LOGIQ S7 Expert

• K Number: K160182
• Device Name: LOGIQ S7 Expert
• Manufacturer: GE Healthcare
• Date Cleared: 2016-02-26 ( 30 days)
• Product Code: IYN ITX IYO
• Regulation Number: 892.1550

Intended Use

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

Device Description

The LOGIQ S7 Expert is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 530mm (Caster), 520mm (Keyboard), 565mm (Monitor) wide, 865mm deep and 1760mm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 10.1-inch LCD touch screen and color 23-inch LCD widescreen monitor.

Predicate Devices

K141261 LOGIQ S7 Expert Diagnostic Ultrasound System, K152195 LOGIQ S8 Diagnostic Ultrasound System, K141639 Voluson S8 Diagnostic Ultrasound System, K143452 Logiq P9 Diagnostic Ultrasound System

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document does not mention AI, ML, deep learning, or any related terms in the device description or intended use. The description focuses on standard ultrasound system components and capabilities.

Therapeutic

No
The description explicitly states it is a "diagnostic ultrasound system," and its intended use is for "ultrasound evaluation," not treatment.

Diagnostic

Yes
The "Device Description" explicitly states, "The LOGIQ S7 Expert is a full featured, general purpose diagnostic ultrasound system." The "Intended Use / Indications for Use" further details its use for "ultrasound evaluation" of various anatomical sites, which is a diagnostic purpose.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical, mobile console with hardware components like a keyboard, touch screen, and monitor, indicating it is not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
• Device Function: The description clearly states that the LOGIQ S7 Expert is a diagnostic ultrasound system. Ultrasound imaging is a non-invasive technique that uses sound waves to create images of internal body structures. It does not involve the analysis of specimens taken from the body.
• Intended Use: The intended use describes various anatomical sites and applications for ultrasound imaging (e.g., Obstetrics, Abdominal, Cardiac, etc.). These are all applications of in-vivo imaging, not in-vitro analysis.

Therefore, the LOGIQ S7 Expert falls under the category of a medical imaging device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The device is intended for use by a qualified physician for ultrasound evaluation of Obstetrics (Fetal); Abdominal (includes renal, GYN/Pelvic); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Cardiac (adult and pediatric); Peripheral Vasculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectal: Transvaginal; Transesophageal and Intraoperative (abdominal, thoracic, vascular). Diagnostic ultrasound imaging or fluid flow analysis of the human body.

Product codes (comma separated list FDA assigned to the subject device)

IYN, IYO, ITX

Device Description

The LOGIQ S7 Expert is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 530mm (Caster), 520mm (Keyboard), 565mm (Monitor) wide, 865mm deep and 1760mm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 10.1-inch LCD touch screen and color 23-inch LCD widescreen monitor.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Obstetrics (Fetal); Abdominal (includes renal, GYN/Pelvic); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Cardiac (adult and pediatric); Peripheral Vasculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (abdominal, thoracic, vascular); Adult Cephalic.

Indicated Patient Age Range

Adult, Pediatric, Neonatal. Covers Fetal, Pediatric, Neonatal Cephalic, Adult Cephalic.

Intended User / Care Setting

Qualified physician. Not Found.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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 to applicable medical device safety standards. LOGIQ S7 Expert and its applications comply with voluntary standards: AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, NEMA UD 3, ISO10993-1, NEMA UD 2, ISO14971, NEMA Digital Imaging and Communications in Medicine (DICOM) Set. Quality assurance measures applied to development include risk analysis, requirements reviews, design reviews, testing on unit level (module verification), integration testing (system verification), final acceptance testing (validation), performance testing (verification), and safety testing (verification). Transducer materials and patient contact materials are biocompatible.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K141261 LOGIQ S7 Expert Diagnostic Ultrasound System, K152195 LOGIQ S8 Diagnostic Ultrasound System, K141639 Voluson S8 Diagnostic Ultrasound System, K143452 Logiq P9 Diagnostic Ultrasound System

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

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

February 26, 2016

GE HEALTHCARE BRYAN BEHN SR. REGULATORY AFFAIRS MANAGER 9900 INNOVATION DR. WAUWATOSA WI 53226

Re: K160182

Trade/Device Name: Logiq S7 Expert Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: January 20, 2016 Received: January 27, 2016

Dear Mr. Behn:

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

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

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

1

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [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.

Michael D.'Hara

For

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

Enclosure

2

Indications for Use

510(k) Number (if known)

1601

Device Name LOGIQ S7 Expert

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)
X 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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Indications for Use Forms

The following forms represent indications with clinical applications and exam types along with the modes of operation for the LOGIQ S7 Expert system and for all of its probe/mode combinations. Combinations identified by "P" represent those previously cleared with the unmodified LOGIQ S7 Expert (K14261) or on another GE ultrasound system in the case of the probes. "N" is new in this submission.

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

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Image /page/4/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a circular border. The letters and the border are both a light blue color, set against a white background. The logo is simple, yet recognizable, representing the multinational conglomerate corporation.

GE Healthcare 510(k) Premarket Notification Submission

Diagnostic Ultrasound Indications for Use Form GE LOGIQ S7 Expert Ultrasound System

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

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

N = new indication; P = previously cleared by FDA

[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)

[*] 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)

5

Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" written in a stylized script, enclosed within a blue circle. The circle has decorative flourishes around its perimeter, giving it a classic and recognizable appearance. The logo is simple, yet distinctive, and is widely recognized as the symbol of the General Electric company.

GE Healthcare 510(k) Premarket Notification Submission

Diagnostic Ultrasound Indications for Use Form GE LOGIQ S7 Expert with C1-5-D Transducer

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

	Mode of Operation
Clinical Application
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]	P	P	P	P	P	P	P	P	P	P	5,6
Abdominal[1]	P	P	P	P	P	P	P	P	P	P	3,5,6
Pediatric	P	P	P	P	P	P	P	P	P	P	3,5,6
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult & Pediatric
Peripheral Vascular	P	P	P	P	P	P	P	P	P	P	3,5,6
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[8]
Transvaginal
Transuretheral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA

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)

[*] 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)

6

Image /page/6/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" written in a stylized script, enclosed within a blue circle. The circle has decorative flourishes around its perimeter, giving it a classic and recognizable appearance. The logo is simple, yet distinctive, and is widely recognized as the symbol of the General Electric company.

Diagnostic Ultrasound Indications for Use Form GE LOGIQ S7 Expert with 9L-D Transducer

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

| Clinical Application
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] | P | P | P | | P | P | P | P | P | P | 5,6 |
| 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 & 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[8] | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative[8] | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA

[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)

[*] 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/7/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" written in a stylized script, enclosed within a blue circle. The circle has decorative swirls around the perimeter, giving it a classic and recognizable appearance. The logo is simple, yet distinctive, representing the brand identity of General Electric.

GE Healthcare 510(k) Premarket Notification Submission

Diagnostic Ultrasound Indications for Use Form GE LOGIQ S7 Expert with ML6-15 Transducer

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

	Mode of Operation
Clinical Application
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	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	3,5,6
Adult Cephalic
Cardiac Adult & 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[8]
Transvaginal
Transuretheral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA

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)

[*] 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/8/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized script, enclosed within a circular border. The color of the logo is blue, and the background is white.

GE Healthcare 510(k) Premarket Notification Submission

Diagnostic Ultrasound Indications for Use Form GE LOGIQ S7 Expert with IC5-9-D Transducer

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

	Mode of Operation
Clinical Application
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]	P	P	P		P	P	P	P	P	P	5,6
Abdominal[1]	P	P	P		P	P	P	P	P	P
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult & Pediatric
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]	P	P	P		P	P	P	P	P	P	3,5,6
Exam Type, Means of Access
Transesophageal
Transrectal[8]	P	P	P		P	P	P	P	P	P	3,5,6
Transvaginal	P	P	P		P	P	P	P	P	P	3.5,6
Transuretheral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA

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)

[*] 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)

9

Image /page/9/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" written in a stylized script, enclosed within a blue circle. The circle has decorative swirls around the perimeter, giving it a classic and recognizable appearance. The logo is simple, yet distinctive, representing the brand identity of General Electric.

Diagnostic Ultrasound Indications for Use Form GE LOGIQ S7 Expert with 3CRF-D Transducer

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

	Mode of Operation
Clinical Application
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]	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 & Pediatric
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]	P	P	P		P	P	P	P	P	P	5,6
Exam Type, Means of Access
Transesophageal
Transrectal[8]
Transvaginal
Transuretheral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA

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)

[*] 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)

10

Image /page/10/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" written in a stylized script, enclosed within a blue circle. The circle has decorative flourishes around its perimeter, giving it a classic and recognizable appearance. The logo is simple, yet distinctive, and is widely recognized as the symbol of the General Electric company.

GE Healthcare 510(k) Premarket Notification Submission

Diagnostic Ultrasound Indications for Use Form GE LOGIQ S7 Expert with L8-18i-D Transducer

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

	Mode of Operation
Clinical Application
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	P	P	P		P	P	P	P	P	P	5,6
Small Organ[2]	P	P	P		P	P	P	P	P	P
Neonatal Cephalic	P	P	P		P	P	P	P	P	P
Adult Cephalic
Cardiac Adult & 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[8]
Transvaginal
Transuretheral
Intraoperative[8]	P	P	P		P	P	P	P	P	P	3,5,6
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA

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)

[*] 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)

11

Image /page/11/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' written in a stylized script, enclosed within a circular shape. The circle is outlined with a thin blue line, and there are small, white, leaf-like shapes evenly spaced around the inside of the circle.

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ S7 Expert with S4-10-D Transducer

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

	Mode of Operation
Clinical Application
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]	P	P	P	P	P	P	P	P	P	P	5
Abdominal[1]	P	P	P	P	P	P	P	P	P	P	5
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	5
Neonatal Cephalic	P	P	P	P	P	P	P	P	P	P	5
Adult Cephalic
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

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)

[*] 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)

12

Image /page/12/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" written in a stylized script, enclosed within a blue circle. The circle has decorative swirls around the perimeter, giving it a classic and recognizable appearance. The logo is simple, yet distinctive, representing the brand identity of General Electric.

Diagnostic Ultrasound Indications for Use Form GE LOGIQ S7 Expert with P2D Transducer

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

	Mode of Operation
Clinical Application
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			P	P
Cardiac Adult & Pediatric			P	P
Peripheral Vascular			P	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

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)

[*] 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)

13

Image /page/13/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" written in a stylized script, enclosed within a blue circle. The circle has decorative swirls around the perimeter, giving it a classic and recognizable appearance. The logo is simple, yet distinctive, representing the brand identity of General Electric.

Diagnostic Ultrasound Indications for Use Form GE LOGIQ S7 Expert with P6D Transducer

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

	Mode of Operation
Clinical Application
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			P	P
Cardiac Adult & Pediatric			P	P
Peripheral Vascular			P	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

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)

[*] 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)

14

Image /page/14/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" written in a stylized script, enclosed within a blue circle. The letters are white, creating a contrast against the blue background.

GE Healthcare 510(k) Premarket Notification Submission

Diagnostic Ultrasound Indications for Use Form GE LOGIQ S7 Expert with RAB4-8-D Transducer

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

	Mode of Operation
Clinical Application
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]	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 & Pediatric
Peripheral Vascular
Musculo-skeletal Conventional	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	5,6
Exam Type, Means of Access
Transesophageal
Transrectal[8]
Transvaginal
Transuretheral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA

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)

[*] 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)

15

Image /page/15/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" written in a stylized script, enclosed within a blue circle. The circle has decorative flourishes around its perimeter, giving it a classic and recognizable appearance. The logo is simple, yet distinctive, and is widely recognized as the symbol of the General Electric company.

GE Healthcare 510(k) Premarket Notification Submission

Diagnostic Ultrasound Indications for Use Form GE LOGIQ S7 Expert with 11L-D Transducer

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

	Mode of Operation
Clinical Application
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]	P	P	P	P	P	P	P	P	P	P	3,5,6
Pediatric	P	P	P	P	P	P	P	P	P	P	3,5,6
Small Organ[2]	P	P	P	P	P	P	P	P	P	P	3,5,6
Neonatal Cephalic
Adult Cephalic
Cardiac Adult & Pediatric
Peripheral Vascular	P	P	P	P	P	P	P	P	P	P	3,5,6
Musculo-skeletal Conventional	P	P	P	P	P	P	P	P	P	P	3,5,6
Musculo-skeletal Superficial	P	P	P	P	P	P	P	P	P	P	3,5,6
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

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)

[*] 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 "GE" written in a stylized script, enclosed within a blue circle. The circle has decorative flourishes around its perimeter, giving it a classic and recognizable appearance. The logo is simple, yet distinctive, and is widely recognized as the symbol of the General Electric company.

Diagnostic Ultrasound Indications for Use Form GE LOGIQ S7 Expert with 8C Transducer

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

| Clinical Application
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] | P | P | P | | P | P | P | P | P | P | 5 |
| Pediatric | P | P | P | | P | P | P | P | P | P | 5 |
| Small Organ[2] | P | P | P | | P | P | P | P | P | P | 5 |
| Neonatal Cephalic | P | P | P | | P | P | P | P | P | P | 5 |
| 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

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)

[*] 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" written in a stylized script, enclosed within a blue circle. The circle has decorative swirls around the perimeter, giving it a classic and recognizable appearance. The logo is simple, yet distinctive, representing the brand identity of General Electric.

Diagnostic Ultrasound Indications for Use Form GE LOGIQ S7 Expert with 3Sp-D Transducer

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

	Mode of Operation
Clinical Application
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]	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 & 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

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)

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

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

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

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

18

Image /page/18/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized script, enclosed within a circular border. The color of the logo is blue, and the background is white.

Diagnostic Ultrasound Indications for Use Form GE LOGIQ S7 Expert with 6S-D Transducer

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

	Mode of Operation
Clinical Application
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]	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 & 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[8]
Transvaginal
Transuretheral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA

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)

[*] 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 logo for General Electric (GE). The logo consists of the letters "GE" written in a stylized script, enclosed within a blue circle. The letters are white, creating a contrast against the blue background.

GE Healthcare 510(k) Premarket Notification Submission

Diagnostic Ultrasound Indications for Use Form GE LOGIQ S7 Expert with RIC5-9-D Transducer

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

	Mode of Operation
Clinical Application
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]	P	P	P	P	P	P	P	P	P	P	5,6
Abdominal[1]	P	P	P	P	P	P	P	P	P	P
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult & 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[8]	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
Transuretheral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA

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)

[*] 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' in a stylized script, enclosed within a circular border. The color of the logo is blue, and the background is white.

GE Healthcare 510(k) Premarket Notification Submission

Diagnostic Ultrasound Indications for Use Form GE LOGIQ S7 Expert with 10C-D Transducer

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

	Mode of Operation
Clinical Application
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	P	P	P		P		P	P	P	P	5,6
Small Organ[2]
Neonatal Cephalic	P	P	P		P		P	P	P	P	5,6
Adult Cephalic
Cardiac Adult & Pediatric	P	P	P		P		P	P	P	P	5,6
Peripheral Vascular	P	P	P		P		P	P	P	P	5,6
Musculo-skeletal Conventional	P	P	P		P		P	P	P	P	5,6
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

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)

[*] 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" written in a stylized script, enclosed within a blue circle. The circle has decorative flourishes around its perimeter, giving it a classic and recognizable appearance. The logo is simple, yet distinctive, and is widely recognized as the symbol of the General Electric company.

Diagnostic Ultrasound Indications for Use Form GE LOGIQ S7 Expert with 6Tc-RS Transducer

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

	Mode of Operation
Clinical Application
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	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	P	P	P	P	P	P	P	P	P	P
Transrectal[8]
Transvaginal
Transuretheral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA

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)

[*] 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

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Image /page/22/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" written in a stylized script, enclosed within a blue circle. The circle has decorative flourishes around its perimeter, giving it a classic and recognizable appearance. The logo is simple, yet distinctive, and is widely recognized as the symbol of the General Electric company.

GE Healthcare 510(k) Premarket Notification Submission

Diagnostic Ultrasound Indications for Use Form GE LOGIQ S7 Expert with BE9CS Transducer

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

	Mode of Operation
Clinical Application
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]	P	P	P		P		P	P	P	P	3, 5, 6
Pediatric	P	P	P		P		P	P	P	P	3, 5, 6
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult & Pediatric
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]	P	P	P		P		P	P	P	P	3, 5, 6
Exam Type, Means of Access
Transesophageal
Transrectal[8]	P	P	P		P		P	P	P	P	3, 5, 6
Transvaginal	P	P	P		P		P	P	P	P	3, 5, 6
Transuretheral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA

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)

[*] 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)

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Image /page/23/Picture/0 description: The image shows the General Electric (GE) logo, which consists of the letters 'GE' in a stylized script, enclosed within a circular border. The logo is colored in a light blue hue. The 'GE' letters are intertwined and have a flowing, cursive appearance. The circular border has decorative flourishes, adding to the logo's overall design.

GE Healthcare 510(k) Premarket Notification Submission

Diagnostic Ultrasound Indications for Use Form GE LOGIQ S7 Expert with L3-12-D Transducer

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

	Mode of Operation
Clinical Application
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]	P	P	P		P	P	P	P	P	P	3, 5, 6
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	N	N	N		N	N	N	N	N	N	3, 5, 6
Adult Cephalic
Cardiac Adult & 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
Transuretheral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA

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)

[*] 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)

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Image /page/24/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" written in a stylized script, enclosed within a blue circle. The circle has decorative flourishes around its perimeter, giving it a classic and recognizable appearance. The logo is simple, yet distinctive, and is widely recognized as the symbol of the General Electric company.

Diagnostic Ultrasound Indications for Use Form GE LOGIQ S7 Expert with S1-4-D Transducer

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

	Mode of Operation
Clinical Application
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]	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	5, 6
Cardiac Adult & Pediatric	P	P	P	P	P	P	P	P	P	P	5, 6
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
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

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)

[*] 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

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Image /page/25/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" written in a stylized script, enclosed within a blue circle. The letters are white, creating a contrast against the blue background.

T

Diagnostic Ultrasound Indications for Use Form GE LOGIQ S7 Expert with C1-6-D Transducer

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

| Clinical Application
Anatomy/Region of Interest | Mode of Operation | | | | | | | | | | | Other
[Notes] | |
|----------------------------------------------------|-------------------|----|---------------|---------------|------------------|--------------------|------------------|--------------------|---------------------|-----------------|----|------------------|---------|
| | B | M | PW
Doppler | CW
Doppler | Color
Doppler | Color M
Doppler | Power
Doppler | Combined
Modes* | Harmonic
Imaging | Coded
Pulse° | | | |
| Ophthalmic | | | | | | | | | | | | | |
| Fetal/Obstetrics[7] | P* | P* | P* | P* | P* | P* | P* | P* | P* | P* | P* | 3, 5, 6 | |
| Abdominal[1] | P* | P* | P* | P* | P* | P* | P* | P* | P* | P* | P* | 3, 5, 6 | |
| Pediatric | P* | P* | P* | P* | P* | P* | P* | P* | P* | P* | P* | 3, 5, 6 | |
| Small Organ[2] | | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | |
| Cardiac Adult & Pediatric | | | | | | | | | | | | | |
| Peripheral Vascular | P* | P* | P* | P* | P* | P* | P* | P* | P* | P* | P* | P* | 3, 5, 6 |
| Musculo-skeletal Conventional | | | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | | | |
| Other[4] | P* | P* | P* | P* | P* | P* | P* | P* | P* | P* | P* | 3, 5, 6 | |
| Exam Type, Means of Access | | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | | |
| Intraoperative[8] | | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | |

N = new indication; P* = previously cleared by FDA on LOGIQ S8 K152195)

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)

[*] 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 logo for General Electric (GE). The logo consists of the letters "GE" written in a stylized script, enclosed within a blue circle. The blue color is a medium shade, and the letters are white.

Diagnostic Ultrasound Indications for Use Form GE LOGIQ S7 Expert 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
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	p*	p*	p*		p*		p*	p*	p*	p*	5
Small Organ [2]
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
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 on LOGIQ S8 K152195)

[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)

[*] 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)

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Image /page/27/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" written in a stylized script, enclosed within a blue circle. The letters are white, creating a contrast against the blue background.

Diagnostic Ultrasound Indications for Use Form GE LOGIQ S7 Expert with BE9CS-D Transducer

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

	Mode of Operation
Clinical Application
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]	P*	P*	P*		P*		P*	P*	P*	P*	3, 5, 6
Pediatric	P*	P*	P*		P*		P*	P*	P*	P*	3, 5, 6
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult & Pediatric
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]	P*	P*	P*		P*		P*	P*	P*	P*	3, 5, 6
Exam Type, Means of Access
Transesophageal
Transrectal[8]	P*	P*	P*		P*		P*	P*	P*	P*	3, 5, 6
Transvaginal	P*	P*	P*		P*		P*	P*	P*	P*	3, 5, 6
Transuretheral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P* = previously cleared by FDA on LOGIQ S8 K152195)

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)

[*] 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)

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Image /page/28/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" written in a stylized script, enclosed within a blue circle. The circle has decorative flourishes around its perimeter, giving it a classic and recognizable appearance. The logo is simple, yet distinctive, and is widely recognized as the symbol of the General Electric company.

Diagnostic Ultrasound Indications for Use Form GE LOGIQ S7 Expert 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	PW Doppler	CW Doppler	Color Doppler	Color M Doppler	Power Doppler	Combined Modes*	Harmonic Imaging	Coded Pulse*	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				P*
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 on LOGIQ S8 K152195)

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)

[*] 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)

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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" written in a stylized script, enclosed within a blue circle. The circle has decorative swirls around the perimeter, giving it a classic and recognizable appearance. The logo is simple, yet distinctive, representing the brand identity of General Electric.

GE Healthcare 510(k) Premarket Notification Submission

Diagnostic Ultrasound Indications for Use Form GE LOGIQ S7 Expert with S2-5-D Transducer

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

	Mode of Operation
Clinical Application
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]	N	N	N	N	N	N	N	N	N	N	5, 6
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic	N	N	N	N	N	N	N	N	N	N	5, 6
Cardiac Adult & Pediatric	N	N	N	N	N	N	N	N	N	N	5, 6
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
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

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)

[*] 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)

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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 logo is colored in a light blue hue.

510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

Date:	January 20, 2016
Submitter:	GE Healthcare
9900 Innovation Dr
Wauwatosa, 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 Behn
Sr. Regulatory Affairs Manager
GE Healthcare
T:[phone]
F:[phone]
Secondary Contact
Person:	Qingmeng Chen
Regulatory Affairs Specialist
GE Healthcare
GE Ultrasound Korea, Ltd.
T: [phone]
F: [phone]
Device:
Trade Name:	LOGIQ S7 Expert
Common/Usual Name:	LOGIQ S7 Expert
Classification Names:	Class II
Product Code:	Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-IYM
Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO
Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX
Predicate Device(s):	K141261 LOGIQ S7 Expert Diagnostic Ultrasound System
K152195 LOGIQ S8 Diagnostic Ultrasound System
K141639 Voluson S8 Diagnostic Ultrasound System
K143452 Logiq P9 Diagnostic Ultrasound System
Device Description:	The LOGIQ S7 Expert is a full featured, general purpose
diagnostic ultrasound system which consists of a mobile
console approximately 530mm (Caster), 520mm (Keyboard),
565mm (Monitor) wide, 865mm deep and 1760mm high that
provides digital acquisition, processing and display capability.
The user interface includes a computer keyboard, specialized

31

Image /page/31/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a circular design with the letters "GE" intertwined in the center. The letters and the surrounding circle are a light blue color. The logo is simple and recognizable, representing the company's brand.

controls, 10.1-inch LCD touch screen and color 23-inch LCD widescreen monitor.

The device is intended for use by a qualified physician for Intended Use: ultrasound evaluation of Obstetrics (Fetal); Abdominal (includes renal, GYN/Pelvic); 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).

The LOGIQ S7 Expert employs the same fundamental scientific Technology: technology as its predicate devices

Determination of Substantial Equivalence:

Comparison to Predicate Devices

The following is an overview of the differences between the proposed LOGIO S7 Expert and the predicate LOGIO S7 Expert (K141261). The proposed LOGIQ S7 Expert has had several features and probes migrated to it currently cleared on other GE Ultrasound systems.

• The systems are all intended for diagnostic ultrasound o imaging and fluid flow analysis.
• o The LOGIQ S7 Expert and predicate LOGIQ S7 Expert system have the same clinical intended use.
• o The LOGIO S7 Expert and predicate LOGIO S7 Expert system have the same imaging modes.
• The systems are manufactured with materials which ● have been evaluated and found to be safe for the intended use of the device.
• The systems have acoustic power levels which are below the applicable FDA limits.
• The LOGIO S7 Expert and predicate LOGIO S7 Expert ● system have similar capability in terms of performing measurements, capturing digital images, reviewing and reporting studies.
• The LOGIQ S7 and predicate systems have been ● designed in compliance with approved electrical and physical safety standards.
• The probes in LOGIQ S7 Expert and predicate LOGIQ S7 Expert system are identical except for C1-6-D, C3-10-D, P8D, BE9CS-D which are the same on predicate LOGIO S8 (K152195); the S2-5-D probe is new and an

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Image /page/32/Picture/0 description: The image shows the General Electric (GE) logo, which is a blue circle with the letters "GE" in a stylized script inside. The letters are also blue, and the circle has a white border. The logo is simple and recognizable, and it is associated with a well-known company.

incremental improvement to the existing 3Sp-D probe and is equivalent.

• New software features added to the proposed LOGIQ 0 S7 Expert: STIC and OmniView are the same features cleared on predicate Voluson S8 device (K141639); Cardiac AFI is the same feature cleared on predicate Logiq S8 (K152195); Email2MMS (smart phone solution) is the feature cleared on predicate Logiq P9 (K143452).

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 to applicable medical device safety standards. LOGIQ S7 Expert 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
• 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

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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) ●
• o Performance testing (Verification)
• Safety testing (Verification) o

Transducer materials and other patient contact materials are biocompatible.

Summary of Clinical Tests:

The subject of this premarket submission, LOGIQ S7 Expert, did not require clinical studies to support substantial equivalence.

• GE Healthcare considers the LOGIQ S7 Expert to be as safe, as Conclusion: effective, and performance is substantially equivalent to the predicate device(s).