K Number
K143452
Device Name
LOGIQ P9, LOGIQ P7
Manufacturer
Date Cleared
2015-01-29

(58 days)

Product Code
Regulation Number
892.1550
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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). Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal / Obstetrics; Abdominal; Pediatric; Small Organ; Neonatal Cephalic; Adult Cephalic; Cardiac Adult & Pediatric; Peripheral Vascular; Musculo-skeletal Conventional; Musculo-skeletal Superficial; Other (Urology/Prostate); Transrectal; Transvaginal; Intraoperative.
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.
More Information

Not Found

No
The document describes standard ultrasound image processing techniques and does not mention AI, ML, or related concepts.

No.
The "Intended Use / Indications for Use" and "Device Description" sections explicitly state that this is a "diagnostic ultrasound system" intended for "ultrasound evaluation" and "imaging or fluid flow analysis," not for treatment.

Yes

The "Intended Use / Indications for Use" and "Device Description" sections explicitly state that the device is for "Diagnostic ultrasound imaging" and a "general purpose diagnostic ultrasound system."

No

The device description explicitly states it 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." This indicates a physical hardware component (the console) is integral to the device's function, not just software running on general-purpose hardware.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health.
  • Device Function: The description clearly states this device is a "general purpose diagnostic ultrasound system." It uses ultrasound waves to create images of structures within the human body.
  • Intended Use: The intended use describes imaging various anatomical sites in vivo (within the living body).
  • No Specimen Analysis: There is no mention of analyzing any biological specimens.

This device is a diagnostic imaging system, not an IVD.

N/A

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).

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

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; and Intraoperative (abdominal, thoracic, vascular).

Indicated Patient Age Range

Adult and Pediatric, Fetal, 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 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.

K141261, K133533, K141639, K133034

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

§ 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.

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected by a flowing line that resembles a ribbon or wave. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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

January 29, 2015

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

Re: K143452 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: December 1, 2014 Received: December 2, 2014

Dear Mr. Behn:

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

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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours.

Robert A Ochs

Robert Ochs. Ph.D. Acting 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)

K143452

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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 PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

Image /page/3/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized script, enclosed within a circular frame. The color of the logo is a light blue.

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 ApplicationBMPW
DopplerCW
DopplerColor
DopplerColor M
DopplerPower
DopplerCombined
ModesHarmonic
ImagingCoded
PulseOther
[Notes]
Anatomy/Region of Interest
Ophthalmic
Fetal / Obstetrics[7]NNNNNNNNNN5,6
Abdominal[1]NNNNNNNNNN3,5,6
PediatricNNNNNNNNNN3,5,6
Small Organ[2]NNNNNNNNNN3,5,6
Neonatal CephalicNNNNNNNNNN5,6
Adult CephalicNNNNNNNNNN5,6
Cardiac Adult & PediatricNNNNNNNNNN
Peripheral VascularNNNNNNNNNN3,5,6
Musculo-skeletal ConventionalNNNNNNNNNN3,5,6
Musculo-skeletal SuperficialNNNNNNNNNN3,5,6
Other[4]NNNNNNNNNN3,5,6
Exam Type, Means of Access
Transesophageal
Transrectal[8]NNNNNNNNNN3,5,6
TransvaginalNNNNNNNNNN3,5,6
Transuretheral
Intraoperative[8]NNNNNNNNNN3,5,6
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 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)

Prescription User (Per 21 CFR 801.109)

Page 2 of 15

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Image /page/4/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" in a stylized script, enclosed within a circular frame. The frame has a decorative, swirling pattern around the letters. The logo is presented in a blue color.

GE Healthcare 510(k) Premarket Notification Submission

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 InterestBMPW
DopplerCW
DopplerColor
DopplerColor M
DopplerPower
DopplerCombined
Modes*Harmonic
ImagingCoded
PulseOther
[Notes]
Ophthalmic
Fetal / Obstetrics[7]PPPPPPPPPP5,6
Abdominal[1]PPPPPPPPPP3,5,6
PediatricPPPPPPPPPP3,5,6
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult & Pediatric
Peripheral VascularPPPPPPPPPP3,5,6
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]PPPPPPPPPP3,5,6
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, K141261)

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

[2] Small organ includes breast, testes and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development

[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)

Prescription User (Per 21 CFR 801.109)

Page 3 of 15

5

Image /page/5/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a blue circle. The circle has decorative swirls around the perimeter, giving it a classic and recognizable appearance. The blue color is consistent throughout the logo, providing a clean and professional look.

GE Healthcare 510(k) Premarket Notification Submission

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 InterestBMPW
DopplerCW
DopplerColor
DopplerColor M
DopplerPower
DopplerCombined
Modes*Harmonic
ImagingCoded
PulseOther
[Notes]
Ophthalmic
Fetal / Obstetrics[7]PPPPPPPPPP5,6
Abdominal[1]PPPPPPPPPP3,5,6
PediatricPPPPPPPPPP3,5,6
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult & Pediatric
Peripheral VascularPPPPPPPPPP3,5,6
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]PPPPPPPPPP3,5,6
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)

Prescription User (Per 21 CFR 801.109)

Page 4 of 15

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Image /page/6/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a blue circle. The circle has decorative swirls around the perimeter, giving it a classic and recognizable appearance.

GE Healthcare 510(k) Premarket Notification Submission

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 InterestBMPW
DopplerCW
DopplerColor
DopplerColor M
DopplerPower
DopplerCombined
Modes*Harmonic
ImagingCoded
PulseOther
[Notes]
Ophthalmic
Fetal / Obstetrics[7]
Abdominal[1]PPPPPPPPP3,5,6
PediatricPPPPPPPPP3,5,6
Small Organ[2]PPPPPPPPP3,5,6
Neonatal Cephalic
Adult Cephalic
Cardiac Adult & Pediatric
Peripheral VascularPPPPPPPPP3,5,6
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)

Prescription User (Per 21 CFR 801.109)

7

Image /page/7/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" in a stylized script, enclosed within a circular frame. The frame has a decorative, swirling pattern around the letters. The logo is presented in a blue color.

GE Healthcare 510(k) Premarket Notification Submission

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 InterestBMPW
DopplerCW
DopplerColor
DopplerColor M
DopplerPower
DopplerCombined
Modes*Harmonic
ImagingCoded
PulseOther
[Notes]
Ophthalmic
Fetal / Obstetrics[7]
Abdominal[1]
PediatricPPPPPPPPPP3,5,6
Small Organ[2]PPPPPPPPPP3,5,6
Neonatal CephalicPPPPPPPPPP3,5,6
Adult Cephalic
Cardiac Adult & Pediatric
Peripheral VascularPPPPPPPPPP3,5,6
Musculo-skeletal ConventionalPPPPPPPPPP3,5,6
Musculo-skeletal SuperficialPPPPPPPPPP3,5,6
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, K141261)

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

[2] Small organ includes breast, testes and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development

[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)

Prescription User (Per 21 CFR 801.109)

8

Image /page/8/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" in a stylized script, enclosed within a circular frame. The frame has a decorative, swirling pattern around the letters. The logo is presented in a blue color.

GE Healthcare 510(k) Premarket Notification Submission

Diagnostic Ultrasound Indications for Use Form GE LOGIQ P9 and LOGIQ P7 with E8C-RS Transducer

Mode of Operation
Clinical Application
Anatomy/Region of InterestBMPW
DopplerCW
DopplerColor
DopplerColor M
DopplerPower
DopplerCombined
Modes*Harmonic
ImagingCoded
PulseOther
[Notes]
Ophthalmic
Fetal / Obstetrics[7]PPPPPPPPPP5,6
Abdominal[1]PPPPPPPPPP
Pediatric
Small Organ [2]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult & Pediatric
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other [4]PPPPPPPPPP3,5,6
Exam Type, Means of Access
Transesophageal
Transrectal [8]PPPPPPPPPP3,5,6
TransvaginalPPPPPPPPPP3,5,6
Transuretheral
Intraoperative [8]
Intraoperative Neurological
Intravascular
Laparoscopic

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

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

Prescription User (Per 21 CFR 801.109)

9

Image /page/9/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a circular border. The letters and the border are both a light blue color, set against a white background. The logo is simple and recognizable, representing the well-known multinational corporation.

GE Healthcare 510(k) Premarket Notification Submission

Diagnostic Ultrasound Indications for Use Form GE LOGIQ P9 and LOGIQ P7 with L8-18i-RS Transducer

Mode of Operation
Clinical Application
Anatomy/Region of InterestBMPW
DopplerCW
DopplerColor
DopplerColor M
DopplerPower
DopplerCombined
Modes*Harmonic
ImagingCoded
PulseOther
[Notes]
Ophthalmic
Fetal / Obstetrics[7]
Abdominal[1]
PediatricPPPPPPPPP5,6
Small Organ[2]PPPPPPPPP5,6
Neonatal CephalicPPPPPPPPP
Adult Cephalic
Cardiac Adult & Pediatric
Peripheral VascularPPPPPPPPP3,5,6
Musculo-skeletal ConventionalPPPPPPPPP3,5,6
Musculo-skeletal SuperficialPPPPPPPPP3,5,6
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal[8]
Transvaginal
Transuretheral
Intraoperative[8]PPPPPPPPP3,5,6
Intraoperative Neurological
Intravascular
Laparoscopic

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

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

Prescription User (Per 21 CFR 801.109)

Page 8 of 15

10

Image /page/10/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" in a stylized script, enclosed within a circular frame. The frame has a decorative, swirling pattern around the letters. The logo is presented in a blue color.

GE Healthcare 510(k) Premarket Notification Submission

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:

Mode of Operation
Clinical Application
Anatomy/Region of InterestBMPW
DopplerCW
DopplerColor
DopplerColor M
DopplerPower
DopplerCombined
Modes*Harmonic
ImagingCoded
PulseOther
[Notes]
Ophthalmic
Fetal / Obstetrics[7]
Abdominal[1]
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult CephalicNN
Cardiac Adult & PediatricNN
Peripheral VascularNN
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)

Prescription User (Per 21 CFR 801.109)

Page 9 of 15

11

Image /page/11/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" in a stylized script, enclosed within a circular frame. The frame has a decorative, swirling pattern around the letters. The logo is presented in a blue color.

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 InterestBMPW
DopplerCW
DopplerColor
DopplerColor M
DopplerPower
DopplerCombined
Modes*Harmonic
ImagingCoded
PulseOther
[Notes)
Ophthalmic
Fetal / Obstetrics[7]PPPPPPPPP5,6
Abdominal[1]PPPPPPPPP5,6
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult & Pediatric
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]PPPPPPPPP5,6
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.

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Page 10 of 15

12

Image /page/12/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" in a stylized script, enclosed within a circular frame. The frame has a decorative, swirling pattern around the letters. The logo is presented in a blue color, which is a common branding element for GE.

GE Healthcare 510(k) Premarket Notification Submission

Diagnostic Ultrasound Indications for Use Form 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:

| 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 (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.

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Page 11 of 15

13

Image /page/13/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" in a stylized script, enclosed within a circular frame. The frame has a decorative, swirling pattern around the letters. The logo is presented in a blue color.

GE Healthcare 510(k) Premarket Notification Submission

Diagnostic Ultrasound Indications for Use Form 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 InterestBMPW
DopplerCW
DopplerColor
DopplerColor M
DopplerPower
DopplerCombined
Modes*Harmonic
ImagingCoded
PulseOther
[Notes)
Ophthalmic
Fetal / Obstetrics[7]
Abdominal[1]PPPPPPPPP3,5,6
PediatricPPPPPPPPP3,5,6
Small Organ[2]PPPPPPPPP3,5,6
Neonatal Cephalic
Adult Cephalic
Cardiac Adult & Pediatric
Peripheral VascularPPPPPPPPP3,5,6
Musculo-skeletal ConventionalPPPPPPPPP3,5,6
Musculo-skeletal SuperficialPPPPPPPPP3,5,6
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.

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Page 12 of 15

14

Image /page/14/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" in a stylized script, enclosed within a circular frame. The frame has a decorative, swirling pattern around the letters. The logo is presented in a blue color.

GE Healthcare 510(k) Premarket Notification Submission

Diagnostic Ultrasound Indications for Use Form 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 InterestBMPW
DopplerCW
DopplerColor
DopplerColor M
DopplerPower
DopplerCombined
Modes*Harmonic
ImagingCoded
PulseOther
[Notes]
Ophthalmic
Fetal / Obstetrics[7]
Abdominal[1]PPPPPPPPP5
PediatricPPPPPPPPP5
Small Organ[2]PPPPPPPPP5
Neonatal CephalicPPPPPPPPP5
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)

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)

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Page 13 of 15

15

Image /page/15/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" in a stylized script, enclosed within a circular frame. The frame has a decorative, swirling pattern around the letters. The logo is presented in a blue color, which is a common branding element for GE.

GE Healthcare 510(k) Premarket Notification Submission

Diagnostic Ultrasound Indications for Use Form 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 InterestBMPW
DopplerCW
DopplerColor
DopplerColor M
DopplerPower
DopplerCombined
Modes*Harmonic
ImagingCoded
PulseOther
[Notes]
Ophthalmic
Fetal / Obstetrics[7]
Abdominal[1]PPPPPPPPPP5,6
PediatricPPPPPPPPPP5,6
Small Organ[2]
Neonatal Cephalic
Adult CephalicPPPPPPPPPP
Cardiac Adult & PediatricPPPPPPPPPP
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)

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Page 14 of 15

16

Image /page/16/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" in a stylized script, enclosed within a circular frame. The frame has a decorative, swirling pattern around the letters. The logo is presented in a blue color.

GE Healthcare 510(k) Premarket Notification Submission

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 InterestBMPW
DopplerCW
DopplerColor
DopplerColor M
DopplerPower
DopplerCombined
Modes*Harmonic
ImagingCoded
PulseOther
[Notes]
Ophthalmic
Fetal / Obstetrics[7]
Abdominal[1]
PediatricPPPPPPPPPP
Small Organ[2]
Neonatal CephalicPPPPPPPPPP
Adult Cephalic
Cardiac Adult & PediatricPPPPPPPPPP
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.

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Page 15 of 15

17

Image /page/17/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a blue circle. There are decorative swirls or flourishes around the perimeter of the circle, giving it a classic and recognizable appearance.

Section 5: 510(k) Summary

LOGIQ P9 and LOGIQ P7

18

510(k) Summary

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

Date: Dec. 1, 2014

GE Healthcare Submitter: 9900 Innovation Dr Wauwatosa, WI 53226

Primary Contact Person:Bryan Behn
Regulatory Affairs Manager
GE Healthcare
T:(414)721-4214
F:(414)918-8275
Secondary Contact Person:Chan Sook Kim
Regulatory Affairs Leader
GE Healthcare
GE Ultrasound Korea, Ltd.
T: +82 31 740 6307
Device:Trade Name:LOGIQ P9 and LOGIQ P7 Ultrasound System
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
Predicate Device(s):K141261 LOGIQ S7 Diagnostic Ultrasound System
K133533 LOGIQ e Diagnostic Ultrasound System
K141639 Voluson S6/S8 Diagnostic Ultrasound System
K133034 LOGIQ F 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.
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

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Image /page/19/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined in a stylized script, enclosed within a blue circle. There are four stylized water droplets or swirls equally spaced around the circle's perimeter, adding a dynamic element to the design.

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

The LOGIQ P9 and LOGIQ P7 employs the same fundamental Technology: scientific technology as its predicate devices

The LOGIQ P9 and P7 systems are substantially equivalent to the Determination of predicate devices with regard to intended use, imaging Substantial Equivalence: capabilities, technological characteristics and safety and effectiveness.

Comparison to Predicate Devices

| | Proposed Device
LOGIO P9/
LOGIQ P7 | Predicate Device
LOGIQ S7
(K141261) | | |
|--------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|----|--|
| Indications and Clinical Applications: | | | | |
| Fetal/Obstetrics: | V | V | | |
| Abdominal | イ | イ | | |
| Pediatric | イ | イ | | |
| Small Organ (breast, testes,
thyroid); | イ | イ | | |
| Neonatal Cephalic; | イ | イ | | |
| Adult Cephalic;
● | イ | V | | |
| Cardiac (adult and
pediatric); | イ | イ | | |
| Peripheral Vascular; | イ | イ | | |
| Musculo-skeletal
Conventional and
Superficial; | イ | イ | | |
| Urology (including

prostate); | イ | イ | | |
| Transesophageal; | | イ | | |
| Transrectal;
● | イ | イ | | |
| Transvaginal; | イ | イ | | |
| Intraoperative (abdominal,
thoracic, and vascular). | > | V | | |
| Contact Type | | | | |
| Surface, Cavitary | V | イ | | |
| Image modes: | | | | |
| • | B, M, Color M, Color &
Power Doppler, Pulsed &
CW Doppler and various
combinations: B/M, B/PW,
Color/Pwr/PW. Harmonic,
Coded Pulse, Realtime 3D
& Multi-plane,
Elastography Imaging, B-
flow | ✓ | | |
| Transducers | | | | |
| • | C1-5-RS | ✓1 | ✓* | |
| • | 4C-RS | ✓1 | | |
| • | 8C-RS | ✓2 | ✓* | |
| • | E8C-RS | ✓2 | | |
| • | 9L-RS | ✓2 | ✓* | |
| • | 12L-RS | ✓2 | | |
| • | L6-12-RS | ✓3 | | |
| • | ML6-15-RS | ✓1 | ✓* | |
| • | L8-18i-RS | ✓2 | ✓* | |
| • | RAB2-6-RS | ✓1 | | |
| • | 3Sc-RS | ✓2 | | |
| • | 6S-RS | ✓2 | ✓* | |
| • | P8D | ✓ | | |
| | | (equivalent to
P6D on predicate
LOGIQ S7) | | |
| • | P6D | | ✓* | |
| Transducer notes: | | | | |
| | ✓1 - cleared on predicate Voluson S6/S8 K141639 | | | |
| | ✓2 - Cleared on predicate LOGIQ e K133533 | | | |
| | ✓3 - Cleared on predicate LOGIQ F Series K133034 | | | |
| | ✓* - Identical transducer cleared on predicate with different (-D) connector | | | |
| | Processing &Display features: | | | |
| • | Image mapping (color &
gray scale), Motion/time &
spatial filtering and
enhancement, TGC, 3D,
Harmonic Imaging, Coded
Excitation, B-Flow,
Pulsatile-Flow and
Extended FOV (Field of
View), Auto Optimization.
X-beam (spatial
| ✓ | ✓ | |
| • | Digital Alphanumeric
Keyboard
Digital TGC
My Page
My Trainer | | ✓ | |

20

Image /page/20/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 designs around the letters, also in blue. The logo is simple and recognizable, representing the company's brand.

21

Image /page/21/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 swirling, wave-like shapes, also in blue. The logo is simple and recognizable, and it is often used to represent the company's brand.

Measurement and Analysis:
• Distance/depth,
Circumference, Area,
Volume, Slope, Angle, HR,
Time and Velocity
measurements; and
Cardiac, OB, Vascular &
Volume Analysis,
Thickness measurement for
IMT, Quantitative
Analysis, Breast Measure
Assistant; OB Measure
Assistant, Auto EF
Tested to meet Electrical
Safety, EMC and
Biocompatibility
Standards
Track 3 (within FDA
limits)

Summary of Non-Clinical Tests:

The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic, and mechanical safety, and has been found to conform to applicable medical device safety standards. LOGIQ P9 and LOGIQ P7 and its applications comply with voluntary standards:

    1. AAMI/ANSI ES60601-1, Medical Electrical Equipment – 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

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 circular frame. The logo is colored in a light blue hue. The logo is simple and recognizable.

    1. NEMA UD 2, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
    1. ISO14971, Application of risk management to medical devices: Second edition
    1. NEMA Digital Imaging and Communications in Medicine (DICOM) Set. (Radiology)

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

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

Transducer materials and other patient contact materials are biocompatible.

Summary of Clinical Tests:

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

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