VENUE 50

• K Number: K133431
• Device Name: VENUE 50
• Manufacturer: GE HEALTHCARE
• Date Cleared: 2013-12-24 ( 46 days)
• Product Code: IYN ITX IYO
• Regulation Number: 892.1550

Intended Use

The Venue 50 is intended for ultrasound imaging, measurement and analysis of the human body for multiple clinical applications including: Ophthalmic; Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Musculoskeletal Conventional & Superficial; Transvaginal; Intraoperative (abdominal, thoracic and peripheral); Thoracic/Pleural for motion and fluid detection and imaging guidance of interventional procedures.

Device Description

The Venue 50 device is a compact and portable ultrasound system consisting of a hand-carried console approximately 282mm in height. 274mm in width and 56mm in depth. The console can be docked with a Docking station or mobile Docking cart. It has a 12.1" LCD display with finger-touch user interface. The single-surface screen can be sanitized and cleaned with medical grade disinfectants. Several connectivity options are available including DICOM.

Predicate Devices

K112122, K113156, K113690, K131527

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other indication of AI/ML technology.

Therapeutic

No
The intended use explicitly states "ultrasound imaging, measurement and analysis," which indicates a diagnostic rather than therapeutic purpose.

Diagnostic

Yes
The "Intended Use / Indications for Use" section states that the device is intended for "ultrasound imaging, measurement and analysis of the human body for multiple clinical applications", which implies the use of the device in the process of diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "compact and portable ultrasound system consisting of a hand-carried console" with a physical display and connectivity options, indicating it includes hardware components beyond just software.

IVD (In Vitro Diagnostic)

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

Here's why:

• Intended Use: The intended use clearly states that the device is for "ultrasound imaging, measurement and analysis of the human body for multiple clinical applications." This describes a device used for in vivo (within the living body) imaging and diagnosis, not in vitro (outside the living body) testing of samples like blood, urine, or tissue.
• Device Description: The description details a portable ultrasound system with a console, display, and connectivity options. This aligns with the description of an imaging device used directly on a patient.
• Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.

Therefore, the Venue 50 is an ultrasound imaging device, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Venue 50 is intended for ultrasound imaging, measurement and analysis of the human body for multiple clinical applications including: Ophthalmic; Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Musculoskeletal Conventional & Superficial; Transvaginal; Intraoperative (abdominal, thoracic and peripheral); Thoracic/Pleural for motion and fluid detection and imaging guidance of interventional procedures.

Product codes

IYN, IYO, ITX

Device Description

The Venue 50 device is a compact and portable ultrasound system consisting of a hand-carried console approximately 282mm in height. 274mm in width and 56mm in depth. The console can be docked with a Docking station or mobile Docking cart. It has a 12.1" LCD display with finger-touch user interface. The single-surface screen can be sanitized and cleaned with medical grade disinfectants. Several connectivity options are available including DICOM.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Ophthalmic; Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Musculoskeletal Conventional & Superficial; Transvaginal; Intraoperative (abdominal, thoracic and peripheral); Thoracic/Pleural

Indicated Patient Age Range

Not Found

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

The subject of this premarket submission, Venue 50, did not require clinical studies to support substantial equivalence.

Key Metrics

Not Found

Predicate Device(s)

K112122, K113156, K113690, K131527

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

K. 133431
page 1 of 5

DEC 2 4 2013

Section 5: 510(k) Summary

Venue 50

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GE Healthcare

510(k) Premarket Notification Submission

510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

Date: November 7. 2013

.

Submitter:	GE Healthcare
	9900 Innovation Drive
	Wauwatosa. WI 53226
Primary Contact Person:	Bryan Behn
Regulatory Affairs Manager
GE Healthcare
T:[phone]
F:[phone]
Secondary Contact Person:	Pernell Abrantes
Regulatory Affairs Leader
GE Healthcare
T:[phone]
Device: Trade Name:	Venue 50 Diagnostic Ultrasound System
Common/Usual Name:	Diagnostic Ultrasound System
Classification Names:	Class II
Product Code:	Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-1YN
Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-1YO
Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX
Predicate Device(s):	Venue 40 - K112122
SonoSite Edge - K113156
LOGIQ e - K113690
LOGIQ S8 - K131527
Device Description:	The Venue 50 device is a compact and portable ultrasound
system consisting of a hand-carried console approximately
282mm in height. 274mm in width and 56mm in depth. The
console can be docked with a Docking station or mobile Docking
cart. It has a 12.1" LCD display with finger-touch user interface.
The single-surface screen can be sanitized and cleaned with
medical grade disinfectants. Several connectivity options are
available including DICOM.

The Venue 50 is intended for ultrasound imaging, measurement Intended Use: and analysis of the human body for multiple clinical applications including: Ophthalmic; Fetal/OB; Abdominal (GYN & Urology);

2

Image /page/2/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circular border. The letters are stylized and connected, creating a distinctive and recognizable mark for the company.

GE Healthcare

510(k) Premarket Notification Submission

Pediatric: Small Organ (breast, testes, thyroid): Neonatal Cephalic: Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Musculoskeletal Conventional & Superficial; Transvaginal: Intraoperative (abdominal, thoracic and peripheral); Thoracic/Pleural for motion and fluid detection and imaging guidance of interventional procedures.

The Venue 50 employs the same fundamental scientific Technology: technology as its predicate devices.

Comparison to Predicate Devices

Determination of Substantial Equivalence:

The Venue 50 system is substantially equivalent to the predicate devices with regard to intended use, imaging capabilities. technological characteristics and safety and effectiveness.

• The systems are all intended for diagnostic ultrasound . imaging and fluid flow analysis.
• The Venue 50 and predicate Venue 40 systems have the . same clinical intended use with the exception of Ophthalmic which is substantially equivalent to Ophthalmic on the SonoSite Edge (K113156).
• . The Venue 50 and predicate Venue 40 systems have the same imaging modes.
• . The Venue 50 and predicate Venue 40 systems transducers are identical accept for the 10C-SC which is similar in materials, manufacture and clinical capability to the 10C-D on the predicate 1.OGIQ S8 (K131527). The only difference is the connector.
• The systems are manufactured with materials which have . been evaluated and found to be safe for the intended use of the device.
• The systems have acoustic power levels which are below o the applicable FDA limits.
• The Venue 50 and predicate Venue 40 systems have . similar capability in terms of performing measurements. capturing digital images, reviewing and reporting studies.
• . The Venue 50 and predicate Venue 40 systems have been designed in compliance with approved electrical and physical safety standards.

3

Summary of Non-Clinical Tests:

been evaluated for acoustic output, lihe device has biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic, and mechanical safety, and has been found to conform with applicable medical device safety standards. The Venue 50 and its applications comply with voluntary standards:

• I. AAMI/ANSI ES60601-1. Medical Electrical I Equipment - Part 1 : General Requirements for Safety
• 2. IEC60601-1-2. Medical Electrical Equipment -Part 1-2:General Requirements for Safety – Collateral Standard: Electromagnetic Compatibility Requirements and Tests
• 3. IEC60601-2-37, Medical Electrical Equipment -Part 2-37:Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment
• 4. NEMA UD 3. Standard for Real Time Display of . Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
• 5. ISO10993-1. Biological Evaluation of Medical Devices- Part 1: Evaluation and Testing- Third Edition
• 6. NEMA UD 2. Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
• 7. ISO14971, Application of risk management to medical devices
• 8. NEMA. Digital Imaging and Communications in Medicine (DICOM) Set. (Radiology)

4

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K133431
Page 5 of 5

The following quality assurance measures were 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) o
• Simulated use testing (Validation) . .

Transducer material and other patient contact materials such as needle guidance kits are biocompatible.

Summary of Clinical Tests:

The subject of this premarket submission, Venue 50, did not require clinical studies to support substantial equivalence.

• Conclusion: GE Healthcare considers the Venue 50 to be as safe, as effective. and performance is substantially equivalent to the predicate device(s).

5

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 24, 2013

GE HEALTHCARE BRYAN BEHN REGULATORY AFFAIRS MANAGER 9900 INNOVATION DR. RP-2138 WAUWATOSA WI 53226

Re: K133431

Trade/Device Name: Venue 50 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: 11 Product Code: IYN, IYO, ITX Dated: November 7, 2013 Received: November 8, 2013

Dear Mr. Behn:

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.

This determination of substantial equivalence applies to the following transducers intended for use with the Venue 50 Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

12L-SC	3S-SC
4C-SC	L8-18i-SC
E8CS-SC	10C-SC

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.

Image /page/5/Picture/13 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract shapes resembling birds in flight, stacked on top of each other.

6

Page 2-Mr. Behn

. ... .

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 (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours

Samingh. M. Mase

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K133431

Device Name: Venue 50

Indications for Use:

The Venue 50 is intended for ultrasound imaging, measurement and analysis of the human body for multiple clinical applications including: Ophthalmic; Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Musculoskeletal Conventional & Superficial; Transvaginal; Intraoperative (abdominal, thoracic and peripheral); Thoracic/Pleural for motion and fluid detection and imaging guidance of interventional procedures.

Prescription Use_x (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use N/A

(Part 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Janning M. Menge

Page 1 of 8

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Diagnostic Ultrasound Indications for Use Form

GE Venue 50 Ultrasound

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

Clinical Application	Mode of Operation
	B	M	Doppler Modes			Combined
Modes	Harmonic
Imaging	Coded
Pulse	Other
Anatomy/Region of Interest			PW	CW	Color
M	Power
Ophthalmic	N	N	N	N	N	N	N	N	N	N
Fetal/OB	N	N	N	N	N	N	N	N	N	N
Abdominal[1]	N	N	N	N	N	N	N	N	N	N
Pediatric	N	N	N	N	N	N	N	N	N	N
Small Organ (specify)[2]	N	N	N	N	N	N	N	N	N	N
Neonatal Cephalic	N	N	N	N	N	N	N	N	N	N
Adult Cephalic	N	N	N	N	N	N	N	N	N	N
Cardiac[3]	N	N	N	N	N	N	N	N	N	N
Peripheral Vascular	N	N	N	N	N	N	N	N	N	N
Musculo-skeletal Conventional	N	N	N	N	N	N	N	N	N	N
Musculo-skeletal Superficial	N	N	N	N	N	N	N	N	N	N
Thoracic/Pleural (specify)[4]	N	N	N	N	N	N	N	N	N	N
Other (specify)
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal	N	N	N	N	N	N	N	N	N	N
Intraoperative (specify)[5]	N	N	N	N	N	N	N	N	N	N
Intraoperative Neurological
Intravascular/Intraluminal
Interventional Guidance
Tissue Biopsy/Fluid Drainage	N	N	N	N	N	N	N	N	N	N
Vascular Access (IV, PICC)	N	N	N	N	N	N	N	N	N	N
Nonvascular (specify)[6]	N	N	N	N	N	N	N	N	N	N

N = new indication: P = previously cleared by FDA

Notes: [ ] Abdominal includes GYN and Urological:

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

[3] Cardiac is Adult and Pediatric;

(4) For detection of fluid and pleural motion/sliding:

[5] Intraoperative includes abdominal, thoracic and peripheral;

[6] Nonvascular is image guidance for freehand needle/catheter placement, including nerve block;

[*] Combined modes are color/power Doppler with B-mode

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

Concurroneo of CDRH, Office of In Vitro Diagnostics and Radiological Hoalth (OfR)

Prescription Use (Per 21 CFR 801.109)

Page 2 of 8

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Image /page/9/Picture/1 description: The image shows a black and white logo of General Electric (GE). The logo consists of the letters 'G' and 'E' intertwined within a circular border. The letters are stylized with curved lines and decorative flourishes, giving the logo a classic and recognizable appearance. The logo is simple, yet distinctive, and is a well-known symbol associated with the General Electric company.

Diagnostic Ultrasound Indications for Use Form

GE Venue 50 with 12L-SC Transducer

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

Clinical Application	Mode of Operation
					Doppler Modes			Combined
Modes*	Harmonic
Imaging	Coded
Pulse*
Anatomy/Region of Interest	B	M	PW	CW	Color	Color
M	Power				Other
Ophthalmic	N	N		N		N	N	N	N
Fetal/OB
Abdominal[1]	P	P			P		P	P	P
Pediatric	P	P			P		P	P	P
Small Organ (specify)[2]	P	P			P		P	P	P
Neonatal Cephalic	P	P			P		P	P	P
Adult Cephalic
Cardiac[3]
Peripheral Vascular	P	P			P		P	P	P
Musculo-skeletal Conventional	P	P			P		P	P	P
Musculo-skeletal Superficial	P	P			P		P	P	P
Thoracic/Pleural (specify)[4]	P	P			P		P	P	P
Other (specify)
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Intraoperative (specify)[1]	P	P			P		P	P	P
Intraoperative Neurological
Intravascular/Intraluminal
Interventional Guidance
Tissue Biopsy/Fluid Drainage	P	P			P		P	P	P
Vascular Access (IV, PICC)	P	P			P		P	P	P
Nonvascular (specify)[6]	P	P			P		P	P	P

N = new indication: P = previously cleared by FDA (KI 12122)

Notes: [1] Abdominal includes GYN and Urological:

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

[3] Cardiac is Adult and Pediatric;

[4] For detection of fluid and pleural motion/sliding:

[5] Intraoperative includes abdominal. thoracic and peripheral:

[6] Nonvascular is image guidance for freehand needle/catheter placement, including nerve block

1° | Combined modes are color/power Doppler with B-mode

(Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDEDI

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OiR)

Prescription Use (Per 21 CFR 801.109)

Page 3 of 8

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Diagnostic Ultrasound Indications for Use Form GE Venue 50 with 3S-SC Transducer

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

Clinical Application	Mode of Operation
					Doppler Modes				Combined
Modes	Harmonic
Imaging	Coded
Pulse
Anatomy/Region of Interest	B	M	PW	CW	Color	Color
M	Power	Other
Ophthalmic	N	N		N		N	N	N	N
Fetal/OB	P	P	P		P	P	P	P	P	P
Abdominal1	P	P	P		P	P	P	P	P	P
Pediatric	P	P	P		P	P	P	P	P	P
Small Organ (specify)[2]			P
Neonatal Cephalic	P	P	P		P	P	P	P	P	P
Adult Cephalic	P	P	P		P	P	P	P	P	P
Cardiac[3]	P	P	P		P	P	P	P	P	P
Peripheral Vascular
Musculo-skeletal Conventional	N	N	N		N	N	N	N	N	N
Musculo-skeletal Superficial
Thoracic/Pleural (specify)[4]	P	P	P		P	P	P	P	P	P
Other (specify)
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Intraoperative (specify)[1]	P	P	P		P	P	P	P	P	P
Intraoperative Neurological
Intravascular/Intraluminal
Interventional Guidance
Tissue Biopsy/Fluid Drainage	P	P	P		P	P	P	P	P	P
Vascular Access (IV, PICC)
Nonvascular (specify) [4]

N = new indication; P = previously cleared by FDA(KII2122)

[ I ] Abdominal includes GYN and Urological; Notes:

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

(3) Cardiac is Adult and Pediatric;

[4] For detection of fluid and pleural motion/sliding;

[5] Intraoperative includes abdominal, thoracic and peripheral;

[6] Nonvascular is image guidance for freehand needle/catheter placement, including nerve block

[*] Combined modes are color/power Doppler with B-mode

iplease do not writte below this line - continue on another page if neededi

Concurronco of CDRH, Office of In Vitro Diagnostics and Radiological Hoalth (OfR)

Prescription Use (Per 21 CFR 801.109)

Page 4 of 8

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Image /page/11/Picture/0 description: The image shows a black and white logo. The logo is circular and contains the letters 'G' and 'E' intertwined. The letters are stylized and surrounded by a textured pattern within the circle. This is the General Electric (GE) logo.

1000 - 1000

GE Healthcare 510(k) Premarket Notification Submission

Diagnostic Ultrasound Indications for Use Form

GE Venue 50 with 4C-SC Transducer

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

Clinical Application	Mode of Operation
Anatomy/Region of Interest	B	M	Doppler Modes			Combined
Modes*	Harmonic
Imaging	Coded
Pulse*	Other
Ophthalmic
Fetal/OB	P	P			P	P	P	P
Abdominal[1]	P	P			P	P	P	P
Pediatric	P	P			P	P	P	P
Small Organ (specify)[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal Conventional	P	P			P	P	P	P
Musculo-skeletal Superficial
Thoracic/Pleural (specify)[4]	P	P			P	P	P	P
Other (specify)
Exam Type. Means of Access
Transesophageal
Transrectal
Transvaginal
Intraoperative (specify)[5]	P	P			P	P	P	P
Intraoperative Neurological
Intravascular/Intraluminal
Intervensional Guidance
Tissue Biopsy/Fluid Drainage	P	P			P	P	P	P
Vascular Access (IV, PICC)
Nonvascular (specify)[6]	P	P			P	P	P	P

N = new indication: P = previously cleared by FDA(KI 12122)

[1] Abdominal includes GYN and Urological: Notes:

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

[3] Cardiac is Adult and Pediatric;

[4] For detection of fluid and pleural motion/sliding;

[5] Intraoperative includes abdominal, thoracic and peripheral;

[6] Nonvascular is image guidance for freehand needle/catheter placement, including nerve block

• | Combined modes are color/power Doppler with B-mode

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDEDI

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Houlth (OlR)

Prescription Use {Per 21 CFR 801.109}

Page 5 of 8

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Diagnostic Ultrasound Indications for Use Form

GE Venue 50 with L8-18i-SC Transducer

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

Clinical Application	Mode of Operation
Anatomy/Region of Interest	B	M	PW	CW	Doppler Modes
Color	Color
M	Power	Combined Modes	Harmonic Imaging	Coded Pulse	Other
Ophthalmic
Fetal/OB
Abdominal[1]	P	P			P		P	P	P
Pediatric	P	P			P		P	P	P
Small Organ (specify)[2]	P	P			P		P	P	P
Neonatal Cephalic	P	P			P		P	P	P
Adult Cephalic
Cardiac[3]
Peripheral Vascular	P	P			P		P	P	P
Musculo-skeletal Conventional	P	P			P		P	P	P
Musculo-skeletal Superficial	P	P			P		P	P	P
Thoracic/Pleural (specify)[4]	P	P			P		P	P	P
Other (specify)
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Intraoperative (specify)[5]	P	P			P		P	P	P
Intraoperative Neurological
Intravascular/Intraluminal
Interventional Guidance
Tissue Biopsy/Fluid Drainage	P	P			P		P	P	P
Vascular Access (IV, PICC)	P	P			P		P	P	P
Nonvascular (specify)[6]	P	P			P		P	P	P

N = new indication: P = previously cleared by FDA(K112122)

[1] Abdominal includes GYN and Urological: Notes:

[2] Small Organ includes breast. Iestes, thyroid;

[3] Cardiac is Adult and Pediatric:

[4] For detection of fluid and pleural motion/sliding;

[5] Intraoperative includes abdominal, thoracic and peripheral;

[6] Nonvascular is image guidance for freehand needle/catheter placement, including nerve block

[*] Combined modes are color/power Doppler with B-mode

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

Concurrenco of CDRH, Offico of In Vitro Diagnostics and Radiological Health (OiR)

Prescription Use (Per 21 CFR 801.109)

Page 6 of 8

13

Image /page/13/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 intertwined letters are enclosed within a circular border, which has a textured or patterned design.

Diagnostic Ultrasound Indications for Use Form

GE Venue 50 with E8CS-SC Transducer

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

| Clinical Application
Anatomy/Region of Interest | Mode of Operation | | | | | | | Combined
Modes | Harmonic
Imaging | Coded
Pulse* | Other |
|----------------------------------------------------|-------------------|---|---------------|----|-------|------------|-------|-------------------|---------------------|-----------------|-------|
| | B | M | Doppler Modes | | | | | | | | |
| | | | PW | CW | Color | Color
M | Power | | | | |
| Ophthalmic | | | | | | | | | | | |
| Fetal/OB | P | P | | | P | | P | P | P | | |
| Abdominal[1] | P | P | | | P | | P | P | P | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (specify)[2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[3] | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Thoracic/Pleural (specify)[4] | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | P | P | | | P | | P | P | P | | |
| Intraoperative (specify)[5] | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular/Intraluminal | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Tissue Biopsy/Fluid Drainage | N | N | | | N | | N | N | N | | |
| Vascular Access (IV, PICC) | | | | | | | | | | | |
| Nonvascular (specify)[6] | | | | | | | | | | | |

N = new indication: P = previously cleared by FDA (KI 12122)

111 Abdominal includes GYN and Urological: Notes:

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

[3] Cardiac is Adult and Pediatric:

[4] For detection of fluid and pleural motion/sliding:

[5] Intraoperative includes abdominal, thoracic and peripheral;

[6] Nonvascular is image guidance for freehand needle/catheter placement, including nerve block

[*] Combined modes are color/power Doppler with B-mode

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANDTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Disgnostics and Radiotogical Health (OIR)

Prescription Use (Per 21 CFR 801.109)

Page 7 of 8

14

Image /page/14/Picture/1 description: The image shows a black and white logo. The logo is circular and contains the letters 'GE' in a stylized, intertwined font. The letters are bold and fill most of the circle, with a thin border around the edge.

Diagnostic Ultrasound Indications for Use Form

GE Venue 50 with 10C-SC Transducer

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

Clinical Application	Mode of Operation
Anatomy/Region of Interest	B	M	PW	CW	Doppler Modes
Color	Color M	Power	Combined
Modes*	Harmonic
Imaging	Coded
Pulse*	Other
Ophthalmic	N	N			N		N	N	N	N
Fetal/OB
Abdominal[1]	N	N			N		N	N	N	N
Pediatric	N	N			N		N	N	N	N
Small Organ (specify)[2]	N	N			N		N	N	N	N
Neonatal Cephalic	N	N			N		N	N	N	N
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial	N	N			N		N	N	N	N
Thoracic/Pleural (specify)[4]	N	N			N		N	N	N	N
Other (specify)
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Intraoperative (specify)[5]	N	N			N		N	N	N	N
Intraoperative Neurological
Intravascular/Intraluminal
Interventional Guidance
Tissue Biopsy/Fluid Drainage
Vascular Access (IV, PICC)
Nonvascular (specify)[6]

N = new indication; P = previously cleared by FDA

Notes: [ I ] Abdominal includes GYN and Urological:

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

[4] For detection of fluid and pleural motion/sliding:

[5] Intraoperative includes abdominal, thoracic and peripheral:

[*] Combined modes are color/power Doppler

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OlR)

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) Number

Page 8 of 8