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K Number
K170445
Device Name
LOGIQ S8
Manufacturer
GE Healthcare
Date Cleared
2017-04-11

(56 days)

Product Code
IYN,ITX,IYO
Regulation Number
892.1550
Type
Traditional
Panel
Radiology
Reference & Predicate Devices
K152195
Predicate For
K092819,K173021
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/Obstetrics; Abdominal; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transvaginal; Transesophageal and Intraoperative (abdominal, thoracic, vascular).

Device Description

The LOGIQ S8 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 520 mm wide (keyboard), 865 mm deep and 1760 mm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 10.1-inch LCD touch screen and color widescreen monitor.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the GE LOGIQ S8 ultrasound system. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel claims or establishing new acceptance criteria through extensive clinical studies.

Therefore, the document does not provide specific acceptance criteria in terms of analytical or clinical performance metrics (e.g., sensitivity, specificity, accuracy for a particular disease or measurement), nor does it detail a study performed to prove such metrics against acceptance criteria. Instead, it demonstrates substantial equivalence based on technological characteristics, intended use, and compliance with recognized safety and performance standards.

Here's an breakdown of the information that can be extracted based on your request, as well as indications of what is not present in this type of regulatory filing:

1. A table of acceptance criteria and the reported device performance

This information is not provided in the document as it is a 510(k) summary for showing substantial equivalence, not a clinical trial report establishing new performance criteria. The "performance" described relates primarily to equivalence with predicate devices and compliance with general safety and performance standards.

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

This information is not provided. The document explicitly states: "The subject of this premarket submission, LOGIQ S8, did not require clinical studies to support substantial equivalence." The testing mentioned is for acoustic output, biocompatibility, cleaning/disinfection, and safety standards.

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)

This information is not provided as no clinical studies are reported to have been conducted for this submission.

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

This information is not provided as no clinical studies are reported to have been conducted for this submission.

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

This information is not provided. The device is an ultrasound imaging system, and there's no mention of AI assistance or MRMC studies in this document.

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

This information is not provided. The device is a diagnostic ultrasound imaging system, not an AI algorithm for standalone interpretation.

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

This information is not provided as no clinical studies are reported to have been conducted for this submission. The "ground truth" for the device's claims are the safety and performance characteristics of its predicate devices and compliance with recognized standards.

8. The sample size for the training set

This information is not provided as no machine learning or AI training is mentioned as being part of this submission's substantial equivalence argument.

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

This information is not provided as no machine learning or AI training is mentioned.

Summary of what the document does provide regarding device performance and compliance:

The document focuses on demonstrating that the GE LOGIQ S8 is substantially equivalent to legally marketed predicate devices. This is achieved by:

  • Intended Use Equivalence: Stating that the LOGIQ S8 has the same clinical intended use as the predicate LOGIQ S8 (K152195).
  • Technological Equivalence: Declaring that it employs the same fundamental scientific technology as its predicate device(s).
  • Imaging Modes: Noting that it has the same imaging modes as the predicate LOGIQ S8, with additions of Fibroscan elastography and CAP (Controlled Attenuation Parameter), which are equivalent to features found on the reference predicate FibroScan (K160524).
  • Safety and Standards Compliance:
    • Manufactured with materials evaluated and found safe.
    • Acoustic power levels are below applicable FDA limits.
    • Designed in compliance with approved electrical and physical safety standards.
    • Compliance with voluntary standards:
      • AAMI/ANSI ES60601-1 (Medical Electrical Equipment - General Requirements for Safety)
      • IEC60601-1-2 (Electromagnetic Compatibility)
      • IEC60601-2-37 (Ultrasonic Medical Diagnostic and Monitoring Equipment Safety)
      • ISO10993-1 (Biological Evaluation of Medical Devices)
      • ISO14971 (Application of risk management to medical devices)
      • NEMA UD 2 (Acoustic Output Measurement Standard)
      • NEMA UD 3 (Real Time Display of Thermal and Mechanical Acoustic Output Indices)
      • NEMA, Digital Imaging and Communications in Medicine (DICOM) Set.
    • Quality assurance measures applied to development (Risk analysis, Requirements Reviews, Design Reviews, Testing on unit level, Integration testing, Final Acceptance Testing, Performance testing, Safety testing).
    • Transducer and patient contact materials are biocompatible.

The document lists various transducers cleared with the system and for which clinical applications and modes of operation they are "previously cleared" (P), "new" (N), or "added under Appendix E" (E), primarily based on equivalence to other GE Ultrasound systems (e.g., LOGIQ E9, VIVID E90/E95).

In conclusion, for this specific 510(k) submission, the "acceptance criteria" are compliance with established medical device safety and performance standards and demonstration of substantial equivalence to predicate devices, rather than predefined performance thresholds from new clinical trials.

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is a stylized symbol consisting of three overlapping human profiles facing to the right, with flowing lines above them.

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

April 11, 2017

GE Healthcare % Mr. Bryan Behn Regulatory Affairs Director 9900 Innovation Drive WAUWATOSA WI 53226

Re: K170445 Trade/Device Name: LOGIO S8 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: February 13, 2017 Received: February 14, 2017

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.

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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.

Michael O'Hara

For

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

Enclosure

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Indications for Use

510(k) Number (if known) K170445

Device Name LOGIO 88

Indications for Use (Describe)

The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/Obstetrics; Abdominal; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transvaginal; Transesophageal 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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Image /page/3/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined in a stylized script, enclosed within a blue circle. The circle has a decorative border with swirling patterns, giving it a classic and recognizable appearance.

GE Healthcare 510(k) Premarket Notification Submission

Indications for Use Forms

The following forms represent indications with clinical applications and exam types along with the modes of operation for the LOGIQ S8 system and for all of its probe/mode combinations. Combinations identified by "P" represent those previously cleared with the unmodified LOGIQ S8. "N" is new in this submission and "E" have been added by Appendix E of the FDA Ultrasound Guidance.

The subject modification does not alter the previously cleared system level indications and clinical applications.

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Image /page/4/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 blue circle, and there are decorative white swirls around the perimeter of the circle.

Diagnostic Ultrasound Indications for Use Form GE LOGIQ S8 Ultrasound System

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

Mode of Operation
Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[Notes]
Ophthalmic
Fetal / Obstetrics[7]PPPPPPPPPP5,6,9
Abdominal[1]PPPPPPPPPP3,5,6,9,10,11,12, 13
PediatricPPPPPPPPPP3,5,6,9,10, 11, 13
Small Organ[2]PPPPPPPPPP3,5,6,9,10
Neonatal CephalicPPPPPPPPPP3,5,6,9
Adult CephalicPPPPPPPPPP3,5,6,9
CardiacPPPPPPPPPP
Peripheral VascularPPPPPPPPPP3,5,6,9,10
Musculo-skeletal ConventionalPPPPPPPPPP3,5,6,9,10
Musculo-skeletal SuperficialPPPPPPPPPP3,5,6,9,10
Other[4]PPPPPPPPPP3,5,6,9,10
Exam Type, Means of Access
TransesophagealPPPPPPPPPP
TransrectalPPPPPPPPPP3,5,6,9
TransvaginalPPPPPPPPPP3,5,6,7,9
Transuretheral
Intraoperative[8]PPPPPPPPPP3,5,6,9
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, GYN

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

[9] Volume navigation

[10] Shear wave elastography

[11] FibroScan elastography

[12] Controlled Attenuation Parameter at 3.5MHz

[13] A Mode

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

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Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a circular border. The border has decorative swirls or flourishes around the letters. The logo is presented in a blue color.

GE LOGIQ S8 with C1-5-D Transducer

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

Mode of Operation
Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[Notes]
Ophthalmic
Fetal / Obstetrics[7]PPPPPPPPPP5,6,9
Abdominal[1]PPPPPPPPPP3,5,6,9
PediatricPPPPPPPPPP3,5,6,9
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac
Peripheral VascularPPPPPPPPPP3,5,6,9
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]PPPPPPPPPP3,5,6,9
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA; E = added under Appendix E

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

[2] Small organ includes breast, testes and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaqing 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

[11] FibroScan elastography

[12] Controlled Attenuation Parameter at 3.5MHz

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

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Image /page/6/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 border, and there are decorative swirls or flourishes surrounding the circle, giving it a classic and recognizable appearance.

GE LOGIQ S8 with 9L-D Transducer

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

Mode of Operation
Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther(Notes)
Ophthalmic
Fetal / Obstetrics[7]PPPPPPPP5,6,9
Abdominal[1]PPPPPPPPP3,5,6,9,10
PediatricPPPPPPPPP3,5,6,9,10
Small Organ[2]PPPPPPPPP3,5,6,9,10
Neonatal Cephalic
Adult Cephalic
Cardiac
Peripheral VascularPPPPPPPPP3,5,6,9,10
Musculo-skeletal ConventionalPPPPPPPPP3,5,6,9,10
Musculo-skeletal SuperficialPPPPPPPPP3,5,6,9,10
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal[8]
Transvaginal
Transuretheral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA; E = added under Appendix E

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

[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

[11] FibroScan elastography

[12] Controlled Attenuation Parameter at 3.5MHz

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

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Image /page/7/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a circular border. The color of the logo is a light blue. The logo is simple and recognizable, representing the General Electric brand.

GE LOGIQ S8 with ML6-15-D Transducer

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

Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[Notes]
Ophthalmic
Fetal / Obstetrics[7]
Abdominal[1]
PediatricPPPPPPPPP3,5,6,9
Small Organ[2]PPPPPPPPP3,5,6,9
Neonatal CephalicPPPPPPPPP9
Adult Cephalic
Cardiac
Peripheral VascularPPPPPPPPP3,5,6,9
Musculo-skeletal ConventionalPPPPPPPPP3,5,6,9
Musculo-skeletal SuperficialPPPPPPPPP3,5,6,9
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal[8]
Transvaginal
Transuretheral
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, GYN

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

[9] Volume navigation

[10] Shear wave elastography

[11] FibroScan elastography

[12] Controlled Attenuation Parameter at 3.5MHz

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

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Image /page/8/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The letters are enclosed within a blue circle, and there are decorative white swirls around the perimeter of the circle.

Diagnostic Ultrasound Indications for Use Form GE LOGIQ S8 with M5S-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 InterestDopplerDopplerDopplerDopplerDopplerModesImagingPulse[Notes]
Ophthalmic
Fetal / Obstetrics[7]
Abdominal[1]PPPPPPPPPP5,9
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult CephalicPPPPPPPPPP5,9
CardiacPPPPPPPPPP
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal[8]
Transvaginal
Transuretheral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA; E = added under Appendix E

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

[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

[11] FibroScan elastography

[12] Controlled Attenuation Parameter at 3.5MHz

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

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Image /page/9/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 border has decorative swirls or flourishes around the letters. The logo is presented in a blue color.

GE LOGIQ S8 with IC5-9-D Transducer

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

Mode of Operation
Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[Notes]
Ophthalmic
Fetal / Obstetrics[7]PPPPPPPPP5,6,9
Abdominal[1]PPPPPPPPP3,5,9
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]PPPPPPPPP3,5,6,9
Exam Type, Means of Access
Transesophageal
Transrectal[8]PPPPPPPPP3,5,6,9
TransvaginalPPPPPPPPP3,5,6,7,9
Transuretheral
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, GYN

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

[9] Volume navigation

[10] Shear wave elastography

[11] FibroScan elastography

[12] Controlled Attenuation Parameter at 3.5MHz

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

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

Image /page/10/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 border has decorative swirls or flourishes around the letters. The logo is presented in a blue color.

GE LOGIQ S8 with 3CRF-D Transducer

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

Mode of Operation
Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[Notes]
Ophthalmic
Fetal / Obstetrics[7]
Abdominal[1]PPPPPPPPP5,6,9
PediatricPPPPPPPPP5,6,9
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal[8]
Transvaginal
Transuretheral
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, GYN

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

[9] Volume navigation

[10] Shear wave elastography

[11] FibroScan elastography

[12] Controlled Attenuation Parameter at 3.5MHz

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

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

Image /page/11/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 a light blue. The logo is simple and recognizable, representing the General Electric brand.

GE LOGIQ S8 with L8-18i-D Transducer

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

Mode of Operation
Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[Notes)
Ophthalmic
Fetal / Obstetrics[7]
Abdominal[1]
Pediatric
Small Organ[2]PPPPPPPPP5,9
Neonatal Cephalic
Adult Cephalic
Cardiac
Peripheral VascularPPPPPPPPP5,9
Musculo-skeletal ConventionalPPPPPPPPP5,9
Musculo-skeletal SuperficialPPPPPPPPP5,9
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal[8]
Transvaginal
Transuretheral
Intraoperative[8]PPPPPPPPP5,9
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA; E = added under Appendix E

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

[2] Small organ includes breast, testes and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaqing 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

[11] FibroScan elastography

[12] Controlled Attenuation Parameter at 3.5MHz

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

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

Image /page/12/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 a light blue. The logo is simple and recognizable, representing the General Electric brand.

GE LOGIQ S8 with S4-10-D Transducer

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

Mode of Operation
Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[Notes]
Ophthalmic
Fetal / Obstetrics[7]
Abdominal[1]
PediatricPPPPPPPPPP5,9
Small Organ[2]
Neonatal CephalicPPPPPPPPPP5,9
Adult Cephalic
CardiacPPPPPPPPPP
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal[8]
Transvaginal
Transuretheral
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, GYN

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

[9] Volume navigation

[10] Shear wave elastography

[11] FibroScan elastography

[12] Controlled Attenuation Parameter at 3.5MHz

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

{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, cursive font, enclosed within a circular border. The color of the logo is a light blue. The logo is simple and recognizable, representing the General Electric brand.

GE LOGIQ S8 with P2D Transducer

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

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

N = new indication; P = previously cleared by FDA; E = added under Appendix E

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

[2] Small organ includes breast, testes and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaqing 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

[11] FibroScan elastography

[12] Controlled Attenuation Parameter at 3.5MHz

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

{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, cursive font, enclosed within a circular border. The color of the logo is a light blue. The logo is simple and recognizable, representing the General Electric brand.

GE LOGIQ S8 with P6D Transducer

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

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

N = new indication; P = previously cleared by FDA; E = added under Appendix E

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

[2] Small organ includes breast, testes and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaqing 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

[11] FibroScan elastography

[12] Controlled Attenuation Parameter at 3.5MHz

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

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

Image /page/15/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 a light blue. The logo is simple and recognizable, representing the General Electric brand.

GE LOGIQ S8 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 InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulse®Other[Notes]
Ophthalmic
Fetal/Obstetrics[7]PPPPPPPPP[5,6,9]
Abdominal[1]PPPPPPPPP[3,5,6,9]
PediatricPPPPPPPPP[3,5,6,9]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral VascularPPPPPPPPP[3,5,6,9]
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

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

[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 quidance 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

[11] FibroScan elastography

[12] Controlled Attenuation Parameter at 3.5MHz

[*] 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)

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

Image /page/16/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined in a stylized script, enclosed within a blue circle. There are small, curved lines around the outer edge of the circle, giving it a textured appearance.

GE LOGIQ S8 with 11L-D Transducer

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

Clinical ApplicationMode of Operation
Anatomy/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]
Small Organ[2]PPPPPPPPP[3,5,6]
Neonatal CephalicPPPPPPPPP[5,6]
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]
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA; E = added under Appendix E

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

[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 quidance 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

[11] FibroScan elastography

[12] Controlled Attenuation Parameter at 3.5MHz

[*] 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)

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

Image /page/17/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined within a blue circle. The letters are stylized with curved lines, and the circle has decorative elements around its perimeter.

Diagnostic Ultrasound Indications for Use Form GE LOGIQ S8 with 6S-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]PPPPPPPPPP5
Abdominal[1]
PediatricPPPPPPPPPP5
Small Organ[2]
Neonatal CephalicPPPPPPPPPP5
Adult Cephalic
Cardiac Adult
Cardiac PediatricPPPPPPPPPP5
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 quidance 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

[11] FibroScan elastography

[12] Controlled Attenuation Parameter at 3.5MHz

[*] 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)

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

Image /page/18/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 blue circle. The circle has a decorative, swirling pattern around the letters, giving it a classic and recognizable appearance.

GE LOGIQ S8 with S1-5-D Transducer

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

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]
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral VascularPPPPPPPPPP[5,6,9]
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

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

[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 quidance 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

[11] FibroScan elastography

[12] Controlled Attenuation Parameter at 3.5MHz

[*] 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)

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

Image /page/19/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 blue circle. The circle has a decorative, swirling pattern around the letters, giving it a classic and recognizable appearance.

Diagnostic Ultrasound Indications for Use Form GE LOGIQ S8 with RAB6-D Transducer

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

Clinical ApplicationMode of OperationOther[Notes]
Anatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulse
Ophthalmic
Fetal/ObstetricsPPPPPPPPP[5,6]
AbdominalPPPPPPPPP[5,6]
PediatricPPPPPPPPP[5,6]
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P* = previously cleared by FDA; E = added under Appendix E

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

[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 quidance 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

[11] FibroScan elastography

[12] Controlled Attenuation Parameter at 3.5MHz

[*] 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)

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

Image /page/20/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined in a stylized script, enclosed within a blue circle. There are small white accents around the perimeter of the circle, giving it a slightly three-dimensional appearance.

Diagnostic Ultrasound Indications for Use Form GE LOGIQ S8 with RIC5-9-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]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

N = new indication; P* = previously cleared by FDA; E = added under Appendix E

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

[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 quidance 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

[11] FibroScan elastography

[12] Controlled Attenuation Parameter at 3.5MHz

[*] 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)

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

Image /page/21/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 has decorative swirls around its perimeter, giving it a classic and recognizable appearance.

Diagnostic Ultrasound Indications for Use Form GE LOGIQ S8 with 6Tc-RS 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]
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

N = new indication; P = previously cleared by FDA; E = added under Appendix E

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

[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 quidance 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

[11] FibroScan elastography

[12] Controlled Attenuation Parameter at 3.5MHz

[*] 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)

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

Image /page/22/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 border has decorative swirls or flourishes around the letters. The logo is presented in a blue color.

GE LOGIQ S8 with 3Sp-D Transducer

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

Mode of Operation
Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[Notes]
Ophthalmic
Fetal / Obstetrics[7]
Abdominal[1]PPPPPPPPPP5
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult CephalicPPPPPPPPPP5
Cardiac Adult & PediatricPPPPPPPPPP5
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal[8]
Transvaginal
Transuretheral
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, GYN

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

[9] Volume navigation

[10] Shear wave elastography

[11] FibroScan elastography

[12] Controlled Attenuation Parameter at 3.5MHz

[*] 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)

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

Image /page/23/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 border has decorative swirls or flourishes around the letters. The logo is presented in a blue color.

GE LOGIQ S8 with C2-6b-D Transducer

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

Mode of Operation
Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[Notes]
Ophthalmic
Fetal / Obstetrics[7]
Abdominal[1]PPPPPPPP5,6,9
PediatricPPPPPPPP5,6,9
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult & Pediatric
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal[8]
Transvaginal
Transuretheral
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, GYN

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

[9] Volume navigation

[10] Shear wave elastography

[11] FibroScan elastography

[12] Controlled Attenuation Parameter at 3.5MHz

[*] 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)

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

Image /page/24/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 a light blue. The logo is simple and recognizable, representing the General Electric brand.

GE LOGIQ S8 with 10C-D Transducer

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

Mode of Operation
Clinical ApplicationAnatomy/Region of InterestBMPW DopplerCW DopplerColor DopplerColor M DopplerPower DopplerCombined ModesHarmonic ImagingCoded PulseOther [Notes]
Ophthalmic
Fetal / Obstetrics[7]
Abdominal[1]
PediatricPPPPPPPP5
Small Organ[2]
Neonatal CephalicPPPPPPPP5
Adult Cephalic
Cardiac Adult & Pediatric
Peripheral VascularPPPPPPPP5
Musculo-skeletal Conventional
Musculo-skeletal SuperficialPPPPPPPP5,6
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal[8]
Transvaginal
Transuretheral
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, GYN

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

[9] Volume navigation

[10] Shear wave elastography

[11] FibroScan elastography

[12] Controlled Attenuation Parameter at 3.5MHz

[*] 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)

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

Image /page/25/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined in a stylized script, enclosed within a circular border. The logo is colored in a light blue hue.

Diagnostic Ultrasound Indications for Use Form GE LOGIQ S8 with RSP6-16-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]
Pediatric
Small Organ[2]PPPPPPPPP[5,6]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral VascularPPPPPPPPP[5,6]
Musculo-skeletal ConventionalPPPPPPPPP[5,6]
Musculo-skeletal SuperficialPPPPPPPPP[5,6]
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 via 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

[11] FibroScan elastography

[12] Controlled Attenuation Parameter at 3.5MHz

[*] 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)

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

Image /page/26/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized monogram. The monogram is enclosed within a circular frame, and the frame has decorative swirls or flourishes around it. The logo is colored in a shade of blue.

Diagnostic Ultrasound Indications for Use Form GE LOGIQ S8 with C1-6-D Transducer

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

Clinical ApplicationAnatomy/Region of InterestMode of OperationOther[Notes]
BMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulse®
Ophthalmic
Fetal/Obstetrics[7]PPPPPPPP[5,6,9]
Abdominal[1]PPPPPPPP[3,5,6,9,10]
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral VascularPPPPPPPP[3,5,6,9,10]
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]PPPPPPPP[3,5,6,9,10]
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 via 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 Imaqing mode

[6] Needle quidance 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

[11] FibroScan elastography

[12] Controlled Attenuation Parameter at 3.5MHz

[*] 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)

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

Image /page/27/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 border has decorative swirls or flourishes around the letters. The logo is presented in a blue color.

GE LOGIQ S8 with L3-12-D Transducer

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

Mode of Operation
Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[Notes]
Ophthalmic
Fetal / Obstetrics[7]PPPPPPPPPP5,6
Abdominal[1]PPPPPPPPPP3,5,6
PediatricPPPPPPPPPP3,5,6
Small Organ[2]PPPPPPPPPP3,5,6
Neonatal Cephalic
Adult Cephalic
Cardiac Adult & Pediatric
Peripheral VascularPPPPPPPPPP3,5,6
Musculo-skeletal ConventionalPPPPPPPPPP3,5,6
Musculo-skeletal SuperficialPPPPPPPPPP3,5,6
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA; E = added via Appendix E

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

[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

[11] FibroScan elastography

[12] Controlled Attenuation Parameter at 3.5MHz

[*] 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)

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

Image /page/28/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 frame. The frame has decorative swirls or flourishes around the perimeter, giving it a classic or vintage appearance. The logo is presented in a blue color.

Diagnostic Ultrasound Indications for Use Form GE LOGIQ S8 with P8D 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]
Abdominal[1]
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral VascularP
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 via 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

[11] FibroScan elastography

[12] Controlled Attenuation Parameter at 3.5MHz

[*] 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)

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

Image /page/29/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 border has decorative swirls or flourishes around the letters. The logo is presented in a blue color.

GE LOGIQ S8 with BE9CS-D Transducer

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

Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[Notes]
Ophthalmic
Fetal / Obstetrics[7]
Abdominal[1]
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult & Pediatric
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]PPPPPPPP3, 5, 6
Exam Type, Means of Access
Transesophageal
Transrectal[8]PPPPPPPP3, 5, 6
TransvaginalPPPPPPPP3, 5, 6
Transuretheral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA, E = added via Appendix E

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

[2] Small organ includes breast, testes and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaqing 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

[11] FibroScan elastography

[12] Controlled Attenuation Parameter at 3.5MHz

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

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

Image /page/30/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 frame. The frame has decorative swirls or flourishes around the perimeter, giving it a classic or vintage appearance. The logo is presented in a blue color.

Diagnostic Ultrasound Indications for Use Form GE LOGIQ S8 with C2-7-D Transducer

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

Clinical ApplicationMode of Operation
Anatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulse®Other[Notes]
Ophthalmic
Fetal/Obstetrics[7]
Abdominal[1]PPPPPPPP5,6,9
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

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

[11] FibroScan elastography

[12] Controlled Attenuation Parameter at 3.5MHz

[*] 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)

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

Image /page/31/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 blue circle, and there are decorative swirls or flourishes around the perimeter of the circle, also in blue. The logo is simple, recognizable, and has been associated with the General Electric company for many years.

Diagnostic Ultrasound Indications for Use Form GE LOGIQ S8 with L3-9i-D Transducer

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

Mode of Operation
Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulse*Other[Notes]
Ophthalmic
Fetal/Obstetrics[7]
Abdominal[1]
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]PPPPPPPP5
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, GYN

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

[9] Volume navigation

[10] Shear wave elastography

[11] FibroScan elastography

[12] Controlled Attenuation Parameter at 3.5MHz

[*] 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)

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

Image /page/32/Picture/0 description: The image shows the General Electric (GE) logo, which is a blue circle with the letters 'g' and 'e' intertwined in the center. The letters are stylized and connected, creating a unique and recognizable design. The logo is simple yet iconic, representing the company's brand identity.

Diagnostic Ultrasound Indications for Use Form GE LOGIQ S8 with C3-10-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]
PediatricPPPPPPPP5,9
Small Organ[2]PPP
Neonatal CephalicPPPPPPPP5,9
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral VascularPPPPPPPP5,9
Musculo-skeletal Conventional
Musculo-skeletal SuperficialPPPPPPPP5,6,9
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, GYN

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

[9] Volume navigation

[10] Shear wave elastography

[11] FibroScan elastography

[12] Controlled Attenuation Parameter at 3.5MHz

[*] 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)

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

Image /page/33/Picture/0 description: The image shows the General Electric (GE) logo, which is a blue circle with the letters 'g' and 'e' intertwined in the center. The letters are stylized and connected, creating a unique and recognizable design. The logo is simple yet iconic, representing the company's brand identity.

Diagnostic Ultrasound Indications for Use Form GE LOGIQ S8 with C1-6VN-D Transducer

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

Mode of Operation
Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulse*Other[Notes]
Ophthalmic
Fetal/Obstetrics[7]EEEEEEEE[5,6,9]
Abdominal[1]EEEEEEEE[3,5,6,9,10]
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral VascularEEEEEEEE[3,5,6,9]
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]EEEEEEEE[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 (previously cleared with LOGIQ E9 K163077)

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

[11] FibroScan elastography

[12] Controlled Attenuation Parameter at 3.5MHz

[*] 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)

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

Image /page/34/Picture/0 description: The image shows the General Electric (GE) logo, which is a blue circle with the letters 'g' and 'e' intertwined in the center. The letters are stylized and connected, creating a unique and recognizable design. The logo is simple, clean, and has been used by GE for many years.

Diagnostic Ultrasound Indications for Use Form GE LOGIQ S8 with C2-9VN-D Transducer

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

Mode of Operation
Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulse°Other[Notes]
Ophthalmic
Fetal/Obstetrics[7]EEEEEEEE[5,6,9]
Abdominal[1]EEEEEEEE[3,5,6,9]
PediatricEEEEEEEE[3,5,6,9]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral VascularEEEEEEEE[3,5,6,9]
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 (previously cleared with LOGIQ E9 K163077)

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

[11] FibroScan elastography

[12] Controlled Attenuation Parameter at 3.5MHz

[*] 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)

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

Image /page/35/Picture/0 description: The image shows the General Electric (GE) logo, which is a blue circle with the letters 'g' and 'e' intertwined in the center. The letters are stylized and connected, creating a unique and recognizable design. The logo is simple yet iconic, representing the company's brand identity.

Diagnostic Ultrasound Indications for Use Form GE LOGIQ S8 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]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

N = new indication; P = previously cleared by FDA; E = added under Appendix E (previously cleared with LOGIQ E9 K163077)

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

[11] FibroScan elastography

[12] Controlled Attenuation Parameter at 3.5MHz

[*] 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)

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

Image /page/36/Picture/0 description: The image shows the General Electric (GE) logo, which is a blue circle with the letters 'g' and 'e' intertwined in the center. The letters are stylized and connected, creating a unique and recognizable design. The logo is simple yet iconic, representing the company's brand identity.

Diagnostic Ultrasound Indications for Use Form GE LOGIQ S8 with M5Sc-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]EEEEEEEEEE[5,9]
Abdominal[1]EEEEEEEEEE[5,9]
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult CephalicEEEEEEEEEE[5,9]
Cardiac AdultEEEEEEEEEE[5,9]
Cardiac PediatricEEEEEEEEEE[5,9]
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 (previously cleared with VIVID E90/E95 K150087)

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

[11] FibroScan elastography

[12] Controlled Attenuation Parameter at 3.5MHz

[*] 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)

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

Image /page/37/Picture/0 description: The image shows the General Electric (GE) logo, which is a blue circle with the letters 'g' and 'e' intertwined in the center. The letters are stylized and connected, creating a unique and recognizable design. The logo is simple, clean, and has been used by GE for many years.

Diagnostic Ultrasound Indications for Use Form GE LOGIQ S8 with FibroScan M+ 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]
Abdominal[1]N[11,12, 13]
PediatricN[11, 13]
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, GYN

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

[9] Volume navigation

[10] Shear wave elastography

[11] FibroScan elastography

[12] Controlled Attenuation Parameter at 3.5MHz

[13] A Mode

[*] 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)

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Image /page/38/Picture/0 description: The image shows the General Electric (GE) logo, which is a blue circle with the letters 'g' and 'e' intertwined in the center. The letters are stylized and connected, creating a unique and recognizable design. The logo is simple yet iconic, representing the company's brand identity.

Diagnostic Ultrasound Indications for Use Form GE LOGIQ S8 with FibroScan XL+ 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]N[11, 12, 13]
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

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

[11] FibroScan elastography

[12] Controlled Attenuation Parameter at 3.5MHz

[13] A Mode

[*] 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)

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GE Healthcare 510(k) Premarket Notification Submission

Section 5: 510(k) Summary

LOGIQ 88

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Image /page/40/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 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.

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:February 13, 2017
Submitter:GE Healthcare9900 Innovation DrWauwatosa, WI 53226
Manufacturer:GE Ultrasound Korea, Ltd.9, Sunhwan-ro 214 beon-gil, Jungwon-gu,Seongnam-si, Gyeonggi-do, Republic of Korea
Primary Contact Person:Bryan BehnRegulatory Affairs DirectorGE HealthcareT:(414)721-4214F:(414)918-8275
Alternate Contact Person:Qingmeng ChenRegulatory Affairs LeaderGE Ultrasound Korea, Ltd.T: +86-28-6272-2040F: +81-42-6272-2462
Device:Trade Name:
LOGIQ S8
Common/Usual Name:LOGIQ S8
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
Primary Predicate Device:K152195 LOGIQ S8 Diagnostic Ultrasound System
Reference Predicate Device(s):K163077 LOGIQ E9 Diagnostic Ultrasound SystemK150087 VIVID E90/E95 Diagnostic Ultrasound SystemK160524 FibroScan 530 Compact Ultrasonic Pulsed EchoImaging SystemK160184 VOLUSON S6/S8/S10 Diagnostic Ultrasound SystemK161047 LOGIQ P7/P9 Diagnostic Ultrasound SystemK160182 LOGIQ S7 EXPERT Diagnostic Ultrasound System
Device Description:The LOGIQ S8 is a full featured, general purpose diagnosticultrasound system which consists of a mobile consoleapproximately 520 mm wide (keyboard), 865 mm deep and 1760
Intended Use:mm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 10.1-inch LCD touch screen and color widescreen monitor.The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/Obstetrics; 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, vascular).
Technology:The LOGIQ S8 employs the same fundamental scientific technology as its predicate device(s).
Determination ofSubstantial Equivalence:Comparison to PredicatesThe following is an overview of the differences between the proposed LOGIQ S8 and the predicate LOGIQ S8 (K152195). The proposed LOGIQ S8 has had several features and probes migrated to it currently cleared on other GE Ultrasound systems. The systems are all intended for diagnostic ultrasound imaging and fluid flow analysis. The LOGIQ S8 and predicate LOGIQ S8 systems have the same clinical intended use. The LOGIQ S8 and predicate LOGIQ S8 systems have the same imaging modes except the new LOGIQ S8 adds Fibroscan elastography and CAP (Controlled Attenuation Parameter) which is substantially equivalent to FibroScan (K160524). 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 S8 and predicate LOGIQ S8 systems have similar capability in terms of performing measurements, capturing digital images, reviewing and reporting studies. The LOGIQ S8 and predicate systems have been designed in compliance with approved electrical and physical safety standards. The following probes and features have been migrated from GE ultrasound systems LOGIQ E9 (K163077): C1-6VN-D, C2-9VN-D, C2-7VN-D probe, and Contrast parametric imaging.

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Image /page/41/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized, cursive font, enclosed within a circular border. The color of the logo is a light blue.

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Image /page/42/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 border. The border has decorative swirls or flourishes around the letters, giving it a classic and recognizable appearance. The logo is presented in a blue color scheme.

  • The following probe has been migrated from the VIVID E90/E95 (K150087): M5Sc-D probe.
  • The following features and probes have been migrated from FibroScan (K160524): FibroScan Elastography, CAP (Controlled Attenuation Parameter), FibroScan M* probe and FiroScan XL+ probe.
  • The following features have been migrated from the VOLUSON S6/S8/S10 (K160184) STIC, and Omniview with VCI.
  • The following features have been migrated from the ● LOGIQ S7 EXPERT (K160182) Email to MMS and Strain elastography on BE9CS-D.
  • The following features have been migrated from the ● LOGIQ P7/P9 (K161047) MyTrainer* and Advanced battery.

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 LOGIO S8 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 Basic Safety and Essential Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment
    1. ISO10993-1. Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing
    1. ISO14971. Application of risk management to medical devices
    1. NEMA UD 2, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment

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Image /page/43/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font in the center. The circle is surrounded by a swirling pattern that resembles water or wind. The logo is simple and recognizable, and it is often used to represent the company's brand.

    1. NEMA UD 3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
    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) ●
  • Final Acceptance Testing (Validation)
  • Performance testing (Verification)
  • Safety testing (Verification) .

Transducer materials and other patient contact materials are biocompatible.

Summary of Clinical Tests:

The subject of this premarket submission, LOGIQ S8, did not require clinical studies to support substantial equivalence.

  • Conclusion: GE Healthcare considers the LOGIQ S8 to be as safe, 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.