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K Number
K032114
Device Name
SEQUOIA 8.0 DIAGNOSTIC ULTRASOUND SYSTEM
Manufacturer
SIEMENS MEDICAL SOLUTIONS USA, INC.
Date Cleared
2003-07-21

(12 days)

Product Code
IYNITXIYO
Regulation Number
892.1550
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Ultrasound imaging or fluid flow analysis of the human body as follows: General Imaging and Cardiology for Fetal, Abdominal, Intraoperative (abdominal and neurological), Pediatrics, Small Organs (breast, thyroid, penis and prostate), Neonatal/Adult Cephalic, Cardiac (adult, pediatric and neonatal), Trans-esophageal, Transrectal, Transvaginal, Peripheral Vessel, and Musculo-skeletal (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 analysis packages that provide information that is used for clinical diagnosis purposes.
Device Description
The Sequoia is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bioeffect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-mode, M-mode, Pulsed (PW) Doppler mode, Continuous (CW) wave Doppler mode, color Doppler mode. Power Amplitude Doppler mode, a combination of these modes, Harmonic Imaging, or 3D imaging, on a CRT display.
More Information

K022567

K022567

No
The document describes a standard diagnostic ultrasound system and does not mention any AI or ML capabilities in the device description or intended use. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".

No
The device is described as a "diagnostic ultrasound system" and its intended use is for "imaging or fluid flow analysis" and for "clinical diagnosis purposes," not for treatment.

Yes
The "Device Description" explicitly states, "The Sequoia is a general purpose, mobile, software-controlled, diagnostic ultrasound system." Additionally, the "Intended Use / Indications for Use" section mentions "analysis packages that provide information that is used for clinical diagnosis purposes."

No

The device description explicitly states it is a "diagnostic ultrasound system" and describes hardware components like transducers and a CRT display, indicating it is not software-only.

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

Here's why:

  • IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro).
  • Device Description: The provided description clearly states that the Sequoia is a "diagnostic ultrasound system." Ultrasound is an imaging modality that uses sound waves to create images of internal body structures. This is an in vivo (within the living body) diagnostic method.
  • Intended Use: The intended use describes imaging and fluid flow analysis of the human body. This further confirms it's an in vivo diagnostic tool.

Therefore, based on the provided information, the Sequoia Diagnostic Ultrasound System is an in vivo diagnostic device, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

The Sequoia diagnostic ultrasound system is intended for the following: General Imaging and Cardiology for Fetal, Abdominal, Intraoperative (abdominal and neurological), Pediatrics, Small Organs (breast, thyroid, penis and prostate), Neonatal/Adult Cephalic, Cardiac (adult, pediatric and neonatal), Trans-esophageal, Transrectal, Transvaginal, Peripheral Vessel, and Musculo-skeletal (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 analysis packages that provide information that is used for clinical diagnosis purposes.

Product codes

90-IYN, 90-IYO, 90-ITX, 90-DQO

Device Description

The Sequoia is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bioeffect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-mode, M-mode, Pulsed (PW) Doppler mode, Continuous (CW) wave Doppler mode, color Doppler mode. Power Amplitude Doppler mode, a combination of these modes, Harmonic Imaging, or 3D imaging, on a CRT display.

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, thyroid, penis and prostate), Neonatal/Adult Cephalic, Cardiac (adult, pediatric and neonatal), Trans-esophageal, Transrectal, Transvaginal, Peripheral Vessel, and Musculo-skeletal (superficial and conventional) applications, Intra-cardiac and Intra-luminal

Indicated Patient Age Range

Fetal, Pediatric, Neonatal, 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)

K022567

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

K032//44

510(k) Submission

510(k) SUMMARY

JUL 21 2003

Sequoia Diagnostic Ultrasound System

This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with the Safe Medical Device Act of 1990 revisions to 21 CFR, Part 807.92, Content and Format of a 510(k) Summary.

Submitted Bv: 1.

Siemens Medical Solutions USA. Inc., Ultrasound Division 1230 Shorebird Way PO Box 7393 Mt. View. California 94039-7393

Contact Person Mr. Jerry W. Tsutsumi Regulatory Affairs Department Phone: (650) 943-7286 Fax: (650) 961-6168

Date Prepared

29 January 2003

2. Proprietary Name:

Sequoia Diagnostic Ultrasound System

Common/ Usual Name:

Diagnostic Ultrasound System with Accessories

Classification Name:

21 CFR 892.1550 Ultrasonic Pulsed Doppler Imaging System Ultrasonic Pulsed Echo Imaging System Diagnostic Ultrasound Transducer Diagnostic Intravascular Catheter

Product Code 90-IYN FR# 892.1550 FR# 892.1560 Product Code 90-IYO FR# 892,1570 Product Code 90-ITX FR # 870.1200 Product Code 90-DQO

3. Predicate Device:

K022567 (8/13/2002) cleared as Axius Edge Assisted Ejection Fraction, FreeStyle Extended Imaging and several new transducers (V7M TEE, 8L5T, 10V4, 13L5SP and 4V1c) for the Sequoia Diagnostic Ultrasound System Signature II.

4. Device Description:

The Sequoia is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bioeffect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-mode, M-mode, Pulsed (PW) Doppler mode, Continuous (CW) wave Doppler mode, color Doppler mode. Power Amplitude Doppler mode, a combination of these modes, Harmonic Imaging, or 3D imaging, on a CRT display.

1

The Sequoia diagnostic ultrasound system has been designed to conform to the following product safety standards:

  • 1 UL 2601-1, Safety Requirements for Medical Equipment
  • CSA C22.2 No. 601-1. Safety Requirements for Medical Equipment 비
  • 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 L Acoustic Output Indices on Diagnostic Ultrasound Equipment
  • 93/42/EEC Medical Devices Directive l
  • Safety and EMC Requirements for Medical Equipment 미
  • 모 EN 60601-1
    • EN 60601-1-1 .
    • s EN 60601-1-2
  • . IEC 1157 Declaration of Acoustic Power
  • 해 ISO 10993 Biocompatibility
  • The systems acoustic output is in accordance with ALARA (as low as reasonably achievable) ● principle

5. Intended Uses:

The Sequoia diagnostic ultrasound system is intended for the following:

General Imaging and Cardiology for Fetal, Abdominal, Intraoperative (abdominal and neurological), Pediatrics, Small Organs (breast, thyroid, penis and prostate), Neonatal/Adult Cephalic, Cardiac (adult, pediatric and neonatal), Trans-esophageal, Transrectal, Transvaginal, Peripheral Vessel, and Musculo-skeletal (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 analysis packages that provide information that is used for clinical diagnosis purposes.

રે. Technological Comparison to Predicate Device:

The Sequoia is substantially equivalent in its technologies and functionality to the Sequoia Diagnostic Ultrasound System Signature II, that is already cleared for USA distribution under 510(k) premarket notification number K022567.

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 two-dimensional 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 twodimensional images. All predicate devices listed above, allow for specialized measurements of structures and flow, and provide various calculations functions.

End of 510(k) Summary

2

Public Health Service

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized eagle-like symbol with three curved lines representing the bird's body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Siemens Medical Solutions USA, Inc. % Ms. Laura Danielson Responsible Third Party 510(k) Program Manager TÜV Product Service 1775 Old Highway 8 NW, Suite 104 NEW BRIGHTON MN 25112-1891

JUL 21 2003

Re: K032114

Trade Name: Sequoia 8.0 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: July 8, 2003 Received: July 9, 2003

Dear Ms. Danielson:

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

This determination of substantial equivalence applies to the following transducers intended for use with the Sequoia 8.0 Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

4C1 5C2

3

6C2
8C4
EC10c5
EV8C4
6L3
AcuNav IC10V5/10F10 (Catheter)
8L5
8L5T
13L5SP
15L8
15L8w
V5M TEE
V7M TEE
V7B TEE
3V2c
4V1
4V1c (Sirius)
4V2
5V2c
7V3c
Gemini
8V5
10V4
AUX CW

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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic

product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

4

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

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

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801, please contact the Office of Compliance at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 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 (301) 594-1212.

Sincerely yours.

David A. Symm

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

Enclosure(s)

5

510(k) Number (if known):

8,0

Device Name: Intended Use:

Sequoia Diagnostic Ultrasound System

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

Mode of OperationOther :
Clinical ApplicationABMPWDCWDColor
DopplerPower
(Amplitude)
DopplerColor
Velocity
ImagingCombined
(Specify)Harmonic
Imaging3D
Ophthalmic
FetalPPPPPPPP*PP
AbdominalPPPPPPPP*PP
Intraoperative
AbdominalPPPPPPPP*PP
Intraoperative
NeurologicalPPPPPPPP*PP
PediatricPPPPPPPP*PP
Small Organ
(Specify) **PPPPPPPP*PP
Neonatal CephalicPPPPPPPP*PP
Adult CephalicPPPPPPPP*PP
CardiacPPPPPPPP*PP
Trans-esophagealPPPPPPPP*PP
TransrectalPPPPPPPP*PP
TransvaginalPPPPPPPP*PP
Transurethral
Intravascular
Peripheral vesselPPPPPPPP*PP
Laparoscopic
Musculo-skeletal
ConventionalPPPPPPPP*PP
Musculo-skeletal
SuperficialPPPPPPPP*PP
Other (specify) ***PPPPPPPP*PP

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Additional Comments:

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

B+PWD+Color Doppler, B+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+M+Power Doppler

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

*** neonatal cardiac

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

Concurre

6

510(k) Number (if known):

Device Name:

4C1

Intended Use:

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

Mode of Operation
Clinical ApplicationABMPWDCWDColor
DopplerPower
(Amplitude)
DopplerColor
Velocity
ImagingCombined
(Specify)Other :
Harmonic
ImagingOther :
3D
Ophthalmic
FetalPPPPPPP*PP
AbdominalPPPPPPP*PP
Intraoperative
Abdominal
Intraoperative
Neurological
PediatricPPPPPPP*PP
Small Organ
(Specify) **PPPPPPP*PP
Neonatal Cephalic
Adult Cephalic
CardiacNNNNNNN*NN
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vesselNNNNNNN*NN
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify) ***

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Additional Comments:

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

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

(PLEASE 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 (0

7

5C2

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Device Name: Intended Use:

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

Mode of Operation
Clinical ApplicationABMPWDCWDColor
DopplerPower
(Amplitude)
DopplerColor
Velocity
ImagingCombined
(Specify)Other :
Harmonic
ImagingOther :
3D
Ophthalmic
FetalPPPPPPP*PP
AbdominalPPPPPPP*PP
Intraoperative
Abdominal
Intraoperative
Neurological
PediatricPPPPPPP*PP
Small Organ
(Specify) **
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vesselNNNNNNN*NN
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify) ***

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Additional Comments:

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

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

David A. Syzman

(Division Sig Division o and Radiolo 510(k) Number

8

510(k) Number (if known):

Device Name:

6C2

Intended Use:

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

Mode of Operation
Clinical ApplicationABMPWDCWDColor
DopplerPower
(Amplitude)
DopplerColor
Velocity
ImagingCombined
(Specify)Other :
Harmonic
ImagingOther :
3D
Ophthalmic
FetalPPPPPPP*PP
AbdominalPPPPPPP*PP
Intraoperative
AbdominalPPPPPPP*PP
Intraoperative
NeurologicalPPPPPPP*PP
PediatricPPPPPPP*PP
Small Organ
(Specify) **PPPPPPP*PP
Neonatal Cephalic
Adult Cephalic
CardiacNNNNNNN*NN
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vesselPPPPPPP*PP
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify) ***

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Additional Comments:

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

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

David R. Ingram

(Divis Divi and Ra 510(k) Number

9

8C4

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Device Name: Intended Use:

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

Mode of Operation
Clinical ApplicationABMPWDCWDColor
DopplerPower
(Amplitude)
DopplerColor
Velocity
ImagingCombined
(Specify)Other :
Harmonic
ImagingOther :
3D
Ophthalmic
FetalPPPPPPP*PP
AbdominalPPPPPPP*PP
Intraoperative
AbdominalPPPPPPP*PP
Intraoperative
NeurologicalPPPPPPP*PP
PediatricPPPPPPP*PP
Small Organ
(Specify) **
Neonatal Cephalic
Adult Cephalic
CardiacNNNNNNN*NN
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vesselNNNNNNN*NN
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify) ***

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Additional Comments:

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

(PLEASE 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. Swanson

(Division Sig Division of Re and Radiological Devi -510k) Numt

10

510(k) Number (if known):

Device Name: Intended Use: EC10c5

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

Mode of Operation
Clinical ApplicationABMPWDCWDColor
DopplerPower
(Amplitude)
DopplerColor
Velocity
ImagingCombined
(Specify)Other :
Harmonic
ImagingOther :
3D
Ophthalmic
Fetal
Abdominal
Intraoperative
Abdominal
Intraoperative
Neurological
Pediatric
Small Organ
(Specify) **
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
TransrectalPPPPPP*PP
TransvaginalPPPPPP*PP
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify) ***

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Additional Comments:

*Combinations include: B+M, B+PWD, B+Color Doppler, B+M+Color Doppler, B+PWD+Color Doppler,

B+Power Doppler, B+PWD+Power Doppler, B+M+Power Doppler

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

David A. Szymanski

(Division Sign Division of Reproductive, Abo and Radiological Devic 510(k) Number

11

EV8C4

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Device Name:

Intended Use:

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

Mode of Operation
Clinical ApplicationABMPWDCWDColor
DopplerPower
(Amplitude)
DopplerColor
Velocity
ImagingCombined
(Specify)Other :
Harmonic
ImagingOther :
3D
Ophthalmic
FetalPPPPPPP*PP
AbdominalPPPPPPP*PP
Intraoperative
Abdominal
Intraoperative
Neurological
Pediatric
Small Organ
(Specify) **
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
TransvaginalPPPPPPP*PP
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify) ***

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Additional Comments:

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

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

Dovid R. Symm
(Division Sign-Off)

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

12

510(k) Number (if known):

er3

Device Name: Intended Use:

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

Mode of OperationOther :
Clinical ApplicationABMPWDCWDColor
DopplerPower
(Amplitude)
DopplerColor
Velocity
ImagingCombined
(Specify)Harmonic
Imaging3D
Ophthalmic
FetalNNNNNNN*NN
Abdominal
Intraoperative
AbdominalPPPPPPP*PP
Intraoperative
NeurologicalPPPPPPP*PP
Pediatric
Small Organ
(Specify) **PPPPPPP*PP
Neonatal Cephalic
Adult Cephalic
CardiacNNNNNNN*NN
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vesselPPPPPPP*PP
Laparoscopic
Musculo-skeletal
ConventionalPPPPPPP*PP
Musculo-skeletal
SuperficialPPPPPPP*PP
Other (specify) ***

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Additional Comments:

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

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

(PLEASE 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 K032114

13

510(k) Number (if known):

Device Name:

Transducer.

Intended Use:

Sequoia Diagnostic Ultrasound System, Harmonic Imaging AcuNav (IC10V5 or 10F10) diagnostic ultrasound catheter For intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, and visualization of other devices in the heart - use in right heart only.

Mode of Operation
Clinical ApplicationABMPWDCWDColor
DopplerPower
(Amplitude)
DopplerColor
Velocity
ImagingCombined
(Specify)Other :
Harmonic
ImagingOther :
3D
Ophthalmic
Fetal
Abdominal
Intraoperative
Abdominal
Intraoperative
Neurological
Pediatric
Small Organ
(Specify) **
Neonatal Cephalic
Adult Cephalic
CardiacPPPPPP*
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)***PPPPPPP*

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Additional Comments:

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

*** Other = Intra-luminal and Intra-cardiac

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

David A. Segmen

Prescription Use (Per 21 CFR 801.109)

(Division Reproductive, Abdo and Radiological Devices 510(k) Number

14

510(k) Number (if known):

Device Name:

8-2

Intended Use:

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

Mode of Operation
Clinical ApplicationABMPWDCWDColor
DopplerPower
(Amplitude)
DopplerColor
Velocity
ImagingCombined
(Specify)Other :
Harmonic
ImagingOther :
3D
Ophthalmic
Fetal
Abdominal
Intraoperative
AbdominalPPPPPPP*PP
Intraoperative
NeurologicalPPPPPPP*PP
Pediatric
Small Organ
(Specify) **PPPPPPP*PP
Neonatal Cephalic
Adult Cephalic
CardiacNNNNNNN*NN
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vesselPPPPPPP*PP
Laparoscopic
Musculo-skeletal
ConventionalPPPPPPP*PP
Musculo-skeletal
SuperficialPPPPPPP*PP
Other (specify) ***

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Additional Comments:

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

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

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

David R. Sigerson

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

15

510(k) Number (if known):

Device Name:

8L5T

Intended Use:

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

Mode of Operation
Clinical ApplicationABMPWDCWDColor
DopplerPower
(Amplitude)
DopplerColor
Velocity
ImagingCombined
(Specify)Other :
Harmonic
ImagingOther :
3D
Ophthalmic
Fetal
Abdominal
Intraoperative
AbdominalPPPPPPPP*PP
Intraoperative
NeurologicalPPPPPPPP*PP
PediatricPPPPPPPP*PP
Small Organ
(Specify) **PPPPPPPP*PP
Neonatal Cephalic
Adult Cephalic
CardiacPPPPPPPP*PP
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vesselPPPPPPPP*PP
Laparoscopic
Musculo-skeletal
ConventionalPPPPPPPP*PP
Musculo-skeletal
SuperficialPPPPPPPP*PP
Other (specify) ***

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Additional Comments:

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

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

(PLEASE 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)

Daniel R. Syverson

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

16

510(k) Number (if known):

Device Name:

1315SP

Intended Use:

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

Mode of Operation
Clinical ApplicationABMPWDCWDColor
DopplerPower
(Amplitude)
DopplerColor
Velocity
ImagingCombined
(Specify)Other :
Harmonic
ImagingOther :
3D
Ophthalmic
Fetal
Abdominal
Intraoperative
AbdominalPPPPPPP*PP
Intraoperative
NeurologicalPPPPPPP*PP
PediatricPPPPPPP*PP
Small Organ
(Specify) **PPPPPPP*PP
Neonatal Cephalic
Adult Cephalic
CardiacPPPPPPP*PP
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vesselPPPPPPP*PP
Laparoscopic
Musculo-skeletal
ConventionalPPPPPPP*PP
Musculo-skeletal
SuperficialPPPPPPP*PP
Other (specify) ***

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Additional Comments:

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

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

(PLEASE 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 R. Symmon
(Division Sign-Off)

Division of Reproductive, Abd and Padiological Devices 510(k) Number_

17

510(k) Number (if known):

Device Name:

1258

Intended Use:

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

Clinical ApplicationMode of Operation
ABMPWDCWDColor
DopplerPower
(Amplitude)
DopplerColor
Velocity
ImagingCombined
(Specify)Other :
Harmonic
ImagingOther :
3D
Ophthalmic
Fetal
Abdominal
Intraoperative
AbdominalPPPPPPPP*PP
Intraoperative
NeurologicalPPPPPPPP*PP
PediatricNNNNNNNN*NN
Small Organ
(Specify) **PPPPPPPP*PP
Neonatal Cephalic
Adult Cephalic
CardiacPPPPPPP*PP
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vesselPPPPPPPP*PP
Laparoscopic
Musculo-skeletal
ConventionalPPPPPPPP*PP
Musculo-skeletal
SuperficialPPPPPPPP*PP
Other (specify) ***

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Additional Comments:

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

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

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

David R. Segerson

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

18

510(k) Number (if known):

Device Name:

15L8w

Intended Use:

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

Mode of Operation
Clinical ApplicationABMPWDCWDColor
DopplerPower
(Amplitude)
DopplerColor
Velocity
ImagingCombined
(Specify)Other :
Harmonic
ImagingOther :
3D
Ophthalmic
FetalPPPPPP*P
AbdominalPPPPPP*P
Intraoperative
AbdominalPPPPPP*P
Intraoperative
NeurologicalPPPPPP*P
PediatricPPPPPP*P
Small Organ
(Specify) **PPPPPP*P
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vesselPPPPPP*P
Laparoscopic
Musculo-skeletal
ConventionalPPPPPP*P
Musculo-skeletal
SuperficialPPPPPP*P
Other (specify) ***

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Additional Comments:

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

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

(PLEASE 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)

sion Sign-Off)
on of Reproductive, Abdominal,
adiological Devices,
5.) Number LD32114

19

510(k) Number (if known):

Device Name:

V5M TEE

Intended Use:

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

Mode of Operation
Clinical ApplicationABMPWDCWDColor
DopplerPower
(Amplitude)
DopplerColor
Velocity
ImagingCombined
(Specify)Other :
Harmonic
ImagingOther :
3D
Ophthalmic
Fetal
AbdominalPPPPPPP*PP
Intraoperative
Abdominal
Intraoperative
Neurological
PediatricPPPPPPPP
Small Organ
(Specify) **
Neonatal Cephalic
Adult Cephalic
CardiacPPPPPPP*PP
Trans-esophagealPPPPPPP*PP
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify) ***

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Additional Comments:

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

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

David A. Lyon

(Division Off)
roductive, Abdominal,
al Devices
32114
De
5
n
Downl

20

510(k) Number (if known):

Device Name:

V7M TEE

Intended Use:

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

Mode of Operation
Clinical ApplicationABMPWDCWDColor
DopplerPower
(Amplitude)
DopplerColor
Velocity
ImagingCombined
(Specify)Other :
Harmonic
ImagingOther :
3D
Ophthalmic
Fetal
AbdominalPPPPPPP*PP
Intraoperative
Abdominal
Intraoperative
Neurological
PediatricPPPPPPP*PP
Small Organ
(Specify) **
Neonatal Cephalic
Adult Cephalic
CardiacPPPPPPP*PP
Trans-esophagealPPPPPPP*PP
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify) ***

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Additional Comments:

and Radiological Devices

510(k) Number _

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

(PLEASE 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)

mil A
(Division Sign-Off)
Division of Reproductive, Abdominal,

21

510(k) Number (if known):

Device Name:

V7B TEE

Intended Use:

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

Mode of Operation
Clinical ApplicationABMPWDCWDColor
DopplerPower
(Amplitude)
DopplerColor
Velocity
ImagingCombined
(Specify)Other :
Harmonic
ImagingOther :
3D
Ophthalmic
Fetal
AbdominalPPPPPPP*PP
Intraoperative
Abdominal
Intraoperative
Neurological
PediatricPPPPPPP*PP
Small Organ
(Specify) **
Neonatal Cephalic
Adult Cephalic
CardiacPPPPPPP*PP
Trans-esophagealPPPPPPP*PP
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify) ***

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Additional Comments:

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

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

David G. Sygman

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

22

510(k) Number (if known):

Device Name:

3V2c

Intended Use:

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

Mode of Operation
Clinical ApplicationABMPWDCWDColor
DopplerPower
(Amplitude)
DopplerColor
Velocity
ImagingCombined
(Specify)Other :
Harmonic
ImagingOther :
3D
Ophthalmic
FetalPPPPPPP*PP
AbdominalPPPPPPP*PP
Intraoperative
Abdominal
Intraoperative
Neurological
PediatricPPPPPPP*PP
Small Organ
(Specify) **
Neonatal Cephalic
Adult CephalicPPPPPPP*PP
CardiacPPPPPPP*PP
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify) ***PPPPPPP*PP

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Additional Comments:

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

*** neonatal cardiac

(PLEASE 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 R. Lynn

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

23

4V1

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Device Name:

Intended Use:

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

Mode of Operation
Clinical ApplicationABત્ત્વPWDCWDColor
DopplerPower
(Amplitude)
DopplerColor
Velocity
ImagingCombined
(Specify)Other :
Harmonic
ImagingOther :
3D
Ophthalmic
FetalPPPPPP*PP
AbdominalPPPPPP*PP
Intraoperative
AbdominalPPPPPP*PP
Intraoperative
Neurological
PediatricPPPPPP*PP
Small Organ
(Specify) **
Neonatal Cephalic
Adult Cephalic
CardiacNNNત્ત્વNN+NN
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vesselਮNNNત્તN*NN
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify) ***

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Additional Comments:

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

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

Ovid A. Sazm

(Division Sign-Off)
Division of Reproductive, Abdominal

Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. D032114

24

510(k) Number (if known):

Device Name:

4V1c (Sirius)

Intended Use:

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

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

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Additional Comments:

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

** neonatal cardiac

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

David A. Sypm

(Division Sign-Off) Division of Reproductive, Abdo ****************************************************************************************************************************************************************************** ******************************************************************************************************************************************************************************

25

510(k) Number (if known):

Device Name:

4V2

Intended Use:

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

Mode of Operation
Clinical ApplicationABMPWDCWDColor
DopplerPower
(Amplitude)
DopplerColor
Velocity
ImagingCombined
(Specify)Other:
Harmonic
ImagingOther:
3D
Ophthalmic
FetalPPPPPPP*PP
AbdominalPPPPPPP*PP
Intraoperative
Abdominal
Intraoperative
Neurological
PediatricPPPPPPP*PP
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) ***

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Additional Comments:

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

(PLEASE 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) Paymon of Reproductive, Abdo .. Badiological Devices 10(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:

Mode of Operation
Clinical ApplicationABMPWDCWDColor
DopplerPower
(Amplitude)
DopplerColor
Velocity
ImagingCombined
(Specify)Other :
Harmonic
ImagingOther :
3D
Ophthalmic
FetalPPPPPPP*PP
AbdominalPPPPPPP*PP
Intraoperative
Abdominal
Intraoperative
Neurological
PediatricPPPPPPP*PP
Small Organ
(Specify) **
Neonatal Cephalic
Adult Cephalic
CardiacPPPPPPP*PP
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vesselNNNNNNN*NN
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify) ***PPPPPPP*PP

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Additional Comments:

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

*** neonatal cardiac

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

David R. Dygert
(Division Sign-Off)

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

27

7V3c

Diagnostic Ultrasound Indications for Use Form

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) | Other :
Harmonic
Imaging | Other :
3D |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------------------|---------------|
| Ophthalmic | | | | | | | | | | | |
| 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 | | P* | P | P |
| Intraoperative
Neurological | | P | P | P | P | P | P | | P* | P | P |
| Pediatric | | P | P | P | P | P | P | | P* | P | P |
| Small Organ
(Specify) ** | | | | | | | | | | | |
| Neonatal Cephalic | | P | P | P | P | P | P | | P* | P | P |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | P | P | P | P | P | P | | P* | P | P |
| Trans-esophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral vessel | | N | N | N | N | N | N | | N* | N | N |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | | |
| Other (specify) *** | | P | P | P | P | P | P | | P* | P | P |

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Additional Comments:

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

*** neonatal cardiac

(PLEASE 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, Abdominal,
and Redological Devices
510(k) Number K032114

28

510(k) Number (if known):

Device Name: Intended Use:

Gemini

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

Mode of Operation
Clinical ApplicationABMPWDCWDColor
DopplerPower
(Amplitude)
DopplerColor
Velocity
ImagingCombined
(Specify)Other :
Harmonic
ImagingOther :
3D
Ophthalmic
FetalNNNNNNN*N
AbdominalNNNNNNN*N
Intraoperative
AbdominalNNNNNNN*N
Intraoperative
NeurologicalNNNNNNN*N
PediatricNNNNNNN*N
Small Organ
(Specify) **
Neonatal CephalicNNNNNNN*N
Adult Cephalic
CardiacNNNNNNN*N
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify) ***NNNNNNN*N

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Additional Comments:

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

*** neonatal cardiac

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

David A. Segerson

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

29

8/5

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Device Name:

Intended Use:

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

Mode of Operation
Clinical ApplicationABMPWDCWDColor
DopplerPower
(Amplitude)
DopplerColor
Velocity
ImagingCombined
(Specify)Other :
Harmonic
ImagingOther :
3D
Ophthalmic
FetalPPPPPPP*PP
AbdominalPPPPPPP*PP
Intraoperative
AbdominalPPPPPPP*PP
Intraoperative
NeurologicalPPPPPPP*PP
PediatricPPPPPPP*PP
Small Organ
(Specify) **
Neonatal CephalicPPPPPPP*PP
Adult Cephalic
CardiacPPPPPPP*PP
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vesselNNNNNNN*NN
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify) ***PPPPPPP*PP

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Additional Comments:

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

*** neonatal cardiac

(PLEASE 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 R. Egerman
(Division Sign-Off)

(Division Sign-On)
Division of Reproductive, Abdor Divice Padiological Devices

30

510(k) Number (if known):

Device Name: Intended Use: 10V4

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

Mode of Operation
Clinical ApplicationABMPWDCWDColor
DopplerPower
(Amplitude)
DopplerColor
Velocity
ImagingCombined
(Specify)Other :
Harmonic
ImagingOther :
3D
Ophthalmic
FetalPPPPPPPP*PP
AbdominalPPPPPPPP*PP
Intraoperative
AbdominalPPPPPPPP*PP
Intraoperative
NeurologicalPPPPPPPP*PP
PediatricPPPPPPPP*PP
Small Organ
(Specify) **PPPPPPPP*PP
Neonatal CephalicPPPPPPPP*PP
Adult Cephalic
CardiacPPPPPPPP*PP
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify) ***PPPPPPPP*PP

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Additional Comments:

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

B+PWD+Color Doppler, B+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+M+Power Doppler

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

*** neonatal cardiac

(PLEASE 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 R. Heyman

(fivision Sign-Off) [ vision of Reproductive, Abdo and 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:

Mode of Operation
Clinical ApplicationABMPWDCWDColor
DopplerPower
(Amplitude)
DopplerColor
Velocity
ImagingCombined
(Specify)Other :
Harmonic
ImagingOther :
3D
Ophthalmic
Fetal
Abdominal
Intraoperative
Abdominal
Intraoperative
Neurological
PediatricP
Small Organ
(Specify) **
Neonatal Cephalic
Adult Cephalic
CardiacP
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vesselP
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify) ***

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Additional Comments:

(PLEASE 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 M. Solomon

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