MODIFICATION TO ACUSON SEQUOIA ULTRASOUND SYSTEM
Device Facts
| Record ID | K063085 |
|---|---|
| Device Name | MODIFICATION TO ACUSON SEQUOIA ULTRASOUND SYSTEM |
| Applicant | Siemens Medical Solutions USA, Inc. |
| Product Code | IYO · Radiology |
| Decision Date | Nov 14, 2006 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 892.1560 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
The Sequoia ultrasound imaging system 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 and penis), Neonatal/Adult Cephalic, Cardiac (adult, pediatric and neonatal), Transesophageal, Transrectal, Transvaginal, Peripheral Vessels, and Musculosceletal (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
The Siemens Acuson Sequoia is a multi-purpose diagnostic ultrasound system. It processes acoustic signals received via various transducers to generate real-time diagnostic images and fluid flow analysis. The system supports multiple imaging modes, including B-mode, M-mode, Pulsed Wave Doppler (PWD), Continuous Wave Doppler (CWD), Color Doppler, Power Doppler, and Harmonic Imaging. It is operated by clinicians in clinical settings for anatomical measurement and diagnostic analysis. The system provides clinicians with visual data to assist in clinical decision-making across a wide range of applications, including cardiology and general imaging. It is designed to comply with safety standards for diagnostic ultrasound equipment.
Clinical Evidence
Bench testing only. The device modifications were verified and validated according to the company's design control process, including compliance with safety standards such as IEC 60601-2-37, AIUM/NEMA UD-2, and AIUM/NEMA UD-3.
Technological Characteristics
Multi-purpose diagnostic ultrasound system. Complies with UL 2601-1, IEC 60601-2-37, CSA C22.2 No. 601-1, AIUM/NEMA UD-2/UD-3, and ISO 10993-1. Supports various transducers (e.g., 4C1, 9L4, 4V1, AcuNav catheters). Connectivity includes standard ultrasound imaging interfaces. Software-based analysis packages for anatomical measurement.
Indications for Use
Indicated for ultrasound imaging or fluid flow analysis of the human body, including fetal, abdominal, intraoperative (abdominal/neurological), pediatric, small organ (breast, testes, thyroid, penis), neonatal/adult cephalic, cardiac (adult, pediatric, neonatal), transesophageal, transrectal, transvaginal, peripheral vessel, and musculoskeletal (superficial/conventional) applications. Prescription use only.
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
- Siemens Acuson Sequoia ultrasound system (K052410)
Reference Devices
Related Devices
- K202683 — ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System, ACUSON Freestyle Diagnostic Ultrasound System,ACUSON S1000, S2000, S3000 Diagnostic Ultrasound Systems, ACUSON P200 Diagnostic Ultrasound System, ACUSON P500 Diagnostic Ultrasound System, ACUSON NX3, NX3 Elite Diagnostic Ultrasound System · Siemens Medical Solutions USA, Inc. · Oct 15, 2020
- K051139 — ACUSON SEQUOIA DIAGNOSTIC ULTRASOUND SYSTEM · Siemens Medical Solutions USA, Inc. · May 13, 2005
- K061980 — SIEMENS ACUSON X500 ULTRASOUND SYSTEM · Siemens Medical Solutions USA, Inc. · Aug 17, 2006
- K032114 — SEQUOIA 8.0 DIAGNOSTIC ULTRASOUND SYSTEM · Siemens Medical Solutions USA, Inc. · Jul 21, 2003
- K022567 — SEQUOIA SIGNATURE II DIAGNOSTIC ULTRASOUND SYSTEM · Acuson Corp. · Aug 13, 2002
Submission Summary (Full Text)
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K063085
ACUSON Sequoia™ Ultrasound System
Special 510(k) Submission
### SECTION 11
#### 510(k) Summary
| Sponsor: | Siemens Medical Solutions USA, Inc.,<br>Ultrasound Division<br>1230 Shorebird Way<br>P.O. Box 7393<br>Mountain View, California 94039-7393 | | | | NOV 14 2006 |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--|--|---------------------|-------------|
| Contact Person: | Sheila W. Pickering<br>Telephone: (650) 943 7187<br>Fax: (650) 943 7053 | | | | |
| Submission Date: | October 06, 2006 | | | | |
| Device Name: | Siemens Acuson Sequoia Ultrasound System | | | | |
| Common Name: | Diagnostic Ultrasound System with Accessories | | | | |
| Classification: | | | | | |
| Regulatory Class: | II | | | | |
| Review Category: | Tier II | | | | |
| Classification Panel: | Radiology | | | | |
| Ultrasonic Pulsed Doppler Imaging System | FR # 892.1550 | | | Product Code 90-IYN | |
| Ultrasonic Pulsed Echo Imaging System | FR # 892.1560 | | | Product Code 90-IYO | |
| Diagnostic Ultrasound Transducer | FR # 892.1570 | | | Product Code 90-ITX | |
### A. Legally Marketed Predicate Devices
Diagnostic Intravascular Catheter
The Siemens Acuson Sequoia ultrasound system is a multi-purpose diagnostic ultrasound system with accessories and proprietary software, and is substantially equivalent to our current product the Siemens Acuson Sequoia ultrasound system (K052410).
FR # 870.1200
Product Code 74-DOO
### B. Device Description:
The Siemens Acuson Sequoia has been designed to meet the following product safety standards:
- . UL 2601-1, Safety Requirements for Medical Equipment
- I IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
- CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment
- 프 AIUM/NEMA UD-3, 1998 Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- I AlUMNEMA UD-2, 1998 Acoustic Output Measurement Standard for Diagnostic Ultrasound
- 트 93/42/EEC Medical Devices Directive I
- Safety and EMC Requirements for Medical Equipment
- 피 EN/IEC 60601-1
- 트 EN/IEC 60601-1-1
- 트 EN/IEC 60601-1-2
- I IEC 1157 Declaration of Acoustic Power
- 제 ISO 10993-1 Biocompatibility
.
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### C. Intended Use
The Sequoia ultrasound imaging system 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 and penis), Neonatal/Adult Cephalic, Cardiac (adult, pediatric and neonatal), Transesophageal, Transvaginal, Peripheral Vessels, and Musculosceletal (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.
### D. Substantial Equivalence
The submission device is substantially equivalent to the predicate with regard to both intended use and technological characteristics.
### E. Performance Data
The Sequoia modifications are verified and validated according to the company's design control process.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three stylized wings or feathers.
NOV 1 4 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Sheila Pickering, Ph.D. Senior Director of Regulatory Affairs Siemens Medical Solutions USA, Inc. 1230 Shorebird Way MOUNTAIN VIEW CA 94039
Re: K063085
Trade Name: ACSON Sequoia™ 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 Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: II Product Code: IYO, IYN, ITX, and DQO Dated: October 6, 2006 Received: October 16, 2006
### Dear Dr. Pickering:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for use with the ACSON Sequoia™ Ultrasound System, as described in your premarket notification:
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| Transducer Model Number | Transducer Model Number | Transducer Model Number |
|--------------------------------------------|-------------------------|-------------------------|
| 4C1 | 9L4 | 4V1 |
| 5C2 | 13L5SP | 4V1c |
| 6C2 | 15L8 | 4V2 |
| 8C4 | 15L8w | 5V2c |
| EC10c5 | 17L5 | 7V3c |
| EV8C4 | V5M TEE | 8V3 |
| 6L3 | V7M TEE | 8V5 |
| 8L5 | V7B TEE | 10V4 |
| 8L5T | 3V2c | AUX CW |
| AcuNav (IC10V5 or 10F) Ultrasound Catheter | | |
| AcuNav 8F Ultrasound Catheter | | |
If your device is classified (sec above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.
The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:
> Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
{4}------------------------------------------------
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
If you have any questions regarding the content of this letter, please contact Andrew Kang at (240) 276-3666.
Sincerely yours,
Nancy C. Brogdon
Nancv C. B. odon 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): K063085
ACUSON Sequoia™ Ultrasound System Device Name:
### Indications for Use:
The Sequoia ultrasound imaging system 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 and penis), Neonatal/Adult Cephalic, Cardiac (adult, pediatric and neonatal), Transesophageal, Transrectal, Transvaginal, Peripheral Vessels, 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.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
### Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Brogdon
Division of Reproductive. Abdi and Radiological Devices 510(k) Number _
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510(k) Number (if known):
# K063085
Device Name:
# Sequoia™ 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 | | | | | | | | | | |
| 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 |
P=previously cleared by the FDA under premarket notifications #K052410, #K051139, #K032114, #K022567, #K002807, #K992631, #K992580, #K973767, #K935595/S1.
#### 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) ***neonatal cardiac
(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
cy C. Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K063085
{7}------------------------------------------------
510(k) Number (if known):
K 063085 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 |
| 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) | | | | | | | | | | |
P=previously cleared by the FDA under premarket notifications #K052410, #K051139, #K032114, #K022567, and #K002807.
#### 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)
Prescription Use (Per 21 CFR 801.109)
Nancycbrayton
(Division Sign-Off) Division of Reproductive, A and Radiological Devices 510(k) Number _
{8}------------------------------------------------
510(k) Number (if known):
Device Name:
<063085 5C2
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 | | | | | | | | | | |
| 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) | | | | | | | | | | |
P=previously cleared by the FDA under premarket notifications #K052410, #K051139, #K032114, #K022567, #K002807, and #K973767.
### 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)
Prescription Use (Per 21 CFR 801.109)
Nancy C
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
2063025
510(k) Number
{9}------------------------------------------------
6C2
14063085 510(k) Number (if known):
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 | | 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) | | | | | | | | | | |
P=previously cleared by the FDA under premarket notifications #K052410, #K051139, #K032114, #K()22567, and #K002807.
### 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)
Prescription Use (Per 21 CFR 801.109)
Nancy C. Bridon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K063085
{10}------------------------------------------------
510(k) Number (if known):
Device Name:
8C4
KO63085
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 | | 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 | | | | | | | | | | |
| Peripheral Vessel | | P | P | P | P | P | P | | P* | P |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>(Conventional) | | | | | | | | | | |
| Musculo-skeletal<br>(Superficial) | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
P=previously cleared by the FDA under premarket notifications #K052410, #K051139, #K032114, #K022567, #K002807, and #K973767.
#### 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)
Prescription Use (Per 21 CFR 801.109)
Nancy C Brogdo
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K063085
{11}------------------------------------------------
Kob3085
510(k) Number (if known):
EC10c5
Intended Use:
Device Name:
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 | | | | | | | | | | | |
| 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-skeletal<br>(Superficial) | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
P=previously cleared by the FDA under premarket notifications #K052410, #K051139, #K041319, #K032114, #K022567, and #K002807.
#### 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 LINF-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Nancy Shoydon
(Division Sign-Division of Reproductive, Ab and Radiological Devices 510(k) Number _
{12}------------------------------------------------
510(k) Number (if known):
Device Name:
12063085
Device Name.
EV8C4
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 | | | | | | | | | | |
| Small Organ<br>(specify)** | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | P | P | P | P | P | P | | P* | P |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>(Conventional) | | | | | | | | | | |
| Musculo-skeletal<br>(Superficial) | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
P=previously cleared by the FDA under premarket notifications #K052410, #K051139, #K032114, #K022567, #K002807, and #K973767.
#### 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)
Prescription Use (Per 21 CFR 801.109)
Nancy Chogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
and Radiological Devices 510(k) Number
{13}------------------------------------------------
K063085
6L3
510(k) Number (if known):
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 | | | | | | | | | | |
| Intraoperative<br>Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative<br>Neurological | | P | P | P | P | P | P | | P* | P |
| Pediatric | | | | | | | | | | |
| 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) | | | | | | | | | | |
P=previously cleared by the FDA under premarket notifications #K052410, #K051139, #K041319, #K032114, #K022567, #K002807, and #K973767.
### 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)
Prescription Use (Per 21 CFR 801.109)
Nancy Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number k063085
{14}------------------------------------------------
510(k) Number (if known):
Device Name:
063085 81 5
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 | | P | P | P | P | P | P | | P* | P |
| Intraoperative<br>Neurological | | P | P | P | P | P | P | | P* | P |
| Pediatric | | | | | | | | | | |
| 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) | | | | | | | | | | |
P=previously cleared by the FDA under premarket notifications #K052410, #K051139, #K041319, #K032114, #K022567, #K002807, and #K973767.
### 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)
Prescription Use (Per 21 CFR 801.109)
Nancy Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number N063085
{15}------------------------------------------------
510(k) Number (if known):
Device Name:
Intended Use:
Kob3085 81.57.
Device Name.
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 | | 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-skelctal<br>(Superficial) | | P | P | P | P | P | P | | P* | P |
| Other (specify) | | | | | | | | | | |
P=previously cleared by the FDA under premarket notifications #K052410, #K051139, #K041319, #K032114, and #K022567.
### 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)
Prescription Use (Per 21 CFR 801.109)
Nancy Thorgdon
(Division Sign-Off) Division of Reproductive, A and Radiological Devices 510(k) Number _
{16}------------------------------------------------
510(k) Number (if known):
Device Name:
91.4
Indications for Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical<br>Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | N | N | N | | N | N | N | N* | N |
| Abdominal | | | | | | | | | | |
| Intraoperative<br>Abdominal | | N | N | N | | N | N | N | N* | N |
| Intraoperative<br>Neurological | | N | N | N | | N | N | N | N* | N |
| Pediatric | | N | N | N | | N | N | N | N* | N |
| Small Organ<br>(specify)** | | N | N | N | | N | N | N | N* | N |
| Neonatal<br>Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vessel | | N | N | N | | N | N | N | N* | N |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>(Conventional) | | N | N | N | | N | N | N | N* | N |
| Musculo-skeletal<br>(Superficial) | | N | N | N | | N | N | N | N* | N |
| Other<br>(specify)*** | | | | | | | | | | |
N=New Indication
#### Additional Comments:
*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE
**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)
Prescription Use (Per 21 CFR 801.109)
Nancy Rigdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices K063085
510(k) Number ________________________________________________________________________________________________________________________________________________________________
{17}------------------------------------------------
510(k) Number (if known):
Device Name:
X063085 13L5SP
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 | | 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)** | | | | | | | | | | | |
P=previously cleared by the FDA under premarket notifications #K052410, #K051139, #K041319, #K032114, and #K022567.
### 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)
| Prescription Use (Per 21 CFR 801.109) | Nancy C. Brogdon |
|---------------------------------------------------------------|------------------|
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K063085 |
{18}------------------------------------------------
510(k) Number (if known):
evice Name:
K063085
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 | | | | | | | | | | | |
| 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) | | | | | | | |…
