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K Number
K052410
Device Name
ACUSON SEQUOIA ULTRASOUND SYSTEM
Manufacturer
SIEMENS MEDICAL SOLUTIONS USA, INC.
Date Cleared
2005-09-22

(20 days)

Product Code
IYNITXIYO
Regulation Number
892.1550
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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.
Device Description
The Sequoia system is a multi-purpose diagnostic ultrasound system with accessories and proprietary software, and is substantially equivalent to our current product that is already cleared for USA distribution under the following 510(k) PreMarket Notification number: K051139 (May 13, 2005) cleared as ACUSON Sequoia™ Diagnostic Ultrasound . System. The Sequoia Diagnostic Ultrasound System has been designed to conform to the following product safety standards: UL 2601-1, Safety Requirements for Medical Equipment . CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment . AIUM/NEMA UD-2, 1998, Acoustic Output Measurement Standard for Diagnostic . Ultrasound AIUM/NEMA UD-3, 1998, Standard for Real Time Display of Thermal and . Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment 93/42/EEC Medical Device Directive . Safety and EMC Requirements for Medical Equipment . . EN 60601-1 · EN 60601-1-1 EN 60601-1-2 . ISO 10993 Biocompatibility . The system's acoustic output is in accordance with ALARA principle (as low as . reasonably achievable)
More Information

K051139

K032114, K022567, K002807, K992631, K992580, K973767, K935595/S1, K041319, K052021, K033650, K033196, K042593

No
The summary does not mention AI, ML, or any related terms like deep learning or neural networks. The device description focuses on standard ultrasound technology and image processing.

No.
Explanation: The device is described as a "multi-purpose diagnostic ultrasound system" used for "clinical diagnosis purposes" and generates images of anatomical structures; it does not mention any therapeutic use.

Yes
The Device Description explicitly states, "The Sequoia system is a multi-purpose diagnostic ultrasound system".

No

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

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly describes the device as a diagnostic ultrasound system used for imaging various anatomical structures and fluid flow within the body. This is the core function of an in-vivo imaging device, not an in-vitro diagnostic device which analyzes samples outside the body.
  • Device Description: The description confirms it's a "multi-purpose diagnostic ultrasound system."
  • Input Imaging Modality: The input modality is explicitly stated as "Ultrasound," which is an in-vivo imaging technique.
  • Mentions image processing: The text mentions "post processing of received echoes is performed to generate two-dimensional on-screen images of anatomic structures and fluid flow within the body." This further reinforces its function as an in-vivo imaging device.

IVD devices are used to examine specimens such as blood, urine, or tissue samples to detect diseases, conditions, or infections. This device operates by sending and receiving ultrasound waves to create images of internal body structures.

N/A

Intended Use / Indications for Use

The Sequoia platform is intended for use in the following applications: General Imaging and Cardiology for Fetal, Abdominal, Intraoperative (abdominal and neurological), Pediatrics, Small Organs (breast, testes, thyroid, penis and prostate), Neonatal/Adult Cephalic, Cardiac (adult, pediatric, and neonatal), Trans-esophageal, Transrectal, Transvaginal, Peripheral Vessel, and Musculo-sceletal (superficial and conventional) applications, and intended uses as defined in the FDA guidance document. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

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

90-IYN, 90-IYO, 90-ITX

Device Description

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

  • K051139 (May 13, 2005) cleared as ACUSON Sequoia™ Diagnostic Ultrasound . System.

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

  • UL 2601-1, Safety Requirements for Medical Equipment .
  • CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment .
  • AIUM/NEMA UD-2, 1998, Acoustic Output Measurement Standard for Diagnostic . Ultrasound
  • AIUM/NEMA UD-3, 1998, Standard for Real Time Display of Thermal and . Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
  • 93/42/EEC Medical Device Directive .
  • Safety and EMC Requirements for Medical Equipment .
  • . EN 60601-1
  • · EN 60601-1-1
  • EN 60601-1-2 .
  • ISO 10993 Biocompatibility .
  • The system's acoustic output is in accordance with ALARA principle (as low as . reasonably achievable)

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

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, Musculo-skeletal (superficial and conventional), Intra-cardiac, Intra-luminal (for AcuNav ultrasound catheters).

Indicated Patient Age Range

Fetal, Neonatal, Pediatric, Adult

Intended User / Care Setting

Not Found

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

Not Found

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

Not Found

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

Not Found

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

Not Found

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

K051139

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

K032114, K022567, K002807, K992631, K992580, K973767, K935595/S1, K041319, K052021, K033650, K033196, K042593

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

Not Found

§ 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.

0

KD524/D

Siemens Medical Solutions USA, Inc. Ultrasound Division

SEP 2 2 2005

ACUSON Sequoia™ Ultrasound System Special 510(k) Submission

SECTION 11

510(k) Summary of Safety and Effectiveness

| Sponsor: | Siemens Medical Solutions USA, Inc., Ultrasound Division
1230 Shorebird Way
P.O. Box 7393
Mountain View, California 94039-7393 |
|------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Iskra Mraković
Manager, Regulatory Affairs
Telephone: (650) 694-5004
Fax: (650) 943-7053 |
| Submission Date: | September 1, 2005 |
| Device Name: | Sequoia Diagnostic Ultrasound System |
| Common Name: | Diagnostic Ultrasound System with Accessories |

Classification:

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

21 CFR 892.1550

FR #Product Code
Ultrasonic Pulsed Doppler Imaging System892.155090-IYN
Ultrasonic Pulsed Echo Imaging System892.156090-IYO
Diagnostic Ultrasound Transducer892.157090-ITX
Diagnostic Intravascular Catheter870.120090-DQO

Predicate Device:

  • K051139 (May 13, 2005) cleared as ACUSON Sequoia™ Diagnostic Ultrasound . System.

1

Device Description:

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

  • K051139 (May 13, 2005) cleared as ACUSON Sequoia™ Diagnostic Ultrasound . System.

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

  • UL 2601-1, Safety Requirements for Medical Equipment .
  • CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment .
  • AIUM/NEMA UD-2, 1998, Acoustic Output Measurement Standard for Diagnostic . Ultrasound
  • AIUM/NEMA UD-3, 1998, Standard for Real Time Display of Thermal and . Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
  • 93/42/EEC Medical Device Directive .
  • Safety and EMC Requirements for Medical Equipment .
  • . EN 60601-1
    • · EN 60601-1-1
    • EN 60601-1-2 .
  • ISO 10993 Biocompatibility .
  • The system's acoustic output is in accordance with ALARA principle (as low as . reasonably achievable)

Intended Use:

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

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

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

2

Technological Comparison to Predicate Device:

The Sequoia is substantially equivalent in its technologies and functionality to the Sequoia Diagnostic Ultrasound System that is already cleared under 510(k) premarket notification number K051139.

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

Remaining of the page left blank intentionally.

3

Image /page/3/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

SEP 2 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K052410

  • Trade Name: Sequoia™ Ultrasound System Trade Name: Bequola Regulation Name: Ultrasonic pulsed doppler imaging system Ultrasound pulsed echo imaging system ·
    Diagnostic ultrasonic transducer

  • : Regulatory Class: II Product Code: IYN, IYO, and ITX

    • Dated: September 1, 2005

  • Received: September 2, 2005

Dear Mr. Mraković:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have forloned four boom determined the device is substantially equivalent (for the ications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device merslate commerce proc to that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include the general controls provision, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

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

Transducer Model Number

4C1EV8C4
5C26L3
6C28L5
8C48L5T
EC10c513L5SP

4

15L87V3c
15L8w8V3
V5M TEE8V5
V7M TEE10V4
V7B TEEAUX CW
3V2cAcuNav (IC10V5 or 10F) Ultrasound
4V1Catheter
4V1cAcuNav 8F Ultrasound Catheter
4V2Apollo
5V2c

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Orth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

Food and Dru
Center for Det
Document Ma
9200 Corpora
Rockville, Ma

.

Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

5

Page 2 - Mr. Mraković

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your ac-1100 on one one the regulation entitled, Colliact the Office of Comphalled at (21 ) = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = Misofanding by reference to premailions in the Act from the Division of Small other general information on your response Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.

Sincerely yours,

Daniel Ch. Leyson

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

Enclosure(s)

. . .

6

510(k) Number (if known):

Device Name:

Sequoia™ Ultrasound System

Intended Use:

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

Clinical ApplicationABMPWDCWDColor DopplerPower (Amplitude) DopplerColor Velocity ImagingCombined (Specify)Harmonic Imaging
OphthalmicP*P
FetalPPPPPPP*P
AbdominalPPPPPPP*P
Intraoperative
AbdominalPPPPPPP*P
Intraoperative
NeurologicalPPPPPPP*P
PediatricPPPPPPP*P
Small Organ
(specify)**PPPPPPP*P
Neonatal CephalicPPPPPPP*P
Adult CephalicPPPPPPP*P
CardiacPPPPPPP*P
Trans-esophagealPPPPPPP*P
TransrectalPPPPPPP*P
TransvaginalPPPPPPP*P
Transurethral
Intravascular
Peripheral VesselPPPPPPP*P
LaparoscopicP*P
Musculo-skeletal
(Conventional)PPPPPPP*P
Musculo-skeletal
(Superficial)PPPPPPP*P

Other (specify)
P=previously cleared by the FDA under premarket notifications #K051139, #K032114, #K022567, #K002807, #K992631, #K992580, #K973767, #K935595/S1.

Additional Comments:

*Combinations include:B+M, B+PWD, B+CWD, B+Color Doppler, B+M+Color Doppler,
B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler,
B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE
**small organs(breast, testes, thyroid, penis)
***neonatal cardiac

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

David A. Leggett

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

7

510(k) Number (if known):

Device Name:

4C1

Intended Use:

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

| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Harmonic
Imaging |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | | | | P* | P |
| Fetal | | P | P | P | P | P | P | | P* | P |
| Abdominal | | P | P | P | P | P | P | | | |
| Intraoperative
Abdominal | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | 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 | | | | | | | | | | |
| Peripheral Vessel | | P | P | P | P | P | P | | P* | P |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | | | | | | | | | | |
| Musculo-skeletal
(Superficial) | | | | | | | | | | |

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

Additional Comments:

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

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

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

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off) /
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K052410

8

510(k) Number (if known):

5C2 Device Name:

Intended Use:

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

| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Harmonic
Imaging |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | | P | | P* | P |
| Fetal | | P | P | P | P | P | P | | P* | P |
| Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative
Abdominal | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | 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 | | | | | | | P | | P* | P |
| Peripheral Vessel | | P | P | P | P | P | P | | P* | P |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | | | | | | | | | | |
| Musculo-skeletal
(Superficial) | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

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

Additional Comments:

Additional Comments:
*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+Color Doppler, -Comomations merade. B+CWD+Color Doppler, B+Power Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+CWD+Power Doppler, B+Clarify VE

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

Elaine K. Ingram

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

9

510(k) Number (if known):

6C2 Device Name:

Intended Use:

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

| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Harmonic
Imaging |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | P | P | | P* | P |
| Fetal | | P | P | P | P | P | P | | P* | P |
| Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative
Abdominal | | P | P | P | P | P | | | P* | P |
| Intraoperative
Neurological | | 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* | 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 (specity) Other (specity)
P-previously cleared by the FDA under premarket notifications #K051139, #K041319, #K032114, #K022567, and #K002807.

Additional Comments:

Additional Comments:
*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+Clarify Doppler, B+C+TB+Color Boppler, B+CWD+Power Doppler, B+Clarify VE

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

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

David R. Syverson

(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices 51()(k) Number _

10

510(k) Number (if known):

Device Name:

8C4

Intended Use:

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

| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Harmonic
Imaging |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | P | P | | P* | P |
| Fetal | | P | P | P | P | P | P | | P* | P |
| Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative
Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative
Neurological | | P | P | P | P | P | P | | P* | P |
| Pediatric | | P | P | P | P | P | P | | P* | P |
| Small Organ
(specify)** | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | P* | P |
| 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) | | | | | | | | | | |
| Musculo-skeletal
(Superficial) | | | | | | | | | | |
| Other (concify) | | | | | | | | | | |

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

Additional Comments:

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

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

Daniel R. Hageman

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

11

510(k) Number (if known):

Device Name:

EC10c5

Intended Use:

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

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

Other (specify) Other (specity)
P=previously cleared by the FDA under premarket notifications #K051139, #K041319, #K032114, #K022567, and #K002807.

Additional Comments:

Additional Comments:
*Combinations include: B+M, B+PWD, B+CWD, B+CWD, B+Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+PWD+Color Doppier, B+C++D+Color Doppion D++ 0++ 0++ 0++ 0++ 0++ 0+Clarify YE_

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

David A. Leyson

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

12

510(k) Number (if known):

EV8C4 Device Name:

Intended Use:

:

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

| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Harmonic
Imaging |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | | P | | P* | P |
| Fetal | | P | P | P | P | P | P | | P* | P |
| Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative
Abdominal | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| 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 (specify) | | | | | | | | | | |

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

Additional Comments:

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

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

Daniel M. Layson

(Division S Division of Reproductive, Abd and Radiological Devic 510(k) Number

13

510(k) Number (if known):

61.3 Device Name:

Intended Use:

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

| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Harmonic
Imaging |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | | P | | P* | P |
| Fetal | | P | P | P | P | P | P | | P* | P |
| Abdominal | | | | | | | P | | P* | P |
| Intraoperative
Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative
Neurological | | P | P | P | P | P | P | | P* | P |
| Pediatric | | | | | | | P | | P* | P |
| 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 | | | | | | | P | | P* | P |
| 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 (specity)
P=previously cleared by the FDA under premarket notifications #K051139, #K032114, #K022567, #K002807, and #K973767.

Additional Comments:

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

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

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

Prescription Use (Per 21 CFR 801.109)

Elnid G. Hanson

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K052440

14

510(k) Number (if known):

81.5 Device Name:

Intended Use:

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

| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Harmonic
Imaging |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | P | | P* | P | |
| Intraoperative
Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative
Neurological | | P | P | P | P | P | P | | P* | P |
| Pediatric | | | | | | | P | | P* | P |
| 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 | | | | | | | | | | |
| Peripheral Vessel | | P | P | P | P | P | P | | P* | P |
| Laparoscopic | | | | | | | | | P* | P |
| 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 (specity)
P-previously cleared by the FDA under premarket notifications #K051139, #K032114, #K022567, #K002807, and #K973767.

Additional Comments:

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

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

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

David A. Ingram

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

15

510(k) Number (if known):

8L5T Device Name:

Intended Use:

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

| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Harmonic
Imaging |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | P | | | P* | P | |
| Intraoperative
Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative
Neurological | | P | P | P | P | P | P | | P* | P |
| Pediatric | | P | P | P | P | P | P | | P* | P |
| Small Organ
(specify)** | | P | P | P | P | P | P | | P* | P |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | P* | P |
| Cardiac | | P | P | P | P | P | P | | P* | P |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | P* | P |
| Peripheral Vessel | | P | P | P | P | P | P | | P* | P |
| Laparoscopic | | | | | | | | | p* | P |
| Musculo-skeletal
(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 #K051139, #K032114, and #K022567.

Additional Comments:

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

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

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

David A. Ingram

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

16

510(k) Number (if known):

13L5SP Device Name:

Intended Use:

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

| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Harmonic
Imaging |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | P | P | | P* | P |
| Intraoperative
Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative
Neurological | | P | P | P | P | P | P | | P* | P |
| Pediatric | | P | P | P | P | P | P | | P* | P |
| Small Organ
(specify)** | | P | P | P | P | P | P | | P* | P |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | P | | P* | P |
| Cardiac | | P | P | P | P | P | P | | P* | P |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | P* | P |
| Peripheral Vessel | | P | P | P | P | P | P | | P* | P |
| Laparoscopic | | P | P | P | P | P | P | | P* | P |
| Musculo-skeletal
(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 #K051139, #K032114, and #K022567.

Additional Comments:

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

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

(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) WRITE BEDOW THISE of Device Evaluation (ODE) _

David A. Ingram

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

17

510(k) Number (if known):

1518 Device Name:

Intended Use:

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

| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Harmonic
Imaging | |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|---|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | P | | p* | P | |
| Intraoperative
Abdominal | | P | P | P | P | P | P | | | p* | P |
| Intraoperative
Neurological | | P | P | P | P | P | P | | | p* | P |
| Pediatric | | P | P | P | P | P | P | | | p* | P |
| Small Organ
(specify)** | | P | P | P | P | P | P | | | p* | P |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | p* | P |
| Cardiac | | P | P | P | P | P | P | | | p* | P |
| Trans-esophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | p* | P |
| Peripheral Vessel | | P | P | P | P | P | P | | | p* | P |
| Laparoscopic | | | | | | | | | | p* | P |
| Musculo-skeletal
(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 #K051139, #K032114, #K022567, #K002807, and #K973767.

Additional Comments:

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

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

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

David A. Severson

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

18

15L8w

510(k) Number (if known):

Device Name:

Intended Use:

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

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

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

Additional Comments:

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

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

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

David h. Seyerson

(Division Sign-Off) Division of Reproductive, At ano Radiological Devices 510(k) Number -

19

510(k) Number (if known):

Device Name:

V5M TEE

Intended Use:

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

| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Harmonic
Imaging |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | P | | P* | P |
| Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative
Abdominal | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | 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 |
| 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 (specify)
P=previously cleared by the FDA under premarket notifications #K052021, #K051139, #K032114, #K022567, #K002807, and #K973767.

Additional Comments:

Additional Comments:
*Combinations include: B+M, B+PWD, B+CWD, B+CWD, B+Color Doppler, Comomations morader, B+CWD+Color Doppler, B+Power Doppler, B+CWD+Color Doppler, B+C++B+Cord: Dopler, 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)

David A. Leyson

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

20

510(k) Number (if known):

Device Name:

V7M TEE

Intended Use:

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

| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Harmonic
Imaging |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | P | P | | P* | P |
| Abdominal | | P | P | P | P | P | P | | | |
| Intraoperative
Abdominal | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | P* | P |
| Small Organ
(specify)** | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | P | | P* | P |
| 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) | | | | | | | | | | |

Oder (spocity)
P=previously cleared by the FDA under premarket notifications #K051139, #K032114, and #K022567.

Additional Comments:

*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, D+1 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) -

David A. Leyman

(Division Sign-O Division of Reproductive, and Padiological Devices 510(k) Number

21

510(k) Number (if known):

Device Name:

V7B TEE

Intended Use:

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

| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Harmonic
Imaging |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | P | | P* | P |
| Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative
Abdominal | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | P | | | |
| 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 | | 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 #K051139, #K032114, and #K022567.

Additional Comments:

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

David H. Henson

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

22

510(k) Number (if known):

3V2c Device Name:

Intended Use:

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

| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Harmonic
Imaging |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | | P | | P* | P |
| Fetal | | P | P | P | P | P | P | | P* | P |
| Abdominal | | P | P | P | P | P | P | | | |
| Intraoperative
Abdominal | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | P | | P* | P |
| Pediatric | | P | P | P | P | P | P | | | |
| Small Organ
(specify)** | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | 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 (specify)***
P=previously cleared by the FDA under premarket notifications #K051139, #K032114, and #K022567.

Additional Comments:

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

David A. Grayson

(Division Sign-Off, Division of Reproductive, Ab and Radiological Devices 51:1(k) Number _______________________________________________________________________________________________________________________________________________________________

23

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 | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Harmonic
Imaging | |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|---|
| Ophthalmic | | | | | | | P | | P* | P | |
| Fetal | | P | P | P | P | P | P | | P* | P | |
| Abdominal | | P | P | P | P | P | P | | P* | P | |
| Intraoperative
Abdominal | | P | P | P | P | P | P | | | | |
| Intraoperative
Neurological | | | | | | | | | | P* | P |
| 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 | | | | |
| 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) | | | | | | | | | | | |

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

Additional Comments:

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

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

Daniel A. Segars

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

24

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 | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Harmonic
Imaging |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | | | | P* | P |
| Fetal | | P | P | P | P | P | P | | P* | P |
| Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative
Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative
Neurological | | P | P | P | P | P | P | | P* | P |
| Pediatric | | P | P | P | P | P | P | | P* | P |
| Small Organ
(specify) ** | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | P* | P |
| 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 |

Other (specify)"
P=previously cleared by the FDA under premarket notifications #K051139, #K041319, #K032114, and #K022567

Additional Comments:

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

David A. Sezman

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

25

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

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

Additional Comments:

*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, Collormations moroler, B+CWD+Color Doppler, B+Power Doppler, B+Clarify D+Color Doppler, B+C++D+Corder, B+CWD+Power Doppler, B+Clarify VE

(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) VRITE BEEOW THIS In This In Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

David A. Dyson

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

26

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 | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Harmonic
Imaging |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | | | | P* | P |
| Fetal | | P | P | P | P | P | P | | P* | P |
| Abdominal | | P | P | P | P | P | P | | | |
| Intraoperative
Abdominal | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| 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 | | | |
| 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 |

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

Additional Comments:

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

***neonatal cardiac

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

Prescription Use (Per 21 CFR 801.109)

David he. Layson

(Division Sign-Off)/
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K052410

Diagnostic Ultrasound Indications for Use Form

27

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 | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Harmonic
Imaging |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | P | P | | P* | P |
| Fetal | | P | P | P | P | P | P | | P* | P |
| Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative
Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative
Neurological | | P | P | P | P | P | P | | P* | P |
| Pediatric | | P | P | P | P | P | P | | P* | P |
| Small Organ
(specify)** | | | | | | P | P | | P* | P |
| Neonatal Cephalic | | P | P | P | P | P | P | | P* | P |
| 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) | | | | | | | | | | |
| Musculo-skeletal
(Superficial) | | | | | | | | | | P |
| Other (specify) *** | | P | P | P | P | P | P | | P* | P |

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

Additional Comments:

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

David A. Syverson

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

28

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

Other (specify)
P=previously cleared by the FDA under premarket notifications #K05 l 139, #K041319, and #K032114.

Additional Comments:

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

David R. Ingram

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

29

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

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

Additional Comments:

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

David A. Hanson

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

30

510(k) Number (if known):

Device Name:

10V4

Intended Use:

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

| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Harmonic
Imaging |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | | P | | P* | P |
| Fetal | | P | P | P | P | P | P | | P* | P |
| Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative
Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative
Neurological | | P | P | P | P | P | P | | P* | P |
| Pediatric | | P | P | P | P | P | P | | P* | P |
| Small Organ
(specify) ** | | 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 (specify)
P=previously cleared by the FDA under premarket notifications #K051139, #K032114, and #K022567.

Additional Comments:

*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, Comomations moraler, B+CWD+Color Doppler, B+Power Doppler, B+CWD+Color Doppler, B+C++D+Color Doppler, B+CWD+Power Doppler, B+Clarify VE ** small organs (breast, testes, thyroid, penis) ***neonatal cardiac

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

David A. Grayson

(Division Sign-Off Division of Reproductive, Abdom ann Radiological Devices 510(k) Number ---

31

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

Other (specify)
P=peviously cleared by the FDA under premarket notifications #K051139, #K041319, #K032114, #K022567, #K002807, and #K973767.

Additional Comments:

__, and I am not going to do that.

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

David A. Seymour

(Division Sign-Off)

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

32

510(k) Number (if known):

Sequoia Ultrasound System

Transducer:

Device Name:

Sequoia Ultrasound System

Transducer:

AcuNav (IC10V5 or 10F) Ultrasound Catheter

The AcuNav™ Ultrasound Catheter is intended for intra-cardiac Indications for Use: The Flour and visualization of cardiac and great vessel and intra-fullimar-vioual as well as visualization of other devices in the heart.

| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Harmonic
Imaging |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative
Abdominal | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ
(specify)** | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | p* | P |
| Cardiac | | P | P | P | P | P | P | | p* | P |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | p* | P |
| 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 |

Other (intra-Laulac)
P=previously cleared by the FDA under premarket notifications #K051139, #K033650, #K033196, and #K992631.

Additional Comments:

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

Prescription Use (Per 21 CFR 801.109

David A. Ingram

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

33

510(k) Number (if known):

Sequoia Ultrasound System Device Name:

Transducer:

AcuNav 8F Ultrasound Catheter

Transducer.

Alray of Ultrasound Seminar

Indications for Use:

The AcuNav™ Ultrasound Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel and intra fullimar risualization of other devices in the heart.

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

Other (under Caratas) - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 1 - 1 1 39, and # K 04 2593.

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, DTT WDT Coler 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

(Division Sign-Off) Thusion of Reproductive, Ab ana Radiological Devices 510(k) Number -

34

510(k) Number (if known):

Device Name:

Apollo

Indications for Use:

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

| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other:
Harmonic
Imaging | Other:
3D | Other:
Real
Time
3D |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|--------------|------------------------------|
| Ophthalmic | | | | | | | | | P* | P | | P |
| Fetal | | P | P | P | P | P | P | | P* | P | | P |
| Abdominal | | P | P | P | P | P | P | | P* | P | | P |
| Intraoperative
Abdominal | | P | P | P | P | P | P | | | | | |
| Intraoperative
Neurological | | | | | | | | | P* | P | | P |
| Pediatric | | P | P | P | P | P | P | | | | | |
| Small Organ
(specify)** | | | | | | | | | | | | |
| Neonatal
Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | P* | P | | P |
| Cardiac | | P | P | P | P | P | | | | | | |
| Trans-esophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | P* | P | | P |
| Peripheral Vessel | | P | P | P | P | P | P | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | | | | | | | | | | | | |
| Musculo-skeletal
(Superficial) | | | | | | | | | | | | P |
| Other
(specify)*** | | P | P | P | P | P | | | P* | P | | P |

(Specify)
P=previously cleared by the FDA under premarket notification #K051139.

Additional Comments:

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

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

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

David A. Logsdon
(Division Sign-Off)

Division of Reproductive, Abdominal,
A Radiological Devices K052410
510(k) Number