Who is the manufacturer of Vivid E80, Vivid E90, Vivid E95?

GE Medical Systems Ultrasound and Primary Care Diagnostics filed the 510(k) submission for Vivid E80, Vivid E90, Vivid E95 (K181685).

What is the FDA product code for Vivid E80, Vivid E90, Vivid E95?

IYN. It is classified under 21 CFR 892.1550 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for Vivid E80, Vivid E90, Vivid E95?

510(k) clearance (submission type: Traditional).

Does Vivid E80, Vivid E90, Vivid E95 use AI or machine learning?

Yes. Vivid E80, Vivid E90, Vivid E95 (K181685) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

What are the predicate devices for Vivid E80, Vivid E90, Vivid E95?

Vivid E80, Vivid E90, Vivid E95 (K173341); LOGIQ E9 (K082185).

Who can help prepare an FDA 510(k) submission like Vivid E80, Vivid E90, Vivid E95?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like Vivid E80, Vivid E90, Vivid E95 get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

Vivid E80, Vivid E90, Vivid E95

K181685 · GE Medical Systems Ultrasound and Primary Care Diagnostics · IYN · Oct 25, 2018 · Radiology

Device Facts

Record ID	K181685
Device Name	Vivid E80, Vivid E90, Vivid E95
Applicant	GE Medical Systems Ultrasound and Primary Care Diagnostics
Product Code	IYN · Radiology
Decision Date	Oct 25, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1550
Device Class	Class 2
Attributes	AI/ML, Pediatric

Intended Use

Vivid E80 / Vivid E90 / Vivid E95 is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified physician for ultrasound imaging and analysis of Fetal/Obstetrics; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculoskeletal Conventional; Musculo-skeletal Superficial; Urology (including prostate), Transesophageal; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).

Device Story

Mobile ultrasound console with keyboard, touch panel, and display; supports linear, curved, sector/phased, and matrix array transducers. Inputs: acoustic signals from transducers. Processing: real-time 2D/3D/4D imaging, Doppler analysis, and automated quantification (AutoEF 2.0, AFI 2.0, 4D Auto LAO). Features include CT Fusion (aligned CT/4D ultrasound), 4D Marker (manual annotation), and Automatic View Recognition (deep neural network). Outputs: real-time ultrasound images/analysis on display; DICOM-compliant networking. Used in clinical settings by physicians/technicians. Benefits: enhanced structural visualization, workflow automation, and remote viewing via secure streaming. Includes cybersecurity (whitelisting, encryption).

Clinical Evidence

No clinical studies were required to support substantial equivalence. Evidence consists of bench testing, including acoustic output, biocompatibility, cleaning/disinfection, thermal, electrical, electromagnetic, and mechanical safety testing, alongside software verification and validation.

Technological Characteristics

Mobile console; OLED/LCD display; electronic array transducers (linear, curved, sector/phased, matrix). Connectivity: DICOM, LAN/WLAN. Software: Windows 10 Embedded. Cybersecurity: Whitelisting, encryption. Imaging: B-mode, M-mode, PW/CW/Color/Power Doppler, 3D/4D. Standards: ANSI/AAMI ES60601-1, IEC60601-1-2, IEC60601-2-37, ISO10993-1, IEC62359, ISO14971.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid flow analysis in fetal/obstetrics, abdominal, pediatric, small organ, neonatal/adult cephalic, cardiac, peripheral vascular, musculoskeletal, urological, transesophageal, transrectal, transvaginal, and intraoperative applications. Used by or under direction of qualified physicians.

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

Vivid E80, Vivid E90, Vivid E95 (K173341)
LOGIQ E9 (K082185)

Related Devices

K170823 — Vivid E80, Vivid E90, Vivid E95 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Jun 12, 2017
K182450 — Vivid S60N, Vivid S70N · GE Medical Systems Ultrasound and Primary Care Diagnostics · Oct 19, 2018
K233439 — HD60 Series Ultrasound Diagnostic System · Qingdao Hisense Medical Equipment Co., Ltd. · Feb 21, 2024
K211216 — Vivid S60N / Vivid S70N · GE Medical Systems Ultrasound and Primary Care Diagnostics · Jun 9, 2021
K233841 — HD80 Series Ultrasound Diagnostic System · Qingdao Hisense Medical Equipment Co., Ltd. · May 16, 2024

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. GE Medical Systems Ultrasound and Primary Care Diagnostics Tracey Ortiz Regulatory Affairs Director 9900 Innovation Drive WAUWATOSA WI 53226 October 25, 2018 ## Re: K181685 Trade/Device Name: Vivid E80, Vivid E90, Vivid E95 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, ITX, IYO Dated: October 8, 2018 Received: October 9, 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 may, 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 aware 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for {1}------------------------------------------------ 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 (QS) 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 medical devices and radiation-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, Image /page/1/Picture/5 description: The image contains a digital signature of Michael D. O'hara-S. It includes the name Michael D. O'hara -S on the left side of the image. The right side of the image contains the digital signature details, including the date 2018.10.25. Robert A. 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) #### K181685 Device Name Vivid E80, Vivid E90, Vivid E95 #### Indications for Use (Describe) Vivid E80 / Vivid E90 / Vivid E95 is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified physician for ultrasound imaging and analysis of Fetal/Obstetrios; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vasculo-skeletal Conventional; Musculo-skeletal Superficial; Urology (including prostate), Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular). Type of Use (Select one or both, as applicable) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | |-----------------------------------------------------------------------------------------| | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/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 three swirls around the letters, evenly spaced. The logo is simple and recognizable, and it is often used to represent the company's brand. # Indications for Use Forms The following forms represent indications with clinical applications and exam types along with the modes of operation for the Vivid E80, Vivid E90 and Vivid E95. Combinations identified "P" represents those previously cleared with another GE Ultrasound system. There are no changes to the Indications for Use compared to the predicate Vivid E95 / Vivid E90 / Vivid E80 (K173341) The following Indication for Use forms are appended: System: Vivid E80 / Vivid E90 / Vivid E95 Transducer: C3-10-D Transducer: 12S-D Transducer: 4V-D Transducer: 4Vc-D Transducer: iC5-9-D Transducer: 8C Transducer: C2-9-D Transducer: 9L-D Transducer: 11L-D Transducer: M5Sc-D Transducer: 6S-D Transducer: C1-6-D Transducer: L8-18i-D Transducer: 6VT-D Transducer: 6Tc Transducer: 6Tc-RS Transducer: 9T Transducer: 9T-RS Transducer: 10T-D Transducer: P2D Transducer: P6D {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized script, enclosed within a blue circle. The circle has a swirling pattern around the letters, giving it a dynamic and recognizable appearance. The logo is simple, yet iconic, representing the brand's long history and global presence. #### Diagnostic Ultrasound Indications for Use Form Vivid E80 / Vivid E90 / Vivid E95 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 [Notes] | | Ophthalmic | | | | | | | | | | | | | Fetal / Obstetrics | P | P | P | P | P | P | P | P | P | P | [6,8,9,11] | | Abdominal | P | P | P | P | P | P | P | P | P | P | [1,6,8,9,10] | | Pediatric | P | P | P | P | P | P | P | P | P | P | [6,8,9] | | Small Organ | P | P | P | P | P | P | P | P | P | P | [2,8] | | Neonatal Cephalic | P | P | P | P | P | P | P | P | P | P | [8,9] | | Adult Cephalic | P | P | P | P | P | P | P | P | P | P | [6,9] | | Cardiac | P | P | P | P | P | P | P | P | P | P | [3,6,9] | | Peripheral Vascular | P | P | P | P | P | P | P | P | P | P | [8] | | Musculo-skeletal Conventional | P | P | P | P | P | P | P | P | P | P | [8] | | Musculo-skeletal Superficial | P | P | P | P | P | P | P | P | P | P | [8] | | Other | P | P | P | P | P | P | P | P | P | P | [4,6,8,9] | | Exam Type, Means of Access | | | | | | | | | | | | | Transesophageal | P | P | P | P | P | P | P | P | P | P | [6,9] | | Transrectal | P | P | P | P | P | P | P | P | P | P | [8] | | Transvaginal | P | P | P | P | P | P | P | P | P | P | [8] | | Transuretheral | | | | | | | | | | | | | Intraoperative | P | P | P | P | P | P | P | P | P | P | [5,8] | | Intraoperative Neurological | | | | | | | | | | | | | Intravascular | | | | | | | | | | | | | Interventional Guidance | | | | | | | | | | | | | Tissue Biopsy | P | P | P | P | P | P | P | P | P | P | [7,8,9] | | Vascular Access (IV, PICC) | | | | | | | | | | | | P = previously cleared by FDA on Vivid E80/Vivid E90/Vivid E95 (K170823); N = New indication Notes: Abdominal includes renal, GYN/Pelvic [1] - Small organ includes breast, testes, thyroid [2] - Cardiac is Adult and Pediatric [3] - [4] Other use includes Urology/Prostate - Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV) [5] - 3D/4D Imaging mode [6] - Includes image guidance for freehand needle placement [7] - Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8] - ləl Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD - [10] Abdominal includes Aorta-Iliac Artery - [11] Fetal/Obstetrics includes Fetal Heart System provides real-time 3D and 4D acquisition when used with special 4D probes. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a blue circle. The circle has decorative swirls around its perimeter, giving it a classic and recognizable appearance. ## Diagnostic Ultrasound Indications for Use Form GE Vivid E80 / Vivid E90 / Vivid E95 with C3-10-D 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 [Notes] | | | Ophthalmic | | | | | | | | | | | | | | Fetal / Obstetrics | | | | | | | | | | | | | | Abdominal | P | P | P | | P | P | P | P | P | P | [8] | | | Pediatric | P | P | P | | P | P | P | P | P | P | [8] | | | Small Organ | | | | | | | | | | | | | | Neonatal Cephalic | P | P | P | | P | P | P | P | P | P | [8] | | | Adult Cephalic | | | | | | | | | | | | | | Cardiac | | | | | | | | | | | | | | Peripheral Vascular | P | P | P | | P | P | P | P | P | P | [8] | | | Musculo-skeletal Conventional | P | P | P | | P | P | P | P | P | P | [8] | | | Musculo-skeletal Superficial | P | P | P | | P | P | P | P | P | P | [8] | | | Other | | | | | | | | | | | | | | Exam Type, Means of Access | | | | | | | | | | | | | | Transesophageal | | | | | | | | | | | | | | Transrectal | | | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | | | Transuretheral | | | | | | | | | | | | | | Intraoperative | | | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | | | Intravascular | | | | | | | | | | | | | | Interventional Guidance | | | | | | | | | | | | | | Tissue Biopsy | P | P | P | | P | P | P | P | P | P | [7,8] | | | Vascular Access (IV. PICC) | P | P | P | | P | P | P | P | P | P | [8] | | P = previously cleared by FDA on Vivid E90/Vivid E90/Vivid E95 (K170823); N = New indication [1] Abdominal includes renal, GYN/Pelvic Notes: [2] Small organ includes breast, testes, thyroid [3] Cardiac is Adult and Pediatric - [4] Other use includes Urology/Prostate - Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV) [5] 3D/4D Imaging mode [6] - [7] Includes image quidance for freehand needle placement Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8] Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD ાં છો [10] Abdominal includes Aorta-Iliac Artery [11] Fetal/Obstetrics includes Fetal Heart System provides real-time 3D and 4D acquisition when used with special 4D probes. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) #### Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a blue circle. The circle has decorative swirls around its perimeter, giving it a classic and recognizable appearance. ## Diagnostic Ultrasound Indications for Use Form GE Vivid E80 / Vivid E90 / Vivid E95 with 12S-D 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 Harmonic Modes | Imaging | Coded Pulse | Other [Notes] | | Ophthalmic | | | | | | | | | | | | | Fetal / Obstetrics | | | | | | | | | | | | | Abdominal | P | P | P | P | P | P | P | P | P | P | [9] | | Pediatric | P | P | P | P | P | P | P | P | P | P | [9] | | Small Organ | | | | | | | | | | | | | Neonatal Cephalic | P | P | P | P | P | P | P | P | P | P | [9] | | Adult Cephalic | | | | | | | | | | | | | Cardiac | P | P | P | P | P | P | P | P | P | P | [3,9] | | Peripheral Vascular | | | | | | | | | | | | | Musculo-skeletal Conventional | | | | | | | | | | | | | Musculo-skeletal Superficial | | | | | | | | | | | | | Other | | | | | | | | | | | | | Exam Type, Means of Access | | | | | | | | | | | | | Transesophageal | | | | | | | | | | | | | Transrectal | | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | | Transuretheral | | | | | | | | | | | | | Intraoperative (specify) | | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | | Intravascular | | | | | | | | | | | | | Interventional Guidance | | | | | | | | | | | | | Tissue Biopsy | | | | | | | | | | | | | Vascular Access (IV, PICC) | | | | | | | | | | | | P = previously cleared by FDA on Vivid E80/Vivid E90/Vivid E95 (K170823); N = New indication Abdominal includes renal, GYN/Pelvic Notes: [1] - [2] Small organ includes breast, testes, thyroid - [3] Cardiac is Adult and Pediatric - [4] Other use includes Urology/Prostate - Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV) [5] - 3D/4D Imaging mode [6] - [7] Includes image guidance for freehand needle placement - Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8] - ləl Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD - [10] Abdominal includes Aorta-Iliac Artery - [11] Fetal/Obstetrics includes Fetal Heart System provides real-time 3D and 4D acquisition when used with special 4D probes. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) #### Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a blue circle. The circle has decorative swirls around its perimeter, giving it a classic and recognizable appearance. ## Diagnostic Ultrasound Indications for Use Form GE Vivid E80 / Vivid E90 / Vivid E95 with 4V-D 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 [Notes] | | Ophthalmic | | | | | | | | | | | | | Fetal / Obstetrics | P | P | P | P | P | P | P | P | P | P | [6,9,11] | | Abdominal | P | P | P | P | P | P | P | P | P | P | [1,6,9] | | Pediatric | P | P | P | P | P | P | P | P | P | P | [6,9] | | Small Organ | | | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | | Adult Cephalic | P | P | P | P | P | P | P | P | P | P | [6,9] | | Cardiac | P | P | P | P | P | P | P | P | P | P | [3,6,9] | | Peripheral Vascular | | | | | | | | | | | | | Musculo-skeletal Conventional | | | | | | | | | | | | | Musculo-skeletal Superficial | | | | | | | | | | | | | Other | P | P | P | P | P | P | P | P | P | P | [4,6,9] | | Exam Type, Means of Access | | | | | | | | | | | | | Transesophageal | | | | | | | | | | | | | Transrectal | | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | | Transuretheral | | | | | | | | | | | | | Intraoperative (specify) | | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | | Intravascular | | | | | | | | | | | | | Interventional Guidance | | | | | | | | | | | | | Tissue Biopsy | | | | | | | | | | | | | Vascular Access (IV, PICC) | | | | | | | | | | | | P = previously cleared by FDA on Vivid E80/Vivid E90/Vivid E95 (K170823); N = New indication Abdominal includes renal, GYN/Pelvic Notes: [1] - [2] Small organ includes breast, testes, thyroid [3] Cardiac is Adult and Pediatric [4] Other use includes Urology/Prostate Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV) [5] 3D/4D Imaging mode [6] [7] Includes image guidance for freehand needle placement Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8] ləl Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD [10] Abdominal includes Aorta-Iliac Artery [11] Fetal/Obstetrics includes Fetal Heart System provides real-time 3D and 4D acquisition when used with special 4D probes. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) #### Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a blue circle. The circle has decorative swirls around its perimeter, giving it a classic and recognizable appearance. ## Diagnostic Ultrasound Indications for Use Form GE Vivid E80 / Vivid E90 / Vivid E95 with 4Vc-D 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 | Modes | Combined Harmonic Coded Imaging | Pulse | Other [Notes] | | Ophthalmic | | | | | | | | | | | | | Fetal / Obstetrics | P | P | P | P | P | P | P | P | P | P | [6,9,11] | | Abdominal | P | P | P | P | P | P | P | P | P | P | [1,6,9] | | Pediatric | P | P | P | P | P | P | P | P | P | P | [6,9] | | Small Organ | | | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | | Adult Cephalic | P | P | P | P | P | P | P | P | P | P | [6,9] | | Cardiac | P | P | P | P | P | P | P | P | P | P | [3,6,9] | | Peripheral Vascular | | | | | | | | | | | | | Musculo-skeletal Conventional | | | | | | | | | | | | | Musculo-skeletal Superficial | | | | | | | | | | | | | Other | P | P | P | P | P | P | P | P | P | P | [4,6,9] | | Exam Type, Means of Access | | | | | | | | | | | | | Transesophageal | | | | | | | | | | | | | Transrectal | | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | | Transuretheral | | | | | | | | | | | | | Intraoperative (specify) | | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | | Intravascular | | | | | | | | | | | | | Interventional Guidance | | | | | | | | | | | | | Tissue Biopsy | P | P | P | P | P | P | P | P | P | P | [9] | | Vascular Access (IV. PICC) | | | | | | | | | | | | P = previously cleared by FDA on Vivid E80/Vivid E90/Vivid E95 (K170823); N = New indication [1] Abdominal includes renal, GYN/Pelvic Notes: [2] Small organ includes breast, testes, thyroid [3] Cardiac is Adult and Pediatric - [4] Other use includes Urology/Prostate Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV) [5] 3D/4D Imaging mode [6] [7] Includes image quidance for freehand needle placement Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8] [9] Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD [10] Abdominal includes Aorta-Iliac Artery [11] Fetal/Obstetrics includes Fetal Heart System provides real-time 3D and 4D acquisition when used with special 4D probes. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) {9}------------------------------------------------ Image /page/9/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 circular frame. The color of the logo is a light blue. The logo is simple and recognizable, representing the brand identity of General Electric. ## Diagnostic Ultrasound Indications for Use Form GE Vivid E80 / Vivid E90 / Vivid E95 with iC5-9-D 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 [Notes] | | | Ophthalmic | | | | | | | | | | | | | | Fetal / Obstetrics | P | P | P | P | P | P | P | P | P | P | [8,11] | | | Abdominal | | | | | | | | | | | | | | Pediatric | | | | | | | | | | | | | | Small Organ (specify) | | | | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | | | Cardiac | | | | | | | | | | | | | | Peripheral Vascular | | | | | | | | | | | | | | Musculo-skeletal Conventional | | | | | | | | | | | | | | Musculo-skeletal Superficial | | | | | | | | | | | | | | Other | P | P | P | P | P | P | P | P | P | P | [4,8] | | | Exam Type, Means of Access | | | | | | | | | | | | | | Transesophageal | | | | | | | | | | | | | | Transrectal | P | P | P | P | P | P | P | P | | P | [8] | | | Transvaginal | P | P | P | P | P | P | P | P | | P | [8] | | | Transuretheral | | | | | | | | | | | | | | Intraoperative (specify) | | | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | | | Intravascular | | | | | | | | | | | | | | Interventional Guidance | | | | | | | | | | | | | | Tissue Biopsy | P | P | P | P | P | P | P | P | | P | [7,8] | | | Vascular Access (IV, PICC) | P | P | P | | P | P | P | P | | P | [8] | | P = previously cleared by FDA on Vivid E80/Vivid E90/Vivid E95 (K170823); N = New indication [1] Abdominal includes renal, GYN/Pelvic Notes: [2] Small organ includes breast, testes, thyroid [3] Cardiac is Adult and Pediatric [4] Other use includes Urology/Prostate Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV). [5] 3D/4D Imaging mode [6] [7] Includes image quidance for freehand needle placement Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8] Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD ાં છો [10] Abdominal includes Aorta-Iliac Artery [11] Fetal/Obstetrics includes Fetal Heart System provides real-time 3D and 4D acquisition when used with special 4D probes. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) #### Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) {10}------------------------------------------------ Image /page/10/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. The circle has a white border with a decorative pattern. The logo is simple and recognizable, and it is associated with a well-known and established company. ## Diagnostic Ultrasound Indications for Use Form GE Vivid E80 / Vivid E90 / Vivid E95 with 8C 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 [Notes] | | | Ophthalmic | | | | | | | | | | | | | | Fetal / Obstetrics | | | | | | | | | | | | | | Abdominal | P | P | P | P | P | P | P | P | P | P | [1,8,10] | | | Pediatric | P | P | P | P | P | P | P | P | P | P | [8] | | | Small Organ (specify) | P | P | P | P | P | P | P | P | P | P | [8] | | | Neonatal Cephalic | P | P | P | P | P | P | P | P | P | P | [8] | | | Adult Cephalic | | | | | | | | | | | | | | Cardiac | | | | | | | | | | | | | | Peripheral Vascular | P | P | P | P | P | P | P | P | P | P | [8] | | | Musculo-skeletal Conventional | P | P | P | | P | P | P | P | P | P | [8] | | | Musculo-skeletal Superficial | | | | | | | | | | | | | | Other | | | | | | | | | | | | | | Exam Type, Means of Access | | | | | | | | | | | | | | Transesophageal | | | | | | | | | | | | | | Transrectal | | | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | | | Transuretheral | | | | | | | | | | | | | | Intraoperative (specify) | | | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | | | Intravascular | | | | | | | | | | | | | | Interventional Guidance | | | | | | | | | | | | | | Tissue Biopsy | P | P | P | P | P | P | P | P | P | P | [8] | | | Vascular Access (IV. PICC) | | | | | | | | | | | | | P = previously cleared by FDA on Vivid E80/Vivid E90/Vivid E95 (K170823); N = New indication [1] Abdominal includes renal, GYN/Pelvic Notes: [2] Small organ includes breast, testes, thyroid [3] Cardiac is Adult and Pediatric - [4] Other use includes Urology/Prostate - Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV) [5] 3D/4D Imaging mode [6] - [7] Includes image quidance for freehand needle placement Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8] Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD ાં છો [10] Abdominal includes Aorta-Iliac Artery [11] Fetal/Obstetrics includes Fetal Heart System provides real-time 3D and 4D acquisition when used with special 4D probes. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) #### Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) {11}------------------------------------------------ Image /page/11/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 circular frame. The logo is colored in blue, with a white outline around the letters and the circular frame. ## Diagnostic Ultrasound Indications for Use Form GE Vivid E80 / Vivid E90 / Vivid E95 with C2-9-D 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 [Notes] | | | Ophthalmic | | | | | | | | | | | | | | Fetal / Obstetrics | P | P | P | | P | P | P | P | P | P | [8,11] | | | Abdominal | P | P | P | | P | P | P | P | P | P | [1,8,10] | | | Pediatric | P | P | P | | P | P | P | P | P | P | [8] | | | Small Organ (specify) | | | | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | | | Cardiac | | | | | | | | | | | | | | Peripheral Vascular | P | P | P | | P | P | P | P | P | P | [8] | | | Musculo-skeletal Conventional | | | | | | | | | | | | | | Musculo-skeletal Superficial | | | | | | | | | | | | | | Other | P | P | P | | P | P | P | P | P | P | [4,8] | | | Exam Type, Means of Access | | | | | | | | | | | | | | Transesophageal | | | | | | | | | | | | | | Transrectal | | | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | | | Transuretheral | | | | | | | | | | | | | | Intraoperative (specify) | | | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | | | Intravascular | | | | | | | | | | | | | | Interventional Guidance | | | | | | | | | | | | | | Tissue Biopsy | P | P | P | | P | P | P | P | P | P | [7,8] | | | Vascular Access (IV, PICC) | P | P | P | | P | P | P | P | P | P | [8] | | P = previously cleared by FDA on Vivid E90/Vivid E90/Vivid E95 (K170823); N = New indication [1] Abdominal includes renal, GYN/Pelvic Notes: [2] Small organ includes breast, testes, thyroid [3] Cardiac is Adult and Pediatric - [4] Other use includes Urology/Prostate Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV) [5] 3D/4D Imaging mode [6] [7] Includes image quidance for freehand needle placement Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8] Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD ાં છો [10] Abdominal includes Aorta-Iliac Artery [11] Fetal/Obstetrics includes Fetal Heart System provides real-time 3D and 4D acquisition when used with special 4D probes. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) #### Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) {12}------------------------------------------------ Image /page/12/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a blue circle. The circle has decorative swirls around its perimeter, giving it a classic and recognizable appearance. ## Diagnostic Ultrasound Indications for Use Form GE Vivid E80 / Vivid E90 / Vivid E95 with 9L-D 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 [Notes] | | | Ophthalmic | | | | | | | | | | | | | | Fetal / Obstetrics | | | | | | | | | | | | | | Abdominal | P | P | P | | P | P | P | P | P | P | [8] | | | Pediatric | P | P | P | | P | P | P | P | P | P | [8] | | | Small Organ | P | P | P | | P | P | P | P | P | P | [2,8] | | | Neonatal Cephalic | | | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | | | Cardiac | | | | | | | | | | | | | | Peripheral Vascular | P | P | P | | P | P | P | P | P | P | [8] | | | Musculo-skeletal Conventional | P | P | P | | P | P | P | P | P | P | [8] | | | Musculo-skeletal Superficial | P | P | P | | P | P | P | P | P | P | [8] | | | Other | | | | | | | | | | | | | | Exam Type, Means of Access | | | | | | | | | | | | | | Transesophageal | | | | | | | | | | | | | | Transrectal | | | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | | | Transuretheral | | | | | | | | | | | | | | Intraoperative (specify) | | | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | | | Intravascular | | | | | | | | | | | | | | Interventional Guidance | | | | | | | | | | | | | | Tissue Biopsy | P | P | P | | P | P | P | P | P | P | [7,8] | | | Vascular Access (IV, PICC) | P | P | P | | P | P | P | P | P | P | [9] | | P = previously cleared by FDA on Vivid E80/Vivid E90/Vivid E95 (K170823); N = New indication [1] Abdominal includes renal, GYN/Pelvic Notes: [2] Small organ includes breast, testes, thyroid [3] Cardiac is Adult and Pediatric - [4] Other use includes Urology/Prostate - Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV) [5] 3D/4D Imaging mode [6] - [7] Includes image quidance for freehand needle placement Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8] Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD ાં છો [10] Abdominal includes Aorta-Iliac Artery [11] Fetal/Obstetrics includes Fetal Heart System provides real-time 3D and 4D acquisition when used with special 4D probes. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) #### Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) {13}------------------------------------------------ Image /page/13/Picture/0 description: The image shows the General Electric (GE) logo. The l…