LOGIQ S8

• K Number: K152195
• Device Name: LOGIQ S8
• Manufacturer: GE Healthcare
• Date Cleared: 2015-09-29 ( 55 days)
• Product Code: IYN , ITX , IYO
• Regulation Number: 892.1550
• Type: Traditional
• Panel: Radiology
• Reference & Predicate Devices: N/A
• Predicate For: K160182 , K170445

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 620 mm wide, 880 mm deep and 1720 mm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 9-inch LCD touch screen and color widescreen monitor.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from GE Healthcare for their LOGIQ S8 ultrasound system. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study to prove acceptance criteria for a novel device or AI algorithm.

Therefore, many of the requested details about acceptance criteria metrics, sample sizes, ground truth establishment, and expert involvement are not applicable or explicitly stated in the context provided. The document primarily attests to the device's technical specifications and safety and effectiveness being equivalent to existing cleared devices.

However, I can extract information related to the device's intended use and the non-clinical tests performed to support its substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission demonstrating substantial equivalence, specific quantitative acceptance criteria and performance metrics (e.g., sensitivity, specificity for a diagnostic task) are generally not provided in the same way they would be for a novel device or an AI algorithm proving clinical utility. Instead, performance is established by demonstrating equivalence to a legally marketed predicate device.

The "acceptance criteria" here relate to conforming to recognized safety and performance standards and maintaining the same intended use. The "reported device performance" is implicitly considered equivalent to the predicate device(s) for the listed clinical applications and imaging modes.

Acceptance Criteria Category	Reported Device Performance (as demonstrated for substantial equivalence)
Intended Use	Identical to predicate LOGIQ S8 and other migration predicates.
Clinical Applications	Covers Fetal/Obstetrics, Abdominal, Pediatric, Small Organ, Neonatal/Adult Cephalic, Cardiac, Peripheral Vascular, Musculo-skeletal (Conventional & Superficial), Urology, Transrectal, Transvaginal, Transesophageal, Intraoperative.
Imaging Modes	Same as predicate LOGIQ S8, including new Shear Wave Elastography (equivalent to LOGIQ E9). Includes B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse, 3D/4D Imaging, Needle Guidance, Elastography, Volume Navigation, Shear Wave Elastography (where applicable per transducer).
Safety Standards	Conforms to AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, NEMA UD 3, ISO10993-1, NEMA UD 2, ISO14971, NEMA DICOM.
Acoustic Output	Below applicable FDA limits.
Biocompatibility	Transducer materials and patient contact materials are biocompatible.
Cleaning/Disinfection	Effectiveness evaluated.
Thermal/Electrical/Electromagnetic/Mechanical Safety	Evaluated and found to conform to applicable medical device safety standards.

2. Sample Sizes Used for the Test Set and Data Provenance

The document explicitly states: "The subject of this premarket submission, LOGIQ S8, did not require clinical studies to support substantial equivalence." This means there was no specific clinical "test set" and associated sample size in the traditional sense of a clinical trial for performance evaluation against a defined ground truth. Instead, the equivalence argument is based on technical and performance similarity to existing cleared devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable, as no dedicated clinical test set with independent ground truth establishment was conducted for this 510(k) submission.

4. Adjudication Method for the Test Set

Not applicable, as no dedicated clinical test set with ground truth establishment was conducted.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The LOGIQ S8 is a diagnostic ultrasound system, not an AI-assisted diagnostic tool that would typically involve human readers interpreting images with and without AI assistance to show an "effect size" of improvement. The document does mention "Shear Wave Elastography" which is an advanced imaging mode, but not an AI-driven interpretation tool in the context of this submission.

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

Not applicable, as the LOGIQ S8 is a hardware and software system for image acquisition and display, not a standalone AI algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Not applicable, as no new clinical studies requiring external ground truth were performed for this substantial equivalence submission. The ground truth for proving substantial equivalence to predicate devices typically involves technical specifications, engineering measurements, and adherence to recognized standards.

8. The Sample Size for the Training Set

Not applicable. The document describes a diagnostic ultrasound system, not a device primarily driven by a machine learning or AI algorithm that would require a "training set" for its core function.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there was no training set for an AI algorithm in the context of this 510(k) submission.

Summary

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

September 29, 2015

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

Re: K152195 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: August 4, 2015 Received: August 5, 2015

Dear Mr. Behn:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Robert Oolo

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)

K152195

Device Name LOGIQ S8

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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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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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:

Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other[Notes]
Ophthalmic
Fetal / Obstetrics[7]	P	P	P	P	P	P	P	P	P	P	5,6,9
Abdominal[1]	P	P	P	P	P	P	P	P	P	P	3,5,6,9,10
Pediatric	P	P	P	P	P	P	P	P	P	P	3,5,6,9,10
Small Organ[2]	P	P	P	P	P	P	P	P	P	P	3,5,6,9,10
Neonatal Cephalic	P	P	P	P	P	P	P	P	P	P	3,5,6,9
Adult Cephalic	P	P	P	P	P	P	P	P	P	P	3,5,6,9
Cardiac	P	P	P	P	P	P	P	P	P	P
Peripheral Vascular	P	P	P	P	P	P	P	P	P	P	3,5,6,9,10
Musculo-skeletal Conventional	P	P	P	P	P	P	P	P	P	P	3,5,6,9,10
Musculo-skeletal Superficial	P	P	P	P	P	P	P	P	P	P	3,5,6,9,10
Other[4]	P	P	P	P	P	P	P	P	P	P	3,5,6,9,10
Exam Type, Means of Access
Transesophageal	P	P	P	P	P	P	P	P	P	P
Transrectal	P	P	P	P	P	P	P	P	P	P	3,5,6,9
Transvaginal	P	P	P	P	P	P	P	P	P	P	3,5,6,7,9
Transuretheral
Intraoperative[8]	P	P	P	P	P	P	P	P	P	P	3,5,6,9
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

[*] 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' intertwined in a stylized script, enclosed within a circular border. The logo is colored in a light blue hue, and the background is white.

Diagnostic Ultrasound Indications for Use Form 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 Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes*	HarmonicImaging	CodedPulse	Other[Notes]
Ophthalmic
Fetal / Obstetrics[7]	P	P	P	P	P	P	P	P	P	P	5,6,9
Abdominal[1]	P	P	P	P	P	P	P	P	P	P	3,5,6,9
Pediatric	P	P	P	P	P	P	P	P	P	P	3,5,6,9
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac
Peripheral Vascular	P	P	P	P	P	P	P	P	P	P	P	3,5,6,9
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]	P	P	P	P	P	P	P	P	P	P	P	3,5,6,9
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 Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development, GYN

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

[9] Volume navigation

[10] Shear wave elastography

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

(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 'GE' intertwined within a circular border. The logo is colored in a light blue hue, and the design is simple and recognizable.

Diagnostic Ultrasound Indications for Use Form 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 Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes*	HarmonicImaging	CodedPulse	Other(Notes)
Ophthalmic
Fetal / Obstetrics[7]	P	P	P		P	P	P	P	P		5,6,9
Abdominal[1]	P	P	P		P	P	P	P	P	P	3,5,6,9,10
Pediatric	P	P	P		P	P	P	P	P	P	3,5,6,9,10
Small Organ[2]	P	P	P		P	P	P	P	P	P	3,5,6,9,10
Neonatal Cephalic
Adult Cephalic
Cardiac
Peripheral Vascular	P	P	P		P	P	P	P	P	P	3,5,6,9,10
Musculo-skeletal Conventional	P	P	P		P	P	P	P	P	P	3,5,6,9,10
Musculo-skeletal Superficial	P	P	P		P	P	P	P	P	P	3,5,6,9,10
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

[*] 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 shape. The logo is blue and has a vintage or classic appearance.

Diagnostic Ultrasound Indications for Use Form GE LOGIQ S8 with ML6-15-D Transducer

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

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other[Notes]
Ophthalmic
Fetal / Obstetrics[7]
Abdominal[1]
Pediatric	P	P	P		P	P	P	P	P	P	3,5,6,9
Small Organ[2]	P	P	P		P	P	P	P	P	P	3,5,6,9
Neonatal Cephalic	P	P	P		P	P	P	P	P	P	9
Adult Cephalic
Cardiac
Peripheral Vascular	P	P	P		P	P	P	P	P	P	3,5,6,9
Musculo-skeletal Conventional	P	P	P		P	P	P	P	P	P	3,5,6,9
Musculo-skeletal Superficial	P	P	P		P	P	P	P	P	P	3,5,6,9
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

[*] 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 script, enclosed within a circular border. The logo is colored in blue, with the letters and border appearing in a lighter shade of blue against a darker blue background.

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 ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other[Notes]
Ophthalmic
Fetal / Obstetrics[7]
Abdominal[1]	P	P	P	P	P	P	P	P	P	P	5,9
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic	P	P	P	P	P	P	P	P	P	P	9
Cardiac	P	P	P	P	P	P	P	P	P	P
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal[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

[*] 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' intertwined within a blue circle. The letters are stylized and appear to be handwritten or cursive.

Diagnostic Ultrasound Indications for Use Form 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 Interest	B	M	PW Doppler	CW Doppler	Color Doppler	Color M Doppler	Power Doppler	Combined Modes	Harmonic Imaging	Coded Pulse	Other [Notes]
Ophthalmic
Fetal / Obstetrics[7]	P	P	P		P	P	P	P	P	P	5,6,9
Abdominal[1]	P	P	P		P	P	P	P	P	P	3,5,9
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]	P	P	P		P	P	P	P	P	P	3,5,6,9
Exam Type, Means of Access
Transesophageal
Transrectal[8]	P	P	P		P	P	P	P	P	P	3,5,6,9
Transvaginal	P	P	P		P	P	P	P	P	P	3,5,6,7,9
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

[*] 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/10/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a blue circle. The letters are stylized and appear to be handwritten or cursive.

Diagnostic Ultrasound Indications for Use Form 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 Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes*	HarmonicImaging	CodedPulse	Other[Notes]
Ophthalmic
Fetal / Obstetrics[7]
Abdominal[1]	P	P	P		P	P	P	P	P	P	5,6,9
Pediatric	P	P	P		P	P	P	P	P	P	5,6,9
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

[*] 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' intertwined in a stylized script, enclosed within a circular frame. The logo is colored in a light blue hue, and the background is white.

Diagnostic Ultrasound Indications for Use Form

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 Interest	B	M	PW Doppler	CW Doppler	Color Doppler	Color M Doppler	Power Doppler	Combined Modes	Harmonic Imaging	Coded Pulse	Other [Notes)
Ophthalmic
Fetal / Obstetrics[7]
Abdominal[1]
Pediatric
Small Organ[2]	P	P	P		P	P	P	P	P	P	5,9
Neonatal Cephalic
Adult Cephalic
Cardiac
Peripheral Vascular	P	P	P		P	P	P	P	P	P	5,9
Musculo-skeletal Conventional	P	P	P		P	P	P	P	P	P	5,9
Musculo-skeletal Superficial	P	P	P		P	P	P	P	P	P	5,9
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal[8]
Transvaginal
Transuretheral
Intraoperative[8]	P	P	P		P	P	P	P	P	P	5,9
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 Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development, GYN

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

[9] Volume navigation

[10] Shear wave elastography

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

(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 shape. The logo is blue and has a vintage or classic appearance.

Diagnostic Ultrasound Indications for Use Form GE LOGIQ S8 with S4-10-D Transducer

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

Clinical ApplicationAnatomy/Region of Interest	B	M	PW Doppler	CW Doppler	Color Doppler	Color M Doppler	Power Doppler	Combined Modes	Harmonic Imaging	Coded Pulse	Other [Notes]
Ophthalmic
Fetal / Obstetrics[7]
Abdominal[1]
Pediatric	P	P	P	P	P	P	P	P	P	P	5,9
Small Organ[2]
Neonatal Cephalic	P	P	P	P	P	P	P	P	P	P	5,9
Adult Cephalic
Cardiac	P	P	P	P	P	P	P	P	P	P
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal[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

[*] 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' intertwined within a circular border. The logo is colored in a light blue hue, and the design is simple and recognizable.

Diagnostic Ultrasound Indications for Use Form

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 Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes*	HarmonicImaging	CodedPulse	Other[Notes]
Ophthalmic
Fetal / Obstetrics[7]
Abdominal[1]
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic				P
Cardiac				P
Peripheral Vascular				P
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

[*] 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 shape. The logo is blue and has a vintage or classic appearance.

Diagnostic Ultrasound Indications for Use Form

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 Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes*	HarmonicImaging	CodedPulse	Other[Notes]
Ophthalmic
Fetal / Obstetrics[7]
Abdominal[1]
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic				P
Cardiac				P
Peripheral Vascular				P
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

[*] 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' intertwined within a circular border. The logo is colored in blue, with the letters and border appearing in a lighter shade of blue against a darker blue background.

기

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

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

Clinical Application	Mode of Operation									Other[Notes]
	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes'	HarmonicImaging
Anatomy/Region of Interest
Ophthalmic
Fetal/Obstetrics[7]	P	P	P		P	P	P	P	P	[5,6,9]
Abdominal[1]	P	P	P		P	P	P	P	P	[3,5,6,9]
Pediatric	P	P	P		P	P	P	P	P	[3,5,6,9]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric	P	P	P		P	P	P	P	P	[5,6,9]
Peripheral Vascular	P	P	P		P	P	P	P	P	[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

[*] 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, cursive font. The letters are enclosed within a circular border that has a decorative, swirling pattern. The logo is presented in a blue color.

Diagnostic Ultrasound Indications for Use Form GE LOGIQ S8 with 11L-D Transducer

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

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes*	HarmonicImaging	CodedPulse*	Other[Notes]
Ophthalmic
Fetal/Obstetrics[7]
Abdominal[1]
Pediatric	P	P	P		P	P	P	P	P	P	[3,5,6]
Small Organ[2]	P	P	P		P	P	P	P	P	P	[3,5,6]
Neonatal Cephalic	P	P	P		P	P	P	P	P	P	[5,6]
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral Vascular	P	P	P		P	P	P	P	P	P	[3,5,6]
Musculo-skeletal Conventional	P	P	P		P	P	P	P	P	P	[3,5,6]
Musculo-skeletal Superficial	P	P	P		P	P	P	P	P	P	[3,5,6]
Other[4]
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

[*] 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 'GE' intertwined within a circular border. The logo is colored in blue, with the letters and border appearing in a lighter shade of blue against a darker blue background.

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:

Clinical ApplicationAnatomy/Region of Interest	Mode of Operation										Other[Notes]
	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes*	HarmonicImaging	CodedPulse*
Ophthalmic
Fetal/Obstetrics[7]	P	P	P	P	P	P	P	P	P	P	5
Abdominal[1]	P	P	P	P	P	P	P	P	P	P
Pediatric	P	P	P	P	P	P	P	P	P	P	5
Small Organ[2]	P	P	P	P	P	P	P	P	P	P
Neonatal Cephalic	P	P	P	P	P	P	P	P	P	P	5
Adult Cephalic
Cardiac Adult
Cardiac Pediatric	P	P	P	P	P	P	P	P	P	P	5
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

[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

[*] 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' intertwined within a circular border. The logo is colored in blue, with the letters and border appearing in a lighter shade of blue against a darker blue background.

기

Diagnostic Ultrasound Indications for Use Form GE LOGIQ S8 with S1-5-D Transducer

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

Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes*	HarmonicImaging	CodedPulse'	Other[Notes]
Ophthalmic
Fetal/Obstetrics[7]	P	P	P	P	P	P	P	P	P	P	[5,6,9]
Abdominal[1]	P	P	P	P	P	P	P	P	P	P	[5,6,9]
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral Vascular	P	P	P	P	P	P	P	P	P	P	[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

[*] 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 'G' and 'E' intertwined in a stylized, cursive font. The letters are enclosed within a circular border that has a decorative, swirling pattern. The logo is presented in a blue color.

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 Application	Mode of Operation										Other[Notes]
	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes*	HarmonicImaging	CodedPulse"
Anatomy/Region of Interest
Ophthalmic
Fetal/Obstetrics[7]	P	P	P		P	P	P	P	P	P	[5,6]
Abdominal[1]	P	P	P		P	P	P	P	P	P	[5,6]
Pediatric	P	P	P		P	P	P	P	P	P	[5,6]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

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

[*] 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 "GE" intertwined in a stylized script, enclosed within a circular border. The logo is colored in a light blue hue, and the design is simple and recognizable.

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:

Clinical Application	Mode of Operation
	Anatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes*	HarmonicImaging	CodedPulse"	Other[Notes]
Ophthalmic
Fetal/Obstetrics[7]	P	P	P	P	P	P	P	P	P	P	[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]	P	P	P	P	P	P	P	P	P	P	[3,5,6]
Exam Type, Means of Access
Transesophageal
Transrectal	P	P	P	P	P	P	P	P	P	P	[3,5,6]
Transvaginal	P	P	P	P	P	P	P	P	P	P	[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

[*] 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 'GE' intertwined within a circular border. The logo is colored in blue, with the letters and border appearing in a lighter shade of blue against a darker blue background.

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:

Clinical Application	Mode of Operation											Other [Notes]
	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes*	HarmonicImaging	CodedPulsea
Anatomy/Region of Interest
Ophthalmic
Fetal/Obstetrics[7]
Abdominal[1]
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult	P	P	P	P	P	P	P	P	P	P
Cardiac Pediatric
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal	P	P	P	P	P	P	P	P	P	P
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

[*] 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 'g' and 'e' intertwined within a blue circle. The letters are stylized and connected, creating a unique and recognizable design.

Diagnostic Ultrasound Indications for Use Form 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 Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes*	HarmonicImaging	CodedPulse	Other[Notes]
Ophthalmic
Fetal / Obstetrics[7]
Abdominal[1]	P	P	P	P	P	P	P	P	P	P	5
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic	P	P	P	P	P	P	P	P	P	P
Cardiac Adult & Pediatric	P	P	P	P	P	P	P	P	P	P
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal[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

[*] 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' intertwined in a stylized script, enclosed within a circular border. The logo is colored in a light blue hue, and the background is white.

Diagnostic Ultrasound Indications for Use Form 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 Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other[Notes]
Ophthalmic
Fetal / Obstetrics[7]
Abdominal[1]	P	P	P		P		P	P	P	P	5,6,9
Pediatric	N	N	N		N		N	N	N	N	5,6,9
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

[*] 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/24/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined within a circular border. The logo is colored in a light blue hue.

Diagnostic Ultrasound Indications for Use Form GE LOGIQ S8 with 10C-D Transducer

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

Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes*	HarmonicImaging	CodedPulse	Other[Notes]
Ophthalmic
Fetal / Obstetrics[7]
Abdominal[1]
Pediatric	P	P	P		P		P	P	P	P	5
Small Organ[2]	P	P	P		P		P	P	P	P	5
Neonatal Cephalic	P	P	P		P		P	P	P	P	5
Adult Cephalic
Cardiac Adult & Pediatric
Peripheral Vascular	P	P	P		P		P	P	P	P	5
Musculo-skeletal Conventional
Musculo-skeletal Superficial	P	P	P		P		P	P	P	P	5,6
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

[*] 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/25/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, wave-like elements around the perimeter. 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 Application	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes*	HarmonicImaging	CodedPulse*	Other[Notes]
Anatomy/Region of Interest
Ophthalmic
Fetal/Obstetrics[7]
Abdominal[1]
Pediatric
Small Organ[2]	E	E	E		E	E	E	E	E	E	[5,6]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral Vascular	E	E	E		E	E	E	E	E	E	[5,6]
Musculo-skeletal Conventional	E	E	E		E	E	E	E	E	E	[5,6]
Musculo-skeletal Superficial	E	E	E		E	E	E	E	E	E	[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 (previously cleared by FDA on LOGIQ E9 K142160)

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

[2] Small organ includes breast, testes and thyroid

[3] Elastography Imaging - Elasticity.

• [4] Other use includes Urology/Prostate
  [5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development, GYN

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

[9] Volume navigation

[10] Shear wave elastography

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

System provides real-time 3D and 4D acquisition when used with special 4D probes

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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Image /page/26/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a blue circle. The circle has decorative, swirling elements around its perimeter, giving it a classic and recognizable appearance.

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:

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PW Doppler	CW Doppler	Color Doppler	Color M Doppler	Power Doppler	Combined Modes*	Harmonic Imaging	Coded Pulse*	Other [Notes]
Ophthalmic
Fetal/Obstetrics[7]	E	E	E	E	E	E	E	E	E	E	[5,6,9]
Abdominal[1]	E	E	E	E	E	E	E	E	E	E	[3,5,6,9,10]
Pediatric	E	E	E	E	E	E	E	E	E	E	[3,5,6,9,10]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral Vascular	E	E	E	E	E	E	E	E	E	E	E	[3,5,6,9,10]
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]	E	E	E	E	E	E	E	E	E	E	E	[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 (previously cleared by FDA on LOGIQ E9 K142160)

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

[2] Small organ includes breast, testes and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development, GYN

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

[9] Volume navigation

[10] Shear wave elastography

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

System provides real-time 3D and 4D acquisition when used with special 4D probes

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OlR)

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Image /page/27/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 and connected, creating a unique and recognizable design.

Diagnostic Ultrasound Indications for Use Form 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 Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other[Notes)
Ophthalmic
Fetal / Obstetrics[7]	E	E	E		E	E	E	E	E	E	5,6
Abdominal[1]	E	E	E		E	E	E	E	E	E	3,5,6
Pediatric	E	E	E		E	E	E	E	E	E	3,5,6
Small Organ[2]	E	E	E		E	E	E	E	E	E	3,5,6
Neonatal Cephalic
Adult Cephalic
Cardiac Adult & Pediatric
Peripheral Vascular	E	E	E		E	E	E	E	E	E	3,5,6
Musculo-skeletal Conventional	E	E	E		E	E	E	E	E	E	3,5,6
Musculo-skeletal Superficial	E	E	E		E	E	E	E	E	E	3,5,6
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 (previously cleared by FDA on LOGIQ S7 K141261)

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

[2] Small organ includes breast, testes and thyroid

[3] Elastography Imaging - Elasticity.

• [4] Other use includes Urology/Prostate
  [5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development, GYN

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

[9] Volume navigation

[10] Shear wave elastography

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

(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/28/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 presented in a blue color scheme, with the letters and border appearing in a solid blue hue.

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 Application	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes*	HarmonicImaging	CodedPulse*	Other[Notes]
Anatomy/Region of Interest
Ophthalmic
Fetal/Obstetrics[7]
Abdominal[1]
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral Vascular				E
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 (previously cleared by FDA on LOGIQ P9 K143452)

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

[2] Small organ includes breast, testes and thyroid

[3] Elastography Imaging - Elasticity.

• [4] Other use includes Urology/Prostate
  [5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development, GYN

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

[9] Volume navigation

[10] Shear wave elastography

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

System provides real-time 3D and 4D acquisition when used with special 4D probes

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OlR)

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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 shape. The logo is blue and has a vintage or classic appearance.

Diagnostic Ultrasound Indications for Use Form GE LOGIQ S8 with BE9CS-D Transducer

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

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PW Doppler	CW Doppler	Color Doppler	Color M Doppler	Power Doppler	Combined Modes*	Harmonic Imaging	Coded Pulse	Other [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]	E	E	E		E		E	E	E	E	5, 6
Exam Type, Means of Access
Transesophageal
Transrectal[8]	E	E	E		E		E	E	E	E	5, 6
Transvaginal	E	E	E		E		E	E	E	E	5, 6
Transuretheral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA, E = added via Appendix E (previously cleared by FDA on LOGIQ S7 K141261)

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

• [2] Small organ includes breast, testes and thyroid
• [3] Elastography Imaging Elasticity.
• [4] Other use includes Urology/Prostate
• [5] 3D/4D Imaging mode

[6] Needle guidance imaging

• [7] Includes infertility monitoring of follicle development, GYN
• [8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)
• [9] Volume navigation
• [10] Shear wave elastography

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

(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 shape. The circle has decorative, swirling elements around it, giving it a dynamic and fluid 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:

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PW Doppler	CW Doppler	Color Doppler	Color M Doppler	Power Doppler	Combined Modes*	Harmonic Imaging	Coded Pulse°	Other [Notes]
Ophthalmic
Fetal/Obstetrics[7]
Abdominal[1]	N	N	N		N		N	N	N	N	5,6,9
Pediatric	N	N	N		N		N	N	N	N	5,6,9
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

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

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

[2] Small organ includes breast, testes and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development, GYN

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

[9] Volume navigation

[10] Shear wave elastography

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

System provides real-time 3D and 4D acquisition when used with special 4D probes

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OlR)

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

Image /page/31/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, swirling elements around the letters. The logo is colored in a light blue hue.

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

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

Clinical Application	Mode of Operation
Anatomy/Region of Interest	B	M	PW Doppler	CW Doppler	Color Doppler	Color M Doppler	Power Doppler	Combined Modes*	Harmonic Imaging	Coded Pulse*	Other [Notes]
Ophthalmic
Fetal/Obstetrics[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]	N	N	N	N	N	N	N	N	N	N	5
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

[*] 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)

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

Image /page/32/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 shape. The circle has decorative, wave-like elements around its perimeter, giving it a dynamic and flowing appearance. The logo is presented in a blue color scheme.

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 Application	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes*	HarmonicImaging	CodedPulse*	Other[Notes]
Anatomy/Region of Interest
Ophthalmic
Fetal/Obstetrics[7]
Abdominal[1]
Pediatric	N	N	N		N		N	N	N	N	5,9
Small Organ[2]
Neonatal Cephalic	N	N	N		N		N	N	N	N	5,9
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral Vascular	N	N	N		N		N	N	N	N	5,9
Musculo-skeletal Conventional
Musculo-skeletal Superficial	N	N	N		N		N	N	N	N	5,6,9
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

[*] 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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Image /page/33/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a blue circle. The letters are white, creating a contrast against the blue background. The logo is a well-known symbol associated with the multinational conglomerate.

510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:
Date:	August 04, 2015
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 BehnSr. Regulatory Affairs ManagerGE HealthcareT:[phone]F:[phone]
Alternate Contact Person:	Qingmeng ChenRegulatory Affairs SpecialistGE Ultrasound Korea, Ltd.T: [phone]F: [phone]
Device:
Trade Name:	LOGIQ S8 Ultrasound System
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
Predicate Device(s):	K131527 LOGIQ S8 Diagnostic Ultrasound SystemK142160 LOGIQ E9 Diagnostic Ultrasound SystemK141261 LOGIQ S7 Diagnostic Ultrasound SystemK143452 LOGIQ P9 Diagnostic Ultrasound SystemK131514 Vivid E9 Diagnostic Ultrasound System
Device Description:	The LOGIQ S8 is a full featured, general purpose diagnosticultrasound system which consists of a mobile consoleapproximately 620 mm wide, 880 mm deep and 1720 mm highthat provides digital acquisition, processing and displaycapability. The user interface includes a computer keyboard,specialized controls, 9-inch LCD touch screen and colorwidescreen monitor.

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Image /page/34/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a blue circle. There are also some white curved lines around the letters.

Intended Use:	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 fundamental scientific technology of the new LOGIQ S8 is the same as the predicate LOGIQ S8 in terms of its main hardware components and software algorithms used for image acquisition and processing. The newly added shear wave imaging mode employs the same fundamental scientific technology of the shear wave imaging mode on predicate LOGIQ E9.Conclusion: The LOGIQ S8 employs the same fundamental scientific technology as its predicate device(s).
Determination of Substantial Equivalence:	Comparison to PredicatesThe following is an overview of the differences between the proposed LOGIQ S8 and the predicate LOGIQ S8 (K131527). 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 ads shear wave elastography which is substantially equivalent to LOGIQ E9 (K142160).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.

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Image /page/35/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in white inside. There are white swirls around the outside of the circle. The logo is simple and recognizable.

• The LOGIQ S8 and predicate LOGIQ S8 systems probes ● are identical except for the C2-7-D, C3-10-D and L3-9i-D which are an incremental improvement to the existing probes and are equivalent.
• . The following probes have been migrated from the LOGIQ E9 (K142160) C1-6-D and RSP6-16-D.
• . The following probes have been migrated from the LOGIQ S7 (K141261) BE9CS and L3-12-D probes.
• The following features and probes have been migrated from the LOGIQ P9 (K143452) Auto TGC and P8D probe.
• The following feature has been migrated from the Vivid E9 (K131514) Cardiac Automated Function Imaging.

Summary of Non-Clinical Tests:

The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic and mechanical safety, and has been found to conform with applicable medical device safety standards. The LOGIQ S8 and its applications comply with voluntary standards:

• 1. AAMI/ANSI ES60601-1, Medical Electrical Equipment – Part 1: General Requirements for Safety
• 2. IEC60601-1-2,Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility Requirements and Tests
• 3. IEC60601-2-37, Medical Electrical Equipment -Part 2-37:Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment
• 4. NEMA UD 3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
• 5. ISO10993-1, Biological Evaluation of Medical Devices- Part 1: Evaluation and Testing- Third Edition
• 6. NEMA UD 2, Acoustic Output Measurement Standard

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Image /page/36/Picture/0 description: The image shows the General Electric (GE) logo. The logo is a blue circle with a stylized "GE" monogram in white in the center. The monogram is surrounded by a swirling pattern, also in white. The logo is simple and recognizable, and it is associated with a well-known and established company.

for Diagnostic Ultrasound Equipment

• 7. ISO14971, Application of risk management to medical devices
• 8. 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).

Regulation Number and Section

§ 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.