No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description does not mention any features or capabilities that would typically be associated with AI or ML, such as automated image analysis, predictive modeling, or advanced pattern recognition beyond standard ultrasound processing.
No
The device is a diagnostic ultrasound system used for imaging, measurement, and analysis, not for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states, "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."
No
The device description explicitly mentions hardware components such as a compact, portable system, high resolution color LCD monitor, internal battery, linear, convex, and phased array transducers, and a barcode reader. It is described as a general-purpose diagnostic ultrasound system, which inherently involves hardware for image acquisition.
Based on the provided information, the Venue Go is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, outside of the body to provide information for diagnosis, monitoring, or screening.
- Venue Go's Function: The Venue Go is a diagnostic ultrasound system. It uses ultrasound waves to create images of internal structures of the human body in vivo (within the living body). It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it's for "ultrasound imaging, measurement and analysis of the human body and fluid." This is consistent with an in vivo imaging device, not an in vitro diagnostic device.
Therefore, the Venue Go falls under the category of medical imaging devices, not In Vitro Diagnostic devices.
N/A
Intended Use / 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).
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
Venue Go is a general-purpose diagnostic ultrasound system intended for use by qualified healthcare professionals to evaluate the body by ultrasound imaging and fluid flow analysis. The Venue Go is a compact, portable system with a small footprint. The system can be hand carried using an integrated handle, placed on a horizontal surface, attached to a mobile cart or wall mounted. It has a high resolution color LCD monitor, with a simple, multi-touch user interface that makes the system intuitive. The system can be powered through an electrical wall outlet for long term use or from an internal battery for a short time. The Venue Go utilizes a variety of linear, convex, and phased array transducers which provide high imaging performance and support standard acquisition modes. Some biopsy kits are available for needle-guidance procedures. The system has the capability for displaying the patient's ECG trace synchronized to the scanned image. This allows the user to view an image from a specific time of the ECG signal. The ECG signal can be input directly from the patient or as an output from an ECG monitoring device. ECG information is not intended for monitoring or diagnosis. A barcode reader is available to be used as an input device. Venue Go is capable of wireless communication through a built-in Wireless LAN device. The system meets DICOM requirements to support users image storage and archiving needs (local PACS or products such as O-Path) and allows for output to printing devices. The user documentation is available electronically. An additional accessory that will also be available for the customer will be a roller bag.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound imaging
Anatomical Site
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)
Indicated Patient Age Range
Adult and neonatal cephalic, Pediatric (for cardiac)
Intended User / Care Setting
Qualified healthcare professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The subject of this premarket submission, Venue Go, did not require clinical studies to support substantial equivalence. GE Healthcare considers the Venue Go to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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
1
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
2
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) | |
|---|---|
| Prescription Use (Part 21 CER 801 Subpart D) | Over-The-Counter Use (21 CER 801 Subpart C) |
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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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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 | ||||||||||||
| Anatomy/Region of Interest | B | M | PW | |||||||||
| Doppler | CW | |||||||||||
| Doppler | Color | |||||||||||
| Doppler | Color M | |||||||||||
| Doppler | Power | |||||||||||
| Doppler | Combined | |||||||||||
| Modes[*] | Harmonic | |||||||||||
| Imaging | Coded | |||||||||||
| 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;
5
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 | |||||||||||
| 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 | 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 | ||||||||||||
| 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 | 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;
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Image /page/7/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' 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 | |||||||||||
| 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 | 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;
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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
Anatomy/Region of Interest | B | M | PW
Doppler | CW
Doppler | Color
Doppler | Color M
Doppler | Power
Doppler | Combined
Modes[*] | Harmonic
Imaging | Coded
Pulse♦ | Other |
|----------------------------------------------------|---|---|---------------|---------------|------------------|--------------------|------------------|----------------------|---------------------|-----------------|-------|
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | |
| Abdominal [1] | 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 | |||||||||||
| 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 | ||||||||||||
| Anatomy/Region of Interest | B | M | PW | |||||||||
| Doppler | CW | |||||||||||
| Doppler | Color | |||||||||||
| Doppler | Color M | |||||||||||
| Doppler | Power | |||||||||||
| Doppler | Combined | |||||||||||
| Modes[*] | Harmonic | |||||||||||
| Imaging | Coded | |||||||||||
| 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 | ||||||||||||
| Anatomy/Region of Interest | B | M | PW | |||||||||
| Doppler | CW | |||||||||||
| Doppler | Color | |||||||||||
| Doppler | Color M | |||||||||||
| Doppler | Power | |||||||||||
| Doppler | Combined | |||||||||||
| Modes[*] | Harmonic | |||||||||||
| Imaging | Coded | |||||||||||
| Pulse* | Other | |||||||||||
| Ophthalmic | ||||||||||||
| Fetal / Obstetrics | ||||||||||||
| Abdominal [1] | ||||||||||||
| Pediatric | ||||||||||||
| Small Organ [2] | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Pediatric Cardiac | ||||||||||||
| Adult Cardiac | 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
Anatomy/Region of Interest | B | M | PW
Doppler | CW
Doppler | Color
Doppler | Color M
Doppler | Power
Doppler | Combined
Modes[*] | Harmonic
Imaging | Coded
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
Anatomy/Region of Interest | B | M | PW
Doppler | CW
Doppler | Color
Doppler | Color M
Doppler | Power
Doppler | Combined
Modes[*] | Harmonic
Imaging | Coded
Pulse• | Other |
|----------------------------------------------------|----|----|---------------|---------------|------------------|--------------------|------------------|----------------------|---------------------|-----------------|-------|
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | |
| Abdominal [1] | 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 | ||||||||||||
| Anatomy/Region of Interest | B | M | PW | |||||||||
| Doppler | CW | |||||||||||
| Doppler | Color | |||||||||||
| Doppler | Color M | |||||||||||
| Doppler | Power | |||||||||||
| Doppler | Combined | |||||||||||
| Modes[*] | Harmonic | |||||||||||
| Imaging | Coded | |||||||||||
| Pulse• | Other | |||||||||||
| Ophthalmic | ||||||||||||
| Fetal / Obstetrics | ||||||||||||
| Abdominal [1] | 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 | P2 | P2 | P2 | P1 | P2 | 6 | ||
| Peripheral Vascular | N | N | N | N | N | N | N | N | N | N | ||
| Musculo-skeletal Conventional | ||||||||||||
| Musculo-skeletal Superficial | ||||||||||||
| Thoracic/Pleural [3] | P2 | P2 | P2 | P2 | P2 | P2 | N | P2 | ||||
| Exam Type, Means of Access | ||||||||||||
| Transesophageal | ||||||||||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Intraoperative [9] | ||||||||||||
| Interventional Guidance | ||||||||||||
| Vascular Access (IV, PICC) | P2 | P2 | P2 | P2 | P2 | P2 | N | P2 | 7 | |||
| 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;
15
Image /page/15/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 circular frame. The logo is colored in a light blue hue, providing a clean and recognizable brand representation.
In accordance with 2
GE Healthcare 510(k) Premarket Notification Submission
| 83362 | 510(k) Summary |
|---|---|
| accordance with 21 CFR 807.92 the following summary of information is provided: | |
| Date: | December 3, 2018 |
| Submitter: | GE Medical Systems Ultrasound and Primary Care Diagnostics |
| 9900 Innovation Drive | |
| Wauwatosa, WI 53226 | |
| Primary Contact Person: | Tracey Ortiz |
| Regulatory Affairs Director | |
| GE Healthcare | |
| T:(262)676-6120 |
| Regulatory Affairs Director | ||
|---|---|---|
| GE Healthcare | ||
| T:(262)676-6120 |
| Secondary Contact Person: | Karin Shimoni
Regulatory Affairs Leader
GE Healthcare |
| --------------------------- | ------------------------------------------------------------- |
|---|
| Device Trade Name: | Venue Go |
|---|---|
| Common/Usual Name: | Diagnostic Ultrasound System |
| Classification Names: | Class II |
| Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90- | |
| Product Code: | IYN; Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO; Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX |
| Primary Predicate Device: | Venue (K180599) |
| Secondary Predicate Device(s): | LOGIQ e (K151028) |
| LOGIQ P9 (K181783) | |
| Device Description: | Venue Go is a general-purpose diagnostic ultrasound system intended for use by qualified healthcare professionals to evaluate the body by ultrasound imaging and fluid flow analysis. |
| The Venue Go is a compact, portable system with a small footprint. The system can be hand carried using an integrated handle, placed on a horizontal surface, attached to a mobile cart or wall mounted. It has a high resolution color LCD monitor, with a simple, multi-touch user interface that makes the system intuitive. The system can be powered through an electrical wall outlet for long term use or from an internal battery for a short time. |
The Venue Go utilizes a variety of linear, convex, and phased array transducers which provide high imaging performance and
16
Image /page/16/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font in the center. There are decorative swirls around the letters. The logo is simple and recognizable, and it is associated with a well-known and established company.
support standard acquisition modes. Some biopsy kits are available for needle-guidance procedures.
The system has the capability for displaying the patient's ECG trace synchronized to the scanned image. This allows the user to view an image from a specific time of the ECG signal. The ECG signal can be input directly from the patient or as an output from an ECG monitoring device. ECG information is not intended for monitoring or diagnosis.
A barcode reader is available to be used as an input device. Venue Go is capable of wireless communication through a builtin Wireless LAN device. The system meets DICOM requirements to support users image storage and archiving needs (local PACS or products such as O-Path) and allows for output to printing devices. The user documentation is available electronically. An additional accessory that will also be available for the customer will be a roller bag.
- Intended 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, Pediatric, 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).
- Technology: The Venue Go employs the same fundamental scientific technology as its predicate devices.
| Determination of | Comparison to Predicate Devices |
|---|---|
| Substantial Equivalence: The Venue Go system is substantially equivalent to the predicate devices with regards to intended use, imaging capabilities, technological characteristics and safety and effectiveness. |
- The systems are all intended for ultrasound imaging, ● measurement and analysis of the human body and fluid for multiple clinical applications.
- The Venue Go and predicate Venue (K180599) have similar clinical indications for use however the proposed
17
Image /page/17/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a blue circle. The circle has decorative swirls around the perimeter, giving it a classic and recognizable appearance. The logo is simple, yet distinctive, and is widely recognized as the symbol of the General Electric company.
510(k) Premarket Notification Submission
Venue Go has the Intraoperative indication which has been cleared on predicate LOGIQ e (K151028). Biopsy is being added and was incorporated in IFU tables of predicate Venue (K180599).
- o The Venue Go and predicate Venue (K180599) have identical imaging modes.
- The Venue Go and predicate Venue (K180599) systems ● transducers are similar, except for addition of L4-12t-RS, L8-18i-RS and 6S-RS, which were cleared in LOGIQ e (K151028).
- The Venue Go is adding the Neonatal Cephalic ● application to L8-18i-RS. cleared in LOGIO P9 (K181783). New applications of Abdominal & Cardiac (Pediatric and Adult) are added to the L4-12t-RS transducer, and Peripheral Vascular is added to the 6S-RS transducer.
- Venue Go is adding imaging modes of "Color M o Doppler", "Combined Modes" (B/Color M) & "Coded Pulse" to L4-12t-RS, and "Combined Modes" (B/Color M) to 6S-RS & L8-18i-RS, all cleared in LOGIQ P9 (K181783).
- New Imaging modes are added to some applications: ●
- "Combined mode" (B/Color M) added to Thoracic/Pleural, Vascular Access & Nonvascular on L4-12t-RS, Thoracic/Pleural on L8-18i-RS, and abdominal, Thoracic/Pleural & Vascular Access on 6S-RS.
- "Color M Doppler" added to Thoracic/Pleural, Vascular Access & Nonvascular on L4-12t-RS. - "Coded pulse" added to Thoracic/Pleural on L4-12t-
- RS.
- The Venue Go and predicate Venue (K180599) have ● similar capability in terms of performing measurements, capturing digital images, reviewing and reporting studies.
- The system is 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 the applicable FDA limits.
- The Venue Go and predicate Venue (K180599) have been ● designed in compliance with approved electrical and physical safety standards.
18
Image /page/18/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in white inside. The letters are stylized and connected, and there are swirling lines around the letters. The logo is simple and recognizable, and it is associated with a large and well-known company.
- The Venue Go and predicate Venue (K180599) have ● identical SW features.
Summary of Non-Clinical Tests:
been evaluated for acoustic Venue Go has output. biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic, and mechanical safety, and has been found to comply with applicable medical device safety standards. The Venue Go complies with voluntary standards:
- o AAMI/ANSI ES60601-1, Medical Electrical Equipment -Part 1: General Requirements for Safety, 2005/ A2:2012
- IEC60601-1-2, Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility Requirements and Tests, 2014
- IEC60601-2-37, Medical Electrical Equipment Part 2-● 37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment, 2015
- ISO10993-1. Biological Evaluation of Medical Devices-● Part 1: Evaluation and Testing- Third Edition, 2009
- . IEC 62359, Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields, 2017
- ISO14971, Application of risk management to medical devices. 2007
- NEMA, Digital Imaging and Communications in ● Medicine (DICOM) Set. (Radiology), 2016
The following quality assurance measures are applied to the development of the system:
- Risk Analysis
- Requirements Reviews
- Design Reviews
- Testing on unit level (Module verification) ●
- Integration testing (System verification)
- Performance testing (Verification) ●
- Safety testing (Verification) ●
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Transducer material and other patient contact materials are biocompatible.
Summary of Clinical Tests:
The subject of this premarket submission, Venue Go, did not require clinical studies to support substantial equivalence.
- GE Healthcare considers the Venue Go to be as safe, as effective, Conclusion: and performance is substantially equivalent to the predicate device(s).