Predicate Devices

K111582, K092271, K101874, K113690, K112213

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard ultrasound system with digital processing and display capabilities, but there is no mention of AI, ML, or related concepts in the provided text. The description of performance studies and training/test sets is also absent, which would typically be included for an AI/ML device.

Therapeutic

No
The device is described as a "general purpose diagnostic ultrasound system" and its intended uses are for "ultrasound evaluation" of various anatomical sites, indicating it is used for diagnosis, not treatment.

Diagnostic

Yes
The 'Device Description' explicitly states, "The LOGIQ S7 Expert AND LOGIQ S7 Pro is a full featured, general purpose diagnostic ultrasound system."

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 62 cm wide, 86 cm deep and 175 cm high" and includes hardware components like a console, keyboard, touch screen, and image display. This indicates it is a hardware-based system with integrated software, not a software-only device.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use clearly states the device is for "ultrasound evaluation" of various anatomical sites. This involves imaging the body directly, not analyzing samples taken from the body (like blood, urine, or tissue).
Device Description: The description details a "diagnostic ultrasound system" that provides "digital acquisition, processing and display capability." This aligns with the function of an ultrasound machine, which uses sound waves to create images of internal structures.
Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostics.

IVD devices are designed to perform tests on samples taken from the human body to provide information about a person's health. This ultrasound system is used to visualize structures within the body.

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 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 and Intraoperative (abdominal, thoracic, vascular and neurosurgical).

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

IYN, IYO, ITX

Device Description

The LOGIQ S7 Expert AND LOGIQ S7 Pro is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 62 cm wide, 86 cm deep and 175 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 7-inch LCD touch screen and color 19-inch LCD image display.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (adult and pediatric), Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Urology (including prostate), Transrectal, Transvaginal, Intraoperative (abdominal, thoracic, vascular and neurosurgical).

Indicated Patient Age Range

Adult and Pediatric, Neonatal Cephalic

Intended User / Care Setting

Qualified physician

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

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.

K111582 LOGIQ S8 Diagnostic Ultrasound System, K092271 LOGIQ E9 Diagnostic Ultrasound System, K101874 LOGIQ P6 Diagnostic Ultrasound System, K113690 LOGIQ e Diagnostic Ultrasound System, K112213 Voluson E6/E8/E8 Expert 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

0

Superficial;

Urology

and

Conventional

Image /page/0/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "G" and "E" intertwined within a circular border. The letters are stylized and have a flowing, cursive appearance. The logo is black and white.

ОСТ Э 2012

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 16, 2012

Submitter: GE Healthcare 9900 Innovation Dr Wauwatosa, WI 53226

Primary Contact Person: Bryan Behn
Regulatory Affairs Manager
GE Healthcare
T:(414)721-4214
F:(414)918-8275

Device: Trade Name:	LOGIQ S7 Expert and LOGIQ S7 Pro Ultrasound System
Common/Usual Name:	LOGIQ S7 Expert and LOGIQ S7 Pro
Classification Names:
Product Code:	Class II
Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-IYN
Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO
Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX
Predicate Device(s):	K111582 LOGIQ S8 Diagnostic Ultrasound System
K092271 LOGIQ E9 Diagnostic Ultrasound System
K101874 LOGIQ P6 Diagnostic Ultrasound System
K113690 LOGIQ e Diagnostic Ultrasound System
K112213 Voluson E6/E8/E8 Expert Diagnostic Ultrasound
System
Device Description:	The LOGIQ S7 Expert AND LOGIQ S7 Pro is a full featured,
general purpose diagnostic ultrasound system which consists of a
mobile console approximately 62 cm wide, 86 cm deep and 175
cm high that provides digital acquisition, processing and display
capability. The user interface includes a computer keyboard,
specialized controls, 7-inch LCD touch screen and color 19-inch
LCD image display.
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

1

Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The letters and the border are in black, contrasting with the white background.

(including prostate); Transrectal; Transvaginal and Intraoperative (abdominal, thoracic, vascular and neurosurgical).

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

Summary of Non-Clinical Tests: Determination of

Substantial Equivalence: 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 LOGIO S7 Pro and its applications comply with voluntary standards:

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

2

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

. Risk Analysis
. Requirements Reviews
. Design Reviews
. Testing on unit level (Module verification)
. Integration testing (System verification)
. Final Acceptance Testing (Validation)
- Performance testing (Verification)
. Safety testing (Verification)

Transducer materials and other patient contact materials are biocompatible.

Summary of Clinical Tests:

.

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

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

3

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10903 New Hampshire Avenue Silver Spring, MD 20993

OCT 3 2012

GE Healthcare c/o Brvan Behn 9900 Innovation Dr. Wauwatosa. WI 53226

Re: K122114 Trade Name: LOGIO S7 Expert LOGIO S7 Pro Ultrasound System Regulation Number: 21 CFR 8892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Codes: IYN, IYO, ITX Dated: July 16, 2012 Received: July 17, 2012

Dear Mr. Behn:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). 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.

This determination of substantial equivalence applies to the following transducers intended for use with the LOGIO S7 Expert and LOGIQ S7 Pro, as described in your premarket notification:

Transducer Model Number

C1-5-D	L8-18i-D	11L-D
9L-D	S4-10-D	8C
ML6-15	P2D	3Sp-D
IC5-9-D	P6D
3CRF-D	RAB4-8-D

4

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

If you have any questions regarding the content of this letter, please contact Joshua Nipper at (301) 796-6524.

Sincerely Yours.

Mark D. Okerblom

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure(s)

5

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510(k) Number (if known):

K122114

Device Name:

LOGIQ S7 Expert and LOGIQ S7 Pro

Indications for 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 and Intraoperative (abdominal, thoracic, vascular and neurosurgical).

Prescription Use_X_ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use NA (Part 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mhhmf D. O
(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

/2-11.

510(k) Number

6

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

	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]	N	N	N	N	N	N	N	N	N	N	5,6
Abdominal[1]	N	N	N	N	N	N	N	N	N	N	3,5,6
Pediatric	N	N	N	N	N	N	N	N	N	N	3,5,6
Small Organ[2]	N	N	N	N	N	N	N	N	N	N	3,5,6
Neonatal Cephalic	N	N	N	N	N	N	N	N	N	N	5,6
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
Peripheral Vascular	N	N	N	N	N	N	N	N	N	N	3,5,6
Musculo-skeletal Conventional	N	N	N	N	N	N	N	N	N	N	3,5,6
Musculo-skeletal Superficial	N	N	N	N	N	N	N	N	N	N	3,5,6
Other[1]	N	N	N	N	N	N	N	N	N	N	3,5,6
Exam Type, Means of Access
Transesophageal
Transrectal(8)	N	N	N	N	N	N	N	N	N	N	3,5,6
Transvaginal	N	N	N	N	N	N	N	N	N	N	3,5,6
Transuretheral
Intraoperative(8)	N	N	N	N	N	N	N	N	N	N	3,5,6
Intraoperative Neurological	N	N	N	N	N	N	N	N	N	N
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;

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)

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

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Prescription User (Per 21 CFR 801.109)

Muhi D. Khm
(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Division of Haclological Dovice Evaluation and Safety

610K 122 114

7

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Diagnostic Ultrasound Indications for Use Form GE LOGIQ S7 Expert and LOGIQ S7 Pro 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[3]
Transvaginal
Transuretheral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA (K111582)

[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

15| 3D/4D Imaging mode

{6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development

[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.

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Prescription User (Per 21 CFR 801.109)
(Division Sign Off)

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Division of Radiological Devices

510K 12.2 11.4

8

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Diagnostic Ultrasound Indications for Use Form GE LOGIQ S7 Expert and LOGIQ S7 Pro with 9L-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	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 (K111582)

[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

[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.

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Prescription User (Per 21 CFR 801,109)

(Division Sign-Off)
Devices

Division of Radiological Devices Division of Radiological Devices
Office of in Vitro Diagnostic Device Evaluation and Safety

S'OK. 112 114

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Diagnostic Ultrasound Indications for Use Form GE LOGIQ S7 Expert and LOGIQ S7 Pro 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	N	N	N		N	N	N	N	N	N
Adult Cephalic
Cardiac Adult & Pediatric
Peripheral Vascular	P	P	P		P	P	P	P	P	P	3,5,6
Musculo-skeletal Conventional	N	N	N		N	N	N	N	N	N	3,5,6
Musculo-skeletal Superficial	N	N	N		N	N	N	N	N	N	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 (K101874)

[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

[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.

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Prescription User (Per 21 CFR 801.109)

Mhhael D. Khm
(Division signa

Division of Radiological Devices Division of Radiological Device Evaluation and Safety

510K 112.114

10

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Diagnostic Ultrasound Indications for Use Form GE LOGIQ S7 Expert and LOGIQ S7 Pro 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	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	b	P	P	5,6
Abdominal(!)
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	b	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 (K111582)

[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

[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.

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Prescription User (Per 21 CFR 801.109)

(Division Sign-Off)

Division of Radiological Devices Division of Radiological Device Evaluation and Safety

510K 172 119

11

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Diagnostic Ultrasound Indications for Use Form GE LOGIQ S7 Expert and LOGIQ S7 Pro 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 (K111582)

[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

[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.

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Prescription User (Per 21 CFR 801.109)

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K-

ડર્

12

Image /page/12/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circle. The letters and the circle are in black, creating a strong contrast. The logo is simple, recognizable, and represents the General Electric brand.

Diagnostic Ultrasound Indications for Use Form GE LOGIQ S7 Expert and LOGIQ S7 Pro 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	B	M	PW	CW	Color	Color M	Power	Combined	Harmonic	Coded	Other
(Notes)
Anatomy/Region of Interest			Doppler	Doppler	Doppler	Doppler	Doppler	Modes	Imaging	Pulse
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(K111582)

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)

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

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Prescription User (Per 21 CFR 801.109)

(Division Sign-Off)

Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

810K 172114

ﺮ

13

Image /page/13/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined and enclosed within a stylized circular border. The letters and the border are solid black, contrasting with the white background. The logo has a slightly rough or textured appearance, possibly due to the image's source or reproduction method.

Diagnostic Ultrasound Indications for Use Form GE LOGIQ S7 Expert and LOGIQ S7 Pro 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	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 (K111582)

(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

[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.

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Prescription User (Per 21 CFR 801.109)

Archi D. Ofil
(Division Sign-Off)

Division of Radiological Devices Office of In Diagnostic Device Evaluation and Safety

510K

14

Image /page/14/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circle. The letters and the circle are black, creating a strong contrast. The logo is simple and recognizable.

Diagnostic Ultrasound Indications for Use Form GE LOGIQ S7 Expert and LOGIQ S7 Pro with P2D 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] | | | | | | | | | | | |
| 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(K111582)

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)

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

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Prescription User (Per 21 CFR 801.109)

Marl D. Kirk

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Division of Radiological Dovice Evaluation and Safety

510K. 12-114

15

Image /page/15/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "G" and "E" intertwined within a circle. The letters are stylized and connected, creating a recognizable and iconic symbol for the company.

Diagnostic Ultrasound Indications for Use Form GE LOGIQ S7 Expert and LOGIQ S7 Pro 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 (K111582)

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)

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

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Prescription User (Per 21 CFR 801.109)

Mull D. O'K
(Division Sign-Off)

Division of Radiological Devices Division of Radiological Device Evaiuation and Safety

510K D2-114

16

Image /page/16/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circle. The letters and the circle are in black, contrasting with the white background.

Diagnostic Ultrasound Indications for Use Form GE LOGIQ S7 Expert and LOGIQ S7 Pro 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]
Pédiatric	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]	N	N	N	N	N	N	N	N	N	[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(K092271)

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)

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

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Prescription User (Per 21 CFR 801.109)

Muth D'A
(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510k

122-114

17

Image /page/17/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "G" and "E" intertwined within a circle. The logo is black and white.

Diagnostic Ultrasound Indications for Use Form GE LOGIQ S7 Expert and LOGIQ S7 Pro 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	[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(K092271)

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)

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

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Prescription User (Per 21 CFR 801. 109

(Division Sign-Off)

Division Digl-POII)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

Elok

22.114

18

Image /page/18/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The letters and the border are depicted in black, contrasting with the white background.

Diagnostic Ultrasound Indications for Use Form GE LOGIQ S7 Expert and LOGIQ S7 Pro with 8C 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	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(K101874)

[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 Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development

[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.

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Prescription User (Per 21 CFR 801.109)

(Division Sign-Off)

Division of Rediological Devices Division of Habiogroup Of Habitogical Device and Safety

510K 102 114

19

Image /page/19/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a circular border. The letters and the border are in black, creating a high-contrast design. The logo is simple and recognizable, representing the well-known multinational corporation.

Diagnostic Ultrasound Indications for Use Form GE LOGIQ S7 Expert and LOGIQ S7 Pro 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
Abdominal11	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(K112213)

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 Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development

[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.

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Prescription User (Per 21 CFR 801.109)

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K. 122.114