SEQUOIA 8.0 DIAGNOSTIC ULTRASOUND SYSTEM
Device Facts
| Record ID | K032114 |
|---|---|
| Device Name | SEQUOIA 8.0 DIAGNOSTIC ULTRASOUND SYSTEM |
| Applicant | Siemens Medical Solutions USA, Inc. |
| Product Code | IYN · Radiology |
| Decision Date | Jul 21, 2003 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric, 3rd-Party Reviewed |
Intended Use
The Sequoia diagnostic ultrasound system is intended for the following: General Imaging and Cardiology for Fetal, Abdominal, Intraoperative (abdominal and neurological), Pediatrics, Small Organs (breast, thyroid, penis and prostate), Neonatal/Adult Cephalic, Cardiac (adult, pediatric and neonatal), Trans-esophageal, Transrectal, Transvaginal, Peripheral Vessel, and Musculo-skeletal (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 analysis packages that provide information that is used for clinical diagnosis purposes.
Device Story
Sequoia is a mobile, software-controlled diagnostic ultrasound system. It acquires primary or secondary harmonic ultrasound echo data via transducers and displays it in B-mode, M-mode, Pulsed (PW) Doppler, Continuous (CW) wave Doppler, color Doppler, Power Amplitude Doppler, or 3D imaging on a CRT display. The system transmits ultrasonic energy into the body; reflected energy is processed to generate 2D images of anatomic structures and fluid flow. Doppler principles are used to display blood flow as a spectrum or color-coded images. The system includes measurement and analysis packages for clinical diagnosis. It is used in clinical settings by healthcare professionals. The output assists clinicians in visualizing anatomy and blood flow, supporting clinical decision-making and patient diagnosis.
Clinical Evidence
Bench testing only. The system conforms to safety standards including UL 2601-1, CSA C22.2 No. 601-1, AIUM/NEMA UD-2 (acoustic output), AIUM/NEMA UD-3 (thermal/mechanical indices), and ISO 10993 (biocompatibility). Acoustic output is in accordance with the ALARA principle.
Technological Characteristics
Mobile, software-controlled diagnostic ultrasound system. Features include B-mode, M-mode, PW/CW Doppler, color Doppler, Power Amplitude Doppler, Harmonic Imaging, and 3D imaging. Conforms to UL 2601-1, CSA C22.2 No. 601-1, AIUM/NEMA UD-2, AIUM/NEMA UD-3, and ISO 10993. Connectivity includes on-screen display for thermal/mechanical indices. Transducers are provided for various clinical applications.
Indications for Use
Indicated for fetal, abdominal, intraoperative (abdominal/neurological), pediatric, small organ (breast, thyroid, penis, prostate), neonatal/adult cephalic, cardiac (adult, pediatric, neonatal), trans-esophageal, transrectal, transvaginal, peripheral vessel, and musculo-skeletal (superficial/conventional) imaging and fluid flow analysis. Prescription use only.
Regulatory Classification
Identification
An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Predicate Devices
- Sequoia Diagnostic Ultrasound System Signature II (K022567)
Related Devices
- K200707 — ACUSON Sequoia Diagnostic Ultrasound System · Siemens Medical Solutions USA, Inc. · Apr 15, 2020
- K041319 — SEQUOIA DIAGNOSTIC ULTRASOUND SYSTEM · Siemens Medical Solutions USA, Inc. · Jun 7, 2004
- K051139 — ACUSON SEQUOIA DIAGNOSTIC ULTRASOUND SYSTEM · Siemens Medical Solutions USA, Inc. · May 13, 2005
- K022567 — SEQUOIA SIGNATURE II DIAGNOSTIC ULTRASOUND SYSTEM · Acuson Corp. · Aug 13, 2002
- 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
Submission Summary (Full Text)
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K032//44
510(k) Submission
#### 510(k) SUMMARY
# JUL 21 2003
### Sequoia Diagnostic Ultrasound System
This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with the Safe Medical Device Act of 1990 revisions to 21 CFR, Part 807.92, Content and Format of a 510(k) Summary.
#### Submitted Bv: 1.
Siemens Medical Solutions USA. Inc., Ultrasound Division 1230 Shorebird Way PO Box 7393 Mt. View. California 94039-7393
Contact Person Mr. Jerry W. Tsutsumi Regulatory Affairs Department Phone: (650) 943-7286 Fax: (650) 961-6168
#### Date Prepared
29 January 2003
#### 2. Proprietary Name:
Sequoia Diagnostic Ultrasound System
#### Common/ Usual Name:
Diagnostic Ultrasound System with Accessories
### Classification Name:
21 CFR 892.1550 Ultrasonic Pulsed Doppler Imaging System Ultrasonic Pulsed Echo Imaging System Diagnostic Ultrasound Transducer Diagnostic Intravascular Catheter
Product Code 90-IYN FR# 892.1550 FR# 892.1560 Product Code 90-IYO FR# 892,1570 Product Code 90-ITX FR # 870.1200 Product Code 90-DQO
#### 3. Predicate Device:
K022567 (8/13/2002) cleared as Axius Edge Assisted Ejection Fraction, FreeStyle Extended Imaging and several new transducers (V7M TEE, 8L5T, 10V4, 13L5SP and 4V1c) for the Sequoia Diagnostic Ultrasound System Signature II.
#### 4. Device Description:
The Sequoia is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bioeffect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-mode, M-mode, Pulsed (PW) Doppler mode, Continuous (CW) wave Doppler mode, color Doppler mode. Power Amplitude Doppler mode, a combination of these modes, Harmonic Imaging, or 3D imaging, on a CRT display.
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The Sequoia diagnostic ultrasound system has been designed to conform to the following product safety standards:
- 1 UL 2601-1, Safety Requirements for Medical Equipment
- CSA C22.2 No. 601-1. Safety Requirements for Medical Equipment 비
- AIUM/NEMA UD-2, 1998, Acoustic Output Measurement Standard for Diagnostic Ultrasound .
- AIUM/NEMA UD-3, 1998, Standard for Real Time Display of Thermal and Mechanical L Acoustic Output Indices on Diagnostic Ultrasound Equipment
- 93/42/EEC Medical Devices Directive l
- Safety and EMC Requirements for Medical Equipment 미
- 모 EN 60601-1
- EN 60601-1-1 .
- s EN 60601-1-2
- . IEC 1157 Declaration of Acoustic Power
- 해 ISO 10993 Biocompatibility
- The systems acoustic output is in accordance with ALARA (as low as reasonably achievable) ● principle
#### 5. Intended Uses:
The Sequoia diagnostic ultrasound system is intended for the following:
General Imaging and Cardiology for Fetal, Abdominal, Intraoperative (abdominal and neurological), Pediatrics, Small Organs (breast, thyroid, penis and prostate), Neonatal/Adult Cephalic, Cardiac (adult, pediatric and neonatal), Trans-esophageal, Transrectal, Transvaginal, Peripheral Vessel, and Musculo-skeletal (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 analysis packages that provide information that is used for clinical diagnosis purposes.
#### રે. Technological Comparison to Predicate Device:
The Sequoia is substantially equivalent in its technologies and functionality to the Sequoia Diagnostic Ultrasound System Signature II, that is already cleared for USA distribution under 510(k) premarket notification number K022567.
The Sequoia functions in the same manner as other diagnostic ultrasound systems, in that they transmit ultrasonic energy into the body via a transducer. In the body, acoustic impedance of different tissues reflect different amounts of ultrasound energy back to the transducer, where post processing of received echoes is performed to generate two-dimensional on-screen images of anatomic structures and fluid flow within the body. Doppler principles are used to process reflected ultrasound energy to display moving blood as a spectrum, or as color-coded twodimensional images. All predicate devices listed above, allow for specialized measurements of structures and flow, and provide various calculations functions.
#### End of 510(k) Summary
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Public Health Service
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized eagle-like symbol with three curved lines representing the bird's body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Siemens Medical Solutions USA, Inc. % Ms. Laura Danielson Responsible Third Party 510(k) Program Manager TÜV Product Service 1775 Old Highway 8 NW, Suite 104 NEW BRIGHTON MN 25112-1891
JUL 21 2003
Re: K032114
Trade Name: Sequoia 8.0 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 IYN, IYO, and ITX Dated: July 8, 2003 Received: July 9, 2003
Dear Ms. Danielson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for use with the Sequoia 8.0 Diagnostic Ultrasound System, as described in your premarket notification:
# Transducer Model Number
4C1 5C2
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| 6C2 |
|--------------------------------|
| 8C4 |
| EC10c5 |
| EV8C4 |
| 6L3 |
| AcuNav IC10V5/10F10 (Catheter) |
| 8L5 |
| 8L5T |
| 13L5SP |
| 15L8 |
| 15L8w |
| V5M TEE |
| V7M TEE |
| V7B TEE |
| 3V2c |
| 4V1 |
| 4V1c (Sirius) |
| 4V2 |
| 5V2c |
| 7V3c |
| Gemini |
| 8V5 |
| 10V4 |
| AUX CW |
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.
{4}------------------------------------------------
The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:
> Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801, please contact the Office of Compliance at (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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
Sincerely yours.
David A. Symm
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
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510(k) Number (if known):
8,0
Device Name: Intended Use:
Sequoia Diagnostic Ultrasound System
Ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | Other : | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|----|
| 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 | 3D |
| Ophthalmic | | | | | | | | | | | |
| Fetal | P | P | P | P | P | P | P | | P* | P | P |
| Abdominal | P | P | P | P | P | P | P | | P* | P | P |
| Intraoperative<br>Abdominal | P | P | P | P | P | P | P | | P* | P | P |
| Intraoperative<br>Neurological | P | P | P | P | P | P | P | | P* | P | P |
| Pediatric | P | P | P | P | P | P | P | | P* | P | P |
| Small Organ<br>(Specify) ** | P | P | P | P | P | P | P | | P* | P | P |
| Neonatal Cephalic | P | P | P | P | P | P | P | | P* | P | P |
| Adult Cephalic | P | P | P | P | P | P | P | | P* | P | P |
| Cardiac | P | P | P | P | P | P | P | | P* | P | P |
| Trans-esophageal | P | P | P | P | P | P | P | | P* | P | P |
| Transrectal | P | P | P | P | P | P | P | | P* | P | P |
| Transvaginal | P | P | P | P | P | P | P | | P* | P | P |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral vessel | P | P | P | P | P | P | P | | P* | P | P |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | P | P | P | P | P | P | P | | P* | P | P |
| Musculo-skeletal<br>Superficial | P | P | P | P | P | P | P | | P* | P | P |
| Other (specify) *** | P | P | P | P | P | P | P | | P* | P | P |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Additional Comments:
*Combinations include: B+M, B+PWD, B+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
** small organs (breast, testes, thyroid, penis, prostate)
*** neonatal cardiac
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Concurre
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510(k) Number (if known):
Device Name:
4C1
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------------------|---------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other :<br>Harmonic<br>Imaging | Other :<br>3D |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | | P* | P | P |
| Abdominal | | P | P | P | P | P | P | | P* | P | P |
| Intraoperative<br>Abdominal | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | P* | P | P |
| Small Organ<br>(Specify) ** | | P | P | P | P | P | P | | P* | P | P |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | N | N | N | N | N | N | | N* | N | N |
| Trans-esophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral vessel | | N | N | N | N | N | N | | N* | N | N |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Other (specify) *** | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Additional Comments:
*Combinations include: 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
** small organs (breast, testes, thyroid, penis, prostate)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices (0
{7}------------------------------------------------
5C2
### Diagnostic Ultrasound Indications for Use Form
510(k) Number (if known):
Device Name: Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------------------|---------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other :<br>Harmonic<br>Imaging | Other :<br>3D |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | | P* | P | P |
| Abdominal | | P | P | P | P | P | P | | P* | P | P |
| Intraoperative<br>Abdominal | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | P* | P | P |
| Small Organ<br>(Specify) ** | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral vessel | | N | N | N | N | N | N | | N* | N | N |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Other (specify) *** | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Additional Comments:
*Combinations include: B+M, B+PWD, 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
> (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Syzman
(Division Sig Division o and Radiolo 510(k) Number
{8}------------------------------------------------
510(k) Number (if known):
Device Name:
6C2
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------------------|---------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other :<br>Harmonic<br>Imaging | Other :<br>3D |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | | P* | P | P |
| Abdominal | | P | P | P | P | P | P | | P* | P | P |
| Intraoperative<br>Abdominal | | P | P | P | P | P | P | | P* | P | P |
| Intraoperative<br>Neurological | | P | P | P | P | P | P | | P* | P | P |
| Pediatric | | P | P | P | P | P | P | | P* | P | P |
| Small Organ<br>(Specify) ** | | P | P | P | P | P | P | | P* | P | P |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | N | N | N | N | N | N | | N* | N | N |
| Trans-esophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral vessel | | P | P | P | P | P | P | | P* | P | P |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Other (specify) *** | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Additional Comments:
*Combinations include: B+M, B+PWD, 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
> (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David R. Ingram
(Divis Divi and Ra 510(k) Number
{9}------------------------------------------------
8C4
## Diagnostic Ultrasound Indications for Use Form
510(k) Number (if known):
Device Name: Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------------------|---------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other :<br>Harmonic<br>Imaging | Other :<br>3D |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | | P* | P | P |
| Abdominal | | P | P | P | P | P | P | | P* | P | P |
| Intraoperative<br>Abdominal | | P | P | P | P | P | P | | P* | P | P |
| Intraoperative<br>Neurological | | P | P | P | P | P | P | | P* | P | P |
| Pediatric | | P | P | P | P | P | P | | P* | P | P |
| Small Organ<br>(Specify) ** | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | N | N | N | N | N | N | | N* | N | N |
| Trans-esophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral vessel | | N | N | N | N | N | N | | N* | N | N |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Other (specify) *** | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Additional Comments:
*Combinations include: 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
> (PLEASE 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)
David A. Swanson
(Division Sig Division of Re and Radiological Devi -510k) Numt
{10}------------------------------------------------
510(k) Number (if known):
Device Name: Intended Use: EC10c5
Ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------------------|---------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other :<br>Harmonic<br>Imaging | Other :<br>3D |
| 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) *** | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Additional Comments:
*Combinations include: B+M, B+PWD, B+Color Doppler, B+M+Color Doppler, B+PWD+Color Doppler,
B+Power Doppler, B+PWD+Power Doppler, B+M+Power Doppler
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Szymanski
(Division Sign Division of Reproductive, Abo and Radiological Devic 510(k) Number
{11}------------------------------------------------
EV8C4
## Diagnostic Ultrasound Indications for Use Form
510(k) Number (if known):
Device Name:
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------------------|---------------|--|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other :<br>Harmonic<br>Imaging | Other :<br>3D | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | | P* | P | P | |
| Abdominal | | P | 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 | P | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | | |
| Other (specify) *** | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Additional Comments:
*Combinations include: 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
> (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Dovid R. Symm
(Division Sign-Off)
Division of Reproductive, Abdon and Radiological Devices 510(k) Number _
{12}------------------------------------------------
510(k) Number (if known):
er3
Device Name: Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | Other : | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|----|
| 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 | 3D |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | N | N | N | N | N | N | | N* | N | N |
| Abdominal | | | | | | | | | | | |
| Intraoperative<br>Abdominal | | P | P | P | P | P | P | | P* | P | P |
| Intraoperative<br>Neurological | | P | P | P | P | P | P | | P* | P | P |
| Pediatric | | | | | | | | | | | |
| Small Organ<br>(Specify) ** | | P | P | P | P | P | P | | P* | P | P |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | N | N | N | N | N | N | | N* | N | N |
| Trans-esophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral vessel | | P | P | P | P | P | P | | P* | P | P |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | P | P | P | P | P | P | | P* | P | P |
| Musculo-skeletal<br>Superficial | | P | P | P | P | P | P | | P* | P | P |
| Other (specify) *** | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Additional Comments:
*Combinations include: B+M, B+PWD, 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
** small organs (breast, testes, thyroid, penis, prostate)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K032114
{13}------------------------------------------------
510(k) Number (if known):
Device Name:
Transducer.
Intended Use:
Sequoia Diagnostic Ultrasound System, Harmonic Imaging AcuNav (IC10V5 or 10F10) diagnostic ultrasound catheter For intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, and visualization of other devices in the heart - use in right heart only.
| | Mode of Operation | | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------------------|---------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other :<br>Harmonic<br>Imaging | Other :<br>3D |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative<br>Abdominal | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ<br>(Specify) ** | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | P | P | P | P | | P | | P* | | |
| Trans-esophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Other (specify)*** | | P | P | P | P | P | P | | P* | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Additional Comments:
*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+Color Doppler, B+CWD+Color Doppler, B+PWD+Color Doppler, B+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+M+Power Doppler
*** Other = Intra-luminal and Intra-cardiac
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Segmen
Prescription Use (Per 21 CFR 801.109)
(Division Reproductive, Abdo and Radiological Devices 510(k) Number
{14}------------------------------------------------
510(k) Number (if known):
Device Name:
8-2
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| | | Mode of Operation | | | | | | | | | | |
|----------------------------------|---|-------------------|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------------------|---------------|--|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other :<br>Harmonic<br>Imaging | Other :<br>3D | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intraoperative<br>Abdominal | | P | P | P | P | P | P | | P* | P | P | |
| Intraoperative<br>Neurological | | P | P | P | P | P | P | | P* | P | P | |
| Pediatric | | | | | | | | | | | | |
| Small Organ<br>(Specify) ** | | P | P | P | P | P | P | | P* | P | P | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac | | N | N | N | N | N | N | | N* | N | N | |
| Trans-esophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral vessel | | P | P | P | P | P | P | | P* | P | P | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | P | P | P | P | P | P | | P* | P | P | |
| Musculo-skeletal<br>Superficial | | P | P | P | P | P | P | | P* | P | P | |
| Other (specify) *** | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Additional Comments:
*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+Color Doppler, B+CWD+Color Doppler, B+PWD+Color Doppler, B+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+M+Power Doppler.
** small organs (breast, testes, thyroid, penis, prostate)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David R. Sigerson
(Division Sign-Off) Division of Reproductive. A and Radiological Devices 510(k) Number .
{15}------------------------------------------------
510(k) Number (if known):
Device Name:
8L5T
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------------------|---------------|--|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other :<br>Harmonic<br>Imaging | Other :<br>3D | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intraoperative<br>Abdominal | P | P | P | P | P | P | P | | P* | P | P | |
| Intraoperative<br>Neurological | P | P | P | P | P | P | P | | P* | P | P | |
| Pediatric | P | P | P | P | P | P | P | | P* | P | P | |
| Small Organ<br>(Specify) ** | P | P | P | P | P | P | P | | P* | P | P | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac | P | P | P | P | P | P | P | | P* | P | P | |
| Trans-esophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral vessel | P | P | P | P | P | P | P | | P* | P | P | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | P | P | P | P | P | P | P | | P* | P | P | |
| Musculo-skeletal<br>Superficial | P | P | P | P | P | P | P | | P* | P | P | |
| Other (specify) *** | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Additional Comments:
*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+Color Doppler, B+CWD+Color Doppler, B+PWD+Color Doppler, B+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+M+Power Doppler
** small organs (breast, testes, thyroid, penis, prostate)
(PLEASE 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)
Daniel R. Syverson
(Division Sign-Off) Division of Reproductive, Abde and Radiological Devices 510(k) Number .
{16}------------------------------------------------
### 510(k) Number (if known):
Device Name:
1315SP
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------------------|---------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other :<br>Harmonic<br>Imaging | Other :<br>3D |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative<br>Abdominal | | P | P | P | P | P | P | | P* | P | P |
| Intraoperative<br>Neurological | | P | P | P | P | P | P |…
