SEQUOIA PLUS DIAGNOSTIC ULTRASOUND SYSTEM

K072365 · Siemens Medical Solutions USA, Inc., Ultrasound DI · IYN · Oct 17, 2007 · Radiology

Device Facts

• Record ID: K072365
• Device Name: SEQUOIA PLUS DIAGNOSTIC ULTRASOUND SYSTEM
• Applicant: Siemens Medical Solutions USA, Inc., Ultrasound DI
• Product Code: IYN · Radiology
• Decision Date: Oct 17, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The Sequoia Plus ultrasound imaging system is intended for the following applications: Cardiac, Neonatal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Intraoperative Neurological, Musculo-skelctal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures 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

The Sequoia Plus is a diagnostic ultrasound system used in clinical settings by physicians and trained clinicians. It transmits ultrasound energy into the body to generate 2D, M-Mode, Color Doppler, Color Power Doppler, Pulsed Wave Doppler, and Continuous Wave Doppler images. The system can acquire ECG signals to synchronize image capture with cardiac cycles. It includes measurement and calculation packages for anatomical structures and blood flow velocity, which clinicians use adjunctively with other medical data for diagnosis. The device aids in evaluating pathology in the heart, great vessels, carotid arteries, veins, musculoskeletal structures, and brain. It supports intraoperative guidance for neurological procedures. The system provides real-time visual output for clinical decision-making and patient assessment.

Clinical Evidence

Bench testing only. The device was verified and validated according to the manufacturer's design control process, including compliance with safety standards (UL 60601-1, IEC 60601-2-37, ISO 10993-1) and acoustic output measurement standards (AIUM/NEMA UD-2, UD-3). No clinical study data was required for this 510(k) clearance.

Technological Characteristics

Diagnostic ultrasound system utilizing pulsed echo and pulsed Doppler imaging. Supports multiple transducer types (e.g., 9L4, V5M TEE, 4V1c, AUX CW2, 4Z1c). Materials comply with ISO 10993-1. Safety standards include UL 60601-1, IEC 60601-2-37, and AIUM/NEMA UD-2/UD-3. Connectivity includes ECG synchronization. System provides B, M, Doppler, and harmonic imaging modes.

Indications for Use

Indicated for ultrasound imaging and fluid flow analysis in adult, pediatric, and neonatal patients for cardiac, vascular, superficial, intraoperative neurological, and transcranial applications. Contraindications not specified.

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 Ultrasound System (K063085, K051139)

Reference Devices

• 9L4 (K063085)
• V5M TEE (K063085, K022567)
• 4V1c (K063085, K022567)
• AUX CW2 (K063085, K001400)
• 4Z1c (K051139)

Submission Summary (Full Text)

{0}------------------------------------------------

K072365

#### 4.2.13b 510(k) Summary/Statement Certification

#### 510(k) Summary Prepared September 17, 2007

007 17 2007

| Sponsor: | Siemens Medical Solutions, Inc.,<br>Ultrasound Division<br>1230 Shorebird Way<br>Mountain View, California 94043 |
|------------------|------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Robert F. Lawrence<br>Telephone: [phone]<br>Fax: [phone] |
| Submission Date: | September 17, 2007 |
| Device Name: | Sequoia™ Plus Ultrasound System |
| Common Name: | Diagnostic Ultrasound System |

#### Classification:

| Regulatory Class: | II |
|-----------------------|-----------|
| Review Category: | Tier II |
| Classification Panel: | Radiology |

| Ultrasonic Pulsed Doppler Imaging System | FR # 892.1550 | Product Code 90-IYN |
|------------------------------------------|---------------|---------------------|
| Ultrasonic Pulsed Echo Imaging System | FR # 892.1560 | Product Code 90-IYO |
| Diagnostic Ultrasound Transducer | FR # 892.1570 | Product Code 90-ITX |

#### A. Legally Marketed Predicate Devices

The Siemens Sequoia™ Plus Ultrasound System is substantially equivalent to the Siemens Acuson Sequoia Ultrasound System.

## B. Device Description:

The Siemens Sequoia™ Plus has been designed to meet the following product safety standards:

- 트 UL 60601-1, Safety Requirements for Medical Equipment
- 트 IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
- . CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment
- 지 AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- . AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound
- 트 93/42/EEC Medical Devices Directive
- 제 Safety and EMC Requirements for Medical Equipment
- . EN/IEC 60601-1
- a EN/IEC 60601-1-1
- . EN/IEC 60601-1-2
- . IEC 1157 Declaration of Acoustic Power
- K ISO 10993-1 Biocompatibility

{1}------------------------------------------------

## C. Intended Use

The Sequoia Plus ultrasound imaging system is intended for the following applications: Cardiac, Neonatal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Intraoperative Neurological, Musculo-skelctal Conventional, and Musculo-skeletal Superficial applications.

The system also provides the ability to measure anatomical structures 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.

The typical examinations performed using the Sequoia™ Plus Ultrasound System are:

#### Cardiac Imaging Applications and Analysis

The system transmits ultrasound energy into the thorax from the chest wall or trans-esophagueal into adult, pediatric, or neonatal patients creating 2D (B), 3D, M-Mode (M), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave (PW) Doppler, and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the heart, cardiac valves, great vessels, and surrounding anatomical structures to evaluate the presence or absence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.

The system has Cardiac Measurements and Calculation Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

#### Vascular Imaging Applications and Analysis

The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the carotid arteries or juggler veins in the neck; superficial and deep veins and arteries in the arms and legs; and surrounding anatomical structures to evaluate the presence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.

The system has Vascular Measurements and Calculation Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

#### Superficial Imaging Applications

The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of conventional or superficial musculoskeletal structures and surrounding anatomical structures to evaluate the presence or absence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.

#### Intraoperative Imaging Applications

The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), and Pulsed Wave Doppler (PWD) to obtain images and blood flow velocity that provide guidance during neurological intraoperative procedures.

#### Transcranial Imaging Applications

The system transmits ultrasound energy into the cranium of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the brain and surrounding anatomical structures to evaluate the presence or absence of pathology.

The system provides Measurement Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

{2}------------------------------------------------

#### D. Substantial Equivalence

The submission device is substantially equivalent to the predicate Acuson Sequoia™ previously cleared under K063085 and K051139 with regard to both intended use and technological characteristics.

#### E. Performance Data

The Sequoia™ Plus is designed, verified, and validated according to the company's design control process.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# OCT 1 7 2007

Siemens Medical Solutions, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K072365

Trade/Device Name: SequoiaTM Plus Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: August 22, 2007 Received: August 23, 2007

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). 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.

This determination of substantial equivalence applies to the following transducers intended for use with the Sequoia™ Plus Diagnostic Ultrasound System, as described in your premarket notification:

#### Transducer Model Number

9L4 V5M TEE 4V1c AUX CW2 4Z1c

{4}------------------------------------------------

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G. (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

> Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

{5}------------------------------------------------

If you have any questions regarding the content of this letter, please contact Andrew Kang, M.D. at [phone].

Sincerely yours,

Vorut M. Whang

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

{6}------------------------------------------------

| | 510(k) Number (if known): | K072365 |
|--|---------------------------|---------|
|--|---------------------------|---------|

Device Name:

Sequoia™ Plus Diagnostic Ultrasound System

Intended Use:

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

| Clinical<br>Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging | Other:<br>3D | Other:<br>Real<br>Time<br>3D |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|--------------|------------------------------|
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intraoperative<br>Abdominal | | | | | | | | | | | | |
| Intraoperative<br>Neurological | | N | N | N | | N | N | | N* | N | | |
| Pediatric | | N | N | N | N | N | N | N | N* | N | N | N |
| Small Organ<br>(specify) | | | | | | | | | | | | |
| Neonatal<br>Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | N | N | N | N | N | N | N | N* | N | | |
| Cardiac | | N | N | N | N | N | N | N | N* | N | N | N |
| Trans-esophageal | | N | N | N | N | N | | | N* | | N | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral Vessel | | N | N | N | | N | N | N | N* | N | | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | N | N | N | | N | N | N | N* | N | | |
| Musculo-skeletal<br>Superficial | | N | N | N | | N | N | N | N* | N | | |
| Other (specify) ** | | N | N | N | N | N | N | | N* | N | | |

N=new indication.

#### Additional Comments:

*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE 1000 - 100

**neonatal cardiac

(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Norris K. Wong

(Division S Division of Reproductive. Abdominal and Radiological Device 510(k) Number

Sequoia™ Plus 510(k) Submission

PagePage 12 of 1739

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

| 510(k) Number (if known): | K072365 |
|---------------------------|---------|
| Device Name: | 9L4 |

Indications for Use:

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

| Clinical<br>Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging | Other:<br>3D | Other:<br>Real<br>Time<br>3D | |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|--------------|------------------------------|--|
| Ophthalmic | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | | |
| Intraoperative<br>Abdominal | | | | | | | | | | | | | |
| Intraoperative<br>Neurological | | P | P | P | | P | P | P | P* | P | | | |
| Pediatric | | | | | | | | | | | | | |
| Small Organ<br>(specify) | | | | | | | | | | | | | |
| Neonatal<br>Cephalic | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | |
| Peripheral Vessel | | P | P | P | | P | P | P | P* | P | | | |
| Laparoscopic | | | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | P | P | P | | P | P | P | P* | P | | | |
| Musculo-skeletal<br>Superficial | | P | P | P | | P | P | P | P* | P | | | |
| Other (specify) | | | | | | | | | | | | | |

N=new indication

P= previously cleared by FDA

E= added under Appendix E

#### Additional Comments:

*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE

Previously Cleared in 510(k) K063085

(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

(ODE)

(Division Sign-Off)

Division of Reproductive, Abdominal and

510(k) Numbe

Sequoia™ Plus 510(k) Submission

PagePage 13 of 1739

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

| 510(k) Number (if known): | K072365 |
|---------------------------|---------|
| Device Name: | V5M TEE |

Intended Use:

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

| Clinical<br>Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging | Other: 3D | Other: Real Time 3D | |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|-----------|---------------------|--|
| Ophthalmic | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | | |
| Intraoperative<br>Abdominal | | | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | | | P* | | P | | |
| Small Organ<br>(specify) | | | | | | | | | | | | | |
| Neonatal<br>Cephalic | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | |
| Cardiac | | P | P | P | P | P | | | P* | | P | | |
| Trans-esophageal | | P | P | P | P | P | | | P* | | P | | |
| Transrectal | | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | |
| Peripheral Vessel | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | | | |

N=new indication

P= previously cleared by FDA

510 k) Nu

E= added under Appendix E

Additional Comments:

*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE

Previously Cleared in 510(k) K063085, K022567

(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices 1077365

Sequoia™ Plus 510(k) Submission

PagePage 14 of 1739

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

| 510(k) Number (if known): | K072365 |
|---------------------------|---------|
| Device Name: | 4V1c |

Intended Use:

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

| Clinical<br>Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging | Other:<br>3D | Other:<br>Real<br>Time<br>3D | |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|--------------|------------------------------|--|
| Ophthalmic | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | | |
| Intraoperative<br>Abdominal | | | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | P* | P | | | |
| Small Organ<br>(specify) | | | | | | | | | | | | | |
| Neonatal<br>Cephalic | | | | | | | | | | | | | |
| Adult Cephalic | | P | P | P | P | P | P | | P* | P | | | |
| Cardiac | | P | P | P | P | P | P | | P* | P | | | |
| Trans-esophageal | | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | |
| Peripheral Vessel | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | | | |
| Other (specify)** | | P | P | P | P | P | P | | P* | P | | | |

N=new indication

P= previously cleared by FDA

E= added under Appendix E

#### Additional Comments:

| *Combinations include: | B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color |
|------------------------|----------------------------------------------------------------------------------------|
| | Doppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, |
| | B+CWD+Power Doppler, B+Clarify VE |
| **neonatal cardiac | |

Previously Cleared in 510(k) K063085, K022567

## (PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Amil Wh
(Division Sign-Off)

Division of Reproductive, Abdominal and Radiolo 510(k) Nun

Sequoia™ Plus 510(k) Submission

PagePage 15 of 1739

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

| 510(k) Number (if known): | K072365 |
|---------------------------|---------|
| Device Name: | AUX CW2 |

Intended Use:

Ultrasound fluid flow analysis of the human body as follows:

| Clinical<br>Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging | Other:<br>3D | Other:<br>Real<br>Time<br>3D |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|--------------|------------------------------|
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intraoperative<br>Abdominal | | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | | |
| Pediatric | | | | | | P | | | | | | |
| Small Organ<br>(specify) | | | | | | | | | | | | |
| Neonatal<br>Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac | | | | | | P | | | | | | |
| 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 FDA

E= added under Appendix E

Additional Comments: Previously Cleared in 510(k) K063085, K001400

> (PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

> > Prescription Use (Per 21 CFR 801.109)

_
(Division Sign-Off)

Sequoia™ Plus 510(k) Submission

Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

PagePage 16 of 1739

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

| 510(k) Number (if known): | | K072365 | | | | | | | | | | |
|----------------------------------|---|---------|---|-----|-----|------------------|-------------------------------------------------------------------------|------------------------------|-----------------------|---------------------|--------------|------------------------------|
| Device Name: | | 4Z1c | | | | | | | | | | |
| Intended Use: | | | | | | | Ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | |
| Clinical<br>Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging | Other:<br>3D | Other:<br>Real<br>Time<br>3D |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intraoperative<br>Abdominal | | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | | | p* | P | P | p |
| Small Organ<br>(specify) | | | | | | | | | | | | |
| Neonatal<br>Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac | | P | P | P | P | P | | | P* | P | P | P |
| Trans-esophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral Vessel | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | | |
| Musculo-skeletai<br>Superficial | | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | | |

N=new indication

P= previously cleared by FDA

Division

E= added under Appendix E

#### Additional Comments:

*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler、B+Clarify VE

Previously Cleared in 510(k) K051139

(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Aomi M. Wils

Sequoia™ Plus 510(k) Submission

oductive. Abdominal and Division of Radiol 510(k) N

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