HARMONIC IMAGING WITH CONTRAST
Device Facts
| Record ID | K973767 |
|---|---|
| Device Name | HARMONIC IMAGING WITH CONTRAST |
| Applicant | Acuson Corp. |
| Product Code | IYO · Radiology |
| Decision Date | Dec 23, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1560 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The Sequoia™ Ultrasound System in conjunction with the administration of ultrasound contrast agents applies ultrasound energy to an organ, vessel/structure to improve opacification, increase delineation, enhance color Doppler and/or spectral Doppler response, increase visualization of blood flow, document uptake of contrast agent and/or demonstrate perfusion of tissue. The images obtained are useful to physicians in detecting normal and abnormal conditions in regions of the body.
Device Story
Sequoia™ Ultrasound System with Harmonic Imaging with Contrast option; utilizes acoustic data inputs from transcutaneous and invasive transducers; creates 2-D, M-mode, color Doppler, and spectral Doppler displays. Operates in two modes: primary imaging (standard transmit/receive) and harmonic imaging (receive frequency is a multiple of transmit frequency). Used by physicians in clinical settings to improve tissue/vessel opacification and blood flow visualization via contrast agent administration. Output allows physicians to detect normal/abnormal conditions and document tissue perfusion. Benefits include enhanced diagnostic clarity for clinical decision-making.
Clinical Evidence
Clinical studies were conducted to verify system performance across all imaging modes. Data was submitted as part of the 510(k) notification to demonstrate safety and effectiveness of the Harmonic Imaging with Contrast option.
Technological Characteristics
System utilizes acoustic energy for imaging. Harmonic imaging mode processes receive signals at a multiple of the transmit frequency. Compatible with existing Sequoia™ transcutaneous and invasive transducers. No material changes to transducers; biocompatibility data on file. Software-based signal processing for harmonic mode. Operates as a standalone diagnostic ultrasound system.
Indications for Use
Indicated for diagnostic ultrasound imaging and fluid flow analysis in conjunction with legally marketed contrast agents. Patient population includes fetal, abdominal, pediatric, small organ, neonatal/adult cephalic, cardiac, trans-esophageal, trans-vaginal, peripheral vascular, and musculo-skeletal applications.
Regulatory Classification
Identification
An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Special Controls
*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Predicate Devices
- Sequoia™ Ultrasound System (K935595/S1)
Submission Summary (Full Text)
{0}------------------------------------------------
K973761
## SUMMARY OF SAFETY AND EFFECTIVENESS
DEC 2 3 1997
#### GENERAL INFORMATION I.
| Device generic name: | Ultrasonic Pulsed Doppler Imaging System,<br>Ultrasonic Pulsed Echo Imaging System, and<br>Diagnostic Ultrasound Transducer |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Device Trade Name: | Sequoia™ Ultrasound System and Harmonic Imaging<br>with Contrast Option |
| 510(k) No: | |
September 25, 1997 Date of 510(k) submission
## II. INDICATION FOR USE:
The Sequoia™ Ultrasound System in conjunction with the administration of ultrasound contrast agents applies ultrasound energy to an organ, vessel/structure to improve opacification, increase delineation, enhance color Doppler and/or spectral Doppler response, increase visualization of blood flow, document uptake of contrast agent and/or demonstrate perfusion of tissue. The images obtained are useful to physicians in detecting normal and abnormal conditions in regions of the body.
## III. DEVICE DESCRIPTION
The Sequoia™ Ultrasound System with the Harmonic Imaging with Contrast utilizes the previously cleared Sequoia™ Ultrasound system (Acuson Model 3001- K935595/S1) and its transcutaneous as well as invasive transducers to create 2-D, M-mode, color Doppler and Spectral Doppler displays of acoustic data in conjunction with administration of ultrasound contrast agent. There are two primary methods by which images are created. First, the images are created in primary imaging mode, with exactly the same transmit and receive settings and controls as are utilized for routine ultrasound imaging without contrast agent administration. Second, images are created in harmonic imaging mode, with the images created using the same transmit settings and controls as are utilized for routine ultrasound imaging without contrast agent administration but in addition the receive frequency is a multiple of the transmit frequency. In both primary and harmonic imaging, exams can be performed using the standard frame rates applicable during routine ultrasound exams. the number of cycles utilized in routine exams.
{1}------------------------------------------------
## IV. WARNING AND PRECAUTIONS
The addition of Harmonic Imaging with Contrast option did not result in the addition of new warning or precautions related to the ultrasound system. Labeling was changed to reflect warnings usually associated with the administration of contrast agents and to provide user information related to operation of the system in conjunction with the administration of contrast agents.
## V. POTENTIAL ADVERSE EFFECTS
Addition of Harmonic Imaging with Contrast did not introduce any new potential hazards to the use of the Sequoia Ultrasound System and transducers. Since the introduction of the Sequoia system to the ultrasound market, no adverse health effects to the patient and user population have been confirmed.
## VI. BIOCOMPATIBILITY
No material changes to the Sequoia transducers were necessary to add Harmonic Imaging with Contrast. Biocompatibility data for all Acuson transducer materials contacting patients is on file.
## VII. IMAGING PERFORMANCE
Clinical studies were conducted to verify the performance of the system in all imaging modes. Clinical data was submitted as part of the Harmonic Imaging with Contrast 510(k).
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle with three stripes forming its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circle's perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 3 1997
William Welch Regulatory Affairs Manager Acuson Corporation 1220 Charleston Road P.O. Box 7393 Mountain View, CA 94039-7393
K973767 Re: Harmonic Imaging with Contrast Option (for the Sequoia™ Ultrasound System) Dated: July 25, 1997 Received: October 2, 1997 Regulatory class: II 21 CFR 892.1550/Procode: 90 IYN 21 CFR 892.1560/Procode: 90 IYO 21 CFR 892.1570/Procode: 90 ITX
Dear Mr. Welch:
We have reviewed your section 510(k) 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 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. You may, therefore, market the device, subject to the general controls provisions Act (Act). The general controls provisions of the Act include requirements for registration, listing of devices, good manufacturing . practices, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for use with the Sequoia™ Ultrasound System, as described in your premarket notification:
| | | | Transducer Model Number |
|---|--|--|-------------------------|
| - | | | |
TE-V5M 815 61.3 1528 8V5 7V3c 5V2c 3V2c 8C4 5C2 4 V 2 EV-8C4 Aux CW
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) 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 895. ਰੇ substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General (GMP) requlation (21 CFR Part
{3}------------------------------------------------
Page 2 - William Welch
820) and that, through periodic QS inspections, the FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register.
Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
Please be advised that the determination above is based on the fact that no medical devices have been demonstrated to be safe and effective for in vitro fertilization or percutaneous umbilical blood sampling, nor have any devices been marketed for these uses in interstate commerce prior to May 28, 1976, or reclassified into class I (General Controls) or class II (Special Controls). FDA considers devices specifically intended for in vitro fertilization and percutaneous umbilical blood sampling to be investigational, and subject to the provision of the investigational device exemptions (IDE) regulations, 21 Therefore, your product labeling must be consistent with FDA's CFR. Part 812. position on this use.
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 (21
CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Other general information on your responsibilities under the Act may 807.97) . be obtained from the Division of Small Manufacturers Assistance at its tollfree number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
{4}------------------------------------------------
Page 3 - William Welch
If you have any questions regarding the content of this letter, please contact
Paul Gammell, Ph.D. at (301) 594-1212.
Sincerely yours,
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
.
{5}------------------------------------------------
## Fill out one form for each ultrasound system and transducer
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
> The Sequoia™ Ultrasound System is intended for Harmonic Imaging and Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved".
Ultrasound System: Sequoia™
| Clinical Applications | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Ampl.)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify)<br>Harmonic<br>Imaging |
|----------------------------------------------------|---|---|---|-----|-----|------------------|-----------------------------|------------------------------|-----------------------|-------------------------------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | X | X | X | X | X | X | X | | * | X |
| Abdominal | X | X | X | X | X | X | X | | * | X |
| Intra-operative<br>(vascular) | X | X | X | X | X | X | X | | * | X |
| Intra-operative<br>Neurological | | | | | | | | | | |
| Pediatric | X | X | X | X | X | X | X | | * | X |
| Small Organ | X | X | X | X | X | X | X | | * | X |
| - Thyroid | | | | | | | | | | |
| - Breast | | | | | | | | | | |
| - Testicle | | | | | | | | | | |
| Neonatal Cephalic | X | X | X | X | X | X | X | | * | X |
| Adult Cephalic | X | X | X | X | X | X | X | | * | X |
| Cardiac | X | X | X | X | X | X | X | | * | X |
| Trans-esophageal | X | X | X | X | X | X | X | | * | X |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | X | X | X | X | X | X | X | | * | X |
| Trans-Urethral | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | |
| Peripheral Vascular | X | X | X | X | X | X | X | | * | X |
| Laparoscopic | | | | | | | | | | |
| Musculo-Skeletal<br>Conventional | X | X | X | X | X | X | X | | * | X |
| Musculo-Skeletal<br>Superficial | X | X | X | X | X | X | X | | * | X |
| Other (Specify) | | | | | | | | | | |
| Clinical Applications | A | B | M | PWD | CWD | Color Doppler | Power (Ampl.) Doppler | Color Velocity Imaging | Combined (Specify) | Other (Specify) Harmonic Imaging |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal (P) | X | X | X | X | X | X | X | | * | X |
| Intra-operative<br>- abdominal<br>- cardiac | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>- Thyroid<br>- Breast<br>- Testicle | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | X | X | X | X | X | X | X | | * | X |
| Trans-esophageal | X | X | X | X | X | X | X | | * | X |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-Skeletal<br>Conventional | | | | | | | | | | |
| Musculo-Skeletal<br>Superficial | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | |
| Clinical Applications | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Ampl.)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify)<br>Harmonic<br>Imaging |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative<br>- vascular | x | x | x | x | x | x | x | | * | x |
| Intra-operative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>- Thyroid<br>- Breast<br>- Testicle | x | x | x | x | x | x | x | | * | x |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | |
| Peripheral Vascular | x | x | x | x | x | x | x | | * | |
| Laparoscopic | | | | | | | | | | x |
| Musculo-Skeletal<br>Conventional | x | x | x | x | x | x | x | | * | x |
| Musculo-Skeletal<br>Superficial | x | x | x | x | x | x | x | | * | x |
| Other (Specify) | | | | | | | | | | |
Additional Comments:
Combinations B+M, B+PWD,B+CWD, B+Color Doppler, B+M+Color Doppler, B+CWD+Color Doppler, B+PWD+Color
Doppler, B+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+M+Power Doppler,
(Division Sinn-Off) Division f Repreductive, Abdominal, ENT, and Radiological Device
Radiological Devices
510(k) Number K973767
Prescription Use . (Per 21 CFR 801.109)
{6}------------------------------------------------
### Fill out one form for each ultrasound system and transducer
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
> The TE-V5M transducer is intended for Harmonic Imaging and Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved".
### Ultrasound System: Sequoia™
### Transducer: TE-V5M
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K973767
Prescription Use ﺎ (Por 21 CFR 801.109)
{7}------------------------------------------------
## Fill out one form for each ultrasound system and transducer
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
> The 8L5 transducer is intended for Harmonic Imaging and Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved".
### Ultrasound System: Sequoia™
### Transducer: 8L5
**Additional Comments**
PWD, B+Cdlor Doppler, B+PWD+Color Doppler, B+Power Doppler, B+PWD+Power Doppler Combinations: B+M, B
(Division Sign-Off)
Division of Reproductive, Abdo:
Division of Reproductive, Abdominal, ENT, and Radiological Devjo
510(k) Number K973767
Prescription Use . (Per 21 CFR 801.109)
{8}------------------------------------------------
### Fill out one form for each ultrasound system and transducer
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
> The 6L3 transducer is intended for Harmonic Imaging and Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved".
### Ultrasound System: Sequoia™
### Transducer: 6L3
| Clinical Applications | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Ampl.)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify)<br>Harmonic<br>Imaging |
|----------------------------------------------------|---|---|---|-----|-----|------------------|-----------------------------|------------------------------|-----------------------|-------------------------------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative<br>- vascular | X | X | X | X | X | X | X | | * | X |
| Intra-operative<br>Neurological | | | | | | | | | | X |
| Pediatric | | | | | | | | | | |
| Small Organ<br>- Thyroid<br>- Breast<br>- Testicle | X | X | X | X | X | X | X | | * | X |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | |
| Peripheral Vascular | X | X | X | X | X | X | X | | * | X |
| Laparoscopic | | | | | | | | | | |
| Musculo-Skeletal<br>Conventional | X | X | X | X | X | X | X | | * | X |
| Musculo-Skeletal<br>Superficial | X | X | X | X | X | X | X | | * | X |
| Other (Specify) | | | | | | | | | | |
Combinations: B+M B+PWD, B+Color Doppler, B+PWD+Color Doppler, B+Power Doppler, B+PWD+Power Doppler
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K97376 7
**Prescription Use**
(Per 21 CFR 801.109)
{9}------------------------------------------------
#### Fill out one form for each ultrasound system and transducer
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
> The 15L8 transducer is intended for Harmonic Imaging and Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved".
### Ultrasound System: Sequoia™
510(k) Number
### Transducer: 15L8
| Clinical Applications | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Ampl.)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify)<br>Harmonic<br>Imaging | |
|----------------------------------------------------|---|---|---|-----|-----|------------------|-----------------------------|------------------------------|-----------------------|-------------------------------------------|---|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intra-operative<br>- vascular | X | X | X | | X | X | | | * | X | |
| Intra-operative<br>Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ<br>- Thyroid<br>- Breast<br>- Testicle | X | X | X | | X | X | | X | | * | X |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | | |
| Peripheral Vascular | X | X | X | | X | X | X | | * | X | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-Skeletal<br>Conventional | X | X | X | | X | X | X | | * | X | |
| Musculo-Skeletal<br>Superficial | X | X | X | | X | X | X | | * | | |
| Other (Specify) | | | | | | | | | | | |
Additional Comments:
Combinations: B+M, B+FWD, B+Color Doppler, B+PWD+Color Doppler, B+Power Doppler, B+PWD+Power Doppler
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
Prescription Use
(Per 21 CFR 801.109)
{10}------------------------------------------------
### Fill out one form for each ultrasound system and transducer
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
> The 8V5 transducer is intended for Harmonic Imaging and Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved". .. . . ..
## Ultrasound System: Sequoia™
### Transducer: 8V5
| Clinical Applications | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Ampl.)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify)<br>Harmonic<br>Imaging |
|----------------------------------------------------|---|---|---|-----|-----|------------------|-----------------------------|------------------------------|-----------------------|-------------------------------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | X | X | X | X | X | X | X | | * | X |
| Abdominal | X | X | X | X | X | X | X | | * | X |
| Intra-operative<br>(Specify) | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | |
| Pediatric | X | X | X | X | X | X | X | | * | X |
| Small Organ<br>- Thyroid<br>- Breast<br>- Testicle | | | | | | | | | | |
| Neonatal Cephalic | X | X | X | X | X | X | X | | * | X |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | X | X | X | X | X | X | X | | * | X |
| Trans-esophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-Skeletal<br>Conventional | | | | | | | | | | |
| Musculo-Skeletal<br>Superficial | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | |
Additional Comments:
* Combinations: 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
(Division Sign-Off)
Division of Reproductive, Abdominal, ENTDivision of Reproductive, Abdominal and Radiological Devic
510(k) Number_
**Prescription Use**
(Per 21 CFR 801.109)
ﺎ
{11}------------------------------------------------
### Fill out one form for each ultrasound system and transducer
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
> The 7V3c transducer is intended for Harmonic Imaging and Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved".
### Ultrasound System: Sequoia™
#### Transducer: 7V3c
510(k) Number
| Clinical Applications | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Ampl.)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify)<br>Harmonic<br>Imaging | |
|----------------------------------------------------|---|---|---|-----|-----|------------------|-----------------------------|------------------------------|-----------------------|-------------------------------------------|--|
| Ophthalmic | | | | | | | | | | | |
| Fetal | X | X | X | X | X | X | X | | * | X | |
| Abdominal | X | X | X | X | X | X | X | | * | X | |
| Intra-operative<br>- abdominal | | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | | |
| Pediatric | X | X | X | X | X | X | X | | * | X | |
| Small Organ<br>- Thyroid<br>- Breast<br>- Testicle | | | | | | | | | | | |
| Neonatal Cephalic | X | X | X | X | X | X | X | | * | X | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | X | X | X | X | X | X | X | | * | X | |
| Trans-esophageal | | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-Skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-Skeletal<br>Superficial | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | |
Additional Comments:
- Combinations: 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
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices,
Prescription Use
(Per 21 CFR 801.109)
{12}------------------------------------------------
## Fill out one form for each ultrasound system and transducer
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
> The 5 V2c transducer is intended for Harmonic Imaging and Contrest Imaging in conjunction in a The 5 v 2c transducer is intended for flamonio incepts as at they have been approved".
## Ultrasound System: Sequoia™
### Transducer: 5V2c
| Clinical Applications | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Ampl.)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify)<br>Harmonic<br>Imaging |
|----------------------------------------------------|---|---|---|-----|-----|------------------|-----------------------------|------------------------------|-----------------------|-------------------------------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | X | X | X | X | X | X | X | | * | X |
| Abdominal | X | X | X | X | X | X | X | | * | X |
| Intra-operative<br>- cardiac<br>- abdominal | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | |
| Pediatric | X | X | X | X | X | X | X | | * | X |
| Small Organ<br>- Thyroid<br>- Breast<br>- Testicle | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | X | X | X | X | X | X | X | | * | X |
| Trans-esophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-Skeletal<br>Conventional | | | | | | | | | | |
| Musculo-Skeletal<br>Superficial | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | |
| Additional Comments: | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| * Combinations: 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 | |
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, ENT,<br>and Radiological Devices | |
| 510(k) Number | K973767 |
| Prescription Use<br>(Per 21 CFR 801.109) | |
{13}------------------------------------------------
# Fill out one form for each ultrasound system and transducer
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
The 3 V2c transducer is intended for Harmonic Imaging and Contrest Imaging in conjunction
ing the support of the same of of alles indications that they have been approved". The 3V2c transducer is intended for flamont maging and the mave been approved".
with legally marketed contrast agents for the indications that they have been approved".
## Ultrasound System: Sequoia™
### Transducer: 3V2c
| Clinical Applications | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Ampl.)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify)<br>Harmonic<br>Imaging |
|----------------------------------|---|---|---|-----|-----|------------------|-----------------------------|------------------------------|-----------------------|-------------------------------------------|
| Ophthalmic | | | | | | | | | * | x |
| Fetal | x | x | x | x | x | x | x | | * | x |
| Abdominal | x | x | x | x | x | x | x | | | |
| Intra-operative<br>- abdominal | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | | | | | | | | | |
| - Thyroid | | | | | | | | | | |
| - Breast | | | | | | | | | | |
| - Testicle | | | | | | | | | | x |
| Neonatal Cephalic | | | | | | | | | * | x |
| Adult Cephalic | x | x | x | x | x | x | x | | * | x |
| Cardiac | x | x | x | x | x | x | x | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-Skeletal<br>Conventional | | | | | | | | | | |
| Musculo-Skeletal<br>Superficial | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | |
Additional Comments:
- Combinations: 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
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
Prescription Use
(Per 21 CFR 801.109)
510(k) Number K973767
{14}------------------------------------------------
### Fill out one form for each ultrasound system and transducer
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
> The 8C4 transducer is intended for Harmonic Imaging and Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved".
### Ultrasound System: Sequoia™
### Transducer: 8C4
| Clinical Applications | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Ampl.)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify)<br>Harmonic<br>Imaging |
|----------------------------------------------------|---|---|---|-----|-----|------------------|-----------------------------|------------------------------|-----------------------|-------------------------------------------|
| Ophthalmic | | | | | | | | | * | |
| Fetal | | X | X | X | X | X | X | | * | X |
| Abdominal | | X | X | X | X | X | X | | * | X |
| Intra-operative<br>- abdominal | | X | X | X | X | X | X | | * | |
| Intra-operative<br>Neurological | | | | | | | | | | |
| Pediatric | | X | X | X | X | X | X | | * | X |
| Small Organ<br>- Thyroid<br>- Breast<br>- Testicle | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-Skeletal<br>Conventional | | | | | | | | | | |
| Musculo-Skeletal<br>Superficial | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | |
Additional Comments/
* Combinations: B+M B+PWD/ B+Color Doppler, B+PWD+Color Doppler, B+Power Doppler, B+PWD+Power Doppler
(Division Sign-Off)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Racliological Devices
510(k) Number K973767
Prescription Use (Per 21 CFR 801.109)
{15}------------------------------------------------
### Fill out one form for each ultrasound system and transducer
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
> The 5C2 transducer is intended for Harmonic Imaging and Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved".
### Ultrasound System: Sequoia™
### Transducer: 5C2
| Clinical Applications | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Ampl.)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify)<br>Harmonic<br>Imaging |
|----------------------------------------------------|---|---|---|-----|-----|------------------|-----------------------------|------------------------------|-----------------------|-------------------------------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | x | x | x | x | x | x | | * | x |
| Abdominal | | x | x | x | x | x | x | | * | x |
| Intra-operative | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | |
| Pediatric | | x | x | x | x | x | x | | * | x |
| Small Organ<br>- Thyroid<br>- Breast<br>- Testicle | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-Skeletal<br>Conventional | | | | | | | | | | |
| Musculo-Skeletal<br>Superficial | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | |
Additional Comments:
* Combinations: B+M, B+PWD, B+Color Doppler, B+PWD+Color Doppler, B+PowerDoppler,B+PWD+PowerDoppler
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
Prescription Use
Radiological Devices
510(k) Number K9723767
(Per 21 CFR 801.109)
{16}------------------------------------------------
## Fill out one form for each ultrasound system and transducer
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
> The 4V2 transducer is intended for Harmonic Imaging and Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved".
### Ultrasound System: Sequoia™
### Transducer: 4V2
| Clinical Applications | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Ampl.)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify)<br>Harmonic<br>Imaging |
|----------------------------------|---|---|---|-----|-----|------------------|-----------------------------|------------------------------|-----------------------|-------------------------------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | x | x | x | x | x | x | | * | x |
| Abdominal | | x | x | x | x | x | x | | * | x |
| Intra-operative<br>- abdominal | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | |
| Pediatric | | x | x | x | x | x | x | | * | x |
| Small Organ<br>- Thyroid | | | | | | | | | | |
| - Breast | | | | | | | | | | |
| - Testicle | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-Skeletal<br>Conventional | | |…
