ACUSON Sequoia Diagnostic Ultrasound System

K200707 · Siemens Medical Solutions USA, Inc. · IYN · Apr 15, 2020 · Radiology

Device Facts

• Record ID: K200707
• Device Name: ACUSON Sequoia Diagnostic Ultrasound System
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: IYN · Radiology
• Decision Date: Apr 15, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The ACUSON Sequoia ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal, Abdominal, Pediatric, Neonatal Cephalic, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Pelvic, Vascular, Adult Cephalic, Musculoskeletal and Peripheral Vascular applications. The system also provides the ability to measure anatomical structures for fetal, abdominal, pediatric, small organ, cardiac, transrectal, transvaginal, peripheral vessel, musculoskeletal and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

Device Story

Mobile, software-controlled diagnostic ultrasound system; transmits/receives ultrasound echo data; displays images in B-Mode, M-Mode, PW/CW Doppler, Color Doppler, Color M Mode, Doppler Tissue Mode, Amplitude Doppler, and harmonic imaging. Used in clinical settings by physicians/trained professionals. Provides anatomical measurements and calculation packages for adjunctive clinical diagnosis. Benefits include non-invasive visualization of internal structures and fluid flow analysis. System integrates hardware/software from previous Sequoia iterations; includes various transducers (phased, linear, curved, endocavity, CW). Output displayed on 21" OLED monitor; clinician uses output to inform diagnostic decisions.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including acoustic output, biocompatibility, and electrical/electromagnetic safety testing per IEC/ISO standards.

Technological Characteristics

Mobile ultrasound system; 21" OLED display; 15" adjustable touch screen. Supports B, M, PW/CW Doppler, Color Doppler, Tissue Doppler, Harmonic, and Panoramic imaging. Patient contact materials tested to ISO 10993-1. Connectivity includes DICOM/DICOM SR, wireless, and TeamViewer. Safety certified to AAMI ES60601-1, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, and IEC 60601-2-37.

Indications for Use

Indicated for fetal, abdominal, pediatric, neonatal cephalic, small parts, OB/GYN, cardiac, pelvic, vascular, adult cephalic, musculoskeletal, and peripheral vascular applications. For use by trained healthcare professionals in clinical settings.

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

• ACUSON Sequoia (K193257)

Reference Devices

• ACUSON S family (K172162)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Siemens Medical Solutions USA, Inc. % Prithul Bom Responsible Third Party Official Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k SAINT PAUL MN 55114

April 15, 2020

### Re: K200707

Trade/Device Name: ACUSON Sequoia Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX, OIJ Dated: March 17, 2020 Received: March 18, 2020

Dear Prithul Bom:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K200707

Device Name

ACUSON Sequoia Diagnostic Ultrasound System

#### Indications for Use (Describe)

The ACUSON Sequoia ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal, Abdominal, Pediatric, Neonatal Cephalic, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Pelvic, Vascular, Adult Cephalic, Musculoskeletal and Peripheral Vascular applications.

The system also provides the ability to measure anatomical structures for fetal, abdominal, pediatric, small organ, cardiac, transrectal, transvaginal, peripheral vessel, musculoskeletal and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

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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Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

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510 (k) Number (if known):

Device Name: Intended Use:

#### ACUSON Sequoia Diagnostic Ultrasound System Ultrasound imaging or fluid flow analysis of the human body as follows:

| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | P | P | P | P | | P | P | | BMDC | |
| Abdominal | P | P | P | P | | P | P | | BMDC | |
| Intraoperative | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | | BMDC | |
| Small Organ<br>(Note 1) | P | P | P | P | | P | P | | BMDC | |
| Neonatal Cephalic | P | P | P | P | | P | P | | BMDC | |
| Adult Cephalic | N | N | N | N | | N | N | | BMDC | |
| Cardiac | P | P | P | P | P | P | P | | BMDC | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | P | P | P | P | | P | P | | BMDC | |
| Transvaginal | P | P | P | P | | P | P | | BMDC | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | P | P | P | P | | P | P | | BMDC | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | P | P | P | P | | P | P | | BMDC | |
| Musculo-skeletal<br>Superficial | P | P | P | P | | P | P | | BMDC | |
| Other (specify) | | | | | | | | | | |

N = new indication; P = previously cleared by K193257

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

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510 (k) Number (if known):

| Device Name: | 4V1 Phased Array Transducer | | | | | | | | | |
|----------------------------------|-------------------------------------------------------------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Intended Use: | Ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | |
| | Mode of Operation | | | | | | | | | |
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | P | P | P | P | | P | P | | BMDC | |
| Abdominal | P | P | P | P | | P | P | | BMDC | |
| Intraoperative | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | P | P | P | P | | P | P | | BMDC | |
| Small Organ<br>(Note 1) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

N = new indication; P = previously cleared by K193257

Additional Comments:

For example: breast, testes, thyroid, penis, prostate, etc. Note 1

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off - Office of In Vitro Diagnostic Devices 510(k)__

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510 (k) Number (if known):

#### Device Name: DAX Curved Array Transducer Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows: Mode of Operation Color Color Amplitude Combined Other CWD Clinical Application A B M PWD Velocity Doppler Doppler (Specify) (Specify) Imaging Ophthalmic Fetal P P P P P BMCD Abdominal P P P P P BMCD Intraoperative

| Intraoperative<br>Neurological | | | | | | | |
|----------------------------------|---|---|---|--|---|---|------|
| Pediatric | P | P | P | | P | P | BMCD |
| Small Organ<br>(Note 1) | | | | | | | |
| Neonatal Cephalic | | | | | | | |
| Adult Cephalic | | | | | | | |
| Cardiac | | | | | | | |
| Trans-esophageal | | | | | | | |
| Transrectal | | | | | | | |
| Transvaginal | | | | | | | |
| Transurethral | | | | | | | |
| Intravascular | | | | | | | |
| Peripheral vessel | | | | | | | |
| Laparoscopic | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | |
| Other (specify) | | | | | | | |

N = new indication; P = previously cleared by K193257

Additional Comments:

For example: breast, testes, thyroid, penis, prostate, etc. Note 1

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off - Office of In Vitro Diagnostic Devices 510(k)_

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510 (k) Number (if known):

| Device Name:<br>Intended Use: | 5C1 Curved Array Transducer<br>Ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | |
|----------------------------------|--------------------------------------------------------------------------------------------------------|-------------------|---|-----|-----|------------------|----------------------|------------------------|-----------------------|--------------------|
| | | Mode of Operation | | | | | | | | |
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color Velocity Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | P | P | P | P | | P | P | | BMCD | |
| Abdominal | P | P | P | P | | P | P | | BMCD | |
| Intraoperative | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | P | P | P | P | | P | P | | BMCD | |
| Small Organ<br>(Note 1) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

N = new indication; P = previously cleared by K193257

Additional Comments:

For example: breast, testes, thyroid, penis, prostate, etc. Note 1

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off - Office of In Vitro Diagnostic Devices 510(k)_

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510 (k) Number (if known):

| Device Name:<br>Intended Use: | 9C3 Curved Array Transducer<br>Ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | |
|----------------------------------|--------------------------------------------------------------------------------------------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| | Mode of Operation | | | | | | | | | |
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | | BMCD | |
| Abdominal | | P | P | P | | P | P | | BMCD | |
| Intraoperative | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | | BMCD | |
| Small Organ<br>(Note 1) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | P | P | P | | P | P | | BMCD | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

N = new indication; P = previously cleared by K193257

Additional Comments:

For example: breast, testes, thyroid, penis, prostate, etc. Note 1

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off - Office of In Vitro Diagnostic Devices 510(k)_

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510 (k) Number (if known):

| Device Name: | 18L6 Linear Array Transducer | | | | | | | | | |
|----------------------------------|-------------------------------------------------------------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Intended Use: | Ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | |
| | Mode of Operation | | | | | | | | | |
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | | BMCD | |
| Small Organ<br>(Note 1) | | P | P | P | | P | P | | BMCD | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | P | P | P | | P | P | | BMCD | |
| Musculo-skeletal<br>Superficial | | P | P | P | | P | P | | BMCD | |
| Other (specify) | | | | | | | | | | |

N = new indication; P = previously cleared by K193257

Additional Comments:

For example: breast, testes, thyroid, penis, prostate, etc. Note 1

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

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510 (k) Number (if known):

| Device Name: | | 14L5 Linear Array Transducer | | | | | | | | | | |
|----------------------------------|---|-------------------------------------------------------------------------------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|--|--|
| Intended Use: | | Ultrasound imaging or fluid flow analysis of the human body as follows: Mode of Operation | | | | | | | | | | |
| | | | | | | | | | | | | |
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) | | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | | BMCD | | | |
| Small Organ<br>(Note 1) | | P | P | P | | P | P | | BMCD | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral vessel | | P | P | P | | P | P | | BMCD | | | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | P | P | P | | P | P | | BMCD | | | |
| Musculo-skeletal<br>Superficial | | P | P | P | | P | P | | BMCD | | | |
| Other (specify) | | | | | | | | | | | | |

N = new indication; P = previously cleared by K193257

Additional Comments:

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off - Office of In Vitro Diagnostic Devices 510(k)_

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#### 510 (k) Number (if known):

| Device Name: | 10L4 Linear Array Transducer | | | | | | | | | | |
|----------------------------------|------------------------------|-------------------------------------------------------------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|--|
| Intended Use: | | Ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | |
| | | Mode of Operation | | | | | | | | | |
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | | BMCD | | |
| Abdominal | | P | P | P | | P | P | | BMCD | | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | | BMCD | | |
| Small Organ<br>(Note 1) | | P | P | P | | P | P | | BMCD | | |
| Neonatal Cephalic | | P | P | P | | P | P | | BMCD | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral vessel | | P | P | P | | P | P | | BMCD | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | P | P | P | | P | P | | BMCD | | |
| Musculo-skeletal<br>Superficial | | P | P | P | | P | P | | BMCD | | |
| Other (specify) | | | | | | | | | | | |

N = new indication; P = previously cleared by K193257

Additional Comments:

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

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510 (k) Number (if known):

Device Name: Intended Use:

#### 9EC4 Endocavity Transducer

Ultrasound imaging or fluid flow analysis of the human body as follows:

| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(Note 1) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | P | P | P | P | | P | P | | BMCD | |
| Transvaginal | P | P | P | P | | P | P | | BMCD | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

N = new indication; P = previously cleared by K193257

Additional Comments:

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off - Office of In Vitro Diagnostic Devices 510(k)_

{12}------------------------------------------------

510 (k) Number (if known):

| Device Name:<br>Intended Use: | | 5V1 Phased Array Transducer<br>Ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | |
|----------------------------------|---|--------------------------------------------------------------------------------------------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|--|
| | | Mode of Operation | | | | | | | | | |
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | | BMCD | | |
| Small Organ<br>(Note 1) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | N | N | N | | N | N | | BMCD | | |
| Cardiac | P | P | P | P | P | P | P | | BMCD | | |
| Trans-esophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |

N = new indication; P = previously cleared by K193257

Additional Comments:

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off - Office of In Vitro Diagnostic Devices 510(k)_

-

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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

#### 510 (k) Number (if known):

| Device Name: | 8V3 Phased Array Transducer | | | | | | | | | | |
|----------------------------------|-------------------------------------------------------------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|--|
| Intended Use: | Ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | | |
| | Mode of Operation | | | | | | | | | | |
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | P | P | P | | P | P | | BMCD | | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | BMCD | | |
| Small Organ<br>(Note 1) | | | | | | | | | | | |
| Neonatal Cephalic | | P | P | P | | P | P | | BMCD | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | P | P | P | P | P | P | | BMCD | | |
| Trans-esophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |

N = new indication; P = previously cleared by K193257

Additional Comments:

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

{14}------------------------------------------------

510 (k) Number (if known):

| Device Name:<br>Intended Use: | CW2 Continuous Wave Transducer<br>Ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | |
|----------------------------------|-----------------------------------------------------------------------------------------------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| | Mode of Operation | | | | | | | | | |
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | P | | | | | |
| Small Organ<br>(Note 1) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | |…