Venue GO
Device Facts
| Record ID | K183362 |
|---|---|
| Device Name | Venue GO |
| Applicant | GE Medical Systems Ultrasound and Primary Care Diagnostics |
| Product Code | IYN · Radiology |
| Decision Date | Jan 28, 2019 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
Venue Go is a general-purpose diagnostic ultrasound system intended for use by qualified healthcare professionals for ultrasound imaging, measurement and analysis of the human body and fluid. Venue Go clinical applications include the following: Abdominal (including Gynecology and Urology), Thoracic/Pleural, Ophthalmic, Fetal/Obstetrics, Small Organ (including breast, testes, thyroid), Peripheral vascular, Adult and neonatal cephalic, Musculoskeletal (Conventional and Superficial), Cardiac (Adults and Pediatric), Transesophageal, Transrectal, Transvaginal, Intraoperative and Imaging guidance for interventional procedures (e.g. Nerve block, biopsy, vascular access).
Device Story
Venue Go is a compact, portable diagnostic ultrasound system for use by qualified healthcare professionals in clinical settings. It accepts acoustic signals via linear, convex, and phased array transducers; processes these signals to generate real-time ultrasound images and fluid flow analysis; and displays output on a high-resolution multi-touch LCD monitor. The system supports ECG synchronization for image timing. It features wireless LAN for DICOM-compliant image storage, archiving, and printing. The device is used for imaging, measurement, and interventional guidance (e.g., nerve block, biopsy, vascular access). By providing high-resolution visualization, it assists clinicians in diagnostic assessment and procedural guidance, potentially improving patient outcomes through accurate, real-time anatomical and physiological evaluation.
Clinical Evidence
No clinical studies were required to support substantial equivalence. Evidence is based on bench testing, including acoustic output, biocompatibility, cleaning/disinfection effectiveness, thermal, electrical, electromagnetic, and mechanical safety testing, all of which comply with applicable standards (e.g., IEC 60601-1, IEC 60601-2-37, ISO 10993-1).
Technological Characteristics
Portable ultrasound system with high-resolution color LCD and multi-touch interface. Supports linear, convex, and phased array transducers. Modes include B, M, PW/CW Doppler, Color/Power Doppler, Color M, Harmonic Imaging, and Coded Pulse. Connectivity via wireless LAN and DICOM. Complies with AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, and ISO 10993-1. Powered by AC or internal battery.
Indications for Use
Indicated for qualified healthcare professionals to perform diagnostic ultrasound imaging, measurement, and analysis of the human body and fluid across various clinical applications including abdominal, thoracic, ophthalmic, fetal/obstetrics, small organ, vascular, cephalic, musculoskeletal, and cardiac regions, as well as 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
Submission Summary (Full Text)
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January 28, 2019
GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC % Tracey Ortiz Regulatory Affairs Director 9900 W. Innovation Drive WAUWATOSA WI 53226
Re: K183362
Trade/Device Name: Venue Go Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: December 3, 2018 Received: December 4, 2018
Dear Tracey Ortiz:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Hole 2. Nils
for Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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### Indications for Use
510(k) Number (if known) K183362
Device Name Venue Go
#### Indications for Use (Describe)
Venue Go is a general-purpose diagnostic ultrasound system intended for use by qualified healthcare professionals for ultrasound imaging, measurement and analysis of the human body and fluid. Venue Go clinical applications include the following: Abdominal (including Gynecology and Urology), Thoracic/Pleural, Ophthalmic, Fetal/Obstetrics, Small Organ (including breast, testes, thyroid), Peripheral vascular, Adult and neonatal cephalic, Musculoskeletal (Conventional and Superficial), Cardiac (Adults and Pediatric), Transesophageal, Transrectal, Transvaginal, Intraoperative and Imaging guidance for interventional procedures (e.g. Nerve block, biopsy, vascular access).
| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CER 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CER 801 Subpart C) </span> </div> |
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Image /page/3/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized script, enclosed within a blue circle. There are decorative swirls or flourishes around the perimeter of the circle, adding to the logo's distinctive design.
### Indications for Use Forms
The following forms represent indications with clinical applications and exam types along with the modes of operation for the Venue Go. Combinations identified "P" represents those previously cleared with another GE Ultrasound system. Combinations identified as "N" are new.
The following Indication for Use forms are appended:
System: Venue Go Transducer: 3Sc-RS Transducer: 9L-RS Transducer: C1-5-RS Transducer: 8C-RS Transducer: E8C-RS Transducer: 12L-RS Transducer: 6Tc-RS Transducer: L4-12t-RS Transducer: L8-18i-RS Transducer: 6S-RS
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Image /page/4/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' written in a stylized, cursive font, enclosed within a blue circle. There are small, white dots placed around the inner edge of the circle, adding a decorative element to the design.
510(k) Premarket Notification Submission
### GE Venue Go Ultrasound System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|----------------------|---------------------|-----------------|-------|--|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes[*] | Harmonic<br>Imaging | Coded<br>Pulse♦ | Other | |
| Ophthalmic | N | | | | N | | N | | | | | |
| Fetal / Obstetrics | N | N | N | | N | N | N | N | N | N | | |
| Abdominal [1] | N | N | N | | N | N | N | N | N | N | | |
| Pediatric | N | N | N | | N | N | N | N | N | N | | |
| Small Organ [2] | N | N | N | | N | N | N | N | N | N | | |
| Neonatal Cephalic | N | N | N | | N | N | N | N | N | N | | |
| Adult Cephalic | N | N | N | | N | N | N | N | N | N | | |
| Pediatric Cardiac | N | N | N | N | N | N | N | N | N | N | 6,8 | |
| Adult Cardiac | N | N | N | N | N | N | N | N | N | N | 6,8 | |
| Peripheral Vascular | N | N | N | | N | N | N | N | N | N | | |
| Musculo-skeletal Conventional | N | N | N | | N | N | N | N | N | N | | |
| Musculo-skeletal Superficial | N | N | N | | N | N | N | N | N | N | | |
| Thoracic/Pleural [3] | N | N | N | | N | N | N | N | N | N | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transesophageal | N | N | N | N | N | N | | N | N | | 6 | |
| Transrectal | N | N | N | | N | N | N | N | N | N | | |
| Transvaginal | N | N | N | | N | N | N | N | N | N | | |
| Intraoperative [9] | N | N | N | | N | N | N | N | N | N | | |
| Interventional Guidance | | | | | | | | | | | | |
| Vascular Access (IV, PICC) | N | N | N | | N | N | N | N | N | N | 5,7 | |
| Nonvascular [4] | N | N | N | | N | N | N | N | N | N | 5,7 | |
N = new indication; P = previously cleared by FDA K170714; P1 = previously cleared by FDA K163596; P2 = previously cleared by FDA K161706;
Notes: [1] Abdominal includes GYN and Urology (includes prostate);
[2] Small Organ includes breast, testes, thyroid;
[3] Including detection of fluid and pleural motion/sliding;
[4] Nonvascular includes nerve block or biopsy;
[5] Biopsy bracket available;
[6] Combined modes as defined in [*], but exclude B/Power/PWD, and include: B/CWD,
B/Color/CWD;
[7] Image guidance supports freehand needle/catheter placement;
[8] Combined modes as defined in [*], but exclude B/Power/PWD;
[9] Intraoperative includes vascular;
[*] Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD;
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Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' written in a stylized script, enclosed within a blue circle. The letters are white, creating a contrast against the blue background. The logo is simple and recognizable, representing the brand identity of General Electric.
510(k) Premarket Notification Submission
### GE Venue Go with 3Sc-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-----------------------|---------------------|------------------|-------|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes[*1] | Harmonic<br>Imaging | Coded<br>Pulse * | Other |
| Ophthalmic | P | | | | P | | P | | | | |
| Fetal / Obstetrics | P | P | P | | P | P | P | P | P | | |
| Abdominal [1] | P | P | P | | P | P | P | P | P | | |
| Pediatric | P | P | P | | P | P | P | P | P | | |
| Small Organ [2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | P | P | P | | P | P | P | P | P | | |
| Pediatric Cardiac | P | P | P | P | P | P | P | P | P | | 6 |
| Adult Cardiac | P | P | P | P | P | P | P | P | P | | 6 |
| Peripheral Vascular | P | P | P | | P | P | P | P | P | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Thoracic/Pleural [3] | P | P | P | | P | P | P | P | P | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Intraoperative [9] | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Vascular Access (IV, PICC) | P | P | P | P | P | P | P | P | P | | |
| Nonvascular [4] | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA K180599; P1 = previously cleared by FDA K181783; P2 = previously cleared by FDA K151028;
Notes: [1] Abdominal includes GYN and Urology (includes prostate);
[2] Small Organ includes breast, testes, thyroid;
[3] Including detection of fluid and pleural motion/sliding;
[4] Nonvascular includes nerve block or biopsy;
[5] Biopsy bracket available;
[6] Combined modes as defined in [*], but exclude B/Power/PWD, and include: B/CWD,
B/Color/CWD;
[7] Image quidance supports freehand needle/catheter placement;
[8] Combined modes as defined in [*], but exclude B/Power/PWD;
[9] Intraoperative includes vascular;
[*] Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD;
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Image /page/6/Picture/0 description: The image shows the General Electric (GE) logo, which is a blue circle with the letters 'GE' in a stylized, cursive font inside. The letters are also blue, matching the color of the circle. The logo is simple and recognizable, representing the well-known multinational corporation.
### GE Venue Go with 9L-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|----------------------|---------------------|-----------------|-------|--|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes[1] | Harmonic<br>Imaging | Coded<br>Pulse• | Other | |
| Ophthalmic | P | | | | P | | P | | | | | |
| Fetal / Obstetrics | P | P | P | | P | P | P | P | P | P | | |
| Abdominal [1] | P | P | P | | P | P | P | P | P | P | | |
| Pediatric | P | P | P | | P | P | P | P | P | P | | |
| Small Organ [2] | P | P | P | | P | P | P | P | P | P | | |
| Neonatal Cephalic | P | P | P | | P | P | P | P | P | P | | |
| Adult Cephalic | | | | | | | | | | | | |
| Pediatric Cardiac | P | P | P | | P | P | P | P | P | P | 8 | |
| Adult Cardiac | P | P | P | | P | P | P | P | P | P | 8 | |
| Peripheral Vascular | P | P | P | | P | P | P | P | P | P | | |
| Musculo-skeletal Conventional | P | P | P | | P | P | P | P | P | P | | |
| Musculo-skeletal Superficial | P | P | P | | P | P | P | P | P | P | | |
| Thoracic/Pleural [3] | P | P | P | | P | P | P | P | P | P | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Intraoperative [9] | | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | | |
| Vascular Access (IV, PICC) | P | P | P | | P | P | P | P | P | P | 5,7 | |
| Nonvascular [4] | P | P | P | | P | P | P | P | P | P | 5,7 | |
N = new indication; P = previously cleared by FDA K180599; P1 = previously cleared by FDA K181783; P2 = previously cleared by FDA K151028;
Notes: [1] Abdominal includes GYN and Urology (includes prostate);
[2] Small Organ includes breast, testes, thyroid;
[3] Including detection of fluid and pleural motion/sliding;
[4] Nonvascular includes nerve block or biopsy;
[5] Biopsy bracket available;
[6] Combined modes as defined in [*], but exclude B/Power/PWD, and include: B/CWD,
B/Color/CWD;
[7] Image quidance supports freehand needle/catheter placement;
[8] Combined modes as defined in [*], but exclude B/Power/PWD;
[9] Intraoperative includes vascular;
[*] Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD;
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' written in a stylized script, enclosed within a blue circle. The letters are white, creating a contrast against the blue background. The logo is simple and recognizable, representing the brand identity of General Electric.
### 510(k) Premarket Notification Submission
### GE Venue Go with C1-5-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|----------------------|---------------------|-----------------|-------|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes[¹] | Harmonic<br>Imaging | Coded<br>Pulse• | Other |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | P | P | P | | P | P | P | P | P | P | |
| Abdominal [1] | P | P | P | | P | P | P | P | P | P | |
| Pediatric | P | P | P | | P | P | P | P | P | P | |
| Small Organ [2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Pediatric Cardiac | P | P | P | | P | P | P | P | P | P | 8 |
| Adult Cardiac | P | P | P | | P | P | P | P | P | P | 8 |
| Peripheral Vascular | P | P | P | | P | P | P | P | P | P | |
| Musculo-skeletal Conventional | P | P | P | | P | P | P | P | P | P | |
| Musculo-skeletal Superficial | P | P | P | | P | P | P | P | P | P | |
| Thoracic/Pleural [3] | P | P | P | | P | P | P | P | P | P | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Intraoperative [9] | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Vascular Access (IV, PICC) | P | P | P | | P | P | P | P | P | P | 7 |
| Nonvascular [4] | P | P | P | | P | P | P | P | P | P | 7 |
N = new indication; P = previously cleared by FDA K180599; P1 = previously cleared by FDA K181783; P2 = previously cleared by FDA K151028;
Notes: [1] Abdominal includes GYN and Urology (includes prostate);
[2] Small Organ includes breast, testes, thyroid;
[3] Including detection of fluid and pleural motion/sliding;
[4] Nonvascular includes nerve block or biopsy;
[5] Biopsy bracket available;
[6] Combined modes as defined in [*], but exclude B/Power/PWD, and include: B/CWD,
B/Color/CWD;
[7] Image quidance supports freehand needle/catheter placement;
[8] Combined modes as defined in [*], but exclude B/Power/PWD;
[9] Intraoperative includes vascular;
[*] Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD;
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized script, enclosed within a blue circle. The blue color is consistent throughout the logo, providing a clean and recognizable design.
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes[*] | Harmonic<br>Imaging | Coded<br>Pulse♦ | Other |
|----------------------------------------------------|---|---|---------------|---------------|------------------|--------------------|------------------|----------------------|---------------------|-----------------|-------|
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | |
| Abdominal [1] | P | P | P | | P | P | P | P | P | P | |
| Pediatric | P | P | P | | P | P | P | P | P | P | |
| Small Organ [2] | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | | P | P | P | P | P | P | |
| Adult Cephalic | | | | | | | | | | | |
| Pediatric Cardiac | P | P | P | | P | P | | P | P | P | 8 |
| Adult Cardiac | P | P | P | | P | P | | P | P | P | 8 |
| Peripheral Vascular | P | P | P | | P | P | P | P | P | P | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Thoracic/Pleural [3] | P | P | P | | P | P | P | P | P | P | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Intraoperative [9] | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Vascular Access (IV, PICC) | | | | | | | | | | | |
| Nonvascular [4] | P | P | P | | P | P | P | P | P | P | |
#### GE Venue Go with 8C-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication: P = previously cleared by FDA K180599; P1 = previously cleared by FDA K181783; P² = previously cleared by FDA K151028;
Notes: [1] Abdominal includes GYN and Urology (includes prostate);
[2] Small Organ includes breast, testes, thyroid;
[3] Including detection of fluid and pleural motion/sliding;
[4] Nonvascular includes nerve block or biopsy;
[5] Biopsy bracket available;
[6] Combined modes as defined in [*], but exclude B/Power/PWD, and include: B/CWD,
B/Color/CWD: [7] Image guidance supports freehand needle/catheter placement;
[8] Combined modes as defined in [*], but exclude B/Power/PWD;
[9] Intraoperative includes vascular;
[*] Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD;
{9}------------------------------------------------
Image /page/9/Picture/0 description: The image shows the General Electric (GE) logo, which is a blue circle with the letters 'GE' in a stylized, cursive font inside. The letters are also blue, matching the color of the circle. The logo is simple and recognizable, representing the well-known multinational corporation.
510(k) Premarket Notification Submission
### GE Venue Go with E8C-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|------------|------------|---------------|-----------------|---------------|-------------------|------------------|--------------|-------|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW Doppler | CW Doppler | Color Doppler | Color M Doppler | Power Doppler | Combined Modes[1] | Harmonic Imaging | Coded Pulse* | Other |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | P | P | P | | P | P | P | P | P | P | |
| Abdominal [1] | P | P | P | | P | P | P | P | P | P | |
| Pediatric | | | | | | | | | | | |
| Small Organ [2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Pediatric Cardiac | | | | | | | | | | | |
| Adult Cardiac | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Thoracic/Pleural [3] | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | P | P | P | | P | P | P | P | P | P | |
| Transvaginal | P | P | P | | P | P | P | P | P | P | |
| Intraoperative [9] | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Vascular Access (IV, PICC) | | | | | | | | | | | |
| Nonvascular [4] | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA K180599; P1 = previously cleared by FDA K181783; P2 = previously cleared by FDA K151028;
Notes: [1] Abdominal includes GYN and Urology (includes prostate);
[2] Small Organ includes breast, testes, thyroid;
[3] Including detection of fluid and pleural motion/sliding;
[4] Nonvascular includes nerve block or biopsy;
[5] Biopsy bracket available;
[6] Combined modes as defined in [*], but exclude B/Power/PWD, and include: B/CWD,
B/Color/CWD;
[7] Image quidance supports freehand needle/catheter placement;
[8] Combined modes as defined in [*], but exclude B/Power/PWD;
[9] Intraoperative includes vascular;
[*] Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD;
{10}------------------------------------------------
Image /page/10/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized script, enclosed within a blue circle. The blue color is consistent throughout the logo, providing a clean and recognizable design.
GE Healthcare 510(k) Premarket Notification Submission
| | Mode of Operation | | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|----------------------|---------------------|-----------------|-------|--|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes[*] | Harmonic<br>Imaging | Coded<br>Pulse• | Other | |
| Ophthalmic | P | | | | P | | P | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | | |
| Abdominal [1] | P | P | P | | P | P | P | P | P | P | | |
| Pediatric | P | P | P | | P | P | P | P | P | P | | |
| Small Organ [2] | P | P | P | | P | P | P | P | P | P | | |
| Neonatal Cephalic | P | P | P | | P | P | P | P | P | P | | |
| Adult Cephalic | | | | | | | | | | | | |
| Pediatric Cardiac | P | P | P | | P | P | P | P | P | P | 8 | |
| Adult Cardiac | P | P | P | | P | P | P | P | P | P | 8 | |
| Peripheral Vascular | P | P | P | | P | P | P | P | P | P | | |
| Musculo-skeletal Conventional | P | P | P | | P | P | P | P | P | P | | |
| Musculo-skeletal Superficial | P | P | P | | P | P | P | P | P | P | | |
| Thoracic/Pleural [3] | P | P | P | | P | P | P | P | P | P | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Intraoperative [9] | | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | | |
| Vascular Access (IV, PICC) | P | P | P | | P | P | P | P | P | P | 5,7 | |
| Nonvascular [4] | P | P | P | | P | P | P | P | P | P | 5,7 | |
#### GE Venue Go with 12L-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication: P = previously cleared by FDA K180599; P1 = previously cleared by FDA K181783; P2 = previously cleared by FDA K151028;
Notes: [1] Abdominal includes GYN and Urology (includes prostate);
[2] Small Organ includes breast, testes, thyroid;
- [3] Including detection of fluid and pleural motion/sliding;
- [4] Nonvascular includes nerve block or biopsy;
- [5] Biopsy bracket available;
[6] Combined modes as defined in [*], but exclude B/Power/PWD, and include: B/CWD,
B/Color/CWD: [7] Image guidance supports freehand needle/catheter placement;
[8] Combined modes as defined in [*], but exclude B/Power/PWD;
[9] Intraoperative includes vascular;
[*] Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD;
{11}------------------------------------------------
Image /page/11/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' written in a stylized, cursive font, enclosed within a blue circle. There are small, white dots placed around the inner edge of the circle, adding a decorative element to the design.
GE Healthcare 510(k) Premarket Notification Submission
| | Mode of Operation | | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|----------------------|---------------------|-----------------|-------|--|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes[*] | Harmonic<br>Imaging | Coded<br>Pulse* | Other | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | | |
| Abdominal [1] | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ [2] | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Pediatric Cardiac | | | | | | | | | | | | |
| Adult Cardiac | P | P | P | P | P | P | P | P | P | | 6 | |
| Peripheral Vascular | | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | | |
| Thoracic/Pleural [3] | | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transesophageal | P | P | P | P | P | P | P | P | P | | 6 | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Intraoperative [9] | | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | | |
| Vascular Access (IV, PICC) | | | | | | | | | | | | |
| Nonvascular [4] | | | | | | | | | | | | |
#### GE Venue Go with 6Tc-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA K180599; P1 = previously cleared by FDA K181783; P2 = previously cleared by FDA K151028;
Notes: [1] Abdominal includes GYN and Urology (includes prostate);
[2] Small Organ includes breast, testes, thyroid;
- [3] Including detection of fluid and pleural motion/sliding;
[4] Nonvascular includes nerve block or biopsy;
[5] Biopsy bracket available;
[6] Combined modes as defined in [*], but exclude B/Power/PWD, and include: B/CWD,
B/Color/CWD;
[7] Image guidance supports freehand needle/catheter placement;
[8] Combined modes as defined in [*], but exclude B/Power/PWD;
[9] Intraoperative includes vascular;
[*] Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD;
{12}------------------------------------------------
Image /page/12/Picture/0 description: The image shows the General Electric (GE) logo, which is a blue circle with the letters 'GE' in a stylized, cursive font inside. The letters are also blue, matching the color of the circle. The logo is simple and recognizable, representing the well-known multinational corporation.
### 510(k) Premarket Notification Submission
### GE Venue Go with L4-12t-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes[*] | Harmonic<br>Imaging | Coded<br>Pulse♦ | Other |
|----------------------------------------------------|----|----|---------------|---------------|------------------|--------------------|------------------|----------------------|---------------------|-----------------|-------|
| Ophthalmic | P2 | | | | P2 | | P2 | | | | |
| Fetal / Obstetrics | | | | | | | | | | | |
| Abdominal [1] | N | N | N | | N | N | N | N | N | N | |
| Pediatric | P2 | P2 | P2 | | P2 | P1 | P2 | P1 | P2 | P1 | |
| Small Organ [2] | P2 | P2 | P2 | | P2 | P1 | P2 | P1 | P2 | P1 | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Pediatric Cardiac | N | N | N | | N | N | N | N | N | N | 8 |
| Adult Cardiac | N | N | N | | N | N | N | N | N | N | 8 |
| Peripheral Vascular | P2 | P2 | P2 | | P2 | P1 | P2 | P1 | P2 | P1 | |
| Musculo-skeletal Conventional | P2 | P2 | P2 | | P2 | P1 | P2 | P1 | P2 | P1 | |
| Musculo-skeletal Superficial | P2 | P2 | P2 | | P2 | P1 | P2 | P1 | P2 | P1 | |
| Thoracic/Pleural [3] | P2 | P2 | P2 | | P2 | N | P2 | N | P2 | N | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Intraoperative [9] | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Vascular Access (IV, PICC) | P2 | P2 | P2 | | P2 | N | P2 | N | P2 | P2 | 5,7 |
| Nonvascular [4] | P2 | P2 | P2 | | P2 | N | P2 | N | P2 | P2 | 5,7 |
N = new indication; P = previously cleared by FDA K180599; P1 = previously cleared by FDA K181783; P2 = previously cleared by FDA K151028;
Notes: [1] Abdominal includes GYN and Urology (includes prostate);
[2] Small Organ includes breast, testes, thyroid;
[3] Including detection of fluid and pleural motion/sliding;
[4] Nonvascular includes nerve block or biopsy;
[5] Biopsy bracket available;
[6] Combined modes as defined in [*], but exclude B/Power/PWD, and include: B/CWD,
B/Color/CWD;
[7] Image quidance supports freehand needle/catheter placement;
[8] Combined modes as defined in [*], but exclude B/Power/PWD;
[9] Intraoperative includes vascular;
[*] Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD;
{13}------------------------------------------------
Image /page/13/Picture/0 description: The image shows the General Electric (GE) logo, which is a blue circle with the letters 'GE' in a stylized, cursive font inside. The letters are also blue, matching the color of the circle. The logo is simple and recognizable, representing the well-known multinational corporation.
510(k) Premarket Notification Submission
### GE Venue Go with L8-18i-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes[*] | Harmonic<br>Imaging | Coded<br>Pulse• | Other |
|----------------------------------------------------|----|----|---------------|---------------|------------------|--------------------|------------------|----------------------|---------------------|-----------------|-------|
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | |
| Abdominal [1] | P2 | P2 | P2 | | P2 | | P2 | P1 | P2 | P2 | |
| Pediatric | P2 | P2 | P2 | | P2 | | P2 | P1 | P2 | P2 | |
| Small Organ [2] | P2 | P2 | P2 | | P2 | | P2 | P1 | P2 | P2 | |
| Neonatal Cephalic | P1 | P1 | P1 | | P1 | | P1 | P1 | P1 | P1 | |
| Adult Cephalic | | | | | | | | | | | |
| Pediatric Cardiac | | | | | | | | | | | |
| Adult Cardiac | | | | | | | | | | | |
| Peripheral Vascular | P2 | P2 | P2 | | P2 | | P2 | P1 | P2 | P2 | |
| Musculo-skeletal Conventional | P2 | P2 | P2 | | P2 | | P2 | P1 | P2 | P2 | |
| Musculo-skeletal Superficial | P2 | P2 | P2 | | P2 | | P2 | P1 | P2 | P2 | |
| Thoracic/Pleural [3] | P2 | P2 | P2 | | P2 | | P2 | N | P2 | P2 | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Intraoperative [9] | P2 | P2 | P2 | | P2 | | P2 | P1 | P2 | P2 | |
| Interventional Guidance | | | | | | | | | | | |
| Vascular Access (IV, PICC) | P2 | P2 | P2 | | P2 | | P2 | P1 | P2 | P2 | 7 |
| Nonvascular [4] | P2 | P2 | P2 | | P2 | | P2 | P1 | P2 | P2 | 7 |
N = new indication: P = previously cleared by FDA K180599; P1 = previously cleared by FDA K181783; P² = previously cleared by FDA K151028;
Notes: [1] Abdominal includes GYN and Urology (includes prostate);
[2] Small Organ includes breast, testes, thyroid;
[3] Including detection of fluid and pleural motion/sliding;
[4] Nonvascular includes nerve block or biopsy;
[5] Biopsy bracket available;
[6] Combined modes as defined in [*], but exclude B/Power/PWD, and include: B/CWD,
B/Color/CWD;
[7] Image quidance supports freehand needle/catheter placement;
[8] Combined modes as defined in [*], but exclude B/Power/PWD;
[9] Intraoperative includes vascular;
[*] Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD;
{14}------------------------------------------------
Image /page/14/Picture/0 description: The image shows the General Electric (GE) logo, which is a blue circle with the letters 'GE' in a stylized, cursive font inside. The letters are also blue, matching the color of the circle. The logo is simple and recognizable, representing the well-known multinational corporation.
510(k) Premarket Notification Submission
### GE Venue Go with 6S-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | | |
|----------------------------------------------------|-------------------|----|---------------|---------------|------------------|--------------------|------------------|----------------------|---------------------|-----------------|-------|--|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes[*] | Harmonic<br>Imaging | Coded<br>Pulse• | Other | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | | |
| Abdominal [1] | P2 | P2 | P2 | | P2 | P2 | P2 | N | P2 | | | |
| Pediatric | P2 | P2 | P2 | | P2 | P2 | P2 | P1 | P2 | | | |
| Small Organ [2] | | | | | | | | | | | | |
| Neonatal Cephalic | P2 | P2 | P2 | | P2 | P2 | P2 | P1 | P2 | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Pediatric Cardiac | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P1 | P2 | | 6 | |
| Adult Cardiac | P2 | P2 | P2 | P2…
