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: 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), Neonatal Cardiac, Intra-luminal, Intra-Cardiac.

Device Description

The Siemens Acuson Sequoia is a multi-purpose diagnostic ultrasound system with accessories and proprietary software.

AI/ML Overview

The provided document is a 510(k) Pre-market Notification for the Siemens ACUSON Sequoia Ultrasound System. It details intended uses and lists various transducers with their cleared applications. However, it does not contain information about specific acceptance criteria or a study proving device performance against those criteria.

The document states in Section E, "Performance Data": "The Sequoia modifications are verified and validated according to the company's design control process." This is a general statement and does not provide details of a study to demonstrate acceptance criteria. The clearance in this 510(k) is based on substantial equivalence to a predicate device (Siemens Acuson Sequoia ultrasound system (K052410)), not on new performance data demonstrating meeting specific acceptance criteria for a novel functionality.

Therefore, many of the requested items cannot be answered from the provided text.

Here's a summary of what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

Not provided in the document. The submission is based on substantial equivalence to a predicate device, not on meeting new quantitative performance criteria described in this document.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable/Not mentioned. No specific test set or data provenance for proving performance against acceptance criteria is described. The document indicates that prior applications for existing transducers were "previously cleared by the FDA under premarket notifications" (e.g., #K052410, #K051139, etc.), implying their performance was established in those earlier submissions.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable/Not mentioned.

4. Adjudication Method for the Test Set

Not applicable/Not mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable/Not mentioned. The submission is for an ultrasound system and transducers, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

Not applicable/Not mentioned.

7. Type of Ground Truth Used

Not applicable/Not mentioned. The document relies on "previously cleared" indications for use from predicate devices.

8. Sample Size for the Training Set

Not applicable/Not mentioned.

9. How the Ground Truth for the Training Set Was Established

Not applicable/Not mentioned.

Additional Information from the Document:

Acceptance Criteria (General): The device (and its modifications) are verified and validated according to the company's design control process. This implies internal acceptance criteria for design validation, but the specifics are not disclosed in this summary.
Proof of Meeting Acceptance Criteria: The submission relies on "substantial equivalence" to a predicate device (Siemens Acuson Sequoia ultrasound system (K052410)) for its intended uses and technological characteristics. The performance of individual transducers for specific clinical applications (e.g., Fetal, Abdominal, Cardiac) is indicated by "P=previously cleared by the FDA under premarket notifications" or "N=New Indication" for specific modes (B, M, PWD, CWD, Color Doppler, Power Doppler, Harmonic Imaging). This means the performance for these indications was established in earlier 510(k) submissions, not in this current one.

In essence, this 510(k) is a "Special 510(k)" submission, which is typically used for modifications to a manufacturer's own legally marketed device. The focus is on demonstrating that the changes do not affect the safety and effectiveness of the device as cleared in the predicate, rather than generating new performance data against specific, public-facing acceptance criteria for a novel technology.

Summary

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K063085

ACUSON Sequoia™ Ultrasound System
Special 510(k) Submission

SECTION 11

510(k) Summary

Sponsor:	Siemens Medical Solutions USA, Inc.,Ultrasound Division1230 Shorebird WayP.O. Box 7393Mountain View, California 94039-7393
Contact Person:	Sheila W. PickeringTelephone: (650) 943 7187Fax: (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:

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	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Combined(Specify)	HarmonicImaging
Ophthalmic
Fetal	P	P	P	P	P	P	P*	P
Abdominal	P	P	P	P	P	P	P*	P
IntraoperativeAbdominal	P	P	P	P	P	P	P*	P
IntraoperativeNeurological	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:

(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	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Combined(Specify)	HarmonicImaging
Ophthalmic
Fetal	P	P	P	P	P	P	P*	P
Abdominal	P	P	P	P	P	P	P*	P
IntraoperativeAbdominal
IntraoperativeNeurological
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:

**small organs (breast, testes, thyroid, penis)

(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Nancycbrayton

(Division Sign-Off) Division of Reproductive, A and Radiological Devices 510(k) Number _

{8}------------------------------------------------

510(k) Number (if known):

Device Name:

<063085 5C2

Intended Use:

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

Clinical Application	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Combined(Specify)	HarmonicImaging
Ophthalmic
Fetal	P	P	P	P	P	P	P*	P
Abdominal	P	P	P	P	P	P	P*	P
IntraoperativeAbdominal
IntraoperativeNeurological
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-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 C

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
2063025

510(k) Number

{9}------------------------------------------------

6C2

14063085 510(k) Number (if known):

Device Name:

Intended Use:

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

Clinical Application	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Combined(Specify)	HarmonicImaging
Ophthalmic
Fetal	P	P	P	P	P	P	P*	P
Abdominal	P	P	P	P	P	P	P*	P
IntraoperativeAbdominal	P	P	P	P	P	P	P*	P
IntraoperativeNeurological	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
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, #K()22567, and #K002807.

Additional Comments:

** small organs (breast, testes, thyroid, penis)

(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Nancy C. Bridon

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

{10}------------------------------------------------

510(k) Number (if known):

Device Name:

8C4

KO63085

Intended Use:

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

Clinical Application	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Combined(Specify)	HarmonicImaging
Ophthalmic
Fetal	P	P	P	P	P	P	P*	P
Abdominal	P	P	P	P	P	P	P*	P
IntraoperativeAbdominal	P	P	P	P	P	P	P*	P
IntraoperativeNeurological	P	P	P	P	P	P	P*	P
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-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 C Brogdo
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K063085

{11}------------------------------------------------

Kob3085

510(k) Number (if known):

EC10c5

Intended Use:

Device Name:

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

Clinical Application	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Combined(Specify)	HarmonicImaging
Ophthalmic
Fetal
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric
Small Organ(specify)**
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal	P	P	P	P	P	P	P*	P
Transvaginal	P	P	P	P	P	P	P*	P
Transurethral
Intravascular
Peripheral Vessel
Laparoscopic
Musculo-skeletal(Conventional)
Musculo-skeletal(Superficial)
Other (specify)

P=previously cleared by the FDA under premarket notifications #K052410, #K051139, #K041319, #K032114, #K022567, and #K002807.

Additional Comments:

(PLESE DO NOT WRITE BELOW THIS LINF-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Nancy Shoydon

(Division Sign-Division of Reproductive, Ab and Radiological Devices 510(k) Number _

{12}------------------------------------------------

510(k) Number (if known):

Device Name:

12063085

Device Name.

EV8C4

Intended Use:

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

Clinical Application	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Combined(Specify)	HarmonicImaging
Ophthalmic
Fetal	P	P	P	P	P	P	P*	P
Abdominal	P	P	P	P	P	P	P*	P
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric
Small Organ(specify)**
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal	P	P	P	P	P	P	P*	P
Transurethral
Intravascular
Peripheral Vessel
Laparoscopic
Musculo-skeletal(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 Chogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices

and Radiological Devices 510(k) Number

{13}------------------------------------------------

K063085

6L3

510(k) Number (if known):

Device Name:

Intended Use:

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

Clinical Application	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Combined(Specify)	HarmonicImaging
Ophthalmic
Fetal	P	P	P	P	P	P	P*	P
Abdominal
IntraoperativeAbdominal	P	P	P	P	P	P	P*	P
IntraoperativeNeurological	P	P	P	P	P	P	P*	P
Pediatric
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)	P	P	P	P	P	P	P*	P
Musculo-skeletal(Superficial)	P	P	P	P	P	P	P*	P
Other (specify)

P=previously cleared by the FDA under premarket notifications #K052410, #K051139, #K041319, #K032114, #K022567, #K002807, and #K973767.

Additional Comments:

**small organs (breast, testes, thyroid, penis)

(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Nancy Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal

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

{14}------------------------------------------------

510(k) Number (if known):

Device Name:

063085 81 5

Intended Use:

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

Clinical Application	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Combined(Specify)	HarmonicImaging
Ophthalmic
Fetal
Abdominal
IntraoperativeAbdominal	P	P	P	P	P	P	P*	P
IntraoperativeNeurological	P	P	P	P	P	P	P*	P
Pediatric
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)	P	P	P	P	P	P	P*	P
Musculo-skeletal(Superficial)	P	P	P	P	P	P	P*	P
Other (specify)

P=previously cleared by the FDA under premarket notifications #K052410, #K051139, #K041319, #K032114, #K022567, #K002807, and #K973767.

Additional Comments:

**small organs (breast, testes, thyroid, penis)

(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Nancy Brogdon

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

510(k) Number N063085

{15}------------------------------------------------

510(k) Number (if known):

Device Name:

Intended Use:

Kob3085 81.57.

Device Name.

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

Clinical Application	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Combined(Specify)	HarmonicImaging
Ophthalmic
Fetal
Abdominal
IntraoperativeAbdominal	P	P	P	P	P	P	P*	P
IntraoperativeNeurological	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
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)	P	P	P	P	P	P	P*	P
Musculo-skelctal(Superficial)	P	P	P	P	P	P	P*	P
Other (specify)

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

Additional Comments:

**small organs (breast, testes, thyroid, penis)

(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Nancy Thorgdon

(Division Sign-Off) Division of Reproductive, A and Radiological Devices 510(k) Number _

{16}------------------------------------------------

510(k) Number (if known):

Device Name:

91.4

Indications for Use:

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

ClinicalApplication	B	M	PWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify)	HarmonicImaging
Ophthalmic
Fetal	N	N	N	N	N	N	N*	N
Abdominal
IntraoperativeAbdominal	N	N	N	N	N	N	N*	N
IntraoperativeNeurological	N	N	N	N	N	N	N*	N
Pediatric	N	N	N	N	N	N	N*	N
Small Organ(specify)**	N	N	N	N	N	N	N*	N
NeonatalCephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vessel	N	N	N	N	N	N	N*	N
Laparoscopic
Musculo-skeletal(Conventional)	N	N	N	N	N	N	N*	N
Musculo-skeletal(Superficial)	N	N	N	N	N	N	N*	N
Other(specify)***

N=New Indication

Additional Comments:

**small organs (breast, testes, thyroid, penis) ***neonatal cardiac

(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Nancy Rigdon

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

510(k) Number ________________________________________________________________________________________________________________________________________________________________

{17}------------------------------------------------

510(k) Number (if known):

Device Name:

X063085 13L5SP

Intended Use:

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

Clinical Application	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Combined(Specify)	HarmonicImaging
Ophthalmic
Fetal
Abdominal
IntraoperativeAbdominal	P	P	P	P	P	P	P*	P
IntraoperativeNeurological	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
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)	P	P	P	P	P	P	P*	P
Musculo-skeletal(Superficial)	P	P	P	P	P	P	P*	P
Other (specify)**

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

Additional Comments:

**small organs (breast, testes, thyroid, penis)

(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)	Nancy C. Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number	K063085

{18}------------------------------------------------

510(k) Number (if known):

evice Name:

K063085

1518

Device Name:

Intended Use:

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

Clinical Application	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Combined(Specify)	HarmonicImaging
Ophthalmic
Fetal
Abdominal
IntraoperativeAbdominal	P	P	P	P	P	P	P*	P
IntraoperativeNeurological	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
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)	P	P	P	P	P	P	P*	P
Musculo-skeletal(Superficial)	P	P	P	P	P	P	P*	P
Other (specify)

One (spenry)
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, J 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)

ート - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Prescription Use (Per 21 CFR 801.109)
	Haney C. Hogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number	K063085

{19}------------------------------------------------

510(k) Number (if known):

Kob3085 15L8w

Device Name: Intended Use:

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

Clinical Application	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Combined(Specify)	HarmonicImaging
Ophthalmic
Fetal	P	P	P	P	P	P	P*	P
Abdominal	P	P	P	P	P	P	P*	P
IntraoperativeAbdominal	P	P	P	P	P	P	P*	P
IntraoperativeNeurological	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
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)	P	P	P	P	P	P	P*	P
Musculo-skeletal(Superficial)	P	P	P	P	P	P	P*	P
Other (specify)

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

Additional Comments:

**small organs (breast, testes, thyroid, penis)

(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Nancy C Bowdon

(Division Sign-Off) Division of Reproductive. A and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

Pg. 6.15 of 6.31

{20}------------------------------------------------

510(k) Number (if known):

Device Name:

17L5

Kob3085

Indications for Use:

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

ClinicalApplication	B	M	PWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify)	HarmonicImaging
Ophthalmic
Fetal	N	N	N	N	N	N	N*	N
Abdominal	N	N	N	N	N	N	N*	N
IntraoperativeAbdominal	N	N	N	N	N	N	N*	N
IntraoperativeNeurological	N	N	N	N	N	N	N*	N
Pediatric	N	N	N	N	N	N	N*	N
Small Organ(specify)**	N	N	N	N	N	N	N*	N
NeonatalCephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vessel	N	N	N	N	N	N	N*	N
Laparoscopic
Musculo-skeletal(Conventional)	N	N	N	N	N	N	N*	N
Musculo-skeletal(Superficial)	N	N	N	N	N	N	N*	N
Other(specify)***

N=New Indication

Additional Comments:

**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 (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	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Combined(Specify)	HarmonicImaging
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	P	P*	P
IntraoperativeAbdominal
IntraoperativeNeurological
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:

(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	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Combined(Specify)	HarmonicImaging
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	P	P*	P
IntraoperativeAbdominal
IntraoperativeNeurological
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	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Combined(Specify)	HarmonicImaging
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	P	P*	P
IntraoperativeAbdominal
IntraoperativeNeurological
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:

(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	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Combined(Specify)	HarmonicImaging
Ophthalmic
Fetal	P	P	P	P	P	P	P*	P
Abdominal	P	P	P	P	P	P	P*	P
IntraoperativeAbdominal
IntraoperativeNeurological
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:

***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	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Combined(Specify)	HarmonicImaging
Ophthalmic
Fetal	P	P	P	P	P	P	P*	P
Abdominal	P	P	P	P	P	P	P*	P
IntraoperativeAbdominal	P	P	P	P	P	P	P*	P
IntraoperativeNeurological
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:

(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	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Combined(Specify)	HarmonicImaging
Ophthalmic
Fetal	P	P	P	P	P	P	P*	P
Abdominal	P	P	P	P	P	P	P*	P
IntraoperativeAbdominal	P	P	P	P	P	P	P*	P
IntraoperativeNeurological	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:

(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	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Combined(Specify)	HarmonicImaging
Ophthalmic
Fetal	P	P	P	P	P	P	P*	P
Abdominal	P	P	P	P	P	P	P*	P
IntraoperativeAbdominal
IntraoperativeNeurological
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:

(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	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Combined(Specify)	HarmonicImaging
Ophthalmic
Fetal	P	P	P	P	P	P	P*	P
Abdominal	P	P	P	P	P	P	P*	P
IntraoperativeAbdominal
IntraoperativeNeurological
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:

***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	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Combined(Specify)	HarmonicImaging
Ophthalmic							p*	P
Fetal	P	P	P	P	P	P	p*	P
Abdominal	P	P	P	P	P	P	p*	P
IntraoperativeAbdominal	P	P	P	P	P	P	p*	P
IntraoperativeNeurological	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:

***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	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Combined(Specify)	HarmonicImaging
Ophthalmic
Fetal	P	P	P	P	P	P	P*	P
Abdominal	P	P	P	P	P	P	P*	P
IntraoperativeAbdominal	P	P	P	P	P	P	P*	P
IntraoperativeNeurological	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:

***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	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Combined(Specify)	HarmonicImaging
Ophthalmic
Fetal	P	P	P	P	P	P	P*	P
Abdominal	P	P	P	P	P	P	P*	P
IntraoperativeAbdominal	P	P	P	P	P	P	P*	P
IntraoperativeNeurological	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:

***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	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Combined(Specify)	HarmonicImaging
Ophthalmic
Fetal	P	P	P	P	P	P	P*	P
Abdominal	P	P	P	P	P	P	P*	P
IntraoperativeAbdominal	P	P	P	P	P	P	P*	P
IntraoperativeNeurological	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	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify)	HarmonicImaging
Ophthalmic
Fetal
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
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	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Combined(Specify)	HarmonicImaging
Ophthalmic
Fetal
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
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:

(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:

Clinical Application	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Combined(Specify)	HarmonicImaging
Ophthalmic
Fetal
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
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:

(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

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.