ACUSON SEQUOIA ULTRASOUND SYSTEM
Device Facts
| Record ID | K052410 |
|---|---|
| Device Name | ACUSON SEQUOIA ULTRASOUND SYSTEM |
| Applicant | Siemens Medical Solutions USA, Inc. |
| Product Code | IYN · Radiology |
| Decision Date | Sep 22, 2005 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The Sequoia platform is intended for use in the following applications: General Imaging and Cardiology for Fetal, Abdominal, Intraoperative (abdominal and neurological), Pediatrics, Small Organs (breast, testes, thyroid, penis and prostate), Neonatal/Adult Cephalic, Cardiac (adult, pediatric, and neonatal), Trans-esophageal, Transrectal, Transvaginal, Peripheral Vessel, and Musculo-sceletal (superficial and conventional) applications, and intended uses as defined in the FDA guidance document. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
Device Story
Multi-purpose diagnostic ultrasound system; transmits ultrasonic energy into body via transducer; reflected echoes processed to generate 2D images of anatomical structures and fluid flow; Doppler principles used for blood flow spectrum or color-coded 2D imaging; used in clinical settings (e.g., radiology, cardiology) by trained healthcare professionals; provides anatomical measurements and analysis packages for clinical diagnosis; aids in clinical decision-making by visualizing internal structures and hemodynamics; benefits patient through non-invasive diagnostic imaging.
Clinical Evidence
Bench testing only. The submission relies on technical performance data, compliance with recognized safety standards (UL 2601-1, CSA C22.2 No. 601-1, EN 60601-1 series), and acoustic output measurements in accordance with AIUM/NEMA UD-2 and UD-3 standards. No clinical study data was required or provided for this 510(k) clearance.
Technological Characteristics
Multi-purpose ultrasound system; utilizes various transducers (e.g., 4C1, 5C2, 6C2, 8C4, 13L5SP, V5M TEE, AcuNav catheters); energy source: ultrasonic; connectivity: standard ultrasound imaging interfaces; software: proprietary analysis packages; safety standards: UL 2601-1, CSA C22.2 No. 601-1, EN 60601-1, ISO 10993 (biocompatibility); acoustic output follows ALARA principle.
Indications for Use
Indicated for ultrasound imaging or fluid flow analysis of the human body in fetal, abdominal, intraoperative, pediatric, small organ, neonatal/adult cephalic, cardiac, trans-esophageal, transrectal, transvaginal, peripheral vessel, and musculoskeletal applications. Includes measurement and analysis packages for clinical diagnosis.
Regulatory Classification
Identification
An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Predicate Devices
- ACUSON Sequoia™ Diagnostic Ultrasound System (K051139)
Reference Devices
Submission Summary (Full Text)
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KD524/D
Siemens Medical Solutions USA, Inc. Ultrasound Division
SEP 2 2 2005
ACUSON Sequoia™ Ultrasound System Special 510(k) Submission
### SECTION 11
## 510(k) Summary of Safety and Effectiveness
| Sponsor: | Siemens Medical Solutions USA, Inc., Ultrasound Division<br>1230 Shorebird Way<br>P.O. Box 7393<br>Mountain View, California 94039-7393 |
|------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Iskra Mraković<br>Manager, Regulatory Affairs<br>Telephone: (650) 694-5004<br>Fax: (650) 943-7053 |
| Submission Date: | September 1, 2005 |
| Device Name: | Sequoia Diagnostic Ultrasound System |
| Common Name: | Diagnostic Ultrasound System with Accessories |
Classification:
Regulatory Class: II Review Category: Tier II Classification Panel: Radiology
21 CFR 892.1550
| | FR # | Product Code |
|------------------------------------------|----------|--------------|
| Ultrasonic Pulsed Doppler Imaging System | 892.1550 | 90-IYN |
| Ultrasonic Pulsed Echo Imaging System | 892.1560 | 90-IYO |
| Diagnostic Ultrasound Transducer | 892.1570 | 90-ITX |
| Diagnostic Intravascular Catheter | 870.1200 | 90-DQO |
### Predicate Device:
- # K051139 (May 13, 2005) cleared as ACUSON Sequoia™ Diagnostic Ultrasound . System.
{1}------------------------------------------------
### Device Description:
The Sequoia system is a multi-purpose diagnostic ultrasound system with accessories and proprietary software, and is substantially equivalent to our current product that is already cleared for USA distribution under the following 510(k) PreMarket Notification number:
- # K051139 (May 13, 2005) cleared as ACUSON Sequoia™ Diagnostic Ultrasound . System.
The Sequoia Diagnostic Ultrasound System has been designed to conform to the following product safety standards:
- UL 2601-1, Safety Requirements for Medical Equipment .
- CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment .
- 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 Acoustic Output Indices on Diagnostic Ultrasound Equipment
- 93/42/EEC Medical Device Directive .
- Safety and EMC Requirements for Medical Equipment .
- . EN 60601-1
- · EN 60601-1-1
- EN 60601-1-2 .
- ISO 10993 Biocompatibility .
- The system's acoustic output is in accordance with ALARA principle (as low as . reasonably achievable)
### Intended Use:
The Sequoia platform is intended for use in the following applications:
General Imaging and Cardiology for Fetal, Abdominal, Intraoperative (abdominal and neurological), Pediatrics, Small Organs (breast, testes, thyroid, penis and prostate), Neonatal/Adult Cephalic, Cardiac (adult, pediatric, and neonatal), Trans-esophageal, Transrectal, Transvaginal, Peripheral Vessel, and Musculo-sceletal (superficial and conventional) applications, and intended uses as defined in the FDA guidance document.
The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
{2}------------------------------------------------
### Technological Comparison to Predicate Device:
The Sequoia is substantially equivalent in its technologies and functionality to the Sequoia Diagnostic Ultrasound System that is already cleared under 510(k) premarket notification number K051139.
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 twodimensional on-screen images of anatomic structures and fluid flow within the body. Doppler principles are used to process reflected ultrasound energy to display moving blood as a spectrum, or as color-coded two-dimensional images. All predicate devices listed above, allow for specialized measurements of structures and flow, and provide various calculations' functions.
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Image /page/3/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
SEP 2 2 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Iskra Mraković Manager, Regulatory Affairs Siemens Medical Solutions USA, Inc. 1230 Shorebird Way P.O. Box 7393 MOUNTAIN VIEW CA 94039-7393
Re: K052410
- Trade Name: Sequoia™ Ultrasound System Trade Name: Bequola Regulation Name: Ultrasonic pulsed doppler imaging system Ultrasound pulsed echo imaging system ·
Diagnostic ultrasonic transducer
- : Regulatory Class: II Product Code: IYN, IYO, and ITX
- Dated: September 1, 2005
- Received: September 2, 2005
Dear Mr. Mraković:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have forloned four boom determined the device is substantially equivalent (for the ications 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 merslate commerce proc to 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 the general controls provision, 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™ Ultrasound System, as described in your premarket notification:
#### Transducer Model Number
| 4C1 | EV8C4 |
|--------|--------|
| 5C2 | 6L3 |
| 6C2 | 8L5 |
| 8C4 | 8L5T |
| EC10c5 | 13L5SP |
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| 15L8 | 7V3c |
|---------|-----------------------------------|
| 15L8w | 8V3 |
| V5M TEE | 8V5 |
| V7M TEE | 10V4 |
| V7B TEE | AUX CW |
| 3V2c | AcuNav (IC10V5 or 10F) Ultrasound |
| 4V1 | Catheter |
| 4V1c | AcuNav 8F Ultrasound Catheter |
| 4V2 | Apollo |
| 5V2c | |
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 Orth 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 Dru
Center for Det
Document Ma
9200 Corpora
Rockville, Ma
.
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.
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### Page 2 - Mr. Mraković
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your ac-1100 on one one the regulation entitled, Colliact the Office of Comphalled at (21 ) = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = Misofanding by reference to premailions in the Act from the Division of Small other general information on your response Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 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 Rodrigo C. Perez at (301) 594-1212.
Sincerely yours,
Daniel Ch. Leyson
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
. . .
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## 510(k) Number (if known):
Device Name:
## Sequoia™ Ultrasound System
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Power (Amplitude) Doppler | Color Velocity Imaging | Combined (Specify) | Harmonic Imaging |
|------------------------------------|---|---|---|-----|-----|---------------|---------------------------|------------------------|--------------------|------------------|
| Ophthalmic | | | | | | | | | P* | P |
| Fetal | | P | P | P | P | P | P | | P* | P |
| Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative<br>Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative<br>Neurological | | P | P | P | P | P | P | | P* | P |
| Pediatric | | P | P | P | P | P | P | | P* | P |
| Small Organ<br>(specify)** | | P | P | P | P | P | P | | P* | P |
| Neonatal Cephalic | | P | P | P | P | P | P | | P* | P |
| Adult Cephalic | | P | P | P | P | P | P | | P* | P |
| Cardiac | | P | P | P | P | P | P | | P* | P |
| Trans-esophageal | | P | P | P | P | P | P | | P* | P |
| Transrectal | | P | P | P | P | P | P | | P* | P |
| Transvaginal | | P | P | P | P | P | P | | P* | P |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vessel | | P | P | P | P | P | P | | P* | P |
| Laparoscopic | | | | | | | | | P* | P |
| 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 #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)
David A. Leggett
(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number _
{7}------------------------------------------------
510(k) Number (if known):
Device Name:
#### 4C1
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | | | | P* | P |
| Fetal | | P | P | P | P | P | P | | P* | P |
| Abdominal | | P | P | P | P | P | P | | | |
| Intraoperative<br>Abdominal | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | P* | P |
| Pediatric | | P | P | P | P | P | P | | P* | P |
| Small Organ<br>(specify)** | | P | P | P | P | P | P | | P* | P |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | P* | P |
| Cardiac | | P | P | P | P | P | P | | P* | P |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vessel | | P | P | P | P | P | P | | P* | P |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>(Conventional) | | | | | | | | | | |
| Musculo-skeletal<br>(Superficial) | | | | | | | | | | |
Other (specify) Other (specify)
P=previously cleared by the FDA under premarket notifications #K051139, #K032114, #K022567, and #K002807.
### Additional Comments:
Additional Comments:
*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, D+Clarify D+Color Doppler, B+O++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)
(Division Sign-Off) /
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K052410
{8}------------------------------------------------
510(k) Number (if known):
5C2 Device Name:
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | | P | | P* | P |
| Fetal | | P | P | P | P | P | P | | P* | P |
| Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative<br>Abdominal | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | P | | P* | P |
| Pediatric | | P | P | P | P | P | P | | P* | P |
| Small Organ<br>(specify)** | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | P | P | P | P | P | P | | P* | P |
| Cardiac | | P | P | P | P | P | P | | P* | P |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | P | | P* | P |
| Peripheral Vessel | | P | P | P | P | P | P | | P* | P |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>(Conventional) | | | | | | | | | | |
| Musculo-skeletal<br>(Superficial) | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
Other (specify)
P=previously cleared by the FDA under premarket notifications #K051139, #K041319, #K032114, #K022567, #K002807, and #K973767.
### Additional Comments:
Additional Comments:
*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+Color Doppler, -Comomations merade. B+CWD+Color Doppler, B+Power Doppler, B+PWD+Color Doppler, B+CWD+Color 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)
Elaine K. Ingram
(Division Sign-C Division of Reproductive, Ab and Radiological Devices 510(k) Number
{9}------------------------------------------------
510(k) Number (if known):
6C2 Device Name:
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | P | P | | P* | P |
| Fetal | | P | P | P | P | P | P | | P* | P |
| Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative<br>Abdominal | | P | P | P | P | P | | | P* | P |
| Intraoperative<br>Neurological | | P | P | P | P | P | P | | P* | |
| Pediatric | | P | P | P | P | P | P | | P* | P |
| Small Organ<br>(specify)** | | P | P | P | P | P | P | | P* | P |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | P | | P* | P |
| Cardiac | | P | P | P | P | P | P | | P* | P |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vessel | | P | P | P | P | P | P | | P* | P |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>(Conventional) | | | | | | | | | | |
| Musculo-skeletal<br>(Superficial) | | | | | | | | | | |
Other (specity) Other (specity)
P-previously cleared by the FDA under premarket notifications #K051139, #K041319, #K032114, #K022567, and #K002807.
#### Additional Comments:
Additional Comments:
*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+Clarify Doppler, B+C+TB+Color Boppler, 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)
David R. Syverson
(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices 51()(k) Number _
{10}------------------------------------------------
510(k) Number (if known):
Device Name:
8C4
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | P | P | | P* | P |
| Fetal | | P | P | P | P | P | P | | P* | P |
| Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative<br>Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative<br>Neurological | | P | P | P | P | P | P | | P* | P |
| Pediatric | | P | P | P | P | P | P | | P* | P |
| Small Organ<br>(specify)** | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | P* | P |
| Cardiac | | P | P | P | P | P | P | | P* | P |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | P* | P |
| Peripheral Vessel | | P | P | P | P | P | P | | P* | P |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>(Conventional) | | | | | | | | | | |
| Musculo-skeletal<br>(Superficial) | | | | | | | | | | |
| Other (concify) | | | | | | | | | | |
Other (specify) Other (specify)
P=previously cleared by the FDA under premarket notifications #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+Clarify 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)
Daniel R. Hageman
(Division Sign-Off Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number __
{11}------------------------------------------------
510(k) Number (if known):
Device Name:
EC10c5
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative<br>Abdominal | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(specify) ** | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | P | | | P* | P |
| Transrectal | | P | P | P | P | P | P | | P* | P |
| Transvaginal | | P | P | P | P | P | | | P* | P |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>(Conventional) | | | | | | | | | | |
| Musculo-skeletal<br>(Superficial) | | | | | | | | | | |
| Other (concify) | | | | | | | | | | |
Other (specify) Other (specity)
P=previously cleared by the FDA under premarket notifications #K051139, #K041319, #K032114, #K022567, and #K002807.
#### Additional Comments:
Additional Comments:
*Combinations include: B+M, B+PWD, B+CWD, B+CWD, B+Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+PWD+Color Doppier, B+C++D+Color Doppion D++ 0++ 0++ 0++ 0++ 0++ 0+Clarify YE_
(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Leyson
(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices 510(k) Number
{12}------------------------------------------------
510(k) Number (if known):
EV8C4 Device Name:
Intended Use:
:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | | P | | P* | P |
| 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 | | | | | | | | | 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) | | | | | | | | | | |
Other (specify)
P=previously cleared by the FDA under premarket notifications #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+Clarify D+Color Doppler, B+C++B+Coller, 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)
Daniel M. Layson
(Division S Division of Reproductive, Abd and Radiological Devic 510(k) Number
{13}------------------------------------------------
## 510(k) Number (if known):
61.3 Device Name:
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | | P | | P* | P |
| Fetal | | P | P | P | P | P | P | | P* | P |
| Abdominal | | | | | | | 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 |
| Small Organ<br>(specify) ** | | P | P | P | P | P | P | | P* | P |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | P* | P |
| Cardiac | | P | P | P | P | P | P | | P* | P |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | P* | P |
| Peripheral Vessel | | P | P | P | P | P | P | | P* | P |
| Laparoscopic | | | | | | | P | | P* | P |
| Musculo-skeletal<br>(Conventional) | | P | P | P | P | P | P | | P* | P |
| Musculo-skeletal<br>(Superficial) | | P | P | P | P | P | P | | P* | P |
| Other (specify) | | | | | | | | | | |
Other (specity)
P=previously cleared by the FDA under premarket notifications #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, D+F WD+Color Doppler, B+C++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)
Elnid G. Hanson
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K052440
{14}------------------------------------------------
510(k) Number (if known):
81.5 Device Name:
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | 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 |
| Small Organ<br>(specify)** | | P | P | P | P | P | P | | P* | P |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | P* | P |
| Cardiac | | P | P | P | P | P | P | | P* | P |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vessel | | P | P | P | P | P | P | | P* | P |
| Laparoscopic | | | | | | | | | P* | P |
| Musculo-skeletal<br>(Conventional) | | P | P | P | P | P | P | | P* | P |
| Musculo-skeletal<br>(Superficial) | | P | P | P | P | P | P | | P* | P |
| Other (specify) | | | | | | | | | | |
Other (specity)
P-previously cleared by the FDA under premarket notifications #K051139, #K032114, #K022567, #K002807, and #K973767.
#### Additional Comments:
*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, Collibiliations moppler, B+CWD+Color Doppler, B+Power Doppler, B+PWD+Color Doppler, B+C++B+Color Doppler, B+CWD+Power Doppler, B+Clarify VE
** small organs (breast, testes, thyroid, penis)
(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANGTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Ingram
(Division Sign-Off) Division of Reproductive, Abd and Radiological Devices 510(k) Number _
{15}------------------------------------------------
## 510(k) Number (if known):
8L5T Device Name:
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | P | | | P* | P | |
| Intraoperative<br>Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative<br>Neurological | | P | P | P | P | P | P | | P* | P |
| Pediatric | | P | P | P | P | P | P | | P* | P |
| Small Organ<br>(specify)** | | P | P | P | P | P | P | | P* | P |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | P* | P |
| Cardiac | | P | P | P | P | P | P | | P* | P |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | P* | P |
| Peripheral Vessel | | P | P | P | P | P | P | | P* | P |
| Laparoscopic | | | | | | | | | p* | P |
| Musculo-skeletal<br>(Conventional) | | P | P | P | P | P | P | | P* | P |
| Musculo-skeletal<br>(Superficial) | | P | P | P | P | P | P | | P* | P |
| Other (specify) | | | | | | | | | | |
Other (specify)
P=previously cleared by the FDA under premarket notifications #K051139, #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, D+F WD+Color Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE
** small organs (breast, testes, thyroid, penis)
(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) _
David A. Ingram
(Division Sign-Off Division of Reproductive, A and Radiological Devices 510(k) Number
{16}------------------------------------------------
510(k) Number (if known):
13L5SP Device Name:
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | P | P | | P* | P |
| Intraoperative<br>Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative<br>Neurological | | P | P | P | P | P | P | | P* | P |
| Pediatric | | P | P | P | P | P | P | | P* | P |
| Small Organ<br>(specify)** | | P | P | P | P | P | P | | P* | P |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | P | | P* | P |
| Cardiac | | P | P | P | P | P | P | | P* | P |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | P* | P |
| Peripheral Vessel | | P | P | P | P | P | P | | P* | P |
| Laparoscopic | | P | P | P | P | P | P | | P* | P |
| Musculo-skeletal<br>(Conventional) | | P | P | P | P | P | P | | P* | P |
| Musculo-skeletal<br>(Superficial) | | P | P | P | P | P | P | | P* | P |
| Other (specify) | | | | | | | | | | |
Other (specify)
P=previously cleared by the FDA under premarket notifications #K051139, #K032114, and #K022567.
#### Additional Comments:
*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, Comfomation Doppler, B+CWD+Color Doppler, B+Power Doppler, B+PWD+Color Doppler, B+CWD+Color 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) WRITE BEDOW THISE of Device Evaluation (ODE) _
David A. Ingram
(Division Sign-Off) Division of Reproductive, A and Radiological Devices 510(k) Number
{17}------------------------------------------------
## 510(k) Number (if known):
1518 Device Name:
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging | |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|---|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | P | | 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 | | | | | | | | | | p* | P |
| Cardiac | | P | P | P | P | P | P | | | p* | P |
| Trans-esophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | p* | P |
| Peripheral Vessel | | P | P | P | P | P | P | | | p* | P |
| Laparoscopic | | | | | | | | | | p* | P |
| Musculo-skeletal<br>(Conventional) | | P | P | P | P | P | P | | | p* | P |
| Musculo-skeletal<br>(Superficial) | | P | P | P | P | P | P | | | p* | P |
| Other (specify) | | | | | | | | | | | |
Other (specify)
P=previously cleared by the FDA under premarket notifications #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+Clarify Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE
** small organs (breast, testes, thyroid, penis)
(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Severson
(Division Sign-Off) Division of Reproductive, Abdomit and Radiological Devices 510(k) Number
{18}------------------------------------------------
15L8w
### 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 | | | | | | | | | P* | P |
| Fetal | | P | P | P | P | P | P | | P* | P |
| Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative<br>Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative<br>Neurological | | P | P | P | P | P | P | | P* | P |
| Pediatric | | P | P | P | P | P | P | | P* | P |
| Small Organ<br>(specify)** | | P | P | P | P | P | P | | P* | P |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | P* | P |
| Cardiac | | P | P | P | P | P | P | | P* | P |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | P* | P |
| Peripheral Vessel | | P | P | P | P | P | P | | P* | P |
| Laparoscopic | | P | P | P | P | P | P | | P* | P |
| Musculo-skeletal<br>(Conventional) | | P | P | P | P | P | P | | P* | P |
| Musculo-skeletal<br>(Superficial) | | P | P | P | P | P | P | | P* | P |
| Other (specify) | | | | | | | | | | |
Other (specity)
P=previously cleared by the FDA under premarket notifications #K051139, #K032114, #K022567, #K002807, and #K973767.
#### Additional Comments:
*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, Comomations Doppler, B+CWD+Color Doppler, B+Power Doppler, B+Clarify D+Color Doppler, B+CWD+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)
David h. Seyerson
(Division Sign-Off) Division of Reproductive, At ano Radiological Devices 510(k) Number -
{19}------------------------------------------------
510(k) Number (if known):
Device Name:
V5M TEE
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | P | | P* | P |
| Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative<br>Abdominal | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | P | | P* | P |
| Pediatric | | P | P | P | P | P | P | | P* | P |
| Small Organ<br>(specify)** | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | 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 | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | |…
