(82 days)
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.
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".
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".
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".
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".
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".
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".
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".
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".
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".
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".
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".
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".
The EV-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".
The Aux CW transducer is intended for Harmonic Imaging and Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved".
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.
The provided document is a 510(k) submission for the Sequoia™ Ultrasound System and Harmonic Imaging with Contrast Option. It serves as a regulatory notification of intent to market the device, asserting its substantial equivalence to previously marketed devices. However, it does not explicitly contain acceptance criteria (e.g., performance metrics, thresholds) or detailed study results that "prove the device meets acceptance criteria" in the way a clinical trial report would for a novel device.
The "IMAGING PERFORMANCE" section [2] briefly states: "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)." This indicates that performance verification was done, but the specifics of what was measured, what the acceptance criteria were, and what the results were are not elaborated in the provided text.
Therefore, many of the requested details cannot be extracted from this document.
However, based on the information available, here's what can be provided:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or report specific performance metrics (e.g., sensitivity, specificity, accuracy). The submission primarily focuses on demonstrating that the addition of "Harmonic Imaging with Contrast" does not introduce new safety concerns and operates effectively within the existing cleared Sequoia™ Ultrasound system's capabilities.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document states "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)." [2] However, it does not provide details on:
- Sample size used for the test set.
- Data provenance (e.g., country of origin).
- Whether the studies were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
The document does not provide any information regarding the number or qualifications of experts used to establish ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
The document does not describe any adjudication method for the test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or any assessment of human reader improvement with or without AI assistance. This device is an ultrasound system and its imaging modes, not an AI-assisted diagnostic tool in the contemporary sense.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable as the device described is an ultrasound imaging system with new imaging modes, not an algorithm, and it explicitly involves human-in-the-loop operation for image acquisition and interpretation by physicians.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document does not specify the type of ground truth used in the clinical studies. Given the nature of an ultrasound system, it is common for the ground truth to be established by clinical diagnoses, pathology, or comparison with other established imaging modalities, but this is not confirmed in the text.
8. The sample size for the training set
This document describes a medical device (ultrasound system) undergoing 510(k) clearance, which typically does not involve a "training set" in the context of machine learning. The clinical studies mentioned were for verification of system performance. Therefore, a "training set" is not applicable in this context.
9. How the ground truth for the training set was established
As there is no "training set" in the context of this device, this question is not applicable.
{0}------------------------------------------------
SUMMARY OF SAFETY AND EFFECTIVENESS
DEC 2 3 1997
GENERAL INFORMATION I.
| Device generic name: | Ultrasonic Pulsed Doppler Imaging System,Ultrasonic Pulsed Echo Imaging System, andDiagnostic Ultrasound Transducer |
|---|---|
| Device Trade Name: | Sequoia™ Ultrasound System and Harmonic Imagingwith 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).
{2}------------------------------------------------
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
- 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 | ColorDoppler | Power(Ampl.)Doppler | ColorVelocityImaging | Combined(Specify) | Other(Specify)HarmonicImaging |
|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||||
| Fetal | X | X | X | X | X | X | X | * | X | |
| Abdominal | X | X | X | X | X | X | X | * | X | |
| Intra-operative(vascular) | X | X | X | X | X | X | X | * | X | |
| Intra-operativeNeurological | ||||||||||
| 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-SkeletalConventional | X | X | X | X | X | X | X | * | X | |
| Musculo-SkeletalSuperficial | 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- abdominal- cardiac | ||||||||||
| Intra-operativeNeurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ- Thyroid- Breast- 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-SkeletalConventional | ||||||||||
| Musculo-SkeletalSuperficial | ||||||||||
| Other (Specify) | ||||||||||
| Clinical Applications | A | B | M | PWD | CWD | ColorDoppler | Power(Ampl.)Doppler | ColorVelocityImaging | Combined(Specify) | Other(Specify)HarmonicImaging |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative- vascular | x | x | x | x | x | x | x | * | x | |
| Intra-operativeNeurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ- Thyroid- Breast- 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-SkeletalConventional | x | x | x | x | x | x | x | * | x | |
| Musculo-SkeletalSuperficial | 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 | ColorDoppler | Power(Ampl.)Doppler | ColorVelocityImaging | Combined(Specify) | Other(Specify)HarmonicImaging |
|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative- vascular | X | X | X | X | X | X | X | * | X | |
| Intra-operativeNeurological | X | |||||||||
| Pediatric | ||||||||||
| Small Organ- Thyroid- Breast- 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-SkeletalConventional | X | X | X | X | X | X | X | * | X | |
| Musculo-SkeletalSuperficial | 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 | ColorDoppler | Power(Ampl.)Doppler | ColorVelocityImaging | Combined(Specify) | Other(Specify)HarmonicImaging | |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intra-operative- vascular | X | X | X | X | X | * | X | ||||
| Intra-operativeNeurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ- Thyroid- Breast- 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-SkeletalConventional | X | X | X | X | X | X | * | X | |||
| Musculo-SkeletalSuperficial | 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 | ColorDoppler | Power(Ampl.)Doppler | ColorVelocityImaging | Combined(Specify) | Other(Specify)HarmonicImaging |
|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||||
| Fetal | X | X | X | X | X | X | X | * | X | |
| Abdominal | X | X | X | X | X | X | X | * | X | |
| Intra-operative(Specify) | ||||||||||
| Intra-operativeNeurological | ||||||||||
| Pediatric | X | X | X | X | X | X | X | * | X | |
| Small Organ- Thyroid- Breast- 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-SkeletalConventional | ||||||||||
| Musculo-SkeletalSuperficial | ||||||||||
| 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 | ColorDoppler | Power(Ampl.)Doppler | ColorVelocityImaging | Combined(Specify) | Other(Specify)HarmonicImaging | |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | |||||||||||
| Fetal | X | X | X | X | X | X | X | * | X | ||
| Abdominal | X | X | X | X | X | X | X | * | X | ||
| Intra-operative- abdominal | |||||||||||
| Intra-operativeNeurological | |||||||||||
| Pediatric | X | X | X | X | X | X | X | * | X | ||
| Small Organ- Thyroid- Breast- 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-SkeletalConventional | |||||||||||
| Musculo-SkeletalSuperficial | |||||||||||
| 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 | ColorDoppler | Power(Ampl.)Doppler | ColorVelocityImaging | Combined(Specify) | Other(Specify)HarmonicImaging |
|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||||
| Fetal | X | X | X | X | X | X | X | * | X | |
| Abdominal | X | X | X | X | X | X | X | * | X | |
| Intra-operative- cardiac- abdominal | ||||||||||
| Intra-operativeNeurological | ||||||||||
| Pediatric | X | X | X | X | X | X | X | * | X | |
| Small Organ- Thyroid- Breast- 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-SkeletalConventional | ||||||||||
| Musculo-SkeletalSuperficial | ||||||||||
| 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 | |
| 510(k) Number | K973767 |
| Prescription Use(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 | ColorDoppler | Power(Ampl.)Doppler | ColorVelocityImaging | Combined(Specify) | Other(Specify)HarmonicImaging |
|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | * | x | ||||||||
| Fetal | x | x | x | x | x | x | x | * | x | |
| Abdominal | x | x | x | x | x | x | x | |||
| Intra-operative- abdominal | ||||||||||
| Intra-operativeNeurological | ||||||||||
| 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-SkeletalConventional | ||||||||||
| Musculo-SkeletalSuperficial | ||||||||||
| 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 | ColorDoppler | Power(Ampl.)Doppler | ColorVelocityImaging | Combined(Specify) | Other(Specify)HarmonicImaging |
|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | * | |||||||||
| Fetal | X | X | X | X | X | X | * | X | ||
| Abdominal | X | X | X | X | X | X | * | X | ||
| Intra-operative- abdominal | X | X | X | X | X | X | * | |||
| Intra-operativeNeurological | ||||||||||
| Pediatric | X | X | X | X | X | X | * | X | ||
| Small Organ- Thyroid- Breast- Testicle | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Trans-esophageal | ||||||||||
| Trans-Rectal | ||||||||||
| Trans-Vaginal | ||||||||||
| Trans-Urethral | ||||||||||
| Intra-Luminal | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-SkeletalConventional | ||||||||||
| Musculo-SkeletalSuperficial | ||||||||||
| 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 | ColorDoppler | Power(Ampl.)Doppler | ColorVelocityImaging | Combined(Specify) | Other(Specify)HarmonicImaging |
|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||||
| Fetal | x | x | x | x | x | x | * | x | ||
| Abdominal | x | x | x | x | x | x | * | x | ||
| Intra-operative | ||||||||||
| Intra-operativeNeurological | ||||||||||
| Pediatric | x | x | x | x | x | x | * | x | ||
| Small Organ- Thyroid- Breast- Testicle | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Trans-esophageal | ||||||||||
| Trans-Rectal | ||||||||||
| Trans-Vaginal | ||||||||||
| Trans-Urethral | ||||||||||
| Intra-Luminal | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-SkeletalConventional | ||||||||||
| Musculo-SkeletalSuperficial | ||||||||||
| 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 | ColorDoppler | Power(Ampl.)Doppler | ColorVelocityImaging | Combined(Specify) | Other(Specify)HarmonicImaging |
|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||||
| Fetal | x | x | x | x | x | x | * | x | ||
| Abdominal | x | x | x | x | x | x | * | x | ||
| Intra-operative- abdominal | ||||||||||
| Intra-operativeNeurological | ||||||||||
| Pediatric | x | x | x | x | x | x | * | x | ||
| Small Organ- Thyroid | ||||||||||
| - Breast | ||||||||||
| - Testicle | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Trans-esophageal | ||||||||||
| Trans-Rectal | ||||||||||
| Trans-Vaginal | ||||||||||
| Trans-Urethral | ||||||||||
| Intra-Luminal | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-SkeletalConventional | ||||||||||
| Musculo-SkeletalSuperficial | ||||||||||
| Other (Specify) |
Additional Comments:
Combinations: B+M, B+PWD, B+Color Doppler, B+PWD+Color Doppler, B+Power Doppler, B+PWD+PowerDoppler
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices,
510(k) Number. K973767
Prescription Use (Per 21 CFR 801.109)
{17}------------------------------------------------
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 EV-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: EV-8C4
| Clinical Applications | A | B | M PWD | CWD | ColorDoppler | Power(Ampl.)Doppler | ColorVelocityImaging | Combined(Specify) | Other(Specify)HarmonicImaging |
|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | |||||||||
| Fetal | x | x | x | x | x | * | x | ||
| Abdominal | |||||||||
| Intra-operative | |||||||||
| - | |||||||||
| Intra-operativeNeurological | |||||||||
| Pediatric | |||||||||
| Small Organ | |||||||||
| - Thyroid | |||||||||
| - Breast | |||||||||
| - Testicle | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Cardiac | |||||||||
| Trans-esophageal | |||||||||
| Trans-Rectal | |||||||||
| Trans-Vaginal | x | x | x | x | x | * | x | ||
| Trans-Urethral | |||||||||
| Intra-Luminal | |||||||||
| Peripheral Vascular | |||||||||
| Laparoscopic | |||||||||
| Musculo-SkeletalConventional | |||||||||
| Musculo-SkeletalSuperficial | |||||||||
| 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 of Reproductive, Abdominal, ENT,
Prescription Use
and Radiological Devices
510(k) Number K97376
Prescription Use
(Per 21 CFR 801.109)
{18}------------------------------------------------
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 Aux CW 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: Aux CW
| Clinical Applications | A | B | M | PWD | CWD | ColorDoppler | Power(Ampl.)Doppler | ColorVelocityImaging | Combined(Specify) | Other(Specify)HarmonicImaging |
|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative(Specify) | ||||||||||
| Intra-operativeNeurological | ||||||||||
| Pediatric | X | X | X | X | X | X | * | X | ||
| Small Organ | ||||||||||
| - Thyroid | ||||||||||
| - Breast | ||||||||||
| - Testicle | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | X | X | X | X | X | X | X | |||
| Trans-esophageal | ||||||||||
| Trans-Rectal | ||||||||||
| Trans-Vaginal | ||||||||||
| Trans-Urethral | ||||||||||
| Intra-Luminal | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-SkeletalConventional | ||||||||||
| Musculo-SkeletalSuperficial | ||||||||||
| 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, and Radiologics ﺯﺍ
510(k) Number: K913161
Prescription Use _ (Per 21 CFR 801.109)
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
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.(b)
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.