SEQUOIA DIAGNOSTIC ULTRASOUND SYSTEM

K041319 · Siemens Medical Solutions USA, Inc. · IYN · Jun 7, 2004 · Radiology

Device Facts

• Record ID: K041319
• Device Name: SEQUOIA DIAGNOSTIC ULTRASOUND SYSTEM
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: IYN · Radiology
• Decision Date: Jun 7, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Sequoia platform is intended for use in the following applications: General Imaging and Cardiology for Fetal, Abdominal, Intraoperative (abdominal and neurological), Pediatrics, Small Organs (breast, testes, thyroid, penis and prostate), Neonatal/Adult Cephalic, Cardiac (adult, pediatric, and neonatal), Trans-esophageal, Transrectal, Transvaginal, Peripheral Vessel, and Musculo-sceletal (superficial and conventional) applications, and intended uses as defined in the FDA guidance document. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

Device Story

Sequoia Diagnostic Ultrasound System is a multi-purpose diagnostic ultrasound system. It transmits ultrasonic energy into the body via a transducer; reflected energy is processed to generate two-dimensional images of anatomical structures and fluid flow. Doppler principles are used to display blood flow as a spectrum or color-coded images. The system includes proprietary software for anatomical measurements and clinical analysis packages. Used in clinical settings (e.g., radiology, cardiology) by trained healthcare professionals. Output is displayed on-screen for clinical diagnosis. Benefits include non-invasive visualization of internal structures and blood flow, aiding in clinical decision-making.

Clinical Evidence

Bench testing only. The device conforms to recognized safety and performance standards including UL 2601-1, CSA C22.2 No. 601-1, AIUM/NEMA UD-2 and UD-3, and ISO 10993 for biocompatibility. No clinical data was required for this 510(k) submission.

Technological Characteristics

Multi-purpose diagnostic ultrasound system. Materials comply with ISO 10993. Sensing via piezoelectric transducers. Energy source: electrical to ultrasonic. Connectivity: standalone system. Software: proprietary analysis packages. Safety standards: UL 2601-1, CSA C22.2 No. 601-1, EN 60601-1, EN 60601-1-1, EN 60601-1-2. Acoustic output follows ALARA principle.

Indications for Use

Indicated for ultrasound imaging or fluid flow analysis of the human body in fetal, abdominal, intraoperative, pediatric, small organ, neonatal/adult cephalic, cardiac, trans-esophageal, transrectal, transvaginal, peripheral vessel, and musculoskeletal 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 8.0 Diagnostic Ultrasound System (K032114)
• SONOLINE® Antares Diagnostic Ultrasound System with Clarify™ VE (K033196)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the text "ACUSON® Sequoia Diagnostic Ultrasound System". Above this text is the alphanumeric string "K04/319". The text appears to be part of a medical document or equipment label, possibly related to ultrasound technology.

JUN - 7 2004

### SECTION 11

# 510(k) Summary of Safety and Effectiveness

Siemens Medical Solutions USA, Inc., Ultrasound Division has not disclosed its intent to market this device modification and requests this notification be held CONFIDENTIAL by the FDA, and not be released to any Freedom of Information request or addressed with any outside parties.

| Sponsor: | Siemens Medical Solutions USA, Inc., Ultrasound Division<br>1230 Shorebird Way<br>P.O. Box 7393<br>Mountain View, California 94039-7393 |
|------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Iskra Mraković<br>Manager of Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone] |
| Submission Date: | May 13, 2004 |
| Device Name: | Sequoia Diagnostic Ultrasound System |
| Common Name: | Diagnostic Ultrasound System with Accessories |
| Classification: | |

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

21 CFR 892.1550

| | FR # | Product Code |
|------------------------------------------|----------|--------------|
| Ultrasonic Pulsed Doppler Imaging System | 892.1550 | 90-IYN |
| Ultrasonic Pulsed Echo Imaging System | 892.1560 | 90-IYO |
| Diagnostic Ultrasound Transducer | 892.1570 | 90-ITX |
| Diagnostic Intravascular Catheter | 870.1200 | 90-DQO |

Predicate Devices:

- # K032114 (July 21, 2003) cleared as ACUSON® Sequoia 8.0 Diagnostic Ultrasound . System.
- # K033196 (October 16, 2003) cleared as SONOLINE® Antares Diagnostic . Ultrasound System with Clarify™ VE.

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

### Device Description:

The Sequoia system is a multi-purpose diagnostic ultrasound system with accessories and proprietary software, and is substantially equivalent to our current product that is already cleared for USA distribution under the following 510(k) PreMarket Notification number:

- # K032114 (July 21, 2003) cleared as ACUSON® Sequoia 8.0 Diagnostic Ultrasound . System.
The Sequoia Diagnostic Ultrasound System has been designed to conform to the following product safety standards:

- UL 2601-1, Safety Requirements for Medical Equipment .
- CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment .
- AIUMNEMA UD-2, 1998, Acoustic Output Measurement Standard for Diagnostic t Ultrasound
- AIUM/NEMA UD-3, 1998, Standard for Real Time Display of Thermal and . Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- 93/42/EEC Medical Device Directive .
- Safety and EMC Requirements for Medical Equipment .
- EN 60601-1 .
- EN 60601-1-1 .
- EN 60601-1-2 .
- ISO 10993 Biocompatibility ●
- The system's acoustic output is in accordance with ALARA principle (as low as . reasonably achievable)

#### Intended Use:

The Sequoia platform is intended for use in the following applications:

General Imaging and Cardiology for Fetal, Abdominal, Intraoperative (abdominal and neurological), Pediatrics, Small Organs (breast, testes, thyroid, penis and prostate), Neonatal/Adult Cephalic, Cardiac (adult, pediatric, and neonatal), Trans-esophageal, Transrectal, Transvaginal, Peripheral Vessel, and Musculo-sceletal (superficial and conventional) applications, and intended uses as defined in the FDA guidance document.

The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

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

# Technological Comparison to Predicate Device:

The Sequoia is substantially equivalent in its technologies and functionality to the Sequoia 8.0 Diagnostic Ultrasound System that is already cleared under 510(k) premarket notification number K032114.

The Sequoia functions in the same manner as other diagnostic ultrasound systems, in that they transmit ultrasonic energy into the body via a transducer. In the body, acoustic impedance of different tissues reflect different amounts of ultrasound energy back to the mipedatios of arrerent rrocessing of received echoes is performed to generate twodimensional on-screen images of anatomic structures and fluid flow within the body. Doppler principles are used to process reflected ultrasound energy to display moving blood as a spectrum, or as color-coded two-dimensional images. All predicate devices listed above, allow for specialized measurements of structures and flow, and provide various calculations' functions.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an emblem featuring a stylized eagle or bird-like figure with three wing-like extensions.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 7 2004

Mr. Iskra Mraković Manager, Regulatory Affairs Siemens Medical Solutions USA, Inc. Ultrasound Division 1230 Shorebird Way P.O. Box 7393 MOUNTAIN VIEW CA 94039-7393

Re: K041319

Trade Name: Sequoia Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 IYN, IYO, and ITX Dated: May 17, 2004 Received: May 18, 2004

Dear Mr. Mraković:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your between mined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass stated on the 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 Cosments Act (ree). "Tou mayy accessors) sprovisions of the Act include requirements for annual provisions of inting 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 Diagnostic Ultrasound System, as described in your premarket notification:

#### Transducer Model Number

| 4C1 | EC10c5 | 8L5T |
|-----|--------|--------|
| 5C2 | EV8C4 | 13L5SP |
| 6C2 | 6L3 | 15L8 |
| 8C4 | 8L5 | 15L8w |

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

#### Page 2 - Mr. Mraković

| V5M TEE | 4V1c | 8V5 |
|---------|------|--------------------------|
| V7M TEE | 4V2 | 10V4 |
| V7B TEE | 5V2c | AUX CW |
| 3V2c | 7V3c | AcuNav (IC10V5 or 10F10) |
| 4V1 | 8V3 | |

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device to such additional controls. Existing major regulations affecting your device can be may be subject to such additional controller and any any any and 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 FICA has made a determination that your device complies with other requirements of the Act or any FDA has made a decemination administered by other Federal agencies. You must comply with all I coral statutes and regulations annumes timited to: registration and listing (21 CFR Part 807); the Act 31cquirements, morading, vanufacturing practice requirements as set forth in the quality labeling (21 CFR Part 001), good manatator, and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 rife I Dr Inding of substantal v 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 rr you dosire of Compliance at [phone]. Additionally, for questions on the promotion contact the Office of Compination as as contact the Office of Compliance at [phone]. Also, and advertising or your as nevel, "Misbranding by reference to premarket notification" (21 CFR prease note in regalation on the on your responsibilities under the Act may be obtained from 1 at 001:57). Other general Manufacturers, International and Consumer Assistance at its toll-free number [phone] or at [phone] or at its Internet address "http://www fda.gov/cdrh/dsmamain.html".

If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at [phone].

Sincerely yours,

Nancy Shoydon

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

Enclosure(s)

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

Device Name:

# Sequoia Diagnostic Ultrasound System

Intended Use:

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

| Clinical 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 |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | | | | P* | P |
| Fetal | | P | P | P | P | P | P | | P* | P |
| Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative<br>Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative<br>Neurological | | P | P | P | P | P | P | | P* | P |
| Pediatric | | P | P | P | P | P | P | | P* | P |
| Small Organ<br>(specify)** | | P | P | P | P | P | P | | P* | P |
| Neonatal Cephalic | | P | P | P | P | P | P | | P* | P |
| Adult Cephalic | | P | P | P | P | P | P | | P* | P |
| Cardiac | | P | P | P | P | P | P | | P* | P |
| Trans-esophageal | | P | P | P | P | P | P | | P* | P |
| Transrectal | | P | P | P | P | P | P | | P* | P |
| Transvaginal | | P | P | P | P | P | P | | P* | P |
| 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) *** | | P | P | P | P | P | P | | P* | P |

Other (specify)
P=previously cleared by the FDA under premarket notifications #K033650 and #K033196.

#### 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, D+CWD+Color Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE **small organs (breast, testes, thyroid, penis) ***neonatal cardiac

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

Nancy Brogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K041319

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

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

4C1 Device Name:

Intended Use:

.

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

| Clinical 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 | |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|--|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | | P* | P | |
| Abdominal | | P | P | P | P | P | P | | P* | P | |
| Intraoperative<br>Abdominal | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | P* | P | |
| Small Organ<br>(specify)** | | P | P | P | P | P | P | | P* | P | |
| Neonatai Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | P | P | P | P | P | P | | P* | P | |
| Trans-csophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvagınal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vessel | | P | P | P | P | P | P | | P* | P | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skelctal<br>(Conventional) | | | | | | | | | | | |
| Musculo-skeletal<br>(Superficial) | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |

P=previously cleared by the FDA under premarket notifications #K033650 and #K033196.

#### 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, D+CWD+Color Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE

**small organs (breast, testes, thyroid, penis)

#### (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) |
|---------------------------------------|
|---------------------------------------|

*Nancy C. Brogdon*

| (Division Sign-Off) | |
|---------------------------------------------------------------|---------|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K041319 |

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

510(k) Number (if known):

5C2 Device Name:

Intended Use:

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

| Clinical 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 |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | | P* | P |
| Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative<br>Abdominal | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | P* | P |
| Small Organ<br>(specify)** | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | P | | P* | P |
| Cardiac | | P | P | P | P | P | P | | P* | P |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vessel | | P | P | P | P | P | P | | P* | P |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>(Conventional) | | | | | | | | | | |
| Musculo-skeletal<br>(Superficial) | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

Onler (specity)
P=previously cleared by the FDA under premarket notifications #K033650 and #K033196.

#### 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+Clarify Dopler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE

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

Nancy C Brogdon

(Division Sign-Off Division of Reproduc and Radiological Devic 510(k) Number

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

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

6C2 Device Name:

Intended Use:

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

| Clinical 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 |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | | | | P* | P |
| Fetal | | P | P | P | P | P | P | | P* | P |
| Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative<br>Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative<br>Neurological | | P | P | P | P | P | P | | P* | P |
| Pediatric | | P | P | P | P | P | P | | P* | P |
| Small Organ<br>(specify)** | | P | P | P | P | P | P | | P* | P |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | P | P | P | P | P | P | | P* | P |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vessel | | P | P | P | P | P | P | | P* | P |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>(Conventional) | | | | | | | | | | |
| Musculo-skeletal<br>(Superficial) | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

(Juler (Speety)
P=previously cleared by the FDA under premarket notifications #K033196.

#### 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+Clarify Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE

** small organs (breast, testes, thyroid, penis)

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

Nancy C. Royston

(Division Sign Division of Reprod and Radiological Device 510(k) Number

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

# 510(k) Number (if known):

8C4 Device Namc:

Intended Use:

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

| Clinical 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 |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | | | | P* | P |
| Fetal | | P | P | P | P | P | P | | P* | P |
| Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative<br>Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative<br>Neurological | | P | P | P | P | P | P | | P* | P |
| Pediatric | | P | P | P | P | P | P | | P* | P |
| Small Organ<br>(specify)** | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | P | P | P | P | P | P | | P* | P |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | P* | |
| Peripheral Vessel | | P | P | P | P | P | P | | P* | P |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>(Conventional) | | | | | | | | | | |
| Musculo-skeletal<br>(Superficial) | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

Other (specity)
P=previously cleared by the FDA under premarket notifications #K033650 and #K033196.

#### 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, D+I WD+Color Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE

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

Nancy C. Hodgson

(Division Sign Division of Reproduc and Radiological Devic 510(k) Number

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

510(k) Number (if known):

EC10c5 Device Name:

Intended Use:

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

| Clinical 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 |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative<br>Abdominal | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(specify)** | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | P | | P* | P |
| Transrectal | | P | P | P | P | P | P | | P* | P |
| Transvaginal | | P | P | P | P | P | P | | P* | P |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>(Conventional) | | | | | | | | | | |
| Musculo-skelctal<br>(Superficial) | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

P=previously cleared by the FDA under premarket notifications #K033650 and #K033196.

#### 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 |

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

Nancy C. Brogdon

(Division Sign Division of Reproduct and Radiological Devices 510(k) Number

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

# 510(k) Number (if known):

EV8C4 Device Name:

Intended Use:

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

| Clinical 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 |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | | | | P* | P |
| Fetal | | P | P | P | P | P | P | | P* | P |
| Abdominal | | P | P | P | P | P | P | | | |
| Intraoperative<br>Abdominal | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(specify)** | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | P* | P |
| Transvaginal | | P | P | P | P | P | P | | P* | P |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>(Conventional) | | | | | | | | | | |
| Musculo-skeletal<br>(Superficial) | | | | | | | | | | |
| Other (concil.) | | | | | | | | | | |

Other (specify) P=previously cleared by the FDA under premarket notifications #K033650 and #K033196.

#### 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, D+CWD+Color Doppler, B+CWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE

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

Nancy Croagdon

(Division Sign-Off Division of Reproductiv and Radiological Devic 510(k) Number

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

# 510(k) Number (if known):

6L3 Device Name:

Intended Use:

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

| Clinical 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 |
|---------------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | | | | P* | P |
| Fetal | | P | P | P | P | P | P | | P* | P |
| Abdominal<br>Intraoperative | | P | P | P | P | P | P | | P* | P |
| Abdominal<br>Intraoperative<br>Neurological | | P | P | P | P | P | P | | P* | P |
| Pediatric | | | | | | | | | P* | P |
| Small Organ<br>(specify)** | | P | P | P | P | P | P | | P* | P |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | P | P | P | P | P | P | | P* | P |
| 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) | | | | | | | | | | |

Oulci (specify)
P=previously cleared by the FDA under premarket notifications #K033650 and #K033196.

#### 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, D+Clarify D+Color Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE

**small organs (breast, testes, thyroid, penis)

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

Nancy Shosdon

ivision Sign Division of Reproduc Ana Radiological Device 1 (ik) Number _

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

# 510(k) Number (if known):

81.5 Device Name:

Intended Use:

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

| Clinical 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 |
|---------------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal<br>Intraoperative | | P | P | P | P | P | P | | P* | P |
| Abdominal<br>Intraoperative<br>Neurological | | P | P | P | P | P | P | | P* | P |
| Pediatric | | | | | | | P | | P* | P |
| Small Organ<br>(specify)** | | P | P | P | P | P | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | P* | P |
| Cardiac | | P | P | P | P | P | P | | P* | P |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | P* | P |
| 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) | | | | | | | | | | |

Other (specify)
P=previously cleared by the FDA under premarket notifications #K033650 and #K033196.

#### 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, D+I WD+Color Doppler, B+C++B ver Doppler, B+CWD+Power Doppler, B+Clarify VE

**small organs (breast, testes, thyroid, penis)

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

Maurice bordon

(Division Sign-Off) Division of Reproductive and Radiological Devices 510(k) Number

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

# 510(k) Number (if known):

8LST Device Name:

Intended Use:

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

| Clinical 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 |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative<br>Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative<br>Neurological | | P | P | P | P | P | P | | P* | P |
| Pediatric | | P | P | P | P | P | P | | P* | P |
| Small Organ<br>(specify)** | | P | P | P | P | P | P | | P* | P |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | P | P | P | P | P | P | | P* | P |
| 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) | | | | | | | | | | |

Other (specify)
P=previously cleared by the FDA under premarket notifications #K033650 and #K033196.

#### 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, D+I WDTColor Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE

** small organs (breast, testes, thyroid, penis)

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

Nancy C. Beadon
(Division Sign-Off)

Division of Reproductive, Abdom and Padiological Devices 5 !! #k) Number __

{15}------------------------------------------------

# 510(k) Number (if known):

13L5SP Device Name:

Intended Use:

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

| Clinical 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 | |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|---|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | P | P | | P | | P* | P | |
| Intraoperative<br>Abdominal | | P | P | P | P | P | | P | | P* | P |
| Intraoperative<br>Neurological | | P | P | P | P | P | | P | | P* | P |
| Pediatric | | P | P | P | P | P | P | P | | P* | P |
| Small Organ<br>(specify)** | | P | P | P | P | P | P | P | | P* | P |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | P | | P* | P |
| Cardiac | | P | P | P | P | P | P | P | | | |
| Trans-esophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | P* | P |
| Peripheral Vessel | | P | P | P | P | P | P | P | | P* | P |
| Laparoscopic | | | | | | | | | | P* | P |
| Musculo-skeletal<br>(Conventional) | | P | P | P | P | P | P | P | | P* | P |
| Musculo-skeletal<br>(Superficial) | | P | P | P | P | P | P | P | | P* | P |
| Other (specify) | | | | | | | | | | | |

Other (specify)
P=previously cleared by the FDA under premarket notifications #K033650 and #K033196.

#### 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

**small organs (breast, testes, thyroid, penis)

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

Nancy C Brogdon

(Division Sign-Off Division of Reproductive and Radiological Device 510(k) Number .

{16}------------------------------------------------

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

1518 Device Name:

Intended Use:

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

| Clinical 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 | |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|---|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | P* | | |
| Intraoperative<br>Abdominal | | P | P | P | P | P | P | | | P* | P |
| Intraoperative<br>Neurological | | P | P | P | P | P | P | | | P* | P |
| Pediatric | | P | P | P | P | P | P | | | P* | P |
| Small Organ<br>(specify)** | | P | P | P | P | P | P | | | P* | P |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | P* | P |
| Cardiac | | P | P | P | P | P | P | | | P* | P |
| Trans-esophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | P* | P |
| 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) | | | | | | | | | | | |

Outler (specify)
P=previously cleared by the FDA under premarket notifications #K033650 and #K033196.

#### Additional Comments:

*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppier, B+CWD+Color Doppler, B+Power Doppler, D+I WD+Color Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE

** small organs (breast, testes, thyroid, penis)

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

Nancy Thompson

(Division Sig Division of Reproductive and Radiological Devices 510(k) Number _

{17}------------------------------------------------

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

15L8w Device Name:

Intended Use:

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

| Clinical 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 |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | | | | P* | P |
| Fetal | | P | P | P | P | P | P | | P* | P |
| Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative<br>Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative<br>Neurological | | P | P | P | P | P | P | | P* | P |
| Pediatric | | P | P | P | P | P | P | | P* | P |
| Small Organ<br>(specify)** | | P | P | P | P | P | P | | P* | P |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | P | P | P | P | P | P | | P* | P |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | P* | P |
| 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) | | | | | | | | | | |

Onler (spectly)
P=previously cleared by the FDA under premarket notifications #K033650 and #K033196.

#### Additional Comments:

*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, -Comomations moraler, B+CWD+Color Doppler, B+Power Doppler, B+Clarify D+Color Doppler, B+C+PD+Dolor Doppler, B+CWD+Power Doppler, B+Clarify VE

** small organs (breast, testes, thyroid, penis)

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

Nancy C. Hodgson

(Division Sign-Off Division of Reproductive and Radiological Device 510(k) Number

{18}------------------------------------------------

510(k) Number (if known):

Device Name:

#### V5M TEE

Intended Use:

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

| Clinical 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 |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative<br>Abdominal | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | P* | P |
| Small Organ<br>(specify)** | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | P | P | P | P | P | P | | P* | P |
| Trans-esophageal | | P | P | P | P | P | P | | P* | P |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | |…