LogoFDA 510(k) Search
K Number
K152309
Device Name
LOGIQ E9, LOGIQ E9 XDClear 2.0
Manufacturer
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS
Date Cleared
2015-09-14

(31 days)

Product Code
IYN,ITX,IYO
Regulation Number
892.1550
Type
Special
Panel
Radiology
Reference & Predicate Devices
K142160,K131527,K131514
Predicate For
K162269,K163077,K222919,K230511,K250381
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (abdominal, thoracic and vascular).

Device Description

The LOGIQ E9 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 58 cm wide, 87cm deep and 130 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 10-inch LCD touch screen and color wide screen image display.

AI/ML Overview

The provided text is a 510(k) Premarket Notification Submission for the GE LOGIQ E9, LOGIQ E9 XDclear 2.0 Diagnostic Ultrasound System. This document focuses on establishing substantial equivalence to previously cleared devices rather than presenting a new clinical study with acceptance criteria and device performance. Therefore, much of the requested information regarding acceptance criteria and performance studies in the traditional sense of a clinical trial for a novel device is not directly available in this document.

However, I can extract information related to the device's intended use, comparison to predicates, and the non-clinical tests performed.

Important Note: The acceptance criteria and performance data requested in the prompt typically refer to a clinical study demonstrating the efficacy and safety of a novel device. As this submission is for substantial equivalence to existing devices (K142160 GE LOGIQ E9, K131527 GE LOGIQ S8, K131514 GE Vivid E9), the "acceptance criteria" here are met by demonstrating that the new device shares the same intended use, imaging capabilities, technological characteristics, and safety and effectiveness as the predicate devices, and complies with applicable safety standards. There is no new clinical study presented that would define novel acceptance criteria and then report performance against them.

Here's the information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a substantial equivalence submission, the "acceptance criteria" are implied by the features and performance of the predicate devices and compliance with relevant standards. The "reported device performance" is the demonstration that the LOGIQ E9, LOGIQ E9 XDclear 2.0 system performs equivalently to the predicates for its intended uses and complies with safety standards.

Acceptance Criteria (Implied by Substantial Equivalence and Standards)Reported Device Performance (Claimed in Submission)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body for specified clinical applications (Fetal, Abdominal, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac, Peripheral Vascular, Musculo-skeletal, Urology, Transrectal, Transvaginal, Transesophageal, Intraoperative).The device is stated to have the same clinical intended use as the predicate LOGIQ E9. The individual Intended Use Forms for various transducers (e.g., 3CRF, 3CRF-D, 6S-D, 6Tc, 9L-D, 11L-D, C1-5-D, IC5-9-D, L8-18i-D, M4S-D, M5S-D, M6C-D, ML6-15-D, P2D, P6D, RAB2-5-D, RAB4-8-D, RIC5-9-D, RNA5-9-D, RSP6-16-D, S1-5, S4-10, S4-10-D, C2-9-D, RAB6-D, S1-5-D, C1-6-D, C2-9VN-D, C1-6VN-D, C2-7-D, C2-7VN-D, L3-9i-D, C3-10-D, C2-6b-D) detail the specific applications and modes (B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse, 3D/4D Imaging, Needle Guidance, Volume Navigation, Elastography Imaging, Shear Wave Elastography).
Imaging Capabilities: Similar imaging modes and capabilities as predicate devices.The LOGIQ E9 and predicate LOGIQ E9 systems have the same imaging modes. The LOGIQ E9 and predicate LOGIQ E9 systems have similar capability in terms of performing measurements, capturing digital images, reviewing, and reporting studies.
Technological Characteristics: Employ the same fundamental scientific technology.The LOGIQ E9 employs the same fundamental scientific technology as its predicate device(s). New transducers (C2-7-D, C2-7VN-D, C3-10-D, L3-9i-D) are described as "incremental improvements to the existing transducers and are equivalent." Two new software features (AutoEF and AFI) have been migrated from a predicate (Vivid E9 K131514).
Safety and Effectiveness: Compliance with safety standards and acoustic power limits.The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, as well as thermal, electrical, electromagnetic, and mechanical safety. It has been found to conform with applicable medical device safety standards (AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, NEMA UD 3, ISO10993-1, NEMA UD 2, ISO14971). Acoustic power levels are below applicable FDA limits. The system has been designed in compliance with approved electrical and physical safety standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document explicitly states: "The subject of this premarket submission, LOGIQ E9, did not require clinical studies to support substantial equivalence." Therefore, there is no test set, sample size, or data provenance from a new clinical study provided in this submission for device performance evaluation. The substantial equivalence relies on demonstrating that the new device operates similarly and safely as the predicate devices, which were previously cleared.

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)

Not applicable, as no new clinical study (and thus no "test set" and "ground truth" to establish) was required for this substantial equivalence submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no new clinical study was conducted.

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 device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool in the sense of image interpretation. The "AutoEF and AFI" mentioned are software features but there's no MRMC study detailed here to show improved human reader performance.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable, as this is a diagnostic ultrasound imaging system, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable, as no new clinical study was required for this substantial equivalence submission. The "ground truth" for the predicate devices' clearance would have been established through methods appropriate for diagnostic ultrasound systems at the time of their original clearance (e.g., comparison to other imaging modalities, clinical correlation).

8. The sample size for the training set

Not applicable. This document describes a medical device, not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for an algorithm described in this submission.

{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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized representation of a caduceus, a symbol often associated with medicine and healthcare.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 08, 2015

GE Medical Systems Ultrasound and Primary Care Diagnostics % Mr. Brvan Behn Sr. Regulatory Affairs Manager 9900 Innovation Drive WAUWATOSA WI 53226

Re: K152309

Trade/Device Name: LOGIQ E9, LOGIQ E9 XDclear 2.0 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: August 14, 2015 Received: August 17, 2015

Dear Mr. Behn:

This letter corrects our substantially equivalent letter of September 14. 2015.

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/ResourcesforYou/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,

erely yours,

For Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K152309

Device Name LOGIQ E9, LOGIQ E9 XDclear 2.0

Indications for Use (Describe)

The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transvaginal; Transesophageal and Intraoperative (abdominal, thoracic and 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.

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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:

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

Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9, LOGIQ E9 XDclear 2.0 Ultrasound System

Mode of Operation
Clinical ApplicationBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[Notes]
Anatomy/Region of Interest
Ophthalmic
Fetal/Obstetrics[7]PPPPPPPPPP[5,6,9]
Abdominal[1]PPPPPPPPPP[3,5,6,9,10]
PediatricPPPPPPPPPP[3,5,6,9]
Small Organ[2]PPPPPPPPPP[3,5,6,9,10]
Neonatal CephalicPPPPPPPPPP[5,6,9]
Adult CephalicPPPPPPPPPP[5,6,9]
Cardiac AdultPPPPPPPPPP
Cardiac PediatricPPPPPPPPPP
Peripheral VascularPPPPPPPPPP[3,5,6,9]
Musculo-skeletal ConventionalPPPPPPPPPP[3,5,6,9]
Musculo-skeletal SuperficialPPPPPPPPPP[3,5,6,9]
Other[4]PPPPPPPPPP[3,5,6,9]
Exam Type, Means of Access
TransesophagealPPPPPPPPPP
TransrectalPPPPPPPPPP[3,5,6,9]
TransvaginalPPPPPPPPPP[3,5,6,9]
Transurethral
Intraoperative[8]PPPPPPPPPP[3,5,6,9]
Intraoperative Neurological
Intravascular
Laparoscopic

Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:

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 and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development, Gyn

[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)

[9] Volume navigation

[10] Shear wave elastography

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

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 36

{4}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9, LOGIQ E9 XDclear 2.0 with 3CRF Transducer

Mode of Operation
Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulse*Other[Notes]
Ophthalmic
Fetal/Obstetrics[7]PPPPPPPPP[5,6,9]
Abdominal[1]PPPPPPPPP[5,6,9]
PediatricPPPPPPPPP[5,6,9]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]PPPPPPPPP[5,6,9]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:

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 and thyroid

  • [3] Elastography Imaging Elasticity.
    [4] Other use includes Urology/Prostate

  • [5] 3D/4D Imaging mode
    [6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development

[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)

[9] Volume navigation

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

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 3 of 36

{5}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9, LOGIQ E9 XDclear 2.0 with 3CRF-D Transducer

Mode of Operation
Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulse*Other[Notes]
Ophthalmic
Fetal/Obstetrics[7]PPPPPPPPP[5,6,9]
Abdominal[1]PPPPPPPPP[5,6,9]
PediatricPPPPPPPPP[5,6,9]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]PPPPPPPPP[5,6,9]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:

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 and thyroid

  • [3] Elastography Imaging Elasticity.
    [4] Other use includes Urology/Prostate

  • [5] 3D/4D Imaging mode
    [6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development

[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)

[9] Volume navigation

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

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 4 of 36

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

Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9, LOGIQ E9 XDclear 2.0 with 6S-D Transducer

Mode of Operation
Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulse*Other[Notes]
Ophthalmic
Fetal/Obstetrics[7]PPPPPPPPPP
Abdominal[1]PPPPPPPPPP
PediatricPPPPPPPPPP
Small Organ[2]
Neonatal CephalicPPPPPPPPPP
Adult Cephalic
Cardiac Adult
Cardiac PediatricPPPPPPPPPP
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:

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 and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development

[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)

[9] Volume navigation

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

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 5 of 36

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

Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9, LOGIQ E9 XDclear 2.0 with 6Tc Transducer

Mode of Operation
Clinical ApplicationBMPWCWColorColor MPowerCombinedModes*HarmonicImagingCodedPulse*Other[Notes]
Anatomy/Region of InterestDopplerDopplerDopplerDopplerDoppler
Ophthalmic
Fetal/Obstetrics[7]
Abdominal [1]
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac AdultPPPPPPPPPP
Cardiac Pediatric
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
TransesophagealPPPPPPPPPP
Transrectal
Transvaginal
Transurethral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:

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 and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development

[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)

[9] Volume navigation

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

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 6 of 36

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

Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9, LOGIQ E9 XDclear 2.0 with 9L-D Transducer

Mode of Operation
Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[Notes]
Ophthalmic
Fetal/Obstetrics[7]PPPPPPPPPP[5,6,9]
Abdominal[1]PPPPPPPPPP[3,5,6,9,10]
PediatricPPPPPPPPPP[3,5,6,9]
Small Organ[2]PPPPPPPPPP[3,5,6,9,10]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral VascularPPPPPPPPPP[3,5,6,9]
Musculo-skeletal ConventionalPPPPPPPPPP[3,5,6,9]
Musculo-skeletal SuperficialPPPPPPPPPP[3,5,6,9]
Other[4]PPPPPPPPPP[3,5,6,9]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:

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 and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development

[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)

[9] Volume navigation

[10] Shear wave elastography

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

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 7 of 36

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

Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9, LOGIQ E9 XDclear 2.0 with 11L-D Transducer

Mode of Operation
Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[Notes]
Ophthalmic
Fetal/Obstetrics[7]
Abdominal[1]PPPPPPPPPP[3,5,6]
PediatricPPPPPPPPPP[3,5,6]
Small Organ[2]PPPPPPPPPP[3,5,6]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral VascularPPPPPPPPPP[3,5,6]
Musculo-skeletal ConventionalPPPPPPPPPP[3,5,6]
Musculo-skeletal SuperficialPPPPPPPPPP[3,5,6]
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:

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 and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development

[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)

[9] Volume navigation

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

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 8 of 36

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

Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9, LOGIQ E9 XDclear 2.0 with C1-5-D Transducer

Mode of Operation
Clinical ApplicationBMPWCWColorColor MPowerCombinedHarmonicCodedOther
Anatomy/Region of InterestDopplerDopplerDopplerDopplerDopplerModes*ImagingPulse[Notes]
Ophthalmic
Fetal/Obstetrics[7]PPPPPPPPPP[5,6,9]
Abdominal[1]PPPPPPPPPP[5,6,9]
PediatricPPPPPPPPPP[5,6,9]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral VascularPPPPPPPPPP[5,6,9]
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other [4]PPPPPPPPPP[5,6,9]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:

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 and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development

[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)

[9] Volume navigation

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

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 9 of 36

{11}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9, LOGIQ E9 XDclear 2.0 with IC5-9-D Transducer

Mode of Operation
Clinical ApplicationBMPWCWColorColor MPowerCombinedHarmonicCodedOther
Anatomy/Region of InterestDopplerDopplerDopplerDopplerDopplerModes*ImagingPulse*[Notes]
Ophthalmic
Fetal/Obstetrics[7]PPPPPPPPP[5,6,9]
Abdominal[1]
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]PPPPPPPPP[3,5,6,9]
Exam Type, Means of Access
Transesophageal
TransrectalPPPPPPPPP[3,5,6,9]
TransvaginalPPPPPPPPP[3,5,6,9]
Transurethral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:

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 and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development, Gyn

[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)

[9] Volume navigation

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

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)

Page10 of 36

{12}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9, LOGIQ E9 XDclear 2.0 with L8-18i-D Transducer

Mode of Operation
Clinical ApplicationBMPWCWColorColor MPowerCombinedHarmonicCodedOther
Anatomy/Region of InterestDopplerDopplerDopplerDopplerDopplerModes*ImagingPulse[Notes]
Ophthalmic
Fetal/Obstetrics[7]
Abdominal[1]
PediatricPPPPPPPPP[3,5,6,9]
Small Organ[2]PPPPPPPPP[3,5,6,9]
Neonatal CephalicPPPPPPPPP[5,6,9]
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral VascularPPPPPPPPP[3,5,6,9]
Musculo-skeletal ConventionalPPPPPPPPP[3,5,6,9]
Musculo-skeletal SuperficialPPPPPPPPP[3,5,6,9]
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative[8]PPPPPPPPP[3,5,6,9]
Intraoperative Neurological
Intravascular
Laparoscopic

Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:

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 and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development

[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)

[9] Volume navigation

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

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 11 of 36

{13}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9, LOGIQ E9 XDclear 2.0 with M4S-D Transducer

Mode of Operation
Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[Notes]
Ophthalmic
Fetal/Obstetrics[7]PPPPPPPPPP[5,6]
Abdominal[1]PPPPPPPPPP[5,6]
PediatricPPPPPPPPPP[5,6]
Small Organ[2]
Neonatal Cephalic
Adult CephalicPPPPPPPPPP
Cardiac AdultPPPPPPPPPP
Cardiac Pediatric
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:

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 and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development

[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)

[9] Volume navigation

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

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 12 of 36

{14}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9, LOGIQ E9 XDclear 2.0 with M5S-D Transducer

Mode of Operation
Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulse®Other[Notes]
Ophthalmic
Fetal/Obstetrics[7]PPPPPPPPPP[5,6,9]
Abdominal[1]PPPPPPPPPP[5,6,9]
PediatricPPPPPPPPPP[5,6,9]
Small Organ[2]
Neonatal Cephalic
Adult CephalicPPPPPPPPPP[9]
Cardiac AdultPPPPPPPPPP
Cardiac PediatricPPPPPPPPPP
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other [4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:

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 and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development

[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)

[9] Volume navigation

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

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)

Page13 of 36

{15}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9, LOGIQ E9 XDclear 2.0 with M6C-D Transducer

Mode of Operation
Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[Notes]
Ophthalmic
Fetal/Obstetrics[7]PPPPPPPPPP[5,6]
Abdominal[1]PPPPPPPPPP[5,6]
PediatricPPPPPPPPPP[5,6]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:

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 and thyroid

  • [3] Elastography Imaging Elasticity.
    [4] Other use includes Urology/Prostate

  • [5] 3D/4D Imaging mode
    [6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development

[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)

[9] Volume navigation

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

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)

Page14 of 36

{16}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9, LOGIQ E9 XDclear 2.0 with ML6-15-D Transducer

Mode of Operation
Clinical ApplicationAnatomy/Region of InterestBMPW DopplerCW DopplerColor DopplerColor M DopplerPower DopplerCombined Modes*Harmonic ImagingCoded Pulse*Other [Notes]
Ophthalmic
Fetal/Obstetrics[7]
Abdominal[1]
PediatricPPPPPPPPP[3,5,6,9]
Small Organ[2]PPPPPPPPP[3,5,6,9]
Neonatal CephalicPPPPPPPPP[9]
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral VascularPPPPPPPPP[3,5,6,9]
Musculo-skeletal ConventionalPPPPPPPPP[3,5,6,9]
Musculo-skeletal SuperficialPPPPPPPPP[3,5,6,9]
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:

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 and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development

[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)

[9] Volume navigation

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

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 15 of 36

{17}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9, LOGIQ E9 XDclear 2.0 with P2D

Clinical ApplicationAnatomy/Region of InterestMode of OperationOther[Notes]
BMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulse*
Ophthalmic
Fetal/Obstetrics[7]
Abdominal[1]
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult CephalicPP
Cardiac AdultPP
Cardiac PediatricPP
Peripheral VascularPP
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:

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 and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development

[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)

[9] Volume navigation

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

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 16 of 36

{18}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9, LOGIQ E9 XDclear 2.0 with P6D Transducer

Mode of Operation
Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[Notes]
Ophthalmic
Fetal/Obstetrics[7]
Abdominal[1]
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult CephalicPP
Cardiac AdultPP
Cardiac PediatricPP
Peripheral VascularPP
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other [4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:

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 and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development

[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)

[9] Volume navigation

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

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 17 of 36

{19}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9, LOGIQ E9 XDclear 2.0 with RAB2-5-D Transducer

Mode of Operation
Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulse*Other[Notes]
Ophthalmic
Fetal/Obstetrics[7]PPPPPPPPPP[5,6]
Abdominal[1]PPPPPPPPPP[5,6]
PediatricPPPPPPPPPP[5,6]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral Vascular
Musculo-skeletal ConventionalPPPPPPPPP[5,6]
Musculo-skeletal Superficial
Other[4]PPPPPPPPPP[5]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:

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 and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development

[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)

[9] Volume navigation

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

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 18 of 36

{20}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9, LOGIQ E9 XDclear 2.0 with RAB4-8-D Transducer

Mode of Operation
Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulse®Other[Notes]
Ophthalmic
Fetal/Obstetrics[7]PPPPPPPPP[5,6]
Abdominal[1]PPPPPPPPP[5,6]
PediatricPPPPPPPPP[5,6]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral Vascular
Musculo-skeletal ConventionalPPPPPPPPP[5,6]
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:

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 and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development

[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)

[9] Volume navigation

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

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 19 of 36

{21}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9, LOGIQ E9 XDclear 2.0 with RIC5-9-D Transducer

Mode of Operation
Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[Notes]
Ophthalmic
Fetal/Obstetrics[7]PPPPPPPPPP[5,6]
Abdominal[1]
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]PPPPPPPPPP[3,5,6]
Exam Type, Means of Access
Transesophageal
TransrectalPPPPPPPPPP[3,5,6]
TransvaginalPPPPPPPPPP[3,5,6]
Transurethral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:

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 and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development, Gyn

[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)

[9] Volume navigation

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

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 20 of 36

{22}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9, LOGIQ E9 XDclear 2.0 with RNA5-9-D Transducer

Mode of Operation
Clinical ApplicationBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[Notes]
Anatomy/Region of Interest
Ophthalmic
Fetal/Obstetrics[7]PPPPPPPPPP[5,6]
Abdominal[1]PPPPPPPPPP[5,6]
PediatricPPPPPPPPPP[5,6]
Small Organ[2]PPPPPPPPPP[5,6]
Neonatal CephalicPPPPPPPPPP[5]
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral VascularPPPPPPPPPP[5,6]
Musculo-skeletal ConventionalPPPPPPPPPP[5,6]
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:

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 and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development

[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)

[9] Volume navigation

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

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 21 of 36

{23}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9, LOGIQ E9 XDclear 2.0 with RSP6-16-D Transducer

Mode of Operation
Clinical ApplicationBMPWCWColorColor MPowerCombinedHarmonicCodedOther
Anatomy/Region of InterestDopplerDopplerDopplerDopplerDopplerModes*ImagingPulse[Notes]
Ophthalmic
Fetal/Obstetrics [7]
Abdominal [1]
PediatricPPPPPPPPP[3,5,6]
Small Organ [2]PPPPPPPPP[3,5,6]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral VascularPPPPPPPPP[3,5,6]
Musculo-skeletal ConventionalPPPPPPPPP[3,5,6]
Musculo-skeletal SuperficialPPPPPPPPP[3,5,6]
Other [4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative [8]PPPPPPPPP
Intraoperative Neurological
Intravascular
Laparoscopic

Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:

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 and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development

[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)

[9] Volume navigation

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

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 22 of 36

{24}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9, LOGIQ E9 XDclear 2.0 with S1-5 Transducer

Mode of Operation
Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulse®Other[Notes]
Ophthalmic
Fetal/Obstetrics [7]PPPPPPPPPP[5,6,9]
Abdominal [1]PPPPPPPPPP[5,6,9]
PediatricPPPPPPPPPP[5,6,9]
Small Organ [2]
Neonatal Cephalic
Adult CephalicPPPPPPPPPP[5,6,9]
Cardiac AdultPPPPPPPPPP
Cardiac Pediatric
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other [4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative [8]
Intraoperative Neurological
Intravascular
Laparoscopic

Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:

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 and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development

[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)

[9] Volume navigation

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

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 23 of 36

{25}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9, LOGIQ E9 XDclear 2.0 with S4-10 Transducer

Mode of Operation
Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[Notes]
Ophthalmic
Fetal/Obstetrics[7]PPPPPPPPPP[5,6,9]
Abdominal[1]PPPPPPPPPP[5,6,9]
PediatricPPPPPPPPPP[5,6,9]
Small Organ[2]PPPPPPPPPP[5,6,9]
Neonatal CephalicPPPPPPPPPP[5,6,9]
Adult Cephalic
Cardiac Adult
Cardiac PediatricPPPPPPPPPP
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:

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 and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development

[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)

[9] Volume navigation

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

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 24 of 36

{26}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9, LOGIQ E9 XDclear 2.0 with S4-10-D Transducer

Mode of Operation
Clinical ApplicationBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[Notes]
Anatomy/Region of Interest
Ophthalmic
Fetal/Obstetrics[7]PPPPPPPPPP[5,6,9]
Abdominal[1]PPPPPPPPPP[5,6,9]
PediatricPPPPPPPPPP[5,6,9]
Small Organ[2]PPPPPPPPPP[5,6,9]
Neonatal CephalicPPPPPPPPPP[5,6,9]
Adult Cephalic
Cardiac Adult
Cardiac PediatricPPPPPPPPPPP
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:

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 and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development

[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)

[9] Volume navigation

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

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 25 of 36

{27}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9, LOGIQ E9 XDclear 2.0 with C2-9-D Transducer

Mode of Operation
Clinical ApplicationBMPWCWColorColor MPowerCombinedHarmonicCodedOther
Anatomy/Region of InterestDopplerDopplerDopplerDopplerDopplerModes*ImagingPulse[Notes]
Ophthalmic
Fetal/Obstetrics[7]PPPPPPPPPP[5,6,9]
Abdominal[1]PPPPPPPPPP[3,5,6,9]
PediatricPPPPPPPPPP[3,5,6,9]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral VascularPPPPPPPPPP[3,5,6,9]
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]PPPPPPPPPP[3,5,6,9]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:

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 and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development

[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)

[9] Volume navigation

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

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 26 of 36

{28}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9, LOGIQ E9 XDclear 2.0 with RAB6-D Transducer

Mode of Operation
Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[Notes]
Ophthalmic
Fetal/Obstetrics[7]PPPPPPPPP[5,6]
Abdominal[1]PPPPPPPPP[5,6]
PediatricPPPPPPPPP[5,6]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral Vascular
Musculo-skeletal ConventionalPPPPPPPPP[5,6]
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:

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 and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development

[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)

[9] Volume navigation

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

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 27 of 36

{29}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9, LOGIQ E9 XDclear 2.0 with S1-5-D Transducer

Mode of Operation
Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulse°Other[Notes]
Ophthalmic
Fetal/Obstetrics[7]PPPPPPPPPP[5,6,9]
Abdominal[1]PPPPPPPPPP[5,6,9]
PediatricPPPPPPPPPP[5,6,9]
Small Organ[2]
Neonatal Cephalic
Adult CephalicPPPPPPPPPP[5,6,9]
Cardiac AdultPPPPPPPPPP
Cardiac Pediatric
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:

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 and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development

[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)

[9] Volume navigation

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

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 28 of 36

{30}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9, LOGIQ E9 XDclear 2.0 with C1-6-D Transducer

Mode of Operation
Clinical ApplicationBMPWCWColorColor MPowerCombinedHarmonicCodedOther
Anatomy/Region of InterestDopplerDopplerDopplerDopplerDopplerModes*ImagingPulse[Notes]
Ophthalmic
Fetal/Obstetrics[7]PPPPPPPPPP[5,6,9]
Abdominal[1]PPPPPPPPPP[3,5,6,9,10]
PediatricPPPPPPPPPP[3,5,6,9]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral VascularPPPPPPPPPP[3,5,6,9]
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]PPPPPPPPPP[3,5,6,9]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:

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 and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development

[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)

[9] Volume navigation

[10] Shear wave elastoqraphy

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

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 29 of 36

{31}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9, LOGIQ E9 XDclear 2.0 with C2-9VN-D Transducer

Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation
Clinical ApplicationBMPWCWColorColor MPowerCombinedHarmonicCodedOther
Anatomy/Region of InterestDopplerDopplerDopplerDopplerDopplerModes*ImagingPulse®[Notes]
Ophthalmic
Fetal/Obstetrics[7]PPPPPPPPPP[5,6,9]
Abdominal[1]PPPPPPPPPP[3,5,6,9]
PediatricPPPPPPPPPP[3,5,6,9]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral VascularPPPPPPPPPP[3,5,6,9]
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]PPPPPPPPPP[3,5,6,9]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative[8]
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 and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development

[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)

[9] Volume navigation

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

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 (OlR)

Prescription User (Per 21 CFR 801.109)

Page 30 of 36

{32}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9, LOGIQ E9 XDclear 2.0 with C1-6VN-D Transducer

Mode of Operation
Clinical ApplicationBMPW DopplerCW DopplerColor DopplerColor M DopplerPower DopplerCombined Modes*Harmonic ImagingCoded PulseOther [Notes]
Anatomy/Region of Interest
Ophthalmic
Fetal/Obstetrics[7]PPPPPPPPPP[5,6,9]
Abdominal[1]PPPPPPPPPP[3,5,6,9,10]
PediatricPPPPPPPPPP[3,5,6,9]
Small Organ(2)
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral VascularPPPPPPPPPP[3,5,6,9]
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]PPPPPPPPPP[3,5,6,9]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:

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 and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development

[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)

[9] Volume navigation

[10] Shear wave elastography

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

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 31 of 36

{33}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9, LOGIQ E9 XDclear 2.0 with C2-7-D Transducer

Mode of Operation
Clinical ApplicationBMPWCWColorColor MPowerCombinedHarmonicCodedOther
Anatomy/Region of InterestDopplerDopplerDopplerDopplerDopplerModes*ImagingPulse[Notes]
Ophthalmic
Fetal/Obstetrics[7]
Abdominal[1]NNNNNNNN[5,6]
PediatricNNNNNNNN[5,6]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other [4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:

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 and thyroid
  • [3] Elastography Imaging Elasticity.
  • [4] Other use includes Urology/Prostate
  • [5] 3D/4D Imaging mode
  • [6] Needle guidance imaging
  • [7] Includes infertility monitoring of follicle development
  • [8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)
  • [9] Volume navigation
  • [10] Shear wave elastography
  • [*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
  • 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 32 of 36

{34}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9, LOGIQ E9 XDclear 2.0 with C2-7VN-D Transducer

Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation
Clinical ApplicationBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulse*Other[Notes]
Anatomy/Region of Interest
Ophthalmic
Fetal/Obstetrics[7]
Abdominal[1]NNNNNNNN[5,6,9]
PediatricNNNNNNNN[5,6,9]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative[8]
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 and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development

[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)

[9] Volume navigation

[10] Shear wave elastoqraphy

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

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 33 of 36

{35}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9, LOGIQ E9 XDclear 2.0 with L3-9i-D Transducer

mishada aoo. Bidanboard Giradooniy imaging o'r naar anaa ay ara maman naan ay an manaan naan ay an manaaMode of Operation
Clinical ApplicationBMPWCWColorColor MPowerCombinedHarmonicCodedOther
Anatomy/Region of InterestDopplerDopplerDopplerDopplerDopplerModes*ImagingPulse[Notes]
Ophthalmic
Fetal/Obstetrics[7]
Abdominal 11
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative®]NNNNNNNN[5]
Intraoperative Neurological
Intravascular
Laparoscopic

Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:

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 and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development

[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)

[9] Volume navigation

[10] Shear wave elastography

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

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 34 of 36

{36}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9, LOGIQ E9 XDclear 2.0 with C3-10-D Transducer

Mode of Operation
Clinical ApplicationAnatomy/Region of InterestBMPW DopplerCW DopplerColor DopplerColor M DopplerPower DopplerCombined Modes*Harmonic ImagingCoded Pulse®Other [Notes]
Ophthalmic
Fetal/Obstetrics[7]
Abdominal[1]
PediatricNNNNNNNN[5,9]
Small Organ[2]
Neonatal CephalicNNNNNNNN[5,9]
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral VascularNNNNNNNN[5,9]
Musculo-skeletal Conventional
Musculo-skeletal SuperficialNNNNNNNN[5,6,9]
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:

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 and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development

[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)

[9] Volume navigation

[10] Shear wave elastography

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

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 35 of 36

{37}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9, LOGIQ E9 XDclear 2.0 with C2-6b-D Transducer

Mode of Operation
Clinical ApplicationBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[Notes]
Anatomy/Region of Interest
Ophthalmic
Fetal/Obstetrics [7]
Abdominal [1]EEEEEEEE[5,6,9]
Pediatric
Small Organ [2]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other [4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative [8]
Intraoperative Neurological
Intravascular
Laparoscopic

Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:

N = new indication; P = previously cleared; E = added via Appendix E- previously cleared by FDA on LOGIQ S8 K131527

Notes: [1] Abdominal includes Renal, GYN/Pelvic.

[2] Small organ includes breast, testes and thyroid

  • [3] Elastography Imaging Elasticity.
    [4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development

[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)

[9] Volume navigation

[10] Shear wave elastography

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

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 36 of 36

{38}------------------------------------------------

Image /page/38/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" written in a stylized script inside. The letters are white, and the circle has a thin white border. The logo is simple and recognizable, and it is often used to represent the company.

GE Healthcare 510(k) Premarket Notification Submission

510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:
Date:August 12, 2015
Submitter/Manufacturer:GE Healthcare, GE Medical Systems Ultrasound and PrimaryCare Diagnostics, LLC.9900 Innovation Dr.Wauwatosa, WI 53226
Contact Person:Bryan BehnSr. Regulatory Affairs ManagerGE Healthcare, GE Medical Systems Ultrasound and PrimaryCare Diagnostics, LLC.Phone: 414-721-4214Fax: 414-918-8275
Device:GE LOGIQ E9, LOGIQ E9 XDClear 2.0 Diagnostic Ultrasound System
Trade Name:
Common/Usual Name:LOGIQ E9
Classification Names:Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-ΙΥΝUltrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYO
Product Code:Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX
Predicate Device(s):K142160 GE LOGIQ E9 Diagnostic Ultrasound SystemK131527 GE LOGIQ S8 Diagnostic Ultrasound SystemK131514 GE Vivid E9 Diagnostic Ultrasound System
Device Description:The LOGIQ E9 is a full featured, general purpose diagnosticultrasound system which consists of a mobile consoleapproximately 58 cm wide, 87cm deep and 130 cm high thatprovides digital acquisition, processing and display capability.The user interface includes a computer keyboard, specializedcontrols, 10-inch LCD touch screen and color wide screen imagedisplay.
Intended Use:The device is intended for use by a qualified physician forultrasound evaluation of Fetal; Abdominal; Pediatric; SmallOrgan (breast, testes, thyroid); Neonatal Cephalic; AdultCephalic; Cardiac (adult and pediatric); Peripheral Vascular;Musculo-skeletal Conventional and Superficial; Urology(including prostate); Transrectal; Transvaginal; Transesophageal

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GE Healthcare 510(k) Premarket Notification Submission

and Intraoperative (abdominal, thoracic and vascular).

The LOGIQ E9 employs the same fundamental scientific Technology: technology as its predicate device(s).

Determination of Comparison to Predicates

Substantial Equivalence:

The LOGIQ E9 is substantially equivalent to the predicate devices with regard to intended use, imaging capabilities, technological characteristics and safety and effectiveness.

  • The systems are all intended for diagnostic ultrasound . imaging and fluid flow analysis.
  • . The LOGIQ E9 and predicate LOGIQ E9 systems have the same clinical intended use.
  • The LOGIQ E9 and predicate LOGIQ E9 systems have the same imaging modes.
  • The systems are manufactured with materials which have been evaluated and found to be safe for the intended use of the device.
  • . The systems have acoustic power levels which are below the applicable FDA limits.
  • The LOGIQ E9 and predicate LOGIQ E9 systems have similar capability in terms of performing measurements. capturing digital images, reviewing and reporting studies.
  • . The LOGIO E9 and predicate systems have been designed in compliance with approved electrical and physical safety standards.
  • . The LOGIO E9 and predicate LOGIO E9 systems transducers are identical except for the C2-7-D, C2-7VN-D. C3-10-D and L3-9i-D which are an incremental improvement to the existing transducers and are equivalent.
  • The LOGIQ E9 adds two software features AutoEF and ● AFI that were not available on the predicate LOGIQ E9 and have been migrated from Vivid E9 K131514.

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Image /page/40/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined in a stylized script, enclosed within a blue circle. The circle is surrounded by swirling, wave-like elements, also in blue, giving the logo a dynamic and recognizable appearance.

GE Healthcare 510(k) Premarket Notification Submission

Summary of Non-Clinical Tests:

The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic and mechanical safety, and has been found to conform with applicable medical device safety standards. The LOGIQ E9 and its applications comply with voluntary standards:

    1. AAMI/ANSI ES60601-1. Medical Electrical Equipment - Part 1: General Requirements for Safety
    1. IEC60601-1-2,Medical Electrical Equipment Part 1-2:General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility Requirements and Tests
    1. IEC60601-2-37, Medical Electrical Equipment Part 2-37:Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment
    1. NEMA UD 3. Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
    1. ISO10993-1. Biological Evaluation of Medical Devices- Part 1: Evaluation and Testing
    1. NEMA UD 2, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
    1. ISO14971, Application of risk management to medical devices: Second edition
    1. NEMA Digital Imaging and Communications in Medicine (DICOM) Set. (Radiology)

The following quality assurance measures are applied to the development of the system:

  • Risk Analysis ●
  • Requirements Reviews
  • Design Reviews
  • Testing on unit level (Module verification)
  • . Integration testing (System verification)

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Image /page/41/Picture/0 description: The image shows the General Electric (GE) logo. The logo is a blue circle with the letters "GE" in a stylized font in the center. There are swirling lines around the letters, giving the logo a dynamic and modern look. The blue color is consistent throughout the logo.

GE Healthcare

510(k) Premarket Notification Submission

  • . Performance testing (Verification)
  • Safety testing (Verification) ●
  • Final Acceptance testing (Validation) .

Summary of Clinical Tests:

The subject of this premarket submission, LOGIQ E9, did not require clinical studies to support substantial equivalence.

  • GE Healthcare considers the LOGIQ E9 to be as safe, as Conclusion: 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.