(48 days)
The device 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, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional; Urology (including prostate); Transesophagea1; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).
GE Vivid E80 / E90 / E95 is a Track 3 diagnostic ultrasound system, which is primarily intended for cardiac imaging and analysis, but which also includes vascular and general radiology applications. The Vivid E80 / E90 / E95 incorporates a variety of electronic array transducers operating in linear, curved linear, sector/phased array or matrix array format, including two dedicated CW transducers and several real time 3D transducers. It consists of a mobile console with keyboard control panel; color LCD/TFT touch panel, Alternative OLED or LCD color video display and optional image storage and printing devices. It provides high performance ultrasound imaging and analysis and has comprehensive networking and DICOM capability.
The provided document is a 510(k) Premarket Notification for the GE Vivid E80/E90/E95 Diagnostic Ultrasound System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance criteria through new clinical studies. Therefore, much of the requested information regarding acceptance criteria, specific study design details, and ground truth establishment is not explicitly available in this document.
However, I can extract the following information based on the document's content:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that the GE Vivid E80/E90/E95 system is substantially equivalent to its predicate devices concerning indications for use, imaging capabilities, technological characteristics, safety, and effectiveness. This "substantial equivalence" acts as the acceptance criterion. The reported device performance is that it meets this criterion by being comparable to the predicate devices.
| Acceptance Criterion (Established by Predicate Devices) | Reported Device Performance (GE Vivid E80/E90/E95) |
|---|---|
| Indications & Clinical Applications: Equivalent to predicate (e.g., Fetal/Obstetrics, Abdominal, Cardiac, Peripheral Vascular, etc.) | Meets: Device has identical indications and clinical applications to the primary predicate, Vivid E9 (K131514). |
| Technology: Employs same fundamental scientific technology as predicate. | Meets: Employs the same fundamental scientific technology as its predicate devices. |
| Transducer Arrays: Capable of matrix phased, phased, linear, curved, and pencil arrays. | Meets: Supports all specified transducer array types, equivalent to predicate. |
| Ultrasound Modes: Capable of B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, combined modes, Harmonic, Coded Pulse, Real-time 3D & Multi-plane. | Meets: Supports all specified ultrasound modes, equivalent to predicate. |
| Processing & Display Features: Equivalent image mapping, filtering, enhancement, TGC, TVI, SI/SRI, TSI, Pulsatile-Flow, B-Flow, Extended FOV, Tissue Tracking, Real-time 3D, Real-time 3D Color Flow, BFI, Spatial Compounding, Slice View, Laser-Lines, CTO, AFI, Multiplane AFI, LCD/OLED display, StereoVision, Stress, HDLive, Virtual Apex, 4D Auto AVQ. | Meets: Incorporates equivalent processing and display features, with OLED display as an alternative to LCD (predicate only had LCD). |
| Standards Compliance: Designed and verified to meet harmonized standards for Electrical Safety, EMC, Biocompatibility, Software Life Cycle Management, Risk Management, and Usability. Track 3 compliance (within FDA limits). | Meets: Designed and verified to meet all listed harmonized standards. Is Track 3 compliant. |
| Safety and Effectiveness: Demonstrated to be as safe and as effective as predicate devices. | Meets: Considered as safe and as effective as the predicate devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily relies on comparisons to predicate devices and adherence to recognized standards. It explicitly states: "The subject of this premarket submission, Vivid E80 / E90 / E95, did not require clinical studies to support substantial equivalence."
Therefore, there is no specific test set or data provenance details relating to clinical performance provided in this document as new clinical studies were not deemed necessary for this 510(k) submission. The evidence is based on demonstrating the new device performs equivalently to existing cleared devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Since new clinical studies were not required, there is no information on experts establishing ground truth for a test set. The predicate devices would have undergone their own validation for their initial clearance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no new clinical test set was required.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a diagnostic ultrasound system, and the submission is for showing substantial equivalence to predicate ultrasound systems, not for evaluating AI assistance or human reader improvement with AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a diagnostic ultrasound system that functions with a human operator for image acquisition and interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no new clinical studies requiring external ground truth were conducted for this 510(k). The "ground truth" for demonstrating substantial equivalence is the established performance and safety profiles of the predicate devices.
8. The sample size for the training set
Not applicable, as this is related to a new clinical study or AI development, neither of which were required for this 510(k) submission.
9. How the ground truth for the training set was established
Not applicable, for the same reasons as above. The submission focuses on demonstrating the device's technical and functional equivalence to already cleared devices.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 4, 2015
GE Vingmed Ultrasound AS % Mr. Bryan Behn Regulatory Affairs Manager GE Healthcare 9900 W Innovation Drive, RP-2138 WAUWATOSA WI 53226
Re: K150087
Trade/Device Name: Vivid E90, Vivid E90 and Vivid E95 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: January 13, 2015 Received: January 15, 2015
Dear Mr. Behn:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{1}------------------------------------------------
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Robert A Ochs
Robert Ochs. Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K150087
Device Name Vivid E80 and Vivid E90 and Vivid E95
Indications for Use (Describe)
The device 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, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional; Urology (including prostate); Transesophagea1; 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.
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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:
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"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 General Electric (GE) logo. The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a circular border. The color of the logo is blue, and the background is white. The logo is simple and recognizable.
Diagnostic Ultrasound Indications for Use Form GE 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 ApplicationAnatomy/Region of Interest | B | M | PWDoppler | CWDoppler | ColorDoppler | Color MDoppler | PowerDoppler | CombinedModes* | HarmonicImaging | CodedPulse | RT3DMode* | |
| Ophthalmic | ||||||||||||
| Fetal / Obstetrics | N | N | N | N | N | N | N | N | N | N | N | |
| Abdominal[1] | N | N | N | N | N | N | N | N | N | N | N | |
| Pediatric | N | N | N | N | N | N | N | N | N | N | N | |
| Small Organ[2] | N | N | N | N | N | N | N | N | N | N | N | |
| Neonatal Cephalic | N | N | N | N | N | N | N | N | N | N | N | |
| Adult Cephalic | N | N | N | N | N | N | N | N | N | N | N | |
| Cardiac[3] | N | N | N | N | N | N | N | N | N | N | N | |
| Peripheral Vascular | N | N | N | N | N | N | N | N | N | N | N | |
| Musculo-skeletal Conventional | N | N | N | N | N | N | N | N | N | N | N | |
| Musculo-skeletal Superficial | N | N | N | N | N | N | N | N | N | N | N | |
| Other[4] | N | N | N | N | N | N | N | N | N | N | N | |
| Exam Type, Means of Access | ||||||||||||
| Transesophageal | N | N | N | N | N | N | N | N | N | N | N | |
| Transrectal | N | N | N | N | N | N | N | N | N | N | N | |
| Transvaginal | N | N | N | N | N | N | N | N | N | N | N | |
| Transuretheral | N | N | N | N | N | N | N | N | N | N | N | |
| Intraoperative[5] | N | N | N | N | N | N | N | N | N | N | N | |
| Intraoperative Neurological | ||||||||||||
| Intravascular | ||||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [1] Abdominal includes renal, GYN/Pelvic
[2] Small organ includes breast, testes, thyroid.
[3] Cardiac is Adult and Pediatric.
[4] Other use includes Urology/Prostate
[5] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
[*] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);
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)
Prescription User (Per 21 CFR 801.109)
Page 2 of 18
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Image /page/4/Picture/1 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 circle has a decorative border that resembles a stylized wave or ribbon pattern.
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:
| Clinical ApplicationAnatomy/Region of Interest | Mode of Operation | RT3DMode * | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||||||
| Fetal / Obstetrics | ||||||||||||
| Abdominal | ||||||||||||
| Pediatric | P | P | P | P | P | P | P | P | P | P | ||
| Small Organ | ||||||||||||
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | P | ||
| Adult Cephalic | ||||||||||||
| Cardiac[1] | P | P | P | P | P | P | P | P | P | P | ||
| Peripheral Vascular | ||||||||||||
| Musculo-skeletal Conventional | ||||||||||||
| Musculo-skeletal Superficial | ||||||||||||
| Other | ||||||||||||
| Exam Type, Means of Access | ||||||||||||
| Transesophageal | ||||||||||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Transuretheral | ||||||||||||
| Intraoperative (specify) | ||||||||||||
| Intraoperative Neurological | ||||||||||||
| Intravascular | ||||||||||||
| Laparoscopic |
P = previously cleared by FDA on Vivid E9 (K131514)
Notes: [1] Cardiac is Adult and Pediatric.
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD.
[ ♦] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);
(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)
Prescription User (Per 21 CFR 801.109)
Page 3 of 18
{5}------------------------------------------------
Image /page/5/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 the circle has a decorative border. The logo is simple and recognizable, and it is associated with a well-known company.
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 ApplicationAnatomy/Region of Interest | B | M | PWDoppler | CWDoppler | ColorDoppler | Color MDoppler | PowerDoppler | CombinedModes* | HarmonicImaging | CodedPulse | RT3DMode* |
| Ophthalmic | |||||||||||
| Fetal / Obstetrics | P | P | P | P | P | P | P | P | P | P | P |
| Abdominal[1] | P | P | P | P | P | P | P | P | P | P | P |
| Pediatric | P | P | P | P | P | P | P | P | P | P | P |
| Small Organ | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | P | P | P | P | P | P | P | P | P | P | P |
| Cardiac [2] | P | P | P | P | P | P | P | P | P | P | P |
| Peripheral Vascular | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other[3] | P | P | P | P | P | P | P | P | P | P | P |
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic |
P = previously cleared by FDA on Vivid E9 (K131514)
Notes: [1] Abdominal includes renal, GYN/Pelvic
[2] Cardiac is Adult and Pediatric.
[3] Other use includes Urology/Prostate
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD.
[ ◆] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);
(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)
Prescription User (Per 21 CFR 801.109)
Page 4 of 18
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters 'GE' in a stylized script, enclosed within a circular frame. The color of the logo is a light blue.
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 | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| ClinicalApplicationAnatomy/ Region of Interest | B | M | PWDoppler | CWDoppler | ColorDoppler | Color MDoppler | PowerDoppler | Combined HarmonicModes | Imaging | CodedPulse | RT3DMode |
| Ophthalmic | |||||||||||
| Fetal / Obstetrics | P | P | P | P | P | P | P | P | P | ||
| Abdominal | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Peripheral Vascular | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other[4] | P | P | P | P | P | P | P | P | P | ||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | P | P | P | P | P | P | P | P | |||
| Transvaginal | P | P | P | P | P | P | P | P | |||
| Transuretheral | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic |
P = previously cleared by FDA on Vivid E9 (K131514)
Notes: [4] Other use includes Urology/Prostate;
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD.
[*] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);
(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)
Prescription User (Per 21 CFR 801.109)
Page 5 of 18
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' written in a stylized script, enclosed within a blue circle. The script is white, creating a contrast against the blue background.
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 ApplicationAnatomy/Region of Interest | B | M | PWDoppler | CWDoppler | ColorDoppler | Color MDoppler | PowerDoppler | CombinedModes* | HarmonicImaging | CodedPulse | RT3DMode* |
| Ophthalmic | |||||||||||
| Fetal / Obstetrics | |||||||||||
| Abdominal[1] | P | P | P | P | P | P | P | P | P | P | |
| Pediatric | P | P | P | P | P | P | P | P | P | P | |
| Small Organ (specify) | P | P | P | P | P | P | P | P | P | P | |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | P | |
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | P | |
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other[4] | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic |
P = previously cleared by FDA on Vivid E9 (K131514)
Notes: [1] Abdominal includes GYN/Pelvic, Renal and Aorta-iliac artery;
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD.
[ ◆] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);
(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)
Prescription User (Per 21 CFR 801.109)
Page 6 of 18
{8}------------------------------------------------
Image /page/8/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 circle has a decorative border with a swirling pattern.
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 ApplicationAnatomy/Region of Interest | B | M | PWDoppler | CWDoppler | ColorDoppler | Color MDoppler | PowerDoppler | CombinedModes* | HarmonicImaging | CodedPulse | 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 (specify) | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Cardiac | ||||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | |||
| Musculo-skeletal Conventional | ||||||||||||
| Musculo-skeletal Superficial | ||||||||||||
| Other[4] | P | P | P | P | P | P | P | P | P | |||
| Exam Type, Means of Access | ||||||||||||
| Transesophageal | ||||||||||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Transuretheral | ||||||||||||
| Intraoperative (specify) | ||||||||||||
| Intraoperative Neurological | ||||||||||||
| Intravascular | ||||||||||||
| Laparoscopic |
P = previously cleared by FDA on Vivid E9 (K131514)
Notes: [1] Abdominal includes GYN/Pelvic, Renal and Aorta-iliac artery;
[4] Other use includes Urology/Prostate;
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD.
(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)
Prescription User (Per 21 CFR 801.109)
Page 7 of 18
{9}------------------------------------------------
Image /page/9/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 script inside. The letters are white and have a flowing, interconnected design. The circle is surrounded by a decorative border, also in blue, that resembles a series of stylized waves or flourishes.
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 | B | M | PW | CW | Color | Color M | Power | Combined Harmonic | Coded | RT3D | ||
| Anatomy/Region of Interest | Doppler | Doppler | Doppler | Doppler | Doppler | Modes | Imaging | Pulse | Mode | |||
| Ophthalmic | ||||||||||||
| Fetal / Obstetrics | ||||||||||||
| Abdominal | ||||||||||||
| Pediatric | P | P | P | P | P | P | P | P | P | |||
| Small Organ[2] | P | P | P | P | P | P | P | P | P | |||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Cardiac | ||||||||||||
| 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 | ||||||||||||
| Other[4] | ||||||||||||
| Exam Type, Means of Access | ||||||||||||
| Transesophageal | ||||||||||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Transuretheral | ||||||||||||
| Intraoperative (specify) | ||||||||||||
| Intraoperative Neurological | ||||||||||||
| Intravascular | ||||||||||||
| Laparoscopic |
P = previously cleared by FDA on Vivid E9 (K131514)
Notes: [2] Small organ includes breast, testes, thyroid.
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD.
[ ◆] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);
(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)
Prescription User (Per 21 CFR 801.109)
Page 8 of 18
{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 letters are white and have a swirling design around them. The logo is simple and recognizable, and it is often used to represent the company's brand.
Diagnostic Ultrasound Indications for Use Form GE Vivid E80 / Vivid E90 / Vivid E95 with 11L-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical ApplicationAnatomy/Region of Interest | B | M | PWDoppler | CWDoppler | ColorDoppler | Color MDoppler | PowerDoppler | CombinedModes* | HarmonicImaging | CodedPulse | RT3DMode* | |
| Ophthalmic | ||||||||||||
| Fetal / Obstetrics | ||||||||||||
| Abdominal | ||||||||||||
| Pediatric | P | P | P | P | P | P | P | P | P | |||
| Small Organ[2] | P | P | P | P | P | P | P | P | P | |||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Cardiac | ||||||||||||
| 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 | ||||||||||||
| Other[4] | ||||||||||||
| Exam Type, Means of Access | ||||||||||||
| Transesophageal | ||||||||||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Transuretheral | ||||||||||||
| Intraoperative[5] | P | P | P | P | P | P | P | P | P | |||
| Intraoperative Neurological | ||||||||||||
| Intravascular | ||||||||||||
| Laparoscopic |
P = previously cleared by FDA on Vivid E9 (K131514)
Notes: [2] Small organ includes breast, testes, thyroid.
[5] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD.
[ ♦] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);
(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)
Prescription User (Per 21 CFR 801.109)
Page 9 of 18
{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 script, enclosed within a blue circle. The circle has a decorative border that resembles a stylized wave or ribbon pattern.
Diagnostic Ultrasound Indications for Use Form GE Vivid E80 / Vivid E90 / Vivid E95 with M5Sc-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| ClinicalApplicationAnatomy/Region of Interest | B | M | PWDoppler | CWDoppler | ColorDoppler | Color MDoppler | PowerDoppler | CombinedModes | HarmonicImaging | CodedPulse | RT3DMode* |
| Ophthalmic | |||||||||||
| Fetal / Obstetrics | P | P | P | P | P | P | P | P | P | P | P |
| Abdominal | P | P | P | P | P | P | P | P | P | P | P |
| Pediatric | P | P | P | P | P | P | P | P | P | P | P |
| Small Organ[2] | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | P | P | P | P | P | P | P | P | P | P | P |
| Cardiac[3] | P | P | P | P | P | P | P | P | P | P | P |
| Peripheral Vascular | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other[4] | P | P | P | P | P | P | P | P | P | P | P |
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic |
P = previously cleared by FDA on Vivid E9 (K131514)
Notes: [2] Small organ includes breast, testes, thyroid.
[3] Cardiac is Adult and Pediatric.
[4] Other use includes Urology/Prostate
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD.
[ ◆ ] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);
(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)
Prescription User (Per 21 CFR 801.109)
Page 10 of 18
{12}------------------------------------------------
Image /page/12/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 script inside. The letters are white and have a flowing, interconnected design. The circle is surrounded by a decorative border, also in blue, that resembles a series of stylized waves or flourishes.
Diagnostic Ultrasound Indications for Use Form GE Vivid E80 / Vivid E90 / Vivid E95 with 6S-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical ApplicationAnatomy/Region of Interest | B | M | PWDoppler | CWDoppler | ColorDoppler | Color MDoppler | PowerDoppler | CombinedModes* | HarmonicImaging | CodedPulse | RT3DMode* | |
| Ophthalmic | ||||||||||||
| Fetal / Obstetrics | P | P | P | P | P | P | P | P | P | P | P | |
| Abdominal | P | P | P | P | P | P | P | P | P | P | P | |
| Pediatric | P | P | P | P | P | P | P | P | P | P | P | |
| Small Organ[2] | ||||||||||||
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | P | P | P |
| Adult Cephalic | ||||||||||||
| Cardiac [3] | P | P | P | P | P | P | P | P | P | P | P | P |
| Peripheral Vascular | ||||||||||||
| Musculo-skeletal Conventional | ||||||||||||
| Musculo-skeletal Superficial | ||||||||||||
| Other[4] | ||||||||||||
| Exam Type, Means of Access | ||||||||||||
| Transesophageal | ||||||||||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Transuretheral | ||||||||||||
| Intraoperative (specify) | ||||||||||||
| Intraoperative Neurological | ||||||||||||
| Intravascular | ||||||||||||
| Laparoscopic |
P = previously cleared by FDA on Vivid E9 (K131514)
Notes: [2] Small organ includes breast, testes, thyroid.
[3] Cardiac is Adult and Pediatric.
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD.
[ ♦] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);
(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)
Prescription User (Per 21 CFR 801.109)
Page 11 of 18
{13}------------------------------------------------
Image /page/13/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 is surrounded by a decorative, swirling pattern, also in blue. The logo is simple, recognizable, and associated with a well-known multinational corporation.
Diagnostic Ultrasound Indications for Use Form GE Vivid E80 / Vivid E90 / Vivid E95 with C1-6-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| ClinicalApplicationAnatomy/Region of Interest | B | M | PWDoppler | CWDoppler | ColorDoppler | Color MDoppler | PowerDoppler | CombinedModes* | HarmonicImaging | CodedPulse | RT3DMode* |
| Ophthalmic | |||||||||||
| Fetal / Obstetrics | P | P | P | P | P | P | P | P | P | P | P |
| Abdominal[1] | P | P | P | P | P | P | P | P | P | P | P |
| Pediatric | P | P | P | P | P | P | P | P | P | P | P |
| Small Organ[2] | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | P | P |
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other[4] | P | P | P | P | P | P | P | P | P | P | P |
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic |
P = previously cleared by FDA on Vivid S60/S70 (K142323)
Notes: [1] Abdominal includes Renal, GYN/Pelvic.
[2] Small organ includes breast, testes, thyroid.
[4] Other use includes Urology/Prostate
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD.
[ ◆] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);
(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)
Prescription User (Per 21 CFR 801.109)
Page 12 of 18
{14}------------------------------------------------
Image /page/14/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 is surrounded by a decorative, swirling pattern, also in blue. The logo is simple, recognizable, and associated with a well-known multinational corporation.
Diagnostic Ultrasound Indications for Use Form GE Vivid E80 / Vivid E90 / Vivid E95 with L8-18i-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical | B | M | PW | CW | Color | Color M | Power | Combined Harmonic | Coded | RT3D | ||
| Application | Doppler | Doppler | Doppler | Doppler | Doppler | Modes | Imaging | Pulse | Mode | |||
| Anatomy/Region of Interest | ||||||||||||
| Ophthalmic | ||||||||||||
| Fetal / Obstetrics | ||||||||||||
| Abdominal[1] | ||||||||||||
| 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 | ||||||||||||
| Cardiac | ||||||||||||
| 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 | ||||||||||||
| Other[4] | ||||||||||||
| Exam Type, Means of Access | ||||||||||||
| Transesophageal | ||||||||||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Transuretheral | ||||||||||||
| Intraoperative [5] | P | P | P | P | P | P | P | P | P | |||
| Intraoperative Neurological | ||||||||||||
| Intravascular | ||||||||||||
| Laparoscopic |
P = previously cleared by FDA on Logiq E9 (K142160)
Notes: [1] Abdominal includes Renal, GYN/Pelvic.
[2] Small organ includes breast, testes, thyroid.
[4] Other use includes Urology/Prostate
[5] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD.
[ ♦] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);
(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)
Prescription User (Per 21 CFR 801.109)
Page 13 of 18
Diagnostic Ultrasound Indications for Use Form
{15}------------------------------------------------
Image /page/15/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 curved lines around the letters. The logo is simple and recognizable.
GE Vivid E80 / Vivid E90 / Vivid E95 with 6VT-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical ApplicationAnatomy/ Region of Interest | B | M | PWDoppler | CWDoppler | ColorDoppler | Color MDoppler | PowerDoppler | CombinedModes* | HarmonicImaging | CodedPulse | RT3DMode* | |
| Ophthalmic | ||||||||||||
| Fetal / Obstetrics | ||||||||||||
| Abdominal | ||||||||||||
| Pediatric | ||||||||||||
| Small Organ (specify) | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Cardiac | P | P | P | P | P | P | P | P | P | P | P | |
| Peripheral Vascular | ||||||||||||
| Musculo-skeletal Conventional | ||||||||||||
| Musculo-skeletal Superficial | ||||||||||||
| Other (specify) | ||||||||||||
| Exam Type, Means of Access | ||||||||||||
| Transesophageal | P | P | P | P | P | P | P | P | P | P | P | |
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Transuretheral | ||||||||||||
| Intraoperative (specify) | ||||||||||||
| Intraoperative Neurological | ||||||||||||
| Intravascular | ||||||||||||
| Laparoscopic |
P = previously cleared by FDA on Vivid E9 (K131514)
Notes: [] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD. [] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);
(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)
Prescription User (Per 21 CFR 801.109)
Page 14 of 18
{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. The letters are also blue, and they are surrounded by a swirling design. The logo is simple and recognizable, and it is a symbol of the company's long history and its commitment to innovation.
Diagnostic Ultrasound Indications for Use Form GE Vivid E80 / Vivid E90 / Vivid E95 with 6Tc/6Tc-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical ApplicationAnatomy/ Region of Interest | B | M | PWDoppler | CWDoppler | ColorDoppler | Color MDoppler | PowerDoppler | Combined HarmonicModes | Imaging | CodedPulse | RT3DMode* | |
| Ophthalmic | ||||||||||||
| Fetal / Obstetrics | ||||||||||||
| Abdominal | ||||||||||||
| Pediatric | ||||||||||||
| Small Organ (specify) | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Cardiac | P | P | P | P | P | P | P | P | P | P | P | |
| Peripheral Vascular | ||||||||||||
| Musculo-skeletal Conventional | ||||||||||||
| Musculo-skeletal Superficial | ||||||||||||
| Other (specify) | ||||||||||||
| Exam Type, Means of Access | ||||||||||||
| Transesophageal | P | P | P | P | P | P | P | P | P | P | P | |
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Transuretheral | ||||||||||||
| Intraoperative (specify) | ||||||||||||
| Intraoperative Neurological | ||||||||||||
| Intravascular | ||||||||||||
| Laparoscopic |
P = previously cleared by FDA on Vivid E9 (K131514)
Notes: [] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD. [] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);
(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)
Prescription User (Per 21 CFR 801.109)
Page 15 of 18
{17}------------------------------------------------
Image /page/17/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 the circle has a decorative border. The logo is simple and recognizable, and it is associated with a well-known company.
Diagnostic Ultrasound Indications for Use Form GE Vivid E80 / Vivid E90 / Vivid E95 with 9T/9T-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical ApplicationAnatomy/ Region of Interest | B | M | PWDoppler | CWDoppler | ColorDoppler | Color MDoppler | PowerDoppler | CombinedModes | HarmonicImaging | CodedPulse | RT3DMode* | |
| Ophthalmic | ||||||||||||
| Fetal / Obstetrics | ||||||||||||
| Abdominal | ||||||||||||
| Pediatric | ||||||||||||
| Small Organ (specify) | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Cardiac [3] | P | P | P | P | P | P | P | P | P | P | P | |
| Peripheral Vascular | ||||||||||||
| Musculo-skeletal Conventional | ||||||||||||
| Musculo-skeletal Superficial | ||||||||||||
| Other (specify) | ||||||||||||
| Exam Type, Means of Access | ||||||||||||
| Transesophageal | P | P | P | P | P | P | P | P | P | P | P | |
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Transuretheral | ||||||||||||
| Intraoperative (specify) | ||||||||||||
| Intraoperative Neurological | ||||||||||||
| Intravascular | ||||||||||||
| Laparoscopic |
P = previously cleared by FDA on Vivid E9 (K131514)
Notes: [*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD. [3] Cardiac is Adult & Pediatric
[*] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);
(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)
Prescription User (Per 21 CFR 801.109)
Page 16 of 18
{18}------------------------------------------------
Image /page/18/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 script is white, creating a contrast against the blue background.
Diagnostic Ultrasound Indications for Use Form GE Vivid E80 / Vivid E90 / Vivid E95 with P2D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical ApplicationAnatomy/ Region of Interest | Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PWDoppler | CWDoppler | ColorDoppler | Color MDoppler | PowerDoppler | Combined Modes | Harmonic Imaging | CodedPulse | RT3DMode | |
| Ophthalmic | |||||||||||
| Fetal / Obstetrics | |||||||||||
| Abdominal | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac[3] | P | P | |||||||||
| Peripheral Vascular | P | P | |||||||||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other (specify) | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic |
P = previously cleared by FDA on Vivid E9 (K131514)
Notes: [3] Cardiac is Adult and Pediatric.
[*] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);
(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)
Prescription User (Per 21 CFR 801.109)
Page 17 of 18
{19}------------------------------------------------
Image /page/19/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 circle has a decorative border with a swirling pattern.
Diagnostic Ultrasound Indications for Use Form GE Vivid E80 / Vivid E90 / Vivid E95 with P6D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical ApplicationAnatomy/ Region of Interest | Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PWDoppler | CWDoppler | ColorDoppler | Color MDoppler | PowerDoppler | Modes | Combined HarmonicImaging | CodedPulse | RT3DMode | |||
| Ophthalmic | |||||||||||||
| Fetal / Obstetrics | |||||||||||||
| Abdominal | |||||||||||||
| Pediatric | |||||||||||||
| Small Organ (specify) | |||||||||||||
| Neonatal Cephalic | |||||||||||||
| Adult Cephalic | |||||||||||||
| Cardiac [3] | P | P | |||||||||||
| Peripheral Vascular | P | P | |||||||||||
| Musculo-skeletal Conventional | |||||||||||||
| Musculo-skeletal Superficial | |||||||||||||
| Other (specify) | |||||||||||||
| Exam Type, Means of Access | |||||||||||||
| Transesophageal | |||||||||||||
| Transrectal | |||||||||||||
| Transvaginal | |||||||||||||
| Transuretheral | |||||||||||||
| Intraoperative (specify) | |||||||||||||
| Intraoperative Neurological | |||||||||||||
| Intravascular | |||||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [3] Cardiac is Adult and Pediatric.
[*] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);
(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)
Prescription User (Per 21 CFR 801.109)
Page 18 of 18
{20}------------------------------------------------
Image /page/20/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 letters are also blue, matching the color of the circle.
510(k) Summary
| In accordance with 21 CFR 807.92 the following summary of information is provided:Date: January 13, 2015 | |
|---|---|
| Submitter: | GE Healthcare, GE Vingmed Ultrasound ASStrandpromenaden 45N-3191, Horten, Norway |
| Primary Contact Person: | Bryan BehnRegulatory Affairs ManagerGE Healthcare, GE Medical Systems Ultrasound and PrimaryCare Diagnostics, LLC.T:(414)721-4214F:(414)918-8275 |
| Secondary Contact Person: | Jan Tore ThollefsenRegulatory Affairs ManagerGE Vingmed Ultrasound AST:(+47)3302-1269F:(+47)3302-1357 |
| Device:Trade Name: | Vivid E80, Vivid E90, Vivid E95 Diagnostic Ultrasound System |
| Common/Usual Name: | Vivid E80, Vivid E90, Vivid E95 |
| Classification Names: | Class II |
| Product Code: | Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-IYNUltrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYODiagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX |
| Predicate Device(s): | K1315141 GE Vivid E9 Diagnostic Ultrasound SystemK142323 GE Vivid S60/S70 Diagnostic Ultrasound SystemK142160 L8-18i-D Diagnostic Ultrasound Transducer on LogiqE9. |
| Device Description: | GE Vivid E80 / E90 / E95 is a Track 3 diagnostic ultrasoundsystem, which is primarily intended for cardiac imaging andanalysis, but which also includes vascular and general radiologyapplications. The Vivid E80 / E90 / E95 incorporates a variety ofelectronic array transducers operating in linear, curved linear,sector/phased array or matrix array format, including twodedicated CW transducers and several real time 3D transducers. Itconsists of a mobile console with keyboard control panel; colorLCD/TFT touch panel, Alternative OLED or LCD color videodisplay and optional image storage and printing devices. Itprovides high performance ultrasound imaging and analysis andhas comprehensive networking and DICOM capability. |
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Image /page/21/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 is surrounded by a decorative, swirling pattern, also in blue. The logo is simple, recognizable, and represents the General Electric brand.
- GE Vivid E80 / E90 / E95 ultrasound system is a general-purpose Intended Use: 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); Musculo-Conventional; Urology (including prostate), skeletal Transesophageal; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).
The Vivid E80 / E90 / E95 employ the same fundamental Technology: scientific technology as its predicate devices.
Determination of Comparison to predicate Substantial Equivalence:
The Vivid E80/E90/E95 systems are substantially equivalent to the predicate devices with regard to intended use, imaging capabilities, technological characteristics and safety and effectiveness.
| Proposed DeviceVivid E80/E90/E95 | Predicate DeviceVivid E9 (K131514) | |
|---|---|---|
| Indications and Clinical Applications: | ||
| ● Fetal/Obstetrics; | ✓ | ✓ |
| ● Abdominal (Including Renal & Gyn) | ✓ | ✓ |
| ● Pediatric | ✓ | ✓ |
| ● Small Organ (breast, testes, thyroid); | ✓ | ✓ |
| ● Neonatal Cephalic; | ✓ | ✓ |
| ● Adult Cephalic; | ✓ | ✓ |
| ● Cardiac (adult and pediatric); | ✓ | ✓ |
| ● Peripheral Vascular; | ✓ | ✓ |
| ● Musculo-skeletal Conventional | ✓ | ✓ |
| ● Urology (including prostate); | ✓ | ✓ |
| ● Transesophageal; | ✓ | ✓ |
| ● Transrectal (TR); | ✓ | ✓ |
| ● Transvaginal (TV); | ✓ | ✓ |
| ● Intraoperative (abdominal, thoracic, & vascular). | ✓ | ✓ |
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Image /page/22/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined in a stylized, cursive font. The letters are enclosed within a circular shape, and the entire logo is presented in a blue color scheme.
GE Healthcare
510(k) Premarket Notification
| Transducer Arrays: | Proposed DeviceVivid E80/E90/E95 | Predicate DeviceVivid E9 (K131514) |
|---|---|---|
| Matrix Phased Array (incl single crystal) | ✓ | ✓ |
| Phased Array | ✓ | ✓ |
| Linear Array | ✓ | ✓ |
| Curved Array | ✓ | ✓ |
| Pencil (Doppler) | ✓ | ✓ |
| Ultrasound Modes: | Proposed DeviceVivid E80/E90/E95 | Predicate DeviceVivid E9 (K131514) |
| B, M, PW Doppler, CW Doppler, ColorDoppler, Color M Doppler, Power | ✓ | ✓ |
| Combined modes: B/M, B/Color M,B/PWD or CWD, B/Color/PWD or CWD,B/Power/PWD. | ✓ | ✓ |
| Harmonic | ✓ | ✓ |
| Coded Pulse | ✓ | ✓ |
| Real-time 3D & Multi-plane. | ✓ | ✓ |
| Processing & Display features: | Proposed DeviceVivid E80/E90/E95 | Predicate DeviceVivid E9 (K131514) |
| Image mapping (color & gray) | ✓ | ✓ |
| Time/ spatial filtering and enhancement, | ✓ | ✓ |
| TGC, TVI, SI/SRI, TSI, TSI w/ surfacerendering, Harmonic Imaging, | ✓ | ✓ |
| Pulsatile-Flow, B-Flow, Extended FOV,Tissue Tracking, | ✓ | ✓ |
| Real-time 3D and Multi-plane processing, | ✓ | ✓ |
| Real-time 3D Color Flow, | ✓ | ✓ |
| Blood Flow Imaging (BFI), SpatialCompounding / Speckle Reductionimaging, Slice View, Laser-Lines,Continuous Tissue Optimization (CTO) | ✓ | ✓ |
| Automated Functional Imaging (AFI) w/Bull's Eye display, Triplane AFI. | ✓ | ✓ |
| LCD display, StereoVision,2D Stress, Multiplane Stress | ✓ | ✓ |
| HDLive, Virtual Apex, 4D Auto AVQ | ✓ | ✓ |
| OLED display | Alternative to LCD | LCD display only |
| Processing & Display features:(Continued) | Proposed DeviceVivid E80/E90/E95 | Predicate DeviceVivid S60/S70(K142323) |
| AFI Stress, Smart Depth, Virtual Apex, 4DStress. | ✓ | ✓ |
| Standards Compliance: | Proposed DeviceVivid E80/E90/E95 | Predicate DeviceVivid E9 (K131514) |
| Designed and verified to meet harmonizedstandards for Electrical Safety, EMC,Biocompatibility. Software Life CycleManagement, Risk Management andUsability. | ✓ | ✓ |
| Track 3 (within FDA limits) | ✓ | ✓ |
| Transducers: | Proposed DeviceVivid E80/E90/E95 | Predicate DeviceVivid E9 (K131514) |
| ● M5Sc-D | ✓ | ✓ |
| ● 6S-D | ✓ | ✓ |
| ● 12S-D | ✓ | ✓ |
| ● 6VT-D | ✓ | ✓ |
| ● 6Tc | ✓ | ✓ |
| ● 6Tc -RS | ✓ | ✓ |
| ● 9T | ✓ | ✓ |
| ● 9T -RS | ✓ | ✓ |
| ● 9L-D | ✓ | ✓ |
| ● 11L-D | ✓ | ✓ |
| ● 8C | ✓ | ✓ |
| ● P2D | ✓ | ✓ |
| ● P6D | ✓ | ✓ |
| ● 4V-D | ✓ | ✓ |
| ● iC5-9-D | ✓ | ✓ |
| ● C2-9-D | ✓ | ✓ |
| Transducers: (Continued) | Proposed DeviceVivid E80/E90/E95 | Predicate DeviceVivid S60/S70(K142323) |
| ● C1-6-D | ✓ | ✓ |
| Transducers: (Continued) | Proposed DeviceVivid E80/E90/E95 | Predicate DeviceLogiq E9 (K142160) |
| ● L8-18i-D | ✓ | ✓ |
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GE Healthcare 510(k) Premarket Notification GE Vivid E80/E90/E95
Image /page/23/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined within a blue circle. There are also three white swirls around the outside of the circle.
Summary of Non-Clinical Tests:
The device has been evaluated for acoustic output safety, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic, and mechanical safety, and has been found to conform to applicable medical device safety standards. The Vivid E80 / E90 / E95 and its applications comply with voluntary standards:
-
- ANSI/AAMI ES60601-1, Medical Electrical Equipment -Part 1: General Requirements for basic safety and essential performance.
-
- IEC60601-1-2, Medical Electrical Equipment -Part 1-2: General Requirements for basic safety and essential performance - Collateral Standard: Electromagnetic Compatibility Requirements and Tests.
-
- IEC60601-2-37, Medical Electrical Equipment -Part 2-37: Particular Requirements for the basic safety and essential performance of Ultrasonic Medical Diagnostic and Monitoring Equipment.
-
- NEMA UD 3, Standard for Real Time Display of
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Image /page/24/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 is surrounded by swirling, decorative elements, also in blue, giving the logo a classic and recognizable appearance.
Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment.
-
- ISO10993-1, Biological Evaluation of Medical Devices- Part 1: Evaluation and Testing- Fourth Edition.
-
- NEMA UD 2, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment.
-
- ISO14971. Application of risk management to medical devices
-
- NEMA, Digital Imaging and Communications in Medicine (DICOM) Set. (Radiology)
The following quality assurance measures were applied to the development of the system:
- Risk Analysis
- Requirement Reviews
- . Design Reviews
- Testing on unit level (Module verification) ●
- Integration testing (System verification) o
- . Performance testing (Verification)
- Safety testing (Verification) ●
- Final Acceptance Testing (Validation) ●
Summary of Clinical Tests:
The subject of this premarket submission, Vivid E80 / E90 / E95, did not require clinical studies to support substantial equivalence.
- GE Healthcare considers the Vivid E80 / E90 / E95 to be as safe, Conclusion: as effective, and performance is substantially equivalent to the predicate device(s).
§ 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.