VENUE 40

K112122 · GE Healthcare · IYN · Sep 23, 2011 · Radiology

Device Facts

• Record ID: K112122
• Device Name: VENUE 40
• Applicant: GE Healthcare
• Product Code: IYN · Radiology
• Decision Date: Sep 23, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Venue 40 is intended for ultrasound imaging, measurement and analysis of the human body for multiple clinical applications including: 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 Story

Venue 40 is a compact, portable ultrasound system; console design allows docking with a station or mobile cart. Input: electronic-array transducers. Operation: digital acquisition, processing, and display of B-mode, Color/Power Doppler, and M-mode ultrasound signals. Output: visual images on a touch-sensitive color LCD display. Used in clinical settings by healthcare professionals for diagnostic imaging and interventional guidance (e.g., needle/catheter placement). Output assists clinicians in real-time visualization, fluid detection, and anatomical assessment, facilitating clinical decision-making and improving patient care through portable, convenient imaging.

Clinical Evidence

No clinical studies were required to support substantial equivalence. Evidence consists of bench testing, including module verification, system integration testing, performance testing, safety testing, and simulated use validation.

Technological Characteristics

Compact, hand-carried ultrasound console; Linux OS; touch-sensitive screen interface; interchangeable electronic-array transducers. Supports B-mode, Color/Power Doppler, M-mode, harmonic imaging, and coded pulse. Biocompatible patient-contact materials. Powered by integrated battery or external supply.

Indications for Use

Indicated for ultrasound imaging, measurement, and analysis of human anatomy including fetal/OB, abdominal (GYN/Urology), pediatric, small organ (breast, testes, thyroid), neonatal/adult cephalic, cardiac, peripheral vascular, musculoskeletal, transvaginal, and intraoperative applications. Used for motion/fluid detection and interventional guidance.

Regulatory Classification

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.

Predicate Devices

• Venue 40 (K102113)
• LOGIQ i/e & Vivide e (K102256)
• Logiq P5 (K060993)

Submission Summary (Full Text)

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Image /page/0/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. The letters are enclosed within a circle, and there are decorative swirls or flourishes around the outer edge of the circle.

SEP 2 3 2011

K112122

510(k) Premarket Notification Submission

# 510(k) Summary

.

| | In accordance with 21 CFR 807.92 the following summary of information is provided: |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | July 21, 2011 |
| Submitter: | GE Healthcare |
| | 9900 Innovation Dr |
| | Wauwatosa, WI 53226 |
| Primary Contact Person: | Bryan Behn<br>Regulatory Affairs Manager<br>GE Healthcare<br>T:[phone]<br>F:[phone] |
| Secondary Contact Person: | Yalan Wu<br>Regulatory Affairs Manager<br>GE Healthcare<br>T: [phone] |
| | F: [phone] |
| Device:<br>Trade Name: | Venue 40 |
| Common/Usual Name: | Venue 40 |
| Classification Names:<br>Product Code: | Class II<br>Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-<br>IYN Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560,<br>90-IYO Diagnostic Ultrasound Transducer, 21 CFR 892.1570,<br>90-ITX |
| Predicate Device(s): | Venue 40 - K102113<br>LOGIQ i/e & Vivide e - K102256<br>Logiq P5 - K060993 |
| Device Description: | The Venue 40 device is a compact and extremely portable<br>ultrasound system consisting of a hand-carried console with the<br>ability to dock it with a Docking station or mobile Docking cart.<br>The primary means of control is a small number of dedicated<br>push buttons and graphical user interface implemented by a touch<br>sensitive screen over the color LCD display providing additional<br>command input and keyboard entry. It utilizes interchangeable<br>electronic-array transducers operating B, Color and Power<br>Doppler, M modes with digital acquisition, processing and<br>display capability operating under a Linux OS. Powered by an<br>integrated battery or from a separate power supply/charger in the |

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Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized font, enclosed within a circular frame. The letters and the frame are solid black, creating a strong contrast against the white background. The logo is a well-known symbol associated with the General Electric company.

# GE Healthcare 510(k) Premarket Notification Submission

docking station or docking cart, the Venue 40 is used primarily where portability, size and convenience are essential.

Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ Intended Use: (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 40 employs the same fundamental scientific Technology: technology as its predicate devices.

Determination of Summary of Non-Clinical Tests: Substantial Equivalence: The Venue 40 and its applications comply with voluntary standards as detailed in Section 9, 11 and 17 of this premarket submission. The following quality assurance measures were applied to the development of the system:

- Risk Analvsis
- Requirements Reviews .
- Design Reviews .
- Testing on unit level (Module verification) .
- Integration testing (System verification)
- . Performance testing (Verification)
- . Safety testing (Verification)
- 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 40, did not require clinical studies to support substantial equivalence.

GE Healthcare considers the Venue 40 to be as safe, as effective, Conclusion: and performance is substantially equivalent to the predicate device(s).

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Image /page/2/Picture/1 description: The image shows a circular seal with text around the perimeter and a stylized bird in the center. The text around the perimeter is in all capital letters, but it is difficult to read due to the image quality. The bird in the center is black and appears to be in flight, with its wings spread. The seal is likely a symbol of an organization or government agency.

Food and Drug Aciministration 10903 New Hampshire Avenue Silver Spring, MD 20993

Mr. Brvan Behn Regulatory Aflairs Manager GE Healtheare 9900 Innovation Dr. WAUWATOSA WI 53226

grp 2 3 2011

Re: K112122

Trade/Device Name: Venue 40 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN Dated: July 21, 2011 Received: August 2, 2011

Dear Mr. Behn:

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

This determination of substantial equivalence applies to the following transducers intended for use with the Venue 40, as described in your premarket notification:

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

Transducer Model Number

{3}------------------------------------------------

Page 2 - Mr. Behn

If vour device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 895. In addition. FDA mav 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 fisting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

If you desire specific advice for vour device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/uem115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.

If you have any questions regarding the content of this letter. please contact Lauren Hefner at [phone].

Sincerely Yours.

Mary Slater

Mary S. Pastel. Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

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Image /page/4/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 letters are stylized and appear to be handwritten or calligraphic. The logo is black and white.

GE Healthcare 510(k) Premarket Notification Submission

510(k) Number (if known): |< | | 2/22

Device Name: Venue 40

Indications for Use:

The Venue 40 is intended for ultrasound imaging, measurement and analysis of the human body for multiple clinical applications including: 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 Diagnostic Devices (OIVD)

Mary S Padilla

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

510(k) Number K112122
Page 1 of 1

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#### GE Venue 40 Ultrasound

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* | Elasto-graphy | Other |
| Ophthalmic | | | | | | | | | | | |
| Fetal/OB | 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 (specify)[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 | | |
| Cardiac[3] | P | P | P | P | P | P | P | P | P | | |
| 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 (specify)[4] | P | P | P | P | P | P | P | P | P | | |
| Other (specify) | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transcranial | P | P | P | P | P | P | P | P | P | | |
| Transorbital | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | N | N | N | N | N | N | N | N | N | | |
| Intraoperative (specify)[5] | P | P | P | P | P | P | P | P | P | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular/Intraluminal | | | | | | | | | | | |
| Intracardiac | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Tissue Biopsy/Fluid Drainage | P | P | P | P | P | P | P | P | P | | |
| Vascular Access (IV, PICC) | P | P | P | P | P | P | P | P | P | | |
| Nonvascular (specify)[6] | P | P | P | P | P | P | P | P | P | | |
| Brachytherapy | | | | | | | | | | | |
| *Combined Modes and Coded Pulse have a mark on top right corner, but I can't render it. | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA

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;

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

**Prescription Use (Per 21 CFR 801.109)**

Mary S. Patel
(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K112122

{6}------------------------------------------------

#### GE Venue 40 with 12L-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<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Elasto-<br>graphy | Other | |
| | | | PW | CW | Color | Color<br>M | Power | | | | | |
| 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 | | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | | |
| Transorbital | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Intraoperative (specify) [5] | P | P | | | P | | P | P | P | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Intravascular/Intraluminal | | | | | | | | | | | | |
| Intracardiac | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| 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 | | | |
| Brachytherapy | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA

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

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

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

**Prescription Use (Per 21 CFR 801.109)**

510K

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Sofotu

{7}------------------------------------------------

### GE Venue 40 with 3S-SC Transducer

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

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

N = new indication; P = previously cleared by FDA

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

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

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off) Division of Ragiological Device Office of In Vitro Diagnostic Device Evaluation and Safety

] 9

510K KI12122

{8}------------------------------------------------

#### GE Venue 40 with 4C-SC Transducer

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

| Clinical Application<br>Anatomy/Region of Interest | Mode of Operation | | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|----|----|-------|---------|-------|----------------|------------------|-------------|--------------|-------|
| | B | M | PW | CW | Color | Color M | Power | Combined Modes | Harmonic Imaging | Coded Pulse | Elastography | 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 | | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | | |
| Transorbital | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Intraoperative (specify) [5] | P | P | | | P | | P | P | P | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Intravascular/Intraluminal | | | | | | | | | | | | |
| Intracardiac | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | | |
| Tissue Biopsy/Fluid Drainage | P | P | | | P | | P | P | P | | | |
| Vascular Access (IV, PICC) | | | | | | | | | | | | |
| Nonvascular (specify) [6] | P | P | | | P | | P | P | P | | | |
| Brachytherapy | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA

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

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

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Prescription Use (Per 21 CFR 801.109)
Mary Postel
(Division Sign-Off)
Division

Division of Pladiological De Office of In Vitro Diagnostic

510K K/12/22

{9}------------------------------------------------

### GE Venue 40 with L8-18i-SC Transducer

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

| Clinical Application | Mode of Operation | | | | | | | | | | | | |
|--------------------------------|-------------------|---|---------------|----|-------|------------|-------|-------|----------|----------|--------|---------|--|
| | | | Doppler Modes | | | | | | Combined | Harmonic | Coded | Elasto- | |
| Anatomy/Region of Interest | B | M | PW | CW | Color | Color<br>M | Power | Modes | Imaging | Pulse | graphy | Other | |
| Ophthalmic | | | | | | | | | | | | | |
| Fetal/OB | | | | | | | | | | | | | |
| 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 (specify)[2] | P | P | P | P | P | P | P | P | P | P | | | |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | P | | | |
| Adult Cephalic | | | | | | | | | | | | | |
| Cardiac[3] | | | | | | | | | | | | | |
| 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 (specify) [4] | P | P | P | P | P | P | P | P | P | P | | | |
| Other (specify) | | | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | | | |
| Transorbital | | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | | |
| Intraoperative (specify) [5] | P | P | P | P | P | P | P | P | P | P | | | |
| Intraoperative Neurological | | | | | | | | | | | | | |
| Intravascular/Intraluminal | | | | | | | | | | | | | |
| Intracardiac | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | | | |
| Tissue Biopsy/Fluid Drainage | P | P | P | P | P | P | P | P | P | P | | | |
| Vascular Access (IV, PICC) | P | P | P | P | P | P | P | P | P | P | | | |
| Nonvascular (specify) (6) | P | P | P | P | P | P | P | P | P | P | | | |
| Brachytherapy | | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA

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

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Prescription Use (Per 21 CFR 801.109)

Mary S. Postil
(Division Sign-Off)

Division of Radiological Devi Office of In Vitro Diagnostic Device Evaluation and Safety

510K K//2/22

{10}------------------------------------------------

### GE Venue 40 with E8CS-SC Transducer

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

| Clinical Application<br>Anatomy/Region of Interest | Doppler Modes | | | | | | | Mode of Operation | | | | |
|----------------------------------------------------|---------------|---|------------|----|-------|------------|-------|-------------------|---------------------|----------------|-------------------|-------|
| | B | M | PW | CW | Color | Color<br>M | Power | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Elasto-<br>graphy | Other |
| | | | Ophthalmic | | | | | | | | | |
| Fetal/OB | N | N | | | N | | N | N | N | | | |
| Abdominal[1] | N | N | | | N | | N | N | N | | | |
| 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 | | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | | |
| Transorbital | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | N | N | | | N | | N | N | N | | | |
| Intraoperative (specify) [5] | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Intravascular/Intraluminal | | | | | | | | | | | | |
| Intracardiac | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | | |
| Tissue Biopsy/Fluid Drainage | | | | | | | | | | | | |
| Vascular Access (IV, PICC) | | | | | | | | | | | | |
| Nonvascular (specify) [6] | | | | | | | | | | | | |
| Brachytherapy | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA

[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 NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Prescription Use (Per 21 CFR 801.109)

Mary S. Postell
(Division Sign-Off)

510K

Division of Radiological Devices
Office In Vitro Diagnostic Device Evaluation and Safety