LOGIQ P9 and LOGIQ P7

• K Number: K161047
• Device Name: LOGIQ P9 and LOGIQ P7
• Manufacturer: GE Healthcare
• Date Cleared: 2016-05-05 ( 22 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 Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transvaginal; and Intraoperative (abdominal, thoracic, vascular).

Device Description

The LOGIQ P9 and LOGIQ P7 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 53 cm wide, 69 cm deep and 157 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 10.4-inch LCD touch screen and color 21.5-inch LCD image display.

Predicate Devices

K143452 LOGIQ P9/P7 Diagnostic Ultrasound System

Reference Devices

K160182 LOGIQ S7 Expert Diagnostic Ultrasound System,K151028 LOGIQ e Diagnostic Ultrasound System,K152309 LOGIQ E9 Diagnostic Ultrasound System,K160277 LOGIQ F Series Diagnostic Ultrasound System,K160184 VOLUSON S Series Diagnostic Ultrasound System

AI/ML (Artificial Intelligence / Machine Learning)

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

Therapeutic

No
The device is described as a "general purpose diagnostic ultrasound system" and is intended for "ultrasound evaluation," indicating its purpose is for diagnosis and imaging, not therapy.

Diagnostic

Yes

The "Device Description" explicitly states, "The LOGIQ P9 and LOGIQ P7 is a full featured, general purpose diagnostic ultrasound system".

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "full featured, general purpose diagnostic ultrasound system which consists of a mobile console" with physical components like a keyboard, controls, and displays, indicating it is a hardware device 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 using ultrasound technology to visualize internal structures, which is a form of medical imaging.
• 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.
• Input Imaging Modality: The input modality is explicitly stated as "Ultrasound."
• Lack of IVD Characteristics: IVD devices are designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided information does not mention any sample collection, analysis of biological samples, or the use of reagents, which are hallmarks of IVD devices.

In summary, the device is a diagnostic ultrasound system used for imaging, not for performing in vitro tests on biological samples.

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; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transvaginal; and Intraoperative (abdominal, thoracic, vascular).

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

IYN, IYO, ITX

Device Description

The LOGIQ P9 and LOGIQ P7 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 53 cm wide, 69 cm deep and 157 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 10.4-inch LCD touch screen and color 21.5-inch LCD image display.

Mentions image processing

Yes

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

Indicated Patient Age Range

Adult and Pediatric (including Fetal and Neonatal)

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 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 P9 and LOGIQ P7 and its applications comply with voluntary standards:

• AAMI/ANSI ES60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 2005/C1:2012
• IEC60601-1-2, Medical Electrical Equipment Part 1-2:General Requirements for Safety – Collateral Standard: Electromagnetic Compatibility Requirements and Tests 2007
• IEC60601-2-37, Medical Electrical Equipment - Part 2-37:Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment, 2007
• NEMA UD 3. Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment:2004
• ISO10993-1, Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing- Third Edition, 2009
• NEMA UD 2, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment:2004
• ISO14971, Application of risk management to medical devices: Second edition 2007
• NEMA PS 3.1 3.20 (2011), Digital Imaging and Communications in Medicine (DICOM) Set. (Radiology)

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

• Risk Analysis
• Requirements Reviews
• Design Reviews
• Testing on unit level (Module verification)
• Integration testing (System verification)
• Performance testing (Verification)
• Safety testing (Verification)

Transducer materials and other patient contact materials are biocompatible.

The subject of this premarket submission, LOGIQ P9 and LOGIQ P7, 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.

K143452 LOGIQ P9/P7 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.

K160182 LOGIQ S7 Expert Diagnostic Ultrasound System, K151028 LOGIQ e Diagnostic Ultrasound System, K152309 LOGIQ E9 Diagnostic Ultrasound System, K160277 LOGIQ F Series Diagnostic Ultrasound System, K160184 VOLUSON S Series Diagnostic Ultrasound System

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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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of human profiles facing to the right, with three distinct head shapes stacked on top of each other.

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

May 5, 2016

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

Re: K161047

Trade/Device Name: LOGIO P9 and LOGIO P7 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: April 12, 2016 Received: April 13, 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,

Robert Oals

Robert Ochs. Ph.D. 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)

K161047

Device Name LOGIQ P9 and LOGIQ P7

Indications for Use (Describe)

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

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

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Image /page/3/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a blue circle. The circle has decorative, wave-like elements around its perimeter, giving it a distinctive and recognizable appearance.

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ P9 and LOGIQ P7 Ultrasound System

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	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
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
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]	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

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 Diagnostics and Radiological Health (OIR)

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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' written in a stylized script, enclosed within a blue circle. The circle has decorative swirls around the letters, 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 P9 and LOGIQ P7 with L4-12t-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	*P	*P	*P		*P	*P	*P	*P	*P	*P	[3,6]
Small Organ[2]	*P	*P	*P		*P	*P	*P	*P	*P	*P	[3,6]
Neonatal Cephalic	*P	*P	*P		*P	*P	*P	*P	*P	*P	[3,6]
Adult Cephalic
Cardiac Adult & Pediatric
Peripheral Vascular	*P	*P	*P		*P	*P	*P	*P	*P	*P	[3,6]
Musculo-skeletal Conventional	*P	*P	*P		*P	*P	*P	*P	*P	*P	[3,6]
Musculo-skeletal Superficial	*P	*P	*P		*P	*P	*P	*P	*P	*P	[3,6]
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 in (K151028)

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 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 swirls around the letters, 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 P9 and LOGIQ P7 with L10-22-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]	*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
Musculo-skeletal Conventional	*P	*P	*P		*P	*P	*P	*P	*P	*P
Musculo-skeletal Superficial	*P	*P	*P		*P	*P	*P	*P	*P	*P
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 in (K151028)

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 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 circular frame. The color of the logo is blue, and the background is white.

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ P9 and LOGIQ P7 with L3-9i-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]	N	N	N		N	N	N	N	N	N
Neonatal Cephalic
Adult Cephalic
Cardiac Adult & Pediatric
Peripheral Vascular	N	N	N		N	N	N	N	N	N
Musculo-skeletal Conventional	N	N	N		N	N	N	N	N	N
Musculo-skeletal Superficial	N	N	N		N	N	N	N	N	N
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal[8]
Transvaginal
Transuretheral
Intraoperative[8]	N	N	N		N	N	N	N	N	N
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

[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 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 circular frame. The frame has decorative swirls or flourishes around the letters. The logo is presented in a blue color.

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ P9 and LOGIQ P7 with E8CS--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]	*P	*P	*P		*P	*P	*P	*P	*P	*P	[3,6]
Abdominal[1]	*P	*P	*P		*P	*P	*P	*P	*P	*P	[3,6]
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	[3,6]
Exam Type, Means of Access
Transesophageal
Transrectal[8]	*P	*P	*P		*P	*P	*P	*P	*P	*P	[3,6]
Transvaginal	*P	*P	*P		*P	*P	*P	*P	*P	*P	[3,6]
Transuretheral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; *P = previously cleared by FDA in (K160184)

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 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' written in a stylized script, enclosed within a blue circle. The circle has decorative swirls around the letters, giving it a classic and recognizable appearance. The logo is simple, yet distinctive, and is widely associated with the multinational conglomerate.

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ P9 and LOGIQ P7 with BE9CS-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 & Pediatric
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]	*P	*P	*P		*P	*P	*P	*P	*P	*P	[3,6]
Exam Type, Means of Access
Transesophageal
Transrectal[8]	*P	*P	*P	*P	*P	*P	*P	*P	*P	*P	[3,6]
Transvaginal
Transuretheral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; *P = previously cleared by FDA in (K160277)

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 Diagnostics and Radiological Health (OIR)

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Image /page/9/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" written in a stylized script, enclosed within a blue circle. The circle has three curved lines emanating from it, giving the impression of movement or energy.

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ P9 and LOGIQ P7 with RIC5-9A-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]	*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
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	*P	*P	*P		*P	*P	*P	*P	*P	*P	[5,6]
Transuretheral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; *P = previously cleared by FDA in (K160184)

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 Diagnostics and Radiological Health (OIR)

10

Image /page/10/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a circular border. The logo is colored in a shade of blue, and the background is white.

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ P9 and LOGIQ P7 with 12S-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	*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
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 in (K160184)

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 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 frame. The color of the logo is blue, and the background is white.

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ P9 and LOGIQ P7 with C1-5-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]	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	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[8]
Transvaginal
Transuretheral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA (K141639, K143452)

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

• [2] Small organ includes breast, testes and thyroid
• [3] Elastography Imaging Elasticity.
• [4] Other use includes Urology/Prostate
• [5] 3D/4D Imaging mode
• [6] Needle guidance imaging
• [7] Includes infertility monitoring of follicle development

[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 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' intertwined in a stylized script, enclosed within a blue circle. The circle is surrounded by a decorative, swirling pattern, also in blue, giving the logo a classic and recognizable appearance.

Diagnostic Ultrasound Indications for Use Form GE LOGIQ P9 and LOGIQ P7 with 4C-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]	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 (K141639)

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 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 'g' and 'e' intertwined in a stylized script, enclosed within a blue circle. There are three stylized swirls around the circle.

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ P9 and LOGIQ P7 with 9L-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]	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
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 (K133533)

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 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 circle has a double-line border, with the inner line being slightly thicker than the outer line. The background of the image is white.

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ P9 and LOGIQ P7 with ML6-15-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	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
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 (K141639, K143452)

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

[2] Small organ includes breast, testes and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development

[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 Diagnostics and Radiological Health (OIR)

15

Image /page/15/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a circular frame. The logo is colored in a light blue hue, providing a clean and recognizable brand representation.

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ P9 and LOGIQ P7 with E8C-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]	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 (K133533)

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

[2] Small organ includes breast, testes and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle quidance imaging

[7] Includes infertility monitoring of follicle development

[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 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 circular frame. The color of the logo is blue, and the background is white.

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ P9 and LOGIQ P7 with L8-18i-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	P	P	P		P	P	P	P	P	P	5,6
Small Organ[2]	P	P	P		P	P	P	P	P	P	5,6
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 (K133533)

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 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' in a stylized, cursive font, enclosed within a circular border. The logo is colored in a shade of blue, and the background is white.

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ P9 and LOGIQ P7 with P8D 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
	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

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

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ P9 and LOGIQ P7 with RAB2-6-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]	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
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	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 (K141639)

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 Diagnostics and Radiological Health (OIR)

19

Image /page/19/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized script, enclosed within a blue circle. There are curved lines emanating from the circle, giving the impression of movement or energy.

GE LOGIQ P9 and LOGIQ P7 with L6-12-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]	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 (K133034)

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 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 blue circle. There are curved lines emanating from the circle, giving the impression of movement or energy.

GE LOGIQ P9 and LOGIQ P7 with 12L-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]	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 (K133533)

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 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' in a stylized script, enclosed within a blue circle. There are curved lines emanating from the circle, giving the impression of movement or energy.

GE LOGIQ P9 and LOGIQ P7 with 8C-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]	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
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 (K133533)

[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 Diagnostics and Radiological Health (OIR)

22

Image /page/22/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized script, enclosed within a blue circle. There are curved lines emanating from the circle, giving the impression of movement or energy.

GE LOGIQ P9 and LOGIQ P7 with 3Sc-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]	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 (K133533)

[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 Diagnostics and Radiological Health (OIR)

23

Image /page/23/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' written in a stylized script, enclosed within a circular frame. The color of the logo is blue, and the background is white.

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ P9 and LOGIQ P7 with 6S-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	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
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 (K133533)

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 Diagnostics and Radiological Health (OIR)

24

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

510(k) Summary

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

Date:	April 12, 2016
Submitter:	GE Healthcare
9900 Innovation Dr
Wauwatosa, WI 53226
Primary Contact Person:	Bryan Behn
Regulatory Affairs Director
GE Healthcare
T:[phone]
F:[phone]
Secondary Contact Person:	Chan Sook Kim
Regulatory Affairs Leader
GE Healthcare
GE Ultrasound Korea, Ltd.
T: [phone]
Device: Trade Name:	LOGIQ P9 and LOGIQ P7
Common/Usual Name:	LOGIQ P9 and LOGIQ P7
Classification Names:	Class II
Product Code:	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
Primary Predicate Device:	K143452 LOGIQ P9/P7 Diagnostic Ultrasound System
Reference Predicate Devices:	K160182 LOGIQ S7 Expert Diagnostic Ultrasound System
K151028 LOGIQ e Diagnostic Ultrasound System
K152309 LOGIQ E9 Diagnostic Ultrasound System
K160277 LOGIQ F Series Diagnostic Ultrasound System
K160184 VOLUSON S Series Diagnostic Ultrasound System
Device Description:	The LOGIQ P9 and LOGIQ P7 is a full featured, general purpose
diagnostic ultrasound system which consists of a mobile console
approximately 53 cm wide, 69 cm deep and 157 cm high that
provides digital acquisition, processing and display capability.
The user interface includes a computer keyboard, specialized
controls, 10.4-inch LCD touch screen and color 21.5-inch LCD
image display.

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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' in a stylized script, enclosed within a blue circle. The circle has a swirling design around the letters, giving the impression of movement or energy. The logo is simple, recognizable, and associated with a well-known multinational corporation.

GE Healthcare

510(k) Premarket Notification Submission

Intended Use:	The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, vascular).
Technology:	The LOGIQ P9 and LOGIQ P7 employs the same fundamental scientific technology as its predicate devices
Determination of Substantial Equivalence:	Comparison to Predicate Devices The LOGIQ P9 and P7 systems are substantially equivalent to the predicate devices with regard to intended use, imaging capabilities, technological characteristics and safety and effectiveness. The systems are all intended for diagnostic ultrasound imaging and fluid flow analysis.The LOGIQ P9/P7 and predicate LOGIQ P9/P7 systems have the same clinical intended uses.The LOGIQ P9/P7 and predicate LOGIQ P9/P7 systems have the same imaging modes.The LOGIQ P9/P7 and predicate LOGIQ P9/P7 systems transducers are identical except for the addition of 7 new transducers L4-12t-RS and L10-22-RS (identical to Logiq E series K151028), L3-9i-RS (smilar to L3-9i-D on predicate Logiq E9 K152309), BE9CS-RS (identical to Logiq F series K160277), E8CS-RS, RIC5-9A-RS, and 12S-RS (identical to Voluson S series K160184).The LOGIQ P9/P7 and predicate LOGIQ P9/P7 systems have the same indications for useThe systems are manufactured with materials which have been evaluated and found to be safe for the intended use of the device.The systems have acoustic power levels which are below the applicable FDA limits.The LOGIQ P9/P7 and predicate LOGIQ P9/P7 systems have similar capability in terms of performing measurements, capturing digital images, reviewing and reporting studies.The LOGIQ P9/P7 and predicate LOGIQ P9/P7 systems have been designed in compliance with approved electrical and physical safety standards.

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Image /page/26/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized script in the center. The circle is surrounded by a swirling pattern that resembles water or wind. The logo is simple and recognizable, and it is associated with a well-known and established company.

• . The LOGIO P9/P7 adds an off-line scanning mode by using a battery power (AC unplugged). (previously cleared with K160182).
• The LOGIO P9/P7 adds software features called STIC . (Spatio-Temporal Image Correlation) and OmniView. (previously cleared with K160182).
• The LOGIQ P9/P7 adds a general measurement tool ● called Cardiac AFI (Automated Function Imaging). (previously cleared with K160182).
• . The LOGIO P9/P7 adds an customizing e-mail service to the system to allow users to send images and text via SMTP (Simple Mail Transfer Protocol) (previously cleared with K160182).

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. LOGIO P9 and LOGIO P7 and its applications comply with voluntary standards:

• AAMI/ANSI ES60601-1, Medical Electrical Equipment -● Part 1: General Requirements for Safety, 2005/C1:2012
• IEC60601-1-2, Medical Electrical Equipment Part 1-. 2:General Requirements for Safety – Collateral Standard: Electromagnetic Compatibility Requirements and Tests 2007
• . IEC60601-2-37, Medical Electrical Equipment - Part 2-37:Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment, 2007
• NEMA UD 3. Standard for Real Time Display of Thermal ● and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment:2004
• ISO10993-1, Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing- Third Edition, 2009
• NEMA UD 2, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment:2004
• ISO14971, Application of risk management to medical ●

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Image /page/27/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font in the center. There are swirling lines around the letters, giving the logo a dynamic and modern look. The blue color is consistent throughout the logo.

GE Healthcare

510(k) Premarket Notification Submission

devices: Second edition 2007

• NEMA PS 3.1 3.20 (2011), Digital Imaging and . Communications in Medicine (DICOM) Set. (Radiology)
  The following quality assurance measures are applied to the development of the system:

• . Risk Analysis

• Requirements Reviews ●

• . Design Reviews

• . Testing on unit level (Module verification)

• Integration testing (System verification)

• . Performance testing (Verification)

• Safety testing (Verification) .

Transducer materials and other patient contact materials are biocompatible.

Summary of Clinical Tests:

The subject of this premarket submission, LOGIO P9 and LOGIO P7, did not require clinical studies to support substantial equivalence.

• Conclusion: GE Healthcare considers the LOGIQ P9 and LOGIQ P7 to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).