Predicate Devices

Reference Devices

K051139, K032114, K022567, K002807, K992631, K992580, K973767, K935595, K041319, K052021, K033196, K042593

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other indication of AI/ML use.

Therapeutic

No

The device is described as a "diagnostic ultrasound system," and its intended use is for "imaging" and "measurement of anatomical structures" to provide information for "clinical diagnosis purposes." It is not described as being used for treating a disease or condition.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" section states that the system provides "analysis packages that provide information that is used for clinical diagnosis purposes." Additionally, the "Device Description" explicitly calls it a "multi-purpose diagnostic ultrasound system."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "multi-purpose diagnostic ultrasound system with accessories and proprietary software," indicating it includes hardware components in addition to software.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVDs are used to examine specimens from the human body. The provided text clearly states that the Sequoia ultrasound system is used for "Ultrasound imaging or fluid flow analysis of the human body" and for "measurement of anatomical structures." This involves imaging the body directly, not analyzing samples taken from the body.
The intended use and device description focus on imaging and analysis within the body. The applications listed (Fetal, Abdominal, Cardiac, etc.) are all related to visualizing and assessing structures and processes within the living patient.

Therefore, based on the provided information, the Siemens Acuson Sequoia ultrasound imaging system is a diagnostic imaging device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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, 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.

Ultrasound imaging or fluid flow analysis of the human body as follows:

For ACUSON Sequoia™ Ultrasound System:
Clinical Application: Fetal, Abdominal, Intraoperative Abdominal, Intraoperative Neurological, Pediatric, Small Organ (breast, testes, thyroid, penis), Neonatal Cephalic, Adult Cephalic, Cardiac, Trans-esophageal, Transrectal, Transvaginal, Peripheral Vessel, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Other (neonatal cardiac).

For Transducer Model Number 4C1:
Clinical Application: Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid, penis), Cardiac, Peripheral Vessel.

For Transducer Model Number 5C2:
Clinical Application: Fetal, Abdominal, Pediatric, Cardiac, Peripheral Vessel.

For Transducer Model Number 6C2:
Clinical Application: Fetal, Abdominal, Intraoperative Abdominal, Intraoperative Neurological, Pediatric, Small Organ (breast, testes, thyroid, penis), Cardiac, Peripheral Vessel.

For Transducer Model Number 8C4:
Clinical Application: Fetal, Abdominal, Intraoperative Abdominal, Intraoperative Neurological, Pediatric, Cardiac, Peripheral Vessel.

For Transducer Model Number EC10c5:
Clinical Application: Transrectal, Transvaginal.

For Transducer Model Number EV8C4:
Clinical Application: Fetal, Abdominal, Transvaginal.

For Transducer Model Number 6L3:
Clinical Application: Fetal, Intraoperative Abdominal, Intraoperative Neurological, Small Organ (breast, testes, thyroid, penis), Cardiac, Peripheral Vessel, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial).

For Transducer Model Number 8L5:
Clinical Application: Intraoperative Abdominal, Intraoperative Neurological, Small Organ (breast, testes, thyroid, penis), Cardiac, Peripheral Vessel, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial).

For Transducer Model Number 8L5T:
Clinical Application: Intraoperative Abdominal, Intraoperative Neurological, Pediatric, Small Organ (breast, testes, thyroid, penis), Cardiac, Peripheral Vessel, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial).

For Transducer Model Number 9L4:
New Indication for: Fetal, Intraoperative Abdominal, Intraoperative Neurological, Pediatric, Small Organ (breast, testes, thyroid, penis), Peripheral Vessel, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial).

For Transducer Model Number 13L5SP:
Clinical Application: Intraoperative Abdominal, Intraoperative Neurological, Pediatric, Small Organ (breast, testes, thyroid, penis), Cardiac, Peripheral Vessel, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial).

For Transducer Model Number 15L8:
Clinical Application: Intraoperative Abdominal, Intraoperative Neurological, Pediatric, Small Organ (breast, testes, thyroid, penis), Cardiac, Peripheral Vessel, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial).

For Transducer Model Number 15L8w:
Clinical Application: Fetal, Abdominal, Intraoperative Abdominal, Intraoperative Neurological, Pediatric, Small Organ (breast, testes, thyroid, penis), Cardiac, Peripheral Vessel, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial).

For Transducer Model Number 17L5:
New Indication for: Fetal, Abdominal, Intraoperative Abdominal, Intraoperative Neurological, Pediatric, Small Organ (breast, testes, thyroid, penis), Peripheral Vessel, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial).

For Transducer Model Number V5M TEE:
Clinical Application: Abdominal, Pediatric, Cardiac, Trans-esophageal.

For Transducer Model Number V7M TEE:
Clinical Application: Abdominal, Pediatric, Cardiac, Trans-esophageal.

For Transducer Model Number V7B TEE:
Clinical Application: Abdominal, Pediatric, Cardiac, Trans-esophageal.

For Transducer Model Number 3V2c:
Clinical Application: Fetal, Abdominal, Pediatric, Adult Cephalic, Cardiac, Other (neonatal cardiac).

For Transducer Model Number 4V1:
Clinical Application: Fetal, Abdominal, Intraoperative Abdominal, Pediatric, Adult Cephalic (new indication), Cardiac, Peripheral Vessel.

For Transducer Model Number 4V1c:
Clinical Application: Fetal, Abdominal, Intraoperative Abdominal, Intraoperative Neurological, Pediatric, Adult Cephalic, Cardiac, Peripheral Vessel, Other (neonatal cardiac).

For Transducer Model Number 4V2:
Clinical Application: Fetal, Abdominal, Pediatric.

For Transducer Model Number 5V2c:
Clinical Application: Fetal, Abdominal, Pediatric, Cardiac, Peripheral Vessel, Other (neonatal cardiac).

For Transducer Model Number 7V3c:
Clinical Application: Fetal, Abdominal, Intraoperative Abdominal, Intraoperative Neurological, Pediatric, Neonatal Cephalic, Cardiac, Peripheral Vessel, Other (neonatal cardiac).

For Transducer Model Number 8V3:
Clinical Application: Fetal, Abdominal, Intraoperative Abdominal, Intraoperative Neurological, Pediatric, Neonatal Cephalic, Cardiac, Peripheral Vessel, Other (neonatal cardiac).

For Transducer Model Number 8V5:
Clinical Application: Fetal, Abdominal, Intraoperative Abdominal, Intraoperative Neurological, Pediatric, Neonatal Cephalic, Cardiac, Peripheral Vessel, Other (neonatal cardiac).

For Transducer Model Number 10V4:
Clinical Application: Fetal, Abdominal, Intraoperative Abdominal, Intraoperative Neurological, Pediatric, Small Organ (breast, testes, thyroid, penis), Neonatal Cephalic, Cardiac, Other (neonatal cardiac).

For Transducer Model Number AUX CW:
Clinical Application: Pediatric, Cardiac, Peripheral Vessel.

For Transducer: AcuNav (IC10V5 or 10F) Ultrasound Catheter and AcuNav 8F Ultrasound Catheter:
The AcuNav™ Ultrasound Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart.
Clinical Application: Cardiac, Intra-luminal, Other (Intra-Cardiac).

Product codes (comma separated list FDA assigned to the subject device)

90-IYN, 90-IYO, 90-ITX, 74-DOO

Device Description

The Siemens Acuson Sequoia is a multi-purpose diagnostic ultrasound system with accessories and proprietary software, designed to meet safety standards UL 2601-1, IEC 60601-2-37, CSA C22.2 No. 601-1, AIUM/NEMA UD-3 (1998), AIUM/NEMA UD-2 (1998), 93/42/EEC Medical Devices Directive (EN/IEC 60601-1, EN/IEC 60601-1-1, EN/IEC 60601-1-2), IEC 1157, and ISO 10993-1.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal, Abdominal, Cardiac, Intraoperative (abdominal and neurological), Pediatric, Small Organs (breast, testes, thyroid, penis), Neonatal/Adult Cephalic, Transesophageal, Transrectal, Transvaginal, Peripheral Vessels, Musculoskeletal (superficial and conventional), Intra-cardiac, Intra-luminal.

Indicated Patient Age Range

Adult, Pediatric, Neonatal, Fetal.

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The Sequoia modifications are verified and validated according to the company's design control process.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K052410

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K051139, K032114, K022567, K002807, K992631, K992580, K973767, K935595, K041319, K052021, K033196, K042593

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Summary

0

K063085

ACUSON Sequoia™ Ultrasound System
Special 510(k) Submission

SECTION 11

510(k) Summary

| Sponsor: | Siemens Medical Solutions USA, Inc.,
Ultrasound Division
1230 Shorebird Way
P.O. Box 7393
Mountain View, California 94039-7393 | | | | NOV 14 2006 |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--|--|---------------------|-------------|
| Contact Person: | Sheila W. Pickering
Telephone: (650) 943 7187
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

.

1

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.

2

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:

3

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)

5

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 _

6

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
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Harmonic
Imaging |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | | P* | P |
| Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative
Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative
Neurological | | P | P | P | P | P | P | | P* | P |
| Pediatric | | P | P | P | P | P | P | | P* | P |
| Small Organ
(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
(Conventional) | | P | P | P | P | P | P | | P* | P |
| Musculo-skeletal
(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
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Harmonic
Imaging |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | | P* | P |
| Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative
Abdominal | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | P* | P |
| Small Organ
(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
(Conventional) | | | | | | | | | | |
| Musculo-skeletal
(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:

Prescription Use (Pen21 CFR 801.109) ancil (Division Sign-Offy Division of Reproductive, Abdomina and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

21

510(k) Number (if known):

Koba085

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
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Harmonic
Imaging |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative
Abdominal | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | P* | P |
| Small Organ
(specify)** | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | P | P | P | P | P | P | | P* | P |
| Trans-esophageal | | P | P | P | P | P | P | | P* | P |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | | | | | | | | | | |
| Musculo-skeletal
(Superficial) | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

P=previously cleared by the FDA under premarket notifications #K052410, #K052021, #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

(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. Hogdon
Division Sign-Off)

Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K063085

Diagnostic Ultrasound Indications for Use Form

Pg. 6.17 of 6.31

22

510(k) Number (if known):

Device Name:

Kob3085

V7M TEE

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 | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative
Abdominal | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | P* | P |
| Small Organ
(specify)** | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | P | P | P | P | P | P | | P* | P |
| Trans-esophageal | | P | P | P | P | P | P | | P* | P |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | | | | | | | | | | |
| Musculo-skeletal
(Superficial) | | | | | | | | | | |
| 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

(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)

Signature

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices

510(k) Number	K063085
---------------	---------

23

510(k) Number (if known):

Device Name:

V7B TEE

KO63085

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 | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative
Abdominal | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | P* | P |
| Small Organ
(specify)** | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | P | P | P | P | P | P | | P* | P |
| Trans-esophageal | | P | P | P | P | P | P | | P* | P |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | | | | | | | | | | |
| Musculo-skeletal
(Superficial) | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

P=previously cleared by the FDA under premarket notifications #K052410, #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, 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. Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number	K063085

24

510(k) Number (if known):

Device Name:

KO63085 3V2c

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 | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | | P* | P |
| Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative
Abdominal | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | P* | P |
| Small Organ
(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 | | | | | | | | | | |
| Peripheral Vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | | | | | | | | | | |
| Musculo-skeletal
(Superficial) | | | | | | | | | | |
| Other (specify)*** | | P | P | P | P | P | P | | P* | P |

P=previously cleared by the FDA under premarket notifications #K052410, #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, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE

***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 C. Hargdon

(Division Sign-Off) Division of Reproductive, Abdr and Radiological Devices

Section 6

Pg. 6.20 of 6.31

25

510(k) Number (if known):

Device Name:

KOB3085

4V1

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 | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | | P* | P |
| Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative
Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | P* | P |
| Small Organ
(specify)** | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | N | N | N | N | N | N | | N* | N |
| 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
(Conventional) | | | | | | | | | | |
| Musculo-skeletal
(Superficial) | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

P=previously cleared by the FDA under premarket notifications #K052410, #K051139, #K041319, #K032114, and #K022567.

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

(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. Roedon

(Division Sign-Off) Division of Reproductive, Ab and Radiological Device 510(k) Number ________________________________________________________________________________________________________________________________________________________________

Diagnostic Ultrasound Indications for Use Form

Pg. 6.21 of 6.31

Section 6

26

510(k) Number (if known):

Device Name:

Kobao85 4V1c

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 | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | | P* | P |
| Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative
Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative
Neurological | | P | P | P | P | P | P | | P* | P |
| Pediatric | | P | P | P | P | P | P | | P* | P |
| Small Organ
(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 | | | | | | | | | | |
| Peripheral Vessel | | P | P | P | P | P | P | | P* | P |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | | | | | | | | | | |
| Musculo-skeletal
(Superficial) | | | | | | | | | | |
| Other (specify)*** | | P | P | P | P | P | P | | P* | P |

P=previously cleared by the FDA under premarket notifications #K052410, #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, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE ***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 C. Brygdon
(Division Sign-Off)

Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K063085

27

K063085

4V2

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
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Harmonic
Imaging |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | | P* | P |
| Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative
Abdominal | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | P* | P |
| Small Organ
(specify)** | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | | | | | | | | | | |
| Musculo-skeletal
(Superficial) | | | | | | | | | | |
| 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

(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. Houghton
Division Sign-Off/

(Division Sign-Off) Division of Reproductive, Abdor and Radiological Devices 510(k) Number .......

28

510(k) Number (if known):

Device Name:

KO63085 5V2c

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 | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | | P* | P |
| Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative
Abdominal | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | P* | P |
| Small Organ
(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
(Conventional) | | | | | | | | | | |
| Musculo-skelctal
(Superficial) | | | | | | | | | | |
| Other (specify)*** | | P | P | P | P | P | P | | P* | P |

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

***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 Brogdon

(Division Sign-Off Division of Reproducti va Ah and Radiological Devices Distriction of Armsonna Indications fo

Section 6

Pg. 6.24 of 6.31

29

510(k) Number (if known):

Device Name:

12063085

Device Name:

7V3c

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
Abdominal | | P | P | P | P | P | P | | p* | P | |
| Intraoperative
Neurological | | P | P | P | P | P | P | | p* | P | |
| Pediatric | | P | P | P | P | P | P | | p* | P | |
| Small Organ
(specify)** | | | | | | | | | | | |
| Neonatal Cephalic | | P | P | P | P | P | P | | p* | P | |
| 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
(Conventional) | | | | | | | | | | | |
| Musculo-skeletal
(Superficial) | | | | | | | | | | | |
| Other (specify) *** | | P | P | P | P | P | P | | p* | P | |

P P | P --Outer (Specify)
P-previously cleared by the FDA under premarket notifications #K052410, #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

***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 C. Brogdon

(Division Sign-Off) Division of Reproductive, Abdo and Radiological Device 510(k) Number ................................................................................................................................................................

Diagnostic Ultrasound Indications for Use Form

Pg. 6.25 of 6.31

30

510(k) Number (if known):

Device Name:

Kob3085 8V3

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 | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | | P* | P |
| Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative
Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative
Neurological | | P | P | P | P | P | P | | P* | P |
| Pediatric | | P | P | P | P | P | P | | P* | P |
| Small Organ
(specify)** | | | | | | | | | | |
| Neonatal Cephalic | | P | P | P | P | P | P | | P* | P |
| 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
(Conventional) | | | | | | | | | | |
| Musculo-skeletal
(Superficial) | | | | | | | | | | |
| Other (specify)*** | | P | P | P | P | P | P | | P* | P |

P=previously cleared by the FDA under premarket notifications #K052410, #K051139, #K041319, and #K032114.

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

***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 C Brogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K063085

Diagnostic Ultrasound Indications for Use Form

Pg. 6.26 of 6.31

31

510(k) Number (if known):

Device Name:

Kob3085

evice Name:

8V5

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 | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | | P* | P |
| Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative
Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative
Neurological | | P | P | P | P | P | P | | P* | P |
| Pediatric | | P | P | P | P | P | P | | P* | P |
| Small Organ
(specify)** | | | | | | | | | | |
| Neonatal Cephalic | | P | P | P | P | P | P | | P* | P |
| 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
(Conventional) | | | | | | | | | | |
| Musculo-skeletal
(Superficial) | | | | | | | | | | |
| Other (specify)*** | | P | P | P | P | P | P | | P* | P |

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

***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)

Yancyi Bogdon
(Division Sign-Off)

Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K063085

32

510(k) Number (if known):

Device Name:

Kop3085 10V4

Name:

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 | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | | P* | P |
| Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative
Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative
Neurological | | P | P | P | P | P | P | | P* | P |
| Pediatric | | P | P | P | P | P | P | | P* | P |
| Small Organ
(specify)** | | P | P | P | P | P | P | | P* | P |
| Neonatal Cephalic | | P | P | P | P | P | P | | P* | P |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | P | P | P | P | P | P | | P* | P |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | | | | | | | | | | |
| Musculo-skeletal
(Superficial) | | | | | | | | | | |
| Other (specify)*** | | P | P | P | P | P | P | | P* | P |

P=previously cleared by the FDA under premarket noufications #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) _____________________________________________________________________________________________________________________________ ***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 C. Brogdon
(Division Sign-Off)

Division of Reproductive, Abdominal and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

33

510(k) Number (if known):

Device Name:

Kobao85

AUX CW

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 | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative
Abdominal | | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | | |
| Pediatric | | | | | P | | | | | | |
| Small Organ
(specify)** | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | P | | | | | | |
| Trans-esophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vessel | | | | | P | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | | | | | | | | | | | |
| Musculo-skeletal
(Superficial) | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |

P=previously cleared by the FDA under premarket notifications #K052410, #K051139, #K032114, #K022567, #K002807, and #K973767.

Additional Comments:

(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, Abo and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

34

510(k) Number (if known):

Device Name:

Transducer:

K063085

Sequoia Ultrasound System

AcuNav (IC10V5 or 10F) Ultrasound Catheter

Indications for Use:

The AcuNav™ Ultrasound Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart.

| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Harmonic
Imaging |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative
Abdominal | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ
(specify)** | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | P | P | P | P | P | P | | P* | P |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intra-luminal | | P | P | P | P | P | P | | P* | P |
| Peripheral Vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | | | | | | | | | | |
| Musculo-skeletal
(Superficial) | | | | | | | | | | |
| Other (Intra-Cardiac) | | P | P | P | P | P | P | | P* | P |

P=previously cleared by the FDA under premarket notifications #K052410, #K051139, #K033196, and #K992631.

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 Brogdon

(Division Sign-Off)

Division of Reproductive, Abdominal,
and Radiological Devices

510(k) Number K063085

35

510(k) Number (if known):

K063085

Device Name:

Transducer:

Sequoia Ultrasound System

AcuNav 8F Ultrasound Catheter

Indications for Use:

The AcuNav™ Ultrasound Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart.

| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Harmonic
Imaging |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative
Abdominal | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ
(specify)** | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | P | P | P | P | P | P | | P* | P |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intra-lumina! | | P | P | P | P | P | P | | P* | P |
| Peripheral Vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skelctai
(Conventional) | | | | | | | | | | |
| Musculo-skeletal
(Superficial) | | | | | | | | | | |
| Other (Intra-Cardiac) | | P | P | P | P | P | P | | P* | P |

P=previously cleared by the FDA under premarket notifications #K052410, #K051139, and #K042593.

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 Brogdon
(Division Sign-Off)

Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number: K063085

Diagnostic Ultrasound Indications for Use Form

Pg. 6.31 of 6.31