The Venue is a general purpose diagnostic ultrasound system for use by qualified healthcare professionals. The clinical environments where the Venue can be used include critical care and emergency room environments, as well as point-of care areas in offices, clinical and hospital settings for diagnosis of patients.

The Venue is intended for ultrasound imaging, measurement and analysis of the human body and fluid for multiple clinical applications including: abdominal (GYN and Urology), thoracic/pleural, ophthalmic, Fetal/Organ (including breast, testes, thyroid). Peripheral vascular, neonatal and adult cephalic, musculoskeletal (conventional and superficial), cardiac (adults and pediatric), Transvaginal, Transesophageal, and imaging guidance of interventional procedures (e.g. Nerve block, vascular access).

Device Description

The proposed Venue system is a general-purpose, Track 3, diagnostic ultrasound device, intended for ultrasound imaging, measurement and analysis of the human body and fluid that provides digital acquisition, processing and display capabilities. Venue can be used in offices, clinical areas and hospitals. The Venue is a mobile system with a small footprint that easily fits into tight spaces and positioned to accommodate the sometimes-awkward work settings of the point of care user. The Venue has a high resolution color LCD monitor, with a simple, multi-touch user interface that makes the system intuitive. The single surface screen can be cleaned with disinfectants. Articulated monitor arm enables flexible display positions in order to be accessible and clearly visible in both user-standing and sitting positions.

The proposed Venue has the capability for displaying the patient's ECG trace synchronized to the scanned image. This allows the user to view an image from a specific time of the ECG signal. The ECG signal can be input directly from the patient or as an output from an ECG monitoring device. ECG is not intended for monitoring or diagnosis.

The Venue has a battery that allows for scanning without the need to plug in to an electrical outlet. The system is capable of wireless communication and a barcode reader is available to be used as an input device. System meets DICOM requirements to support users image storage and archiving needs and allows for output to printing devices. The user documentation is available via electronic media.

The Venue utilizes a variety of linear, convex, and phased array transducers which provide high imaging capability, supporting all standard acquisition modes. Some biopsy kits are available for needle-guidance procedures. The system includes several automated tools designed to simplify and shorten the workflow time of the healthcare professional for some common assessments.

AI/ML Overview

The provided document does not describe an acceptance criterion or a study to prove a device meets acceptance criteria related to clinical performance or algorithm accuracy.

Instead, this document is a 510(k) premarket notification for the GE Venue ultrasound system, asserting its substantial equivalence to previously cleared predicate devices. The review focuses on:

Intended Use and Indications for Use: Defining the clinical applications and environments where the Venue can be used.
Technological Characteristics: Comparing the Venue's technology (imaging modes, transducers, automated features, ECG module) to predicate devices.
Safety and Effectiveness: Demonstrating compliance with voluntary standards for acoustic output, biocompatibility, cleaning/disinfection, and electrical/mechanical safety through non-clinical tests.

The document explicitly states: "The subject of this premarket submission, Venue, did not require clinical studies to support substantial equivalence." This means that for the purpose of this 510(k) submission, the device's performance was not evaluated against specific clinical acceptance criteria in a study that would involve metrics like sensitivity, specificity, or reader performance.

Therefore, I cannot provide the requested information from the given text. The device's "performance" in this context refers to its technological capabilities and safety features, which are demonstrated through compliance with established standards and comparison to predicate devices, rather than through a clinical performance study with defined acceptance criteria.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right of it is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC GE Healthcare % Tracey Ortiz Regulatory Affairs Director 9900 W. Innovation Drive WAUWATOSA WI 53226

Re: K180599

Trade/Device Name: Venue Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: March 7, 2018 Received: March 8, 2018

Dear Tracey Ortiz:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

May 2, 2018

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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn

(http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D. O'Hara For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K180599

Device Name

Venue

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

See PRA Statement below.

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/3/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The letters are white and are set against a blue circular background. The blue background is surrounded by a white border with three stylized swirls.

Indications for Use Forms

The following forms represent indications with clinical applications and exam types along with the modes of operation for the Venue. Combinations identified "P" represents those previously cleared with another GE Ultrasound system. Combinations identified as "N" are new.

The following Indication for Use forms are appended:

System: Venue Transducer: 3Sc-RS Transducer: 9L-RS Transducer: C1-5-RS Transducer: 8C-RS Transducer: E8C-RS Transducer: 12L-RS Transducer: L12n-RS Transducer: 6Tc-RS

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Image /page/4/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a circular shape. The circle is made up of a series of wave-like lines that create a swirling effect around the letters. The logo is colored in a light blue hue.

GE Healthcare 510(k) Premarket Notification Submission

Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes[*]	HarmonicImaging	CodedPulse♦	Other
Ophthalmic	P				P		P
Fetal / Obstetrics	P	P	P		P	P	P	P	P	P
Abdominal [1]	P	P	P		P	P	P	P	P	P
Pediatric	P	P	P		P	P	P	P	P	P
Small Organ [2]	P	P	P		P	P	P	P	P	P
Neonatal Cephalic	P	P	P		P	P	P	P	P	P
Adult Cephalic	P	P	P		P	P	P	P	P	P
Pediatric Cardiac	P	P	P	P	P	P	P2	P	P	P2	6
Adult Cardiac	P	P	P	P	P	P	P2	P	P	P2	6
Peripheral Vascular	P	P	P		P	P	P	P	P	P
Musculo-skeletal Conventional	P	P	P		P	P	P	P	P	P
Musculo-skeletal Superficial	P	P	P		P	P	P	P	P	P
Thoracic/Pleural [3]	P	P	P		P	P	P	P	P	P
Exam Type, Means of Access
Transesophageal	P2	P2	P2	P2	P2	P2		N	P2	P2	6
Transrectal	P	P	P		P	P	P	P	P	P
Transvaginal	P	P	P		P	P	P	P	P	P
Interventional Guidance
Vascular Access (IV, PICC)	P	P	P		P	P	P	P	P	P	5,7
Nonvascular [5]	P	P	P		P	P	P	P	P	P	5,7

GE Venue Ultrasound System

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N = new indication; P = previously cleared by FDA K170714; P1 = previously cleared by FDA K163596; P2 = previously cleared by FDA K161706;

Notes: [1] Abdominal includes GYN and Urology (includes prostate);

[2] Small Organ includes breast, testes, thyroid;

[3] Including detection of fluid and pleural motion/sliding;

[4] Nonvascular includes nerve block or biopsy;

[5] Biopsy bracket available;

[6] Combined modes as defined in [*], but exclude B/Power/PWD, and include: B/CWD, B/Color/CWD;

[7] Image guidance supports freehand needle/catheter placement;

[*] Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD;

[+] Coded pulse is for digitally encoded harmonics;

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Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' written in a stylized script, enclosed within a blue circle. The circle has a decorative border with wave-like patterns around the edge.

GE Healthcare

510(k) Premarket Notification Submission

GE Venue with 3Sc-RS Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes[*]	HarmonicImaging	CodedPulse•	Other
Ophthalmic	P				P		P
Fetal / Obstetrics	P	P	P		P	P	P	P	P
Abdominal [1]	P	P	P		P	P	P	P	P
Pediatric	P1	P1	P1		P1	P1	P1	P1	P1
Small Organ [2]
Neonatal Cephalic
Adult Cephalic	P	P	P		P	P	P	P	P
Pediatric Cardiac	P	P	P	P	P	P	P	P	P		6
Adult Cardiac	P	P	P	P	P	P	P	P	P		6
Peripheral Vascular	P	P	P		P	P	P	P	P
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Thoracic/Pleural [3]	P	P	P		P	P	P	P	P
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Interventional Guidance
Vascular Access (IV, PICC)	P	P	P		P	P	P	P	P		7
Nonvascular [5]

N = new indication; P = previously cleared by FDA K170714; P1 = previously cleared by FDA K163596; P2 = previously cleared by FDA K161706;

Notes: [1] Abdominal includes GYN and Urology (includes prostate);

[2] Small Organ includes breast, testes, thyroid;

[3] Including detection of fluid and pleural motion/sliding;

[4] Nonvascular includes nerve block or biopsy;

[5] Biopsy bracket available;

[6] Combined modes as defined in [*], but exclude B/Power/PWD, and include: B/CWD,

B/Color/CWD:

[7] Image quidance supports freehand needle/catheter placement;

[*] Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD;

[ +] Coded pulse is for digitally encoded harmonics;

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Image /page/6/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized script, enclosed within a blue circle. The circle has decorative swirls around the letters, giving it a classic and recognizable appearance.

GE Venue with 9L-RS Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes[*]	HarmonicImaging	CodedPulse	Other
Ophthalmic	N				N		N
Fetal / Obstetrics	N	N	N		N	N	N	N	N	N
Abdominal [1]	P	P	P	P	P	P	P	P	P	P
Pediatric	P	P	P	P	P	P	P	P	P	P
Small Organ [2]	P	P	P	P	P	P	P	P	P	P
Neonatal Cephalic	P2	P2	P2	P2	P2	N	P2	N	P2	P2
Adult Cephalic
Pediatric Cardiac	N	N	N	N	N	N	N	N	N	N
Adult Cardiac	N	N	N	N	N	N	N	N	N	N
Peripheral Vascular	P	P	P	P	P	P	P	P	P	P
Musculo-skeletal Conventional	P	P	P	P	P	P	P	P	P	P
Musculo-skeletal Superficial	P	P	P	P	P	P	P	P	P	P
Thoracic/Pleural [3]	P	P	P	P	P	P	P	P	P	P
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Interventional Guidance
Vascular Access (IV, PICC)	P	P	P	P	P	P	P	P	P	P	5,7
Nonvascular [5]	P	P	P	P	P	P	P	P	P	P	5,7

N = new indication; P = previously cleared by FDA K170714; P1 = previously cleared by FDA K163596; P2 = previously cleared by FDA K161706;

Notes: [1] Abdominal includes GYN and Urology (includes prostate);

[2] Small Organ includes breast, testes, thyroid;

[3] Including detection of fluid and pleural motion/sliding;

[4] Nonvascular includes nerve block or biopsy;

[5] Biopsy bracket available;

[6] Combined modes as defined in [*], but exclude B/Power/PWD, and include: B/CWD,

B/Color/CWD:

[7] Image quidance supports freehand needle/catheter placement;

[*] Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD;

[+] Coded pulse is for digitally encoded harmonics.

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Image /page/7/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized script, enclosed within a blue circle. The circle has decorative swirls around the letters, giving it a classic and recognizable appearance.

GE Healthcare

510(k) Premarket Notification Submission

GE Venue with C1-5-RS Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes[*]	HarmonicImaging	CodedPulse♦	Other
Ophthalmic
Fetal / Obstetrics	P	P	P	P	P	P	P	P	P	P
Abdominal [1]	P	P	P	P	P	P	P	P	P	P
Pediatric	P	P	P	P	P	P	P	P	P	P
Small Organ [2]
Neonatal Cephalic
Adult Cephalic
Pediatric Cardiac	N	N	N	N	N	N	N	N	N	N
Adult Cardiac	N	N	N	N	N	N	N	N	N	N
Peripheral Vascular	P	P	P	P	P	P	P	P	P	P
Musculo-skeletal Conventional	P	P	P	P	P	P	P	P	P	P
Musculo-skeletal Superficial	P	P	P	P	P	P	P	P	P	P
Thoracic/Pleural [3]	P	P	P	P	P	P	P	P	P	P
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Interventional Guidance
Vascular Access (IV, PICC)	P	P	P	P	P	P	P	P	P	P	7
Nonvascular [5]	P	P	P	P	P	P	P	P	P	P	7

N = new indication; P = previously cleared by FDA K170714; P1 = previously cleared by FDA K163596; P2 = previously cleared by FDA K161706;

Notes: [1] Abdominal includes GYN and Urology (includes prostate);

[2] Small Organ includes breast, testes, thyroid;

[3] Including detection of fluid and pleural motion/sliding;

[4] Nonvascular includes nerve block or biopsy;

[5] Biopsy bracket available;

[6] Combined modes as defined in [*], but exclude B/Power/PWD, and include: B/CWD,

B/Color/CWD:

[7] Image quidance supports freehand needle/catheter placement;

[*] Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD;

[↓] Coded pulse is for digitally encoded harmonics.

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Image /page/8/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized script, enclosed within a blue circle. The circle has decorative swirls around the letters, giving it a classic and recognizable appearance.

GE Healthcare

510(k) Premarket Notification Submission

GE Venue with 8C-RS Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes[*]	HarmonicImaging	CodedPulse *	Other
Ophthalmic
Fetal / Obstetrics
Abdominal [1]	P	P	P	P	P	P	P	P	P	P
Pediatric	P	P	P	P	P	P	P	P	P	P
Small Organ [2]
Neonatal Cephalic	P	P	P	P	P	P	P	P	P	P
Adult Cephalic	P	P	P	P	P	P	P	P	P	P
Pediatric Cardiac	P2	P2	P2	P2	P2	P2	P2	N	P2	P2
Adult Cardiac	P2	P2	P2	P2	P2	P2	P2	N	P2	P2
Peripheral Vascular	P2	P2	P2	P2	P2	P2	P2	N	P2	P2
Musculo-skeletal Conventional	P	P	P	P	P	P	P	P	P	P
Musculo-skeletal Superficial	P	P	P	P	P	P	P	P	P	P
Thoracic/Pleural [3]	P	P	P	P	P	P	P	P	P	P
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Interventional Guidance
Vascular Access (IV, PICC)
Nonvascular [5]	N	N	N		N	N	N	N	N	N

N = new indication; P = previously cleared by FDA K170714; P1 = previously cleared by FDA K163596; P2 = previously cleared by FDA K161706;

Notes: [1] Abdominal includes GYN and Urology (includes prostate);

[2] Small Organ includes breast, testes, thyroid;

[3] Including detection of fluid and pleural motion/sliding;

[4] Nonvascular includes nerve block or biopsy;

[5] Biopsy bracket available;

[6] Combined modes as defined in [*], but exclude B/Power/PWD, and include: B/CWD,

B/Color/CWD:

[7] Image quidance supports freehand needle/catheter placement;

[*] Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD;

[↓] Coded pulse is for digitally encoded harmonics.

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Image /page/9/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' written in a stylized script, enclosed within a blue circle. The circle has a decorative border with wave-like patterns around the edge.

Mode of Operation Clinical Application Color Color M PW CW Power Combined Harmonic Coded Other B M Doppler Doppler Doppler Doppler Doppler Modes[] lmaqinq Anatomy/Region of Interest Pulse Ophthalmic Fetal / Obstetrics P P P P P P P P P P P P P P P P P P Abdominal [1] Pediatric Small Organ [2] Neonatal Cephalic Adult Cephalic Pediatric Cardiac Adult Cardiac Peripheral Vascular Musculo-skeletal Conventional Musculo-skeletal Superficial Thoracic/Pleural [3] Exam Type, Means of Access Transesophageal b P P P P P Р b b Transrectal P P P P P P P P P Transvaginal Interventional Guidance Vascular Access (IV, PICC) Nonvascular [5]

GE Venue with E8C-RS Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N = new indication; P = previously cleared by FDA K170714; P1 = previously cleared by FDA K163596; P2 = previously cleared by FDA K161706;

Notes: [1] Abdominal includes GYN and Urology (includes prostate);

[2] Small Organ includes breast, testes, thyroid;

[3] Including detection of fluid and pleural motion/sliding;

[4] Nonvascular includes nerve block or biopsy;

[5] Biopsy bracket available;

[6] Combined modes as defined in [*], but exclude B/Power/PWD, and include: B/CWD, B/Color/CWD:

[7] Image guidance supports freehand needle/catheter placement;

[*] Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD;

[↓] Coded pulse is for digitally encoded harmonics.

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Image /page/10/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" written in a stylized script, enclosed within a blue circle. The letters are white, creating a contrast against the blue background. The logo is simple and recognizable, representing the well-known multinational corporation.

GE Healthcare 510(k) Premarket Notification Submission

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes[*]	HarmonicImaging	CodedPulse♦	Other
Ophthalmic	P				P		P
Fetal / Obstetrics
Abdominal [1]	P	P	P	P	P	P	P	P	P	P
Pediatric	P	P	P	P	P	P	P	P	P	P
Small Organ [2]	P	P	P	P	P	P	P	P	P	P
Neonatal Cephalic	P2	P2	P2	P2	P2	N	P2	P2	P2	P2
Adult Cephalic
Pediatric Cardiac	N	N	N	N	N	N	N	N	N	N
Adult Cardiac	N	N	N	N	N	N	N	N	N	N
Peripheral Vascular	P	P	P	P	P	P	P	P	P	P
Musculo-skeletal Conventional	P	P	P	P	P	P	P	P	P	P
Musculo-skeletal Superficial	P	P	P	P	P	P	P	P	P	P
Thoracic/Pleural [3]	P	P	P	P	P	P	P	P	P	P
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Interventional Guidance
Vascular Access (IV, PICC)	P	P	P	P	P	P	P	P	P	P	5,7
Nonvascular [5]	P	P	P	P	P	P	P	P	P	P	5,7

GE Venue with 12L-RS Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N = new indication; P = previously cleared by FDA K170714; P1 = previously cleared by FDA K163596; P2 = previously cleared by FDA K161706;

Notes: [1] Abdominal includes GYN and Urology (includes prostate);

[2] Small Organ includes breast, testes, thyroid;

[3] Including detection of fluid and pleural motion/sliding;

[4] Nonvascular includes nerve block or biopsy;

[5] Biopsy bracket available;

[6] Combined modes as defined in [*], but exclude B/Power/PWD, and include: B/CWD, B/Color/CWD:

[7] Image guidance supports freehand needle/catheter placement;

[*] Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD;

[+] Coded pulse is for digitally encoded harmonics.

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Image /page/11/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a blue circle. The circle has decorative, swirling elements around the perimeter, giving it a classic and recognizable appearance. The logo is simple, yet distinctive, representing the long-standing brand identity of General Electric.

GE Healthcare 510(k) Premarket Notification Submission

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes[*]	HarmonicImaging	CodedPulse•	Other
Ophthalmic	P				P		P
Fetal / Obstetrics
Abdominal [1]	P	P	P	P	P	P	P	P	P	P
Pediatric	P	P	P	P	P	P	P	P	P	P
Small Organ [2]	P	P	P	P	P	P	P	P	P	P
Neonatal Cephalic	P1	P1	N		P1	N	P1	P1	P1	N
Adult Cephalic
Pediatric Cardiac	N	N	N	N	N	N	N	N	N	N
Adult Cardiac	N	N	N	N	N	N	N	N	N	N
Peripheral Vascular	P	P	P	P	P	P	P	P	P	P
Musculo-skeletal Conventional	P	P	P	P	P	P	P	P	P	P
Musculo-skeletal Superficial	P	P	P	P	P	P	P	P	P	P
Thoracic/Pleural [3]	P	P	P	P	P	P	P	P	P	P
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Interventional Guidance
Vascular Access (IV, PICC)	P	P	P		P	P	P	P	P	P	5,7
Nonvascular [5]	P	P	P		P	P	P	P	P	P	5,7

GE Venue with L12n-RS Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N = new indication; P = previously cleared by FDA K170714; P1 = previously cleared by FDA K163596; P2 = previously cleared by FDA K161706;

Notes: [1] Abdominal includes GYN and Urology (includes prostate);

[2] Small Organ includes breast, testes, thyroid;

[3] Including detection of fluid and pleural motion/sliding;

[4] Nonvascular includes nerve block or biopsy;

[5] Biopsy bracket available;

[6] Combined modes as defined in [*], but exclude B/Power/PWD, and include: B/CWD, B/Color/CWD:

[7] Image guidance supports freehand needle/catheter placement;

[*] Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD;

[+] Coded pulse is for digitally encoded harmonics.

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Image /page/12/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized script, enclosed within a blue circle. The letters are white, creating a contrast against the blue background of the circle.

GE Healthcare 510(k) Premarket Notification Submission

Clinical ApplicationAnatomy/Region of Interest		Mode of Operation
	B	M	PW Doppler	CW Doppler	Color Doppler	Color M Doppler	Power Doppler	Combined Modes[*]	Harmonic Imaging	Coded Pulse •	Other
Ophthalmic
Fetal / Obstetrics
Abdominal [1]
Pediatric
Small Organ [2]
Neonatal Cephalic
Adult Cephalic
Pediatric Cardiac
Adult Cardiac	P2	P2	P2	P2	P2	P2	P2	N	P2	P2	6
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Thoracic/Pleural [3]
Exam Type, Means of Access
Transesophageal	P2	P2	P2	P2	P2	P2	P2	N	P2	P2	6
Transrectal
Transvaginal
Interventional Guidance
Vascular Access (IV, PICC)
Nonvascular [5]

GE Venue with 6Tc-RS Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N = new indication; P = previously cleared by FDA K170714; P1 = previously cleared by FDA K163596; P2 = previously cleared by FDA K161706;

Notes: [1] Abdominal includes GYN and Urology (includes prostate);

[2] Small Organ includes breast, testes, thyroid;

[3] Including detection of fluid and pleural motion/sliding;

[4] Nonvascular includes nerve block or biopsy;

[5] Biopsy bracket available;

[6] Combined modes as defined in [*], but exclude B/Power/PWD, and include: B/CWD,

B/Color/CWD;

[7] Image guidance supports freehand needle/catheter placement;

[*] Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD;

[ +] Coded pulse is for digitally encoded harmonics.

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Image /page/13/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a blue circle. The circle has decorative swirls around the perimeter, giving it a dynamic and recognizable appearance. The logo is simple, yet iconic, representing the long-standing brand identity of General Electric.

510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:
Date:Submitter:	March 6, 2018GE Medical Systems Ultrasound and Primary Care Diagnostics9900 Innovation DriveWauwatosa, WI 53226
Primary Contact Person:	Tracey OrtizRegulatory Affairs DirectorGE HealthcareT:(262)470-1003F:(414)918-8275
Secondary Contact Person:	Karin ShimoniRegulatory Affairs LeaderGE Healthcare
Device Trade Name:Common/Usual Name:Classification Names:	VenueDiagnostic Ultrasound SystemClass IIUltrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-
Product Code:	IYN; Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560,90-IYO; Diagnostic Ultrasound Transducer, 21 CFR 892.1570,90-ITX
Primary Predicate Device:Secondary PredicateDevice(s):	Venue (K170714)LOGIQ e (K151028)Vivid iq (K161706)LOGIQ P9 and LOGIQ P7 (K163596)
Device Description:	The proposed Venue system is a general-purpose, Track 3,diagnostic ultrasound device, intended for ultrasound imaging,measurement and analysis of the human body and fluid thatprovides digital acquisition, processing and display capabilities.Venue can be used in offices, clinical areas and hospitals.The Venue is a mobile system with a small footprint that easilyfits into tight spaces and positioned to accommodate thesometimes-awkward work settings of the point of care user.The Venue has a high resolution color LCD monitor, with asimple, multi-touch user interface that makes the system intuitive.The single surface screen can be cleaned with disinfectants.Articulated monitor arm enables flexible display positions in

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Image /page/14/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a circular frame. The frame has decorative swirls or flourishes around the letters. The logo is presented in a blue color.

order to be accessible and clearly visible in both user-standing and sitting positions.

The Venue is a general purpose diagnostic ultrasound system for Intended Use: use by qualified healthcare professionals. The clinical environments where the Venue can be used include critical care and emergency room environments, as well as point-of care areas in offices, clinical and hospital settings for diagnosis of patients. The Venue is intended for ultrasound imaging, measurement and analysis of the human body and fluid for multiple clinical applications including: abdominal (GYN and Urology), thoracic/pleural, ophthalmic, Fetal/OB, Small Organ (including breast, testes, thyroid), Peripheral vascular, neonatal and adult cephalic, pediatric, musculoskeletal (conventional and superficial), cardiac (adults and pediatric), Transrectal, Transvaginal, Transesophageal, and imaging guidance of interventional procedures (e.g. Nerve block, vascular access).
Technology: The Venue employs the same fundamental scientific technology as its predicate devices.

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Image /page/15/Picture/0 description: The image shows the General Electric (GE) logo. The logo is a blue circle with the letters 'GE' in a stylized script inside. The letters are also blue, and the circle is surrounded by a series of curved lines that resemble water droplets or waves. The logo is simple and recognizable, and it is associated with a well-known and established company.

GE Healthcare 510(k) Premarket Notification Submission

Determination ofSubstantial Equivalence:	Comparison to Predicate Devices
	The Venue system is substantially equivalent to the predicatedevices with regards to intended use, imaging capabilities,technological characteristics and safety and effectiveness.
	The systems are all intended for ultrasound imaging,measurement and analysis of the human body and fluidfor multiple clinical applications. The Venue and predicate Venue (K170714) have similarclinical indications for use however the proposed Venuehas the Transesophageal indication which has beencleared on predicate Vivid iq (K161706). Proposed Venuehas removed Pinpoint™ GT Technology SW. The Venue and predicate Venue (K170714) have identicalimaging modes. The Venue and predicate Venue (K170714) systemstransducers are similar, except for adding 6Tc-RS, clearedin Vivid iq (K161706), and adding clinical applications tothe 9L-RS, C1-5-RS, 8C-RS, 12L-RS and L12n-RSprobes. Automated features cleared on predicate Venue(K170714) have improvements, to assist the userworkflow. Addition of the ECG module for ECG trace/imagesynchronization that was cleared with predicate LOGIQ e(K151028). Adding eFAST Navigation Tool and Review Summaryfeature that automates the workflow for the eFAST examthat can be done manually. The Venue and predicate Venue (K170714) have similarcapability in terms of performing measurements,capturing digital images, reviewing and reporting studies. The system is manufactured with materials which havebeen evaluated and found to be safe for the intended useof the device. The systems have acoustic power levels which are belowthe applicable FDA limits. The Venue and predicate Venue (K170714) have beendesigned in compliance with approved electrical andphysical safety standards.

Determination ofSubstantial Equivalence:

Comparison to Predicate Devices

The Venue system is substantially equivalent to the predicatedevices with regards to intended use, imaging capabilities,technological characteristics and safety and effectiveness.

The systems are all intended for ultrasound imaging,measurement and analysis of the human body and fluidfor multiple clinical applications. The Venue and predicate Venue (K170714) have similarclinical indications for use however the proposed Venuehas the Transesophageal indication which has beencleared on predicate Vivid iq (K161706). Proposed Venuehas removed Pinpoint™ GT Technology SW. The Venue and predicate Venue (K170714) have identicalimaging modes. The Venue and predicate Venue (K170714) systemstransducers are similar, except for adding 6Tc-RS, clearedin Vivid iq (K161706), and adding clinical applications tothe 9L-RS, C1-5-RS, 8C-RS, 12L-RS and L12n-RSprobes. Automated features cleared on predicate Venue(K170714) have improvements, to assist the userworkflow. Addition of the ECG module for ECG trace/imagesynchronization that was cleared with predicate LOGIQ e(K151028). Adding eFAST Navigation Tool and Review Summaryfeature that automates the workflow for the eFAST examthat can be done manually. The Venue and predicate Venue (K170714) have similarcapability in terms of performing measurements,capturing digital images, reviewing and reporting studies. The system is manufactured with materials which havebeen evaluated and found to be safe for the intended useof the device. The systems have acoustic power levels which are belowthe applicable FDA limits. The Venue and predicate Venue (K170714) have beendesigned in compliance with approved electrical andphysical safety standards.

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Image /page/16/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized, cursive font, enclosed within a circular frame. The logo is colored in a light blue hue, and the background is white.

Summary of Non-Clinical Tests:

Venue has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic, and mechanical safety, and has been found to comply with applicable medical device safety standards. The Venue complies with voluntary standards:

. AAMI/ANSI ES60601-1, Medical Electrical Equipment -Part 1: General Requirements for Safety, 2005/ A2:2012
. IEC60601-1-2, Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility Requirements and Tests, 2014
IEC60601-2-37, Medical Electrical Equipment Part 2-● 37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment, 2007
ISO10993-1, Biological Evaluation of Medical Devices-. Part 1: Evaluation and Testing- Third Edition, 2009
NEMA UD 2, Acoustic Output Measurement Standard for . Diagnostic Ultrasound Equipment, 2004
ISO14971. Application of risk management to medical . devices, 2007
. NEMA, Digital Imaging and Communications in Medicine (DICOM) Set. (Radiology), 2016

The following quality assurance measures are applied to the development of the system:

Risk Analysis
Requirements Reviews
Design Reviews ●
Testing on unit level (Module verification)
Integration testing (System verification) ●
Performance testing (Verification) ●
. Safety testing (Verification)

Transducer material and other patient contact materials are biocompatible.

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Image /page/17/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font in the center. There are decorative swirls around the letters. The logo is simple and recognizable, and it is associated with a well-known company.

Summary of Clinical Tests:

The subject of this premarket submission, Venue, did not require clinical studies to support substantial equivalence.

Conclusion: GE Healthcare considers the Venue to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

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