SEQUOIA DIAGNOSTIC ULTRASOUND SYSTEM

• K Number: K041319
• Device Name: SEQUOIA DIAGNOSTIC ULTRASOUND SYSTEM
• Manufacturer: SIEMENS MEDICAL SOLUTIONS USA, INC.
• Date Cleared: 2004-06-07 ( 20 days)
• Product Code: IYN , ITX , IYO
• Regulation Number: 892.1550
• Type: Special
• Panel: Radiology
• Reference & Predicate Devices: K033650 , K033196 , K032114
• Predicate For: K042770 , K051139 , K060992

Intended Use

Ultrasound imaging or fluid flow analysis of the human body as follows: Ophthalmic, Fetal, Abdominal, Intraoperative Abdominal, Intraoperative Neurological, Pediatric, Small Organ (breast, testes, thyroid, penis), Neonatal Cephalic, Adult Cephalic, Cardiac (adult, pediatric, and neonatal), Trans-esophageal, Transrectal, Transvaginal, Transurethral, Intravascular, Peripheral Vessel, Laparoscopic, Musculo-skeletal (Conventional and Superficial) applications, and intended uses as defined in the FDA guidance document. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

Device Description

The Sequoia system is a multi-purpose diagnostic ultrasound system with accessories and proprietary software, and is substantially equivalent to our current product that is already cleared for USA distribution under the following 510(k) PreMarket Notification number: K032114 (July 21, 2003) cleared as ACUSON® Sequoia 8.0 Diagnostic Ultrasound System. The Sequoia Diagnostic Ultrasound System has been designed to conform to the following product safety standards: UL 2601-1, Safety Requirements for Medical Equipment; CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment; AIUMNEMA UD-2, 1998, Acoustic Output Measurement Standard for Diagnostic Ultrasound; AIUM/NEMA UD-3, 1998, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment; 93/42/EEC Medical Device Directive; Safety and EMC Requirements for Medical Equipment; EN 60601-1, EN 60601-1-1, EN 60601-1-2; ISO 10993 Biocompatibility. The system's acoustic output is in accordance with ALARA principle (as low as reasonably achievable).

AI/ML Overview

The provided document is a 510(k) summary for the ACUSON® Sequoia Diagnostic Ultrasound System. It primarily focuses on demonstrating substantial equivalence to a predicate device and discussing the intended uses and safety standards. It does not contain information about acceptance criteria for device performance, or details of a study (test set, training set, ground truth, expert qualifications, etc.) that proves the device meets specific performance criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based solely on the provided text. The document is a regulatory submission, not a performance study report.

The tables in the document (pages 5-31) are "Indications for Use" tables for various transducers, listing the clinical applications for which each transducer is cleared, and the imaging modes (A, B, M, PWD, CWD, Color Doppler, Power Doppler, Color Velocity Imaging, Combined, Harmonic Imaging) that can be used for those applications. The 'P' indicates that these indications and modes were "previously cleared by the FDA under premarket notifications #K033650 and #K033196." This shows that the current submission is for modifications to an existing and cleared device, and not a de novo submission requiring extensive new performance validation data to establish acceptance criteria.

Summary

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Image /page/0/Picture/1 description: The image shows the text "ACUSON® Sequoia Diagnostic Ultrasound System". Above this text is the alphanumeric string "K04/319". The text appears to be part of a medical document or equipment label, possibly related to ultrasound technology.

JUN - 7 2004

SECTION 11

510(k) Summary of Safety and Effectiveness

Siemens Medical Solutions USA, Inc., Ultrasound Division has not disclosed its intent to market this device modification and requests this notification be held CONFIDENTIAL by the FDA, and not be released to any Freedom of Information request or addressed with any outside parties.

Sponsor:	Siemens Medical Solutions USA, Inc., Ultrasound Division1230 Shorebird WayP.O. Box 7393Mountain View, California 94039-7393
Contact Person:	Iskra MrakovićManager of Regulatory AffairsTelephone: [phone]Fax: [phone]
Submission Date:	May 13, 2004
Device Name:	Sequoia Diagnostic Ultrasound System
Common Name:	Diagnostic Ultrasound System with Accessories
Classification:

Regulatory Class: II Review Category: Tier II Classification Panel: Radiology

21 CFR 892.1550

	FR #	Product Code
Ultrasonic Pulsed Doppler Imaging System	892.1550	90-IYN
Ultrasonic Pulsed Echo Imaging System	892.1560	90-IYO
Diagnostic Ultrasound Transducer	892.1570	90-ITX
Diagnostic Intravascular Catheter	870.1200	90-DQO

Predicate Devices:

• K032114 (July 21, 2003) cleared as ACUSON® Sequoia 8.0 Diagnostic Ultrasound . System.

• K033196 (October 16, 2003) cleared as SONOLINE® Antares Diagnostic . Ultrasound System with Clarify™ VE.

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Device Description:

The Sequoia system is a multi-purpose diagnostic ultrasound system with accessories and proprietary software, and is substantially equivalent to our current product that is already cleared for USA distribution under the following 510(k) PreMarket Notification number:

• K032114 (July 21, 2003) cleared as ACUSON® Sequoia 8.0 Diagnostic Ultrasound . System.

The Sequoia Diagnostic Ultrasound System has been designed to conform to the following product safety standards:

• UL 2601-1, Safety Requirements for Medical Equipment .
• CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment .
• AIUMNEMA UD-2, 1998, Acoustic Output Measurement Standard for Diagnostic t Ultrasound
• AIUM/NEMA UD-3, 1998, Standard for Real Time Display of Thermal and . Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
• 93/42/EEC Medical Device Directive .
• Safety and EMC Requirements for Medical Equipment .
• EN 60601-1 .
  • EN 60601-1-1 .
  • EN 60601-1-2 .
• ISO 10993 Biocompatibility ●
• The system's acoustic output is in accordance with ALARA principle (as low as . reasonably achievable)

Intended Use:

The Sequoia platform is intended for use in the following applications:

General Imaging and Cardiology for Fetal, Abdominal, Intraoperative (abdominal and neurological), Pediatrics, Small Organs (breast, testes, thyroid, penis and prostate), Neonatal/Adult Cephalic, Cardiac (adult, pediatric, and neonatal), Trans-esophageal, Transrectal, Transvaginal, Peripheral Vessel, and Musculo-sceletal (superficial and conventional) applications, and intended uses as defined in the FDA guidance document.

The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

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Technological Comparison to Predicate Device:

The Sequoia is substantially equivalent in its technologies and functionality to the Sequoia 8.0 Diagnostic Ultrasound System that is already cleared under 510(k) premarket notification number K032114.

The Sequoia functions in the same manner as other diagnostic ultrasound systems, in that they transmit ultrasonic energy into the body via a transducer. In the body, acoustic impedance of different tissues reflect different amounts of ultrasound energy back to the mipedatios of arrerent rrocessing of received echoes is performed to generate twodimensional on-screen images of anatomic structures and fluid flow within the body. Doppler principles are used to process reflected ultrasound energy to display moving blood as a spectrum, or as color-coded two-dimensional images. All predicate devices listed above, allow for specialized measurements of structures and flow, and provide various calculations' functions.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an emblem featuring a stylized eagle or bird-like figure with three wing-like extensions.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 7 2004

Mr. Iskra Mraković Manager, Regulatory Affairs Siemens Medical Solutions USA, Inc. Ultrasound Division 1230 Shorebird Way P.O. Box 7393 MOUNTAIN VIEW CA 94039-7393

Re: K041319

Trade Name: Sequoia Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 IYN, IYO, and ITX Dated: May 17, 2004 Received: May 18, 2004

Dear Mr. Mraković:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your between mined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass stated on the 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 Cosments Act (ree). "Tou mayy accessors) sprovisions of the Act include requirements for annual provisions of inting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for use with the Sequoia Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

4C1	EC10c5	8L5T
5C2	EV8C4	13L5SP
6C2	6L3	15L8
8C4	8L5	15L8w

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Page 2 - Mr. Mraković

V5M TEE	4V1c	8V5
V7M TEE	4V2	10V4
V7B TEE	5V2c	AUX CW
3V2c	7V3c	AcuNav (IC10V5 or 10F10)
4V1	8V3

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device to such additional controls. Existing major regulations affecting your device can be may be subject to such additional controller and any any any and 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 FICA has made a determination that your device complies with other requirements of the Act or any FDA has made a decemination administered by other Federal agencies. You must comply with all I coral statutes and regulations annumes timited to: registration and listing (21 CFR Part 807); the Act 31cquirements, morading, vanufacturing practice requirements as set forth in the quality labeling (21 CFR Part 001), good manatator, and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 rife I Dr Inding of substantal v 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 rr you dosire of Compliance at [phone]. Additionally, for questions on the promotion contact the Office of Compination as as contact the Office of Compliance at [phone]. Also, and advertising or your as nevel, "Misbranding by reference to premarket notification" (21 CFR prease note in regalation on the on your responsibilities under the Act may be obtained from 1 at 001:57). Other general Manufacturers, International and Consumer Assistance at its toll-free number [phone] or at [phone] or at its Internet address "http://www fda.gov/cdrh/dsmamain.html".

If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at [phone].

Sincerely yours,

Nancy Shoydon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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510(k) Number (if known):

Device Name:

Sequoia Diagnostic Ultrasound System

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									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)**		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

Other (specify)
P=previously cleared by the FDA under premarket notifications #K033650 and #K033196.

Additional Comments:

*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, D+CWD+Color 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)

Nancy Brogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K041319

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510(k) Number (if known):

4C1 Device Name:

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		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
Neonatai Cephalic
Adult Cephalic
Cardiac		P	P	P	P	P	P		P*	P
Trans-csophageal
Transrectal
Transvagınal
Transurethral
Intravascular
Peripheral Vessel		P	P	P	P	P	P		P*	P
Laparoscopic
Musculo-skelctal(Conventional)
Musculo-skeletal(Superficial)
Other (specify)

P=previously cleared by the FDA under premarket notifications #K033650 and #K033196.

Additional Comments:

*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, _______________________________________________________________________________________________ B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, D+CWD+Color Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE

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

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

Prescription Use (Per 21 CFR 801.109)
---------------------------------------

Nancy C. Brogdon

(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number	K041319

{7}------------------------------------------------

510(k) Number (if known):

5C2 Device Name:

Intended Use:

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

Clinical Application	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	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
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)

Onler (specity)
P=previously cleared by the FDA under premarket notifications #K033650 and #K033196.

Additional Comments:

*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+Clarify Dopler, 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)

Nancy C Brogdon

(Division Sign-Off Division of Reproduc and Radiological Devic 510(k) Number

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510(k) Number (if known):

6C2 Device Name:

Intended Use:

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

Clinical Application	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	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)**		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)

(Juler (Speety)
P=previously cleared by the FDA under premarket notifications #K033196.

Additional Comments:

*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+Clarify Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE

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

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

Nancy C. Royston

(Division Sign Division of Reprod and Radiological Device 510(k) Number

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510(k) Number (if known):

8C4 Device Namc:

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									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
Adult Cephalic
Cardiac		P	P	P	P	P	P		P*	P
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular									P*
Peripheral Vessel		P	P	P	P	P	P		P*	P
Laparoscopic
Musculo-skeletal(Conventional)
Musculo-skeletal(Superficial)
Other (specify)

Other (specity)
P=previously cleared by the FDA under premarket notifications #K033650 and #K033196.

Additional Comments:

*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, D+I WD+Color 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)

Nancy C. Hodgson

(Division Sign Division of Reproduc and Radiological Devic 510(k) Number

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510(k) Number (if known):

EC10c5 Device Name:

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
Small Organ(specify)**
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal							P		P*	P
Transrectal		P	P	P	P	P	P		P*	P
Transvaginal		P	P	P	P	P	P		P*	P
Transurethral
Intravascular
Peripheral Vessel
Laparoscopic
Musculo-skeletal(Conventional)
Musculo-skelctal(Superficial)
Other (specify)

P=previously cleared by the FDA under premarket notifications #K033650 and #K033196.

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)

Nancy C. Brogdon

(Division Sign Division of Reproduct and Radiological Devices 510(k) Number

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

510(k) Number (if known):

EV8C4 Device Name:

Intended Use:

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

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

Other (specify) P=previously cleared by the FDA under premarket notifications #K033650 and #K033196.

Additional Comments:

*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, D+CWD+Color Doppler, B+CWD+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)

Nancy Croagdon

(Division Sign-Off Division of Reproductiv and Radiological Devic 510(k) Number

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510(k) Number (if known):

6L3 Device Name:

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									P*	P
Fetal		P	P	P	P	P	P		P*	P
AbdominalIntraoperative		P	P	P	P	P	P		P*	P
AbdominalIntraoperativeNeurological		P	P	P	P	P	P		P*	P
Pediatric									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)

Oulci (specify)
P=previously cleared by the FDA under premarket notifications #K033650 and #K033196.

Additional Comments:

*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, D+Clarify D+Color Doppler, B+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)

Nancy Shosdon

ivision Sign Division of Reproduc Ana Radiological Device 1 (ik) Number _

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

510(k) Number (if known):

81.5 Device Name:

Intended Use:

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

Clinical Application	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify)	HarmonicImaging
Ophthalmic
Fetal
AbdominalIntraoperative		P	P	P	P	P	P		P*	P
AbdominalIntraoperativeNeurological		P	P	P	P	P	P		P*	P
Pediatric							P		P*	P
Small Organ(specify)**		P	P	P	P	P
Neonatal Cephalic
Adult Cephalic									P*	P
Cardiac		P	P	P	P	P	P		P*	P
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular									P*	P
Peripheral Vessel		P	P	P	P	P	P		P*	P
Laparoscopic
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 (specify)
P=previously cleared by the FDA under premarket notifications #K033650 and #K033196.

Additional Comments:

*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, D+I WD+Color Doppler, B+C++B ver 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)

Maurice bordon

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

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

510(k) Number (if known):

8LST Device Name:

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		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 (specify)
P=previously cleared by the FDA under premarket notifications #K033650 and #K033196.

Additional Comments:

*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, D+I WDTColor 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)

Nancy C. Beadon
(Division Sign-Off)

Division of Reproductive, Abdom and Padiological Devices 5 !! #k) Number __

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

510(k) Number (if known):

13L5SP Device Name:

Intended Use:

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

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

Other (specify)
P=previously cleared by the FDA under premarket notifications #K033650 and #K033196.

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)

Nancy C Brogdon

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

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

510(k) Number (if known):

1518 Device Name:

Intended Use:

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

Clinical Application	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify)	HarmonicImaging
Ophthalmic
Fetal
Abdominal									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										P*	P
Cardiac		P	P	P	P	P	P			P*	P
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular										P*	P
Peripheral Vessel		P	P	P	P	P	P			P*	P
Laparoscopic
Musculo-skeletal(Conventional)		P	P	P	P	P	P			P*	P
Musculo-skeletal(Superficial)		P	P	P	P	P	P			P*	P
Other (specify)

Outler (specify)
P=previously cleared by the FDA under premarket notifications #K033650 and #K033196.

Additional Comments:

*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppier, B+CWD+Color Doppler, B+Power Doppler, D+I WD+Color Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE

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

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

Nancy Thompson

(Division Sig Division of Reproductive and Radiological Devices 510(k) Number _

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

510(k) Number (if known):

15L8w Device Name:

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									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)**		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									P*	P
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)

Onler (spectly)
P=previously cleared by the FDA under premarket notifications #K033650 and #K033196.

Additional Comments:

*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, -Comomations moraler, B+CWD+Color Doppler, B+Power Doppler, B+Clarify D+Color Doppler, B+C+PD+Dolor 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)

Nancy C. Hodgson

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

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

510(k) Number (if known):

Device Name:

V5M TEE

Intended Use:

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

Clinical Application	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	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)

Other (specif)
P=previously cleared by the FDA under premarket notifications #K033650 and #K033196.

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)

Nancy Brogdon

(Division Sign-Division of Reproductiv and Radiological Devices 510(k) Number

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

510(k) Number (if known):

V7M TEE Device Name:

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									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-csophageal		P	P	P	P	P	P		P*	P
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vessel
Laparoscopic
Musculo-skeletal(Conventional)
Musculo-skeletal(Superficial)
Other (specify)

Other (specify)
P=previously cleared by the FDA under premarket notifications #K033650 and #K033196.

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)

Nancy C. Brogdon

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

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

510(k) Number (if known):

V7B TEE Device Name:

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									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
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)

Other (specity)
P=previously cleared by the FDA under premarket notifications #K033650 and #K033196.

Additional Comments:

*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, Comomations Doppler, B+CWD+Color Doppler, B+Power Doppler, D+I WD+Color Doppler, B+C+FB Foor 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)

Nancy C. Thompson

(Division Sigr Division of Reproduct and Radiological Device 510(k) Number

{21}------------------------------------------------

510(k) Number (if known):

Device Name:

3V2c

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				P		P	P		P*	P
Fetal		P	P	P	P	P	P		P*	P
Abdominal		P	P	P	P	P	P
IntraoperativeAbdominal
IntraoperativeNeurological							P		P*	P
Pediatric		P	P	P	P	P	P
Small Organ(specify)**
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
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vessel
Laparoscopic
Musculo-skeletal(Conventional)
Musculo-skeletal(Superficial)		P	P	P	P	P	P		P*	P

Other (specify)***
P=previously cleared by the FDA under premarket notifications #K033650 and #K033196. Other (specify)

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)
CODE (ODE) Comment of CORPL Office Evaluation (ODE) VRITE BELOW THIS EINE-CONTITUE - ---------------------------------------------------------------------------------------------------------------------------------------------

Nancy C hoydon

(Division Sign-Off) Division of Reproductive, Abdomina on Rediological Devices ; > as) Number _______________________________________________________________________________________________________________________________________________________________

{22}------------------------------------------------

510(k) Number (if known):

4V1 Device Name:

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

Other (specity)
P=previously cleared by the FDA under premarket notifications #K033650 and #K033196.

Additional Comments:

*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, D+C WD+Color 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)

Nancy C. Brogdon

(Division Sign-O Division of Reproductiv and Radiological Devices 510(k) Number

{23}------------------------------------------------

510(k) Number (if known):

4V1c Device Name:

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		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
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular									P*	P
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

Omet (Specify)
P=previously cleared by the FDA under premarket notifications #K033650 and #K033196.

Additional Comments:

*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+Clarify Doppler, B+C+P+Color Dopper, 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)

Nancy C. Hogdon

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

{24}------------------------------------------------

510(k) Number (if known):

4V2 Device Name:

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									P*
Fetal		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)

Onler (specify)
P=previously cleared by the FDA under premarket notifications #K033650 and #K033196.

Additional Comments:

*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+Clarify Dopler, 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)

Nancy C. Broydon

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

{25}------------------------------------------------

510(k) Number (if known):

5V2c Device Name:

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									P*	P
Fetal		P	P	P	P	P	P		P*	P
Abdominal		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
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-skeleta!(Conventional)
Musculo-skeletal(Superficial)
Other (specify)***		P	P	P	P	P	P		P*	P

Other (specis)
P=previously cleared by the FDA under premarket notifications #K033650 and #K033196.

Additional Comments:

*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, Comomations menader, B+CWD+Color Doppler, B+Power Doppler, B+Clarify Doppler, B+C WD+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)

Nancy C. Bragdon
(Division Sign-Off)

Division of Reproductive, Abdomin and Radiological Device 510(k) Number J

{26}------------------------------------------------

510(k) Number (if known):

7V3c Device Name:

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									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									P*	P
Cardiac		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

Outer (specify)
P=previously cleared by the FDA under premarket notifications #K033650 and #K033196.

Additional Comments:

*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, D+I WD+Color 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)

Nancy Chrogdon

(Division Sign-O Division of Reproductive and Radiological Devices 510(k) Number .

{27}------------------------------------------------

510(k) Number (if known):

8V3 Device Name:

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		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

Other (specity)
P=previously cleared by the FDA under premarket notifications #K033650 and #K033196.

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)

Naveen Gordon

(Division Sign Division of Reproductiv Ahdom and Radiological Devices 510(k) Number

{28}------------------------------------------------

510(k) Number (if known):

8V5 Device Name:

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		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

Other (specify)
P=previously cleared by the FDA under premarket notifications #K033650 and #K033196.

Additional Comments:

*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, D+I WD+Color Doppler, B+C+FB+Corr 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)

Nancy C. Roepke

(Division Sign. Abdomi! Division of Reproductive, and Radiological Devices : (x) Nember

{29}------------------------------------------------

510(k) Number (if known):

10V4 Device Name:

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									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)**		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
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vessel
Laparoscopic
Musculo-skeletal(Conventional)
Musculo-skeletal(Superficial)
Other (specify)***		P	P	P	P	P	P		P*	P

Other (specity)
P=previously cleared by the FDA under premarket notifications #K033650 and #K033196.

Additional Comments:

*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, Comomations monoler, B+CWD+Color Doppler, B+Power Doppler, D+Clarify D+Color Doppler, B+CWD+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)

Nancy C Brogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
1(k) Number K041319

{30}------------------------------------------------

510(k) Number (if known):

Device Name:

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-skcletal(Conventional)
Musculo-skelctal(Superficial)
Other (specify)

P=previously cleared by the FDA under premarket notification # K032114.

Additional Comments:

(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Broadbent

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

{31}------------------------------------------------

510(k) Number (if known):

Device Name:

Transducer:

Sequoia Diagnostic Ultrasound System, Harmonic Imaging

AcuNav (IC10V5 or 10F10) Diagnostic Ultrasound Catheter

Indications for Use:

The AcuNav™ Diagnostic Ultrasound Catheter is intended fur 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	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	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

Onler (intra-Cardiae)
P=previously cleared by the FDA under premarket notifications #K033650 and #K033196.

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)

Nancy Snowdon

(Division Sign(Off)
Division of Reproductive, Abdominal,
and Radiological Devices
(k) Number R041319
Diagnostic Ultrasound Indications for Use Form

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.