | | | | | | |
| MSK Superficial | | | | | | | |
| Vascular Access | | | | | | | |
| Nerve Block | | | | | | | |
| Other (Specify) | | | | | | | |

N = New indication; P = Previously cleared

### Additional Comments:

Small Organ: Breast, Thyroid, Testicle

*1. B/M, B/PWD, B/CWD, B/CF/PWD, (B includes Simple B (SB) imaging, Harmonic Imaging (HI) , SB/HI ) *2. Elastography, Power Doppler (DPD). Biopsy Guidance Imaging, Tissue Doppler Imaging,

Compound Imaging, Freehand 3D Imaging, Live 3D/4D Imaging.

*3. Imaging for guidance of nerve block injections

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Transducer: E8C1

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

| Clinical Application | Mode of Operation | | | | | | |
|----------------------------|-------------------|---|-----|-----|------------------|-----------------------|---------------------|
| Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Fetal | | | | | | | |
| Abdominal | | | | | | | |
| Small Organ (Specify) | | | | | | | |
| Neonatal Cephalic | | | | | | | |
| Adult Cephalic | | | | | | | |
| Pediatric | | | | | | | |
| Trans-rectal | N | N | N | N | N | N(*1) | N(*2) |
| Trans-vaginal | N | N | N | N | N | N(*1) | N(*2) |
| Cardiac Adult | | | | | | | |
| Peripheral Vessel | | | | | | | |
| MSK Conventional | | | | | | | |
| MSK Superficial | | | | | | | |
| Vascular Access | | | | | | | |
| Nerve Block | | | | | | | |
| Other (Specify) | | | | | | | |

N = New indication; P = Previously cleared

Additional Comments:

Small Organ: Breast, Thyroid, Testicle

*1. B/M, B/PWD, B/CF/PWD, (B includes Simple B (SB) imaging, Harmonic Imaging (HI) , SB/H )

*2. Elastography, Power Doppler (DPD). Biopsy Guidance Imaging, Tissue Doppler Imaging, Tissue Doppler Imaging, Compound Imaging, Freehand 3D Imaging, Live 3D/4D Imaging.

*3. Imaging for guidance of nerve block injections

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

Transducer: A3D1 Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | Mode of Operation | | | | | | |
|----------------------------|-------------------|---|-----|-----|------------------|-----------------------|---------------------|
| Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Fetal | N | N | N | N | N | N(*1) | N(*2) |
| Abdominal | N | N | N | N | N | N(*1) | N(*2) |
| Small Organ (Specify) | N | N | N | N | N | N(*1) | N(*2) |
| Neonatal Cephalic | | | | | | | |
| Adult Cephalic | | | | | | | |
| Pediatric | N | N | N | N | N | N(*1) | N(*2) |
| Trans-rectal | | | | | | | |
| Trans-vaginal | | | | | | | |
| Cardiac Adult | | | | | | | |
| Peripheral Vessel | N | N | N | N | N | N(*1) | N(*2) |
| MSK Conventional | | | | | | | |
| MSK Superficial | | | | | | | |
| Vascular Access | | | | | | | |
| Nerve Block | | | | | | | |
| Other (Specify) | | | | | | | |

N = New indication; P = Previously cleared

Additional Comments:

Small Organ: Breast, Thyroid, Testicle

*1. B/M, B/PWD, B/CF/PWD, (B includes Simple B (SB) imaging, Harmonic Imaging (HI) , SB/H )

*2. Elastography, Power Doppler (DPD). Biopsy Guidance Imaging, Tissue Doppler Imaging, Tissue Doppler Imaging, Compound Imaging, Freehand 3D Imaging, Live 3D/4D Imaging.

*3. Imaging for guidance of nerve block injections

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## 510K SUMMARY

LinkQuest Diagnostic Ultrasound System and Transducers Model SQ860

| Submitter: | LinkQuest, Inc.<br>6749 Top Gun Street, Suite 100<br>San Diego, CA 92121<br>Phone: [phone]<br>Fax: [phone] |
|-----------------|--------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Xiaolong Yu, Ph.D.<br>Phone: [phone]<br>Fax: [phone]<br>E-Mail: [e-mail] |
| Trade Name: | LinkQuest Diagnostic Ultrasound System model SQ860 |

### Classification and Regulatory Class:

| Description | Class | Product Code |
|----------------------------------------------------------|-------|--------------|
| 21 CFR 892.1550 Ultrasonic Pulsed Doppler Imaging System | II | IYN |
| 21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System | II | IYO |
| 21 CFR 892.1570 Diagnostic Ultrasound Transducer | II | ITX |

#### Panel Identification: Radiolagy

Prior Submissions Statement: No previous submissions for this device.

### Device Description:

The LinkQuest Diagnostic Ultrasound System SQ860 is a general purpose, mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-Mode, M-Mode, Color-Mode, PW-Mode, TDI mode, CW mode, 3D/4D mode, Elastography (Strain imaging) and/or the combined modes. This system is a Track 3 device that employs a set of probes that include linear array, convex array, Intracavity array, phased array and 4D array with a frequency range of approximately 2 MHz to 10.0 MHz.

### Predicate Devices:

Ultrasonics Touch Manufactured by: Ultrasonix Medical Corporation k083095 130-4311 Viking Way Richmond, British Columbia Canada V6V 2K9

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Manufactured by: FUJIFILM SonoSite Inc SonoSite maxx k130173 21919 301 Drive SE Bothell, WA 98021-3904

### Indications for Use:

The LinkQuest Diagnostic Ultrasound System and Transducers model SQ860 are intended for diagnostic ultrasound imaging analysis of adults, pregnant women, pediatric patients and neonates. They are intended for use by or on the order of a physician or similarly qualified health care professional in fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), cardiac adult, cardiac pediatric, peripheral vessel and urology exams.

Clinical Test: Clinical testing is not required.

## Non - clinical Test:

The following safety standards and regulations are complied with by the subject device:

1. IEC 60601-1:2005 Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance;

- 2. IEC 60601-1-2:2007 for electromagnetic compatibility;
- 3. IEC 60601-1-2-37,
- 4. ISO 14971.

5. NEMA UD-2 2004: Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment

6. AIUM and NEMA UD-3 2004: The Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment 7. ISO 10993 Biological Evaluation of Medical Devices

## Comparison with predicate device

SQ860 Diagnostic Ultrasound System is comparable with and substantially equivalent to the listed predicate devices. SQ860 has the similar technological characteristics, is comparable in key safety and effectiveness features, and has the similar intended uses and basic operating modes as the predicate devices.

## Substantially Equivalent Dtermination

The evaluation of the LinkQuest Diagnostic Ultrasound Systems and Transducers based on the technical characteristics and the results of the performance tests we conclude that SQ860 Diagnostic Ultrasound System and Transducers are substantially equivalent and as safe and effective as the predicate devices.