LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM

• K Number: K142160
• Device Name: LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM
• Manufacturer: GE HEALTHCARE
• Date Cleared: 2014-10-10 ( 65 days)
• Product Code: IYN , ITX , IYO
• Regulation Number: 892.1550
• Type: Traditional
• Panel: Radiology
• Reference & Predicate Devices: N/A
• Predicate For: K150087 , K151451 , K152195 , K152309 , K152763 , K153529 , K162094 , K163691 , K171048

Intended Use

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

Device Description

The LOGIQ E9 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 58 cm wide, 86cm deep and 141 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 10-inch LCD touch screen and color 19-inch LCD image display.

AI/ML Overview

The provided text describes the GE LOGIQ E9 Diagnostic Ultrasound System and its various transducers. It highlights the device's indications for use and a summary of non-clinical tests conducted to prove its safety and substantial equivalence to predicate devices. However, it explicitly states that no clinical studies were required or performed to support substantial equivalence.

Therefore, I cannot provide details on the acceptance criteria and a study that proves the device meets those criteria, as no such clinical study is reported in the provided document.

Here's a breakdown of the information that can be extracted or inferred based on your prompt and the document:

---

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

Since no clinical studies were performed, there are no specific performance metrics derived from such studies to present in a table. The "acceptance criteria" are implicitly met by demonstrating substantial equivalence to predicate devices through non-clinical testing and adherence to recognized standards.

Acceptance Criteria (Inferred from Substantial Equivalence and Standards Adherence)	Reported Device Performance (as stated in document)
Safety:	Adherence to medical device safety standards.
Acoustic Output below FDA limits	Acoustic power levels are below applicable FDA limits.
Biocompatibility	Biocompatibility evaluated and found safe.
Cleaning and Disinfection Effectiveness	Cleaning and disinfection effectiveness evaluated.
Thermal, Electrical, Electromagnetic, Mechanical Safety	Conforms with applicable medical device safety standards.
Effectiveness (Substantial Equivalence):	Same fundamental scientific technology as predicate devices.
Intended Use	Same clinical intended use as predicate LOGIQ E9.
Imaging Capabilities	Same imaging modes as predicate LOGIQ E9 (with Shear Wave Elastography for Aixplorer).
Transducer Equivalence/Improvement	Transducers are identical to predicate LOGIQ E9 versions, or incremental improvements (C1-6VN-D, C2-9-VN-D).
Capability for Measurements, Digital Images, Reviewing, Reporting	Similar to predicate LOGIQ E9 systems.

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

• Sample Size for Test Set: Not applicable, as no clinical studies were conducted that would involve a "test set" of patients for performance evaluation. Non-clinical tests typically involve phantom, bench, or ex-vivo testing.
• Data Provenance: Not applicable for patient data, as no clinical studies were conducted. The document details adherence to international and national standards (AAMI/ANSI, IEC, NEMA, ISO), indicating these standards and tests were likely performed according to established protocols in manufacturing or testing facilities.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

Not applicable, as no clinical studies were conducted requiring ground truth established by experts for a patient test set.

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

Not applicable, as no clinical studies were conducted requiring adjudication for a patient test set.

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 GE LOGIQ E9 is a diagnostic ultrasound system and the document does not suggest or describe any AI components or MRMC studies for improved human reader performance.

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

Not applicable. The device is a diagnostic ultrasound system, not an algorithm, and the document does not describe standalone algorithm performance.

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

Not applicable for clinical ground truth, as no clinical studies were described. For non-clinical tests (acoustic output, safety, etc.), the "ground truth" would be defined by the specifications, standards, and established methodologies for each test (e.g., calibrated measurement devices for acoustic output).

8. The sample size for the training set:

Not applicable, as no clinical studies involving machine learning or AI models with a "training set" were described.

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

Not applicable, as no clinical studies involving machine learning or AI models with a "training set" were described.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized emblem with three abstract human profiles facing right, stacked on top of each other. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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

October 10, 2014

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

Re: K142160

Trade/Device Name: LOGIQ E9 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: September 29, 2014 Received: September 30, 2014

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.

This determination of substantial equivalence applies to the following transducers intended for use with the LOGIQ E9 Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number
3CRF	3CRF-D	6S-D	6Tc
9L-D	11L-D	C1-5-D	IC5-9-D
L8-18i-D	M4S-D	M5S-D	M6C-D
ML6-15-D	P2D	P6D	RAB2-5D
RAB4-8-D	RIC5-9-D	RNA5-9-D	RSP6-16-D
S1-5	S4-10	S4-10-D	C2-9-D
RAB6-D	S1-5-D	C1-6-D	C2-9VN-D

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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.

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,

for

Janine M. Morris 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) K142160

Device Name LOGIQ E9

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9 Ultrasound System

	Mode of Operation
Clinical Application	B	M	PW	CW	Color	Color M	Power	Combined	Harmonic	Coded	Other
Anatomy/Region of Interest			Doppler	Doppler	Doppler	Doppler	Doppler	Modes*	Imaging	Pulse	(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]
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	[5,6,9]
Adult Cephalic	P	P	P	P	P	P	P	P	P	P	[5,6,9]
Cardiac Adult	P	P	P	P	P	P	P	P	P	P
Cardiac Pediatric	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]
Musculo-skeletal Conventional	P	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	P	[3,5,6,9]
Other[4]	P	P	P	P	P	P	P	P	P	P	[3,5,6,9]
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	[3,5,6,9]
Transurethral
Intraoperative[8]	P	P	P	P	P	P	P	P	P	P	[3,5,6,9]
Intraoperative Neurological
Intravascular
Laparoscopic

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

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

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

[2] Small organ includes breast, testes and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development, Gyn

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

[9] Volume navigation

[10] Shear wave elastography

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

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

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

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

Prescription User (Per 21 CFR 801.109)

Page 2 of 31

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

Clinical Application		Mode of Operation
	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other[Notes]
Anatomy/Region of Interest
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	P	P	P	P	P	P	P	P	P	P	[5,6,9]
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	[5,6,9]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

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

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

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

[2] Small organ includes breast, testes and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development

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

[9] Volume navigation

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

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

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

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

Prescription User (Per 21 CFR 801.109)

Page 3 of 31

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

	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	E	[5,6,9]
Abdominal[1]	E	E	E	E	E	E	E	E	E	E	[5,6,9]
Pediatric	E	E	E	E	E	E	E	E	E	E	[5,6,9]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]	E	E	E	E	E	E	E	E	E	E	E	[5,6,9]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

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

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

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

[2] Small organ includes breast, testes and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development

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

[9] Volume navigation

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

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

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

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

Prescription User (Per 21 CFR 801.109)

Page 4 of 31

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

	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	P
Abdominal [1]	P	P	P	P	P	P	P	P	P	P
Pediatric	P	P	P	P	P	P	P	P	P	P
Small Organ[2]
Neonatal Cephalic	P	P	P	P	P	P	P	P	P	P	P
Adult Cephalic
Cardiac Adult
Cardiac Pediatric	P	P	P	P	P	P	P	P	P	P	P
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other [4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

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

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

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

[2] Small organ includes breast, testes and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development

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

[9] Volume navigation

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

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

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

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

Prescription User (Per 21 CFR 801.109)

Page 5 of 31

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

	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
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

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

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

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

[2] Small organ includes breast, testes and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development

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

[9] Volume navigation

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

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

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

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

Prescription User (Per 21 CFR 801.109)

Page 6 of 31

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

	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	[5,6,9]
Abdominal[1]	P	P	P		P	P	P	P	P	P	[3,5,6,9]
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	[3,5,6,9,10]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
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]	P	P	P		P	P	P	P	P	P	[3,5,6,9]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

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

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

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

[2] Small organ includes breast, testes and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development

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

[9] Volume navigation

[10] Shear wave elastography

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

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

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

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

Prescription User (Per 21 CFR 801.109)

Page 7 of 31

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

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]	P	P	P		P	P	P	P	P	P	[3,5,6]
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
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[8]
Intraoperative Neurological
Intravascular
Laparoscopic

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

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

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

[2] Small organ includes breast, testes and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development

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

[9] Volume navigation

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

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

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

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

Prescription User (Per 21 CFR 801.109)

Page 8 of 31

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

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

	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	[5,6,9]
Pediatric	P	P	P	P	P	P	P	P	P	P	[5,6,9]
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]	P	P	P	P	P	P	P	P	P	P	[5,6,9]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

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

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

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

[2] Small organ includes breast, testes and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development

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

[9] Volume navigation

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

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

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

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

Prescription User (Per 21 CFR 801.109)

Page 9 of 31

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

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

	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	[5,6,9]
Abdominal[1]
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]	P	P	P		P	P	P	P	P	P	[3,5,6,9]
Exam Type, Means of Access
Transesophageal
Transrectal	P	P	P		P	P	P	P	P	P	[3,5,6,9]
Transvaginal	P	P	P		P	P	P	P	P	P	[3,5,6,9]
Transurethral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

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

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

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

[2] Small organ includes breast, testes and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development, Gyn

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

[9] Volume navigation

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

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

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

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

Prescription User (Per 21 CFR 801.109)

Page10 of 31

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

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

Clinical Application	Anatomy/Region of Interest	Mode of Operation
		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	[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	[5,6,9]
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
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
Transvaginal
Transurethral
Intraoperative[8]	P	P	P		P	P	P	P	P	P	[3,5,6,9]
Intraoperative Neurological
Intravascular
Laparoscopic

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

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

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

[2] Small organ includes breast, testes and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development

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

[9] Volume navigation

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

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

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

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

Prescription User (Per 21 CFR 801.109)

Page 11 of 31

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

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

Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes*	HarmonicImaging	CodedPulse	Other[Notes]
Fetal/Obstetrics[7]	P	P	P	P	P	P	P	P	P	P	[5,6]
Abdominal[1]	P	P	P	P	P	P	P	P	P	P	[5,6]
Pediatric	P	P	P	P	P	P	P	P	P	P	[5,6]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic	P	P	P	P	P	P	P	P	P	P
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
Transrectal
Transvaginal
Transurethral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

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

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

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

[2] Small organ includes breast, testes and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development

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

[9] Volume navigation

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

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

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

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

Prescription User (Per 21 CFR 801.109)

Page 12 of 31

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

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

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	P	P	P	P	P	P	P	P	P	P	[5,6,9]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic	P	P	P	P	P	P	P	P	P	P	[9]
Cardiac Adult	P	P	P	P	P	P	P	P	P	P
Cardiac 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
Transvaginal
Transurethral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

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

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

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

[2] Small organ includes breast, testes and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development

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

[9] Volume navigation

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

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

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

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

Prescription User (Per 21 CFR 801.109)

Page13 of 31

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

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

	Mode of Operation
Clinical Application	B	M	PW	CW	Color	Color M	Power	Combined	Harmonic	Coded	Other
Anatomy/Region of Interest			Doppler	Doppler	Doppler	Doppler	Doppler	Modes*	Imaging	Pulse•	[Notes]
Ophthalmic
Fetal/Obstetrics[7]	P	P	P	P	P	P	P	P	P	P	[5,6]
Abdominal [1]	P	P	P	P	P	P	P	P	P	P	[5,6]
Pediatric	P	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

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

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

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

[2] Small organ includes breast, testes and thyroid

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

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

[7] Includes infertility monitoring of follicle development

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

[9] Volume navigation

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

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

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

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

Prescription User (Per 21 CFR 801.109)

Page14 of 31

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

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

	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 Adult
Cardiac Pediatric
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
Transvaginal
Transurethral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

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

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

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

[2] Small organ includes breast, testes and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development

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

[9] Volume navigation

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

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

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

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

Prescription User (Per 21 CFR 801.109)

Page 15 of 31

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

Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9 with P2D Transducer

	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	P
Cardiac Adult			P	P
Cardiac Pediatric			P	P
Peripheral Vascular			P	P
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other [4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

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

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

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

[2] Small organ includes breast, testes and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development

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

[9] Volume navigation

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

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

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

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

Prescription User (Per 21 CFR 801.109)

Page 16 of 31

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

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

	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			P	P
Cardiac Adult			P	P
Cardiac Pediatric			P	P
Peripheral Vascular			P	P
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

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

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

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

[2] Small organ includes breast, testes and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development

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

[9] Volume navigation

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

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

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

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

Prescription User (Per 21 CFR 801.109)

Page 17 of 31

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

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

	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]
Abdominal [1]	P	P	P	P	P	P	P	P	P	P	[5,6]
Pediatric	P	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	P	P	P	P	P	P	P	P	P	P	[5,6]
Musculo-skeletal Superficial
Other[4]	P	P	P	P	P	P	P	P	P	P	[5]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative [8]
Intraoperative Neurological
Intravascular
Laparoscopic

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

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

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

[2] Small organ includes breast, testes and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development

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

[9] Volume navigation

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

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

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

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

Prescription User (Per 21 CFR 801.109)

Page 18 of 31

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

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

	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	[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	P	P	P		P	P	P	P	P	P	[5,6]
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

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

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

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

[2] Small organ includes breast, testes and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development

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

[9] Volume navigation

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

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

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

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

Prescription User (Per 21 CFR 801.109)

Page 19 of 31

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

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

	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]
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

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

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

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

[2] Small organ includes breast, testes and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development, Gyn

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

[9] Volume navigation

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

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

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

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

Prescription User (Per 21 CFR 801.109)

Page 20 of 31

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

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

	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]
Abdominal[1]	P	P	P	P	P	P	P	P	P	P	[5,6]
Pediatric	P	P	P	P	P	P	P	P	P	P	[5,6]
Small Organ[2]	P	P	P	P	P	P	P	P	P	P	[5,6]
Neonatal Cephalic	P	P	P	P	P	P	P	P	P	P	[5]
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral Vascular	P	P	P	P	P	P	P	P	P	P	[5,6]
Musculo-skeletal Conventional	P	P	P	P	P	P	P	P	P	P	[5,6]
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

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

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

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

[2] Small organ includes breast, testes and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development

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

[9] Volume navigation

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

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

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

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

Prescription User (Per 21 CFR 801.109)

Page 21 of 31

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

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

D	cDMode of Operation
Clinical Application	B	M	PW	CW	Color	Color M	Power	Combined	Harmonic	Coded	Other
Anatomy/Region of Interest			Doppler	Doppler	Doppler	Doppler	Doppler	Modes*	Imaging	Pulse	[Notes]
Ophthalmic
Fetal/Obstetrics[7]
Abdominal[1]
Pediatric	b	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
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral Vascular	P	P	P		P	P	b	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[8]	b	P	P		P	P	P	P	P	P
Intraoperative Neurological
Intravascular
Laparoscopic

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

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

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

[2] Small organ includes breast, testes and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development

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

[9] Volume navigation

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

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

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

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

Prescription User (Per 21 CFR 801.109)

Page 22 of 31

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

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

	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]	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	P	P	P	P	P	P	P	P	P	P	[5,6,9]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic	P	P	P	P	P	P	P	P	P	P	[5,6,9]
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
Transrectal
Transvaginal
Transurethral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

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

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

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

[2] Small organ includes breast, testes and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development

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

[9] Volume navigation

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

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

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

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

Prescription User (Per 21 CFR 801.109)

Page 23 of 31

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

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

	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	[5,6,9]
Pediatric	P	P	P	P	P	P	P	P	P	P	[5,6,9]
Small Organ[2]	P	P	P	P	P	P	P	P	P	P	[5,6,9]
Neonatal Cephalic	P	P	P	P	P	P	P	P	P	P	[5,6,9]
Adult Cephalic
Cardiac Adult
Cardiac 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
Transvaginal
Transurethral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

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

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

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

[2] Small organ includes breast, testes and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development

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

[9] Volume navigation

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

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

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

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

Prescription User (Per 21 CFR 801.109)

Page 24 of 31

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

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

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

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

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

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

[2] Small organ includes breast, testes and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development

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

[9] Volume navigation

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

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

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

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

Prescription User (Per 21 CFR 801.109)

Page 25 of 31

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

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

	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 Adult
Cardiac Pediatric
Peripheral Vascular	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	[3,5,6,9]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

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

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

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

[2] Small organ includes breast, testes and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development

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

[9] Volume navigation

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

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

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

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

Prescription User (Per 21 CFR 801.109)

Page 26 of 31

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

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

	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	[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	P	P	P		P	P	P	P	P	P	[5,6]
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

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

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

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

[2] Small organ includes breast, testes and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development

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

[9] Volume navigation

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

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

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

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

Prescription User (Per 21 CFR 801.109)

Page 27 of 31

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

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

	Mode of Operation
Clinical Application	B	M	PW	CW	Color	Color M	Power	Combined	Harmonic	Coded	Other
Anatomy/Region of Interest			Doppler	Doppler	Doppler	Doppler	Doppler	Modes*	Imaging	Pulse	[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	P	P	P	P	P	P	P	P	P	P	[5,6,9]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic	P	P	P	P	P	P	P	P	P	P	[5,6,9]
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
Transrectal
Transvaginal
Transurethral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

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

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

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

[2] Small organ includes breast, testes and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development

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

[9] Volume navigation

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

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

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

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

Prescription User (Per 21 CFR 801.109)

Page 28 of 31

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

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

	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]	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]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral Vascular	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	[3,5,6,9]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

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

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

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

[2] Small organ includes breast, testes and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development

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

[9] Volume navigation

[10] Shear wave elastoqraphy

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

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

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

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

Prescription User (Per 21 CFR 801.109)

Page 29 of 31

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

Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9 with C2-9VN-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]	N	N	N	N	N	N	N	N	N	N	[5,6,9]
Abdominal[1]	N	N	N	N	N	N	N	N	N	N	[3,5,6,9]
Pediatric	N	N	N	N	N	N	N	N	N	N	[3,5,6,9]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral Vascular	N	N	N	N	N	N	N	N	N	N	[3,5,6,9]
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]	N	N	N	N	N	N	N	N	N	N	[3,5,6,9]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

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

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

[2] Small organ includes breast, testes and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development

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

[9] Volume navigation

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

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

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

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

Prescription User (Per 21 CFR 801.109)

Page 30 of31

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

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

	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]	N	N	N	N	N	N	N	N	N	N	[5,6,9]
Abdominal[1]	N	N	N	N	N	N	N	N	N	N	[3,5,6,9,10]
Pediatric	N	N	N	N	N	N	N	N	N	N	[3,5,6,9]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral Vascular	N	N	N	N	N	N	N	N	N	N	[3,5,6,9]
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]	N	N	N	N	N	N	N	N	N	N	[3,5,6,9]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

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

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

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

[2] Small organ includes breast, testes and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development

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

[9] Volume navigation

[10] Shear wave elastography

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

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

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

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

Prescription User (Per 21 CFR 801.109)

Page 31 of 31

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

Image /page/33/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized script inside. There are swirling lines around the letters, and the circle is outlined in white. The logo is simple and recognizable, and it is associated with a well-known company.

GE Healthcare 510(k) Premarket Notification Submission

510(k) Summary

	In accordance with 21 CFR 807.92 the following summary of information is provided:
Date:	July 17, 2014
Submitter/Manufacturer:	GE Healthcare, GE Medical Systems Ultrasound and PrimaryCare Diagnostics, LLC.9900 Innovation Dr.Wauwatosa, WI 53226
Contact Person:	Bryan BehnRegulatory Affairs ManagerGE Healthcare, GE Medical Systems Ultrasound and PrimaryCare Diagnostics, LLC.Phone: [phone]Fax: [phone]
Device:Trade Name:	GE LOGIQ E9 Diagnostic Ultrasound System
Common/Usual Name:Classification Names:Product Code:	LOGIQ E9Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYNUltrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYODiagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX
Predicate Device(s):	K123564 GE LOGIQ E9 Diagnostic Ultrasound SystemK132274 SuperSonic Imagine, Aixplorer Diagnostic UltrasoundSystem
Device Description:	The LOGIQ E9 is a full featured, general purpose diagnosticultrasound system which consists of a mobile consoleapproximately 58 cm wide, 86cm deep and 141 cm high thatprovides digital acquisition, processing and display capability.The user interface includes a computer keyboard, specializedcontrols, 10-inch LCD touch screen and color 19-inch LCDimage display.
Intended Use:	The device is intended for use by a qualified physician forultrasound evaluation of Fetal; Abdominal; Pediatric; SmallOrgan (breast, testes, thyroid); Neonatal Cephalic; AdultCephalic; Cardiac (adult and pediatric); Peripheral Vascular;Musculo-skeletal Conventional and Superficial; Urology(including prostate); Transrectal; Transvaginal; Transesophageal

and Intraoperative (abdominal, thoracic and vascular).

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

Image /page/34/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" in a stylized script, enclosed within a circular frame. The frame is decorated with swirling, wave-like elements, giving it a dynamic and fluid appearance. The color of the logo is a light blue.

GE Healthcare 510(k) Premarket Notification Submission

Technology:

The LOGIQ E9 employs the same fundamental scientifictechnology as its predicate device(s).

Determination ofSubstantial Equivalence:

Comparison to PredicatesThe LOGIQ E9 is substantially equivalent to the predicatedevices with regard to intended use, imaging capabilities,technological characteristics and safety and effectiveness. The systems are all intended for diagnostic ultrasoundimaging and fluid flow analysis. The LOGIQ E9 and predicate LOGIQ E9 systems havethe same clinical intended use. The LOGIQ E9 and predicate LOGIQ E9 systems havethe same imaging modes with the exception of ShearWave elastography which is substantially equivalent toSuperSonic Imagine Aixplorer (K132274). The LOGIQ E9 and predicate LOGIQ E9 systemstransducers are identical except for the C1-6VN-D, C2-9-VN-D which are an incremental improvement to theexisting C1-6-D and C-2-9-D transducers and areequivalent.

• The systems are manufactured with materials which have been evaluated and found to be safe for the intended use of the device.
• The systems have acoustic power levels which are below the applicable FDA limits.
• The LOGIQ E9 and predicate LOGIQ E9 systems have ● similar capability in terms of performing measurements, capturing digital images, reviewing and reporting studies.
• . The LOGIQ E9 and predicate systems have been designed in compliance with approved electrical and physical safety standards.

Summary of Non-Clinical Tests:

The device has been evaluated for acoustic output,

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

• 1. AAMI/ANSI ES60601-1, Medical Electrical Equipment – Part 1: General Requirements for Safety

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

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 a stylized script inside. There are three swirling lines around the letters, which are also in blue. The logo is simple and recognizable, and it is associated with a well-known and established company.

GE Healthcare 510(k) Premarket Notification Submission

• 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
• 6. NEMA UD 2, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
• 7. ISO14971, Application of risk management to medical devices: Second edition
• 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)
• Performance testing (Verification)
• Safety testing (Verification)
• Final Acceptance testing (Validation) ●

Summary of Clinical Tests:

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

GE Healthcare considers the LOGIQ E9 to be as safe, as Conclusion: effective, and performance is substantially equivalent to the predicate device(s).

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.