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.

AI/ML Overview

The provided document is a 510(k) Premarket Notification Submission for the GE Healthcare Venue 50 Diagnostic Ultrasound System. It primarily focuses on demonstrating substantial equivalence to predicate devices and does not describe acceptance criteria for device performance based on a study of the device itself. Instead, it outlines the device's intended use, technological similarity to predicate devices, and compliance with various non-clinical safety and performance standards.

Therefore, many of the requested items (e.g., acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance, training sets) cannot be extracted or are not applicable from this document, as it explicitly states:

"The subject of this premarket submission, Venue 50, did not require clinical studies to support substantial equivalence." (Page 4)

This implies that the device's safety and effectiveness were demonstrated through a comparison to already cleared predicate devices and adherence to recognized standards, rather than through new clinical performance studies with specific acceptance criteria that would involve human readers, ground truth consensus, or effect sizes of AI assistance.

However, I can provide the information that is present:

1. Table of Acceptance Criteria and Reported Device Performance:

As the document explicitly states no clinical studies were required to support substantial equivalence, there are no specific performance acceptance criteria or reported device performance metrics in terms of clinical accuracy, sensitivity, or specificity. The "acceptance criteria" here are implicitly related to demonstrating substantial equivalence, meaning the device performs similarly to or no worse than the predicate devices in its intended use.

The non-clinical "acceptance criteria" are related to compliance with voluntary standards:

Acceptance Criteria (Compliance with Standards)	Reported Device Performance
AAMI/ANSI ES60601-1 (Safety)	Conforms
IEC60601-1-2 (Electromagnetic Compatibility)	Conforms
IEC60601-2-37 (Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment)	Conforms
NEMA UD 3 (Real Time Display of Thermal and Mechanical Acoustic Output Indices)	Conforms
ISO10993-1 (Biocompatibility)	Conforms
NEMA UD 2 (Acoustic Output Measurement Standard)	Conforms
ISO14971 (Risk Management)	Conforms
NEMA DICOM Set (Digital Imaging and Communications in Medicine)	Conforms

2. Sample size used for the test set and the data provenance: Not applicable. No clinical test set defined to assess performance against specific acceptance criteria.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set with ground truth established by experts.

4. Adjudication method for the test set: Not applicable. No clinical test set.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. The device is a diagnostic ultrasound system, not an AI-assisted interpretation tool, and no MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The device is a diagnostic ultrasound system, not a standalone algorithm.

7. The type of ground truth used: Not applicable. No clinical test set with ground truth used.

8. The sample size for the training set: Not applicable. No machine learning algorithm requiring a training set is described.

9. How the ground truth for the training set was established: Not applicable. No machine learning algorithm and thus no training set ground truth established.

Summary

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K. 133431
page 1 of 5

DEC 2 4 2013

Section 5: 510(k) Summary

Venue 50

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Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "G" and "E" intertwined within a circle. The logo is black and white.

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 BehnRegulatory Affairs ManagerGE HealthcareT:(414)721-4214F:(414)918-8275
Secondary Contact Person:	Pernell AbrantesRegulatory Affairs LeaderGE HealthcareT:(414) 647-4422
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 90-1YNUltrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-1YODiagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX
Predicate Device(s):	Venue 40 - K112122SonoSite Edge - K113156LOGIQ e - K113690LOGIQ S8 - K131527
Device Description:	The Venue 50 device is a compact and portable ultrasoundsystem consisting of a hand-carried console approximately282mm in height. 274mm in width and 56mm in depth. Theconsole can be docked with a Docking station or mobile Dockingcart. It has a 12.1" LCD display with finger-touch user interface.The single-surface screen can be sanitized and cleaned withmedical grade disinfectants. Several connectivity options areavailable 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);

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

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Image /page/4/Picture/17 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The logo is black and white.

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).

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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.

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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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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:

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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Image /page/8/Picture/1 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 enclosed within a circular border, which has a textured or patterned design. The logo is black and white.

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			CombinedModes	HarmonicImaging	CodedPulse	Other
Anatomy/Region of Interest			PW	CW	ColorM	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/0 description: The image shows a constellation of stars. The stars are arranged in a linear pattern, with some stars clustered together. The stars are of varying sizes and brightness. The image is a black and white photograph.

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			CombinedModes*	HarmonicImaging	CodedPulse*
Anatomy/Region of Interest	B	M	PW	CW	Color	ColorM	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				CombinedModes	HarmonicImaging	CodedPulse
Anatomy/Region of Interest	B	M	PW	CW	Color	ColorM	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		CombinedModes*	HarmonicImaging	CodedPulse*	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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Image /page/12/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "G" and "E" intertwined within a circular border. The letters and the border are black, while the background is white.

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 ModesColor	ColorM	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

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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 ApplicationAnatomy/Region of Interest	Mode of Operation							CombinedModes	HarmonicImaging
	B	M	Doppler Modes
			PW	CW	Color	ColorM	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

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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 ModesColor	Color M	Power	CombinedModes*	HarmonicImaging	CodedPulse*	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

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.