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K Number
K181783
Device Name
LOGIQ P9; LOGIQ P7
Manufacturer
GE Healthcare
Date Cleared
2018-09-20

(79 days)

Product Code
IYN,ITX,IYO
Regulation Number
892.1550
Type
Traditional
Panel
Radiology
Reference & Predicate Devices
K163596
Predicate For
K191792,K191798,K203114
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (abdominal, thoracic, vascular).
When Pinpoint™ GT Technology, from C.R. Bard, Inc., is included with the system, the Indications for Use include: Pinpoint GT Technology is intended to provide clinicians with visual tools for passive magnetic tracking of a needle with respect to ultrasound image data.

Device Description

The LOGIQ P9; LOGIQ P7 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 53 cm wide, 74 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.

AI/ML Overview

This document is a 510(k) Premarket Notification from GE Healthcare for their LOGIQ P9 and LOGIQ P7 diagnostic ultrasound systems. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a de novo clinical study with detailed performance metrics against specific acceptance criteria. Therefore, the information typically found in an AI/Software as a Medical Device (SaMD) study for performance reporting (such as ROC curves, sensitivity/specificity, sample sizes for test/training sets, or expert ground truth adjudication) is not present.

However, based on the provided text, we can infer and extracting relevant safety and effectiveness information as follows:

1. Table of Acceptance Criteria (Inferred from Compliance and Testing) and Reported Device Performance

Acceptance Criteria (Inferred)Reported Device Performance and Compliance
Safety and Effectiveness (General Equivalence)The LOGIQ P9; LOGIQ P7 systems are substantially equivalent to predicate devices with regard to intended use, imaging capabilities, technological characteristics, safety, and effectiveness.
Clinical Intended UsesThe LOGIQ P9; LOGIQ P7 systems have the same clinical intended uses as their predicate devices, with the addition of Transesophageal exams. The device is intended for use for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ; Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (abdominal, thoracic, vascular).
Imaging ModesThe LOGIQ P9; LOGIQ P7 systems have the same imaging modes as their predicate devices, except for the addition of Shear wave elastography (migrated from LOGIQ S8) and enhancement of B-flow/B-flow color mode with high definition color. HDlive®, Tricefy, and LOGIQ P Apps features have also been migrated from other GE Ultrasound systems.
Transducer CompatibilityTransducers are identical to predicate devices, with the addition of L3-12-RS, 6Tc-RS, P2D, and IC9-RS transducers.
BiocompatibilityManufactured with materials evaluated and found to be safe; transducer materials and patient contact materials are biocompatible.
Acoustic Output LevelsAcoustic power levels are below applicable FDA limits and conform to NEMA UD 2 (2004).
Electrical, Electromagnetic, and Mechanical SafetyDesigned in compliance with approved electrical and physical safety standards, including AAMI/ANSI ES60601-1, IEC60601-1-2, and IEC60601-2-37.
Risk ManagementApplication of risk management to medical devices (ISO14971:2007).
Measurements, Digital Imaging, Reviewing, and ReportingSimilar capability to predicate devices for performing measurements, capturing digital images, reviewing, and reporting studies. Can recall non-ultrasound DICOM images.
Compliance with FDA Ultrasound Specific GuidanceComplies with "Guidance for Industry and FDA Staff - Information for manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers (September 9, 2008)".
Quality Assurance MeasuresRisk Analysis, Requirements Reviews, Design Reviews, Testing on unit level (Module verification), Integration testing (System verification), Performance testing (Verification), Safety testing (Verification).

2. Sample Sizes and Data Provenance for Test Set

The document explicitly states: "The subject of this premarket submission, LOGIQ P9; LOGIQ P7, did not require clinical studies to support substantial equivalence."

This means there wasn't a separate "test set" in the context of a prospective clinical trial or performance study against pre-defined metrics. The submission relies on bench testing, compliance with standards, and comparison to predicate devices to demonstrate substantial equivalence, rather than a clinical performance study with patient data.

  • Sample Size for Test Set: Not applicable as a clinical test set was not used for this 510(k) submission.
  • Data Provenance: Not applicable for clinical performance data. The data provenance discussed is related to compliance with engineering standards and existing clearances for predicate and reference devices (e.g., K163596, K170445, K160162, K173555).

3. Number of Experts and Qualifications for Ground Truth for the Test Set

  • Not applicable, as a clinical test set requiring expert ground truth establishment for a performance study was not performed. The evaluation relies on technical performance and safety testing, and substantial equivalence to existing devices cleared through other means.

4. Adjudication Method for the Test Set

  • Not applicable, as a clinical test set requiring adjudication was not utilized.

5. MRMC Comparative Effectiveness Study

  • Not applicable. This submission is for a diagnostic ultrasound system, not an AI or imaging assistance device that would typically undergo an MRMC study to show human reader improvement with AI assistance. The focus is on the device's inherent safety and performance for imaging.

6. Standalone Performance (Algorithm Only)

  • Not applicable in the context of an "algorithm only" performance typical for AI/SaMD. The device itself is an ultrasound imaging system. Its performance relates to its ability to generate diagnostic ultrasound images and fluid flow analysis, which is demonstrated through engineering and safety evaluations and comparison to predicate devices.
    • While new features like "Shear wave elastography" involve processing, their performance is demonstrated via technical validation and substantial equivalence, not a standalone algorithm efficacy study in the typical AI sense.

7. Type of Ground Truth Used

  • Not applicable in the sense of 'ground truth' defined by expert consensus or pathology for a clinical performance study. The "ground truth" here is compliance with established engineering and safety standards, and the capabilities of the already cleared predicate devices.

8. Sample Size for the Training Set

  • Not applicable. This is a hardware/software system, and the submission does not describe a machine learning model that was "trained" on a dataset in the way an AI/SaMD product would be. The "training" here refers to the device's design and engineering based on established physics and medical imaging principles.

9. How the Ground Truth for the Training Set was Established

  • Not applicable, as no external "training set" with established ground truth was utilized for a machine learning model. The device's design and functionality are based on long-standing principles of ultrasound imaging and adherence to regulatory standards.

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

September 20, 2018

GE Healthcare Bryan Behn RA Director 9900 Innovation Drive WAUWATOSA, WI 53226

Re: K181783

Trade/Device Name: LOGIO P9; LOGIO P7 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: July 2, 2018 Received: July 3, 2018

Dear Bryan 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Hse 2. Nils

for Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K181783

Device Name LOGIQ P9; 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; Transesophageal and Intraoperative (abdominal, thoracic, vascular).

When Pinpoint GT Technology, from C.R. Bard, Inc., is included with the system, the Indications for Use include: Pinpoint GT Technology is intended to provide clinicians with visual tools for passive magnetic tracking of a needle with respect to ultrasound image data.

Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/3/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 is further embellished with decorative, swirling elements around its perimeter, giving it a classic and recognizable appearance.

Indications for Use Forms

The following forms represent indications with clinical applications and exam types along with the modes of operation for the LOGIQ P9 and LOGIQ P7 system. Combinations identified "P" for the transducers represents those previously cleared with LOGIQ P9 and LOGIQ P7 and *P for those cleared on another GE Ultrasound system and those identified and "N" are new. Please see section 11 Table 11.2.1 for information on previous clearance information on these transducers.

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Image /page/4/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a blue circle. The circle is surrounded by eight curved, white shapes that resemble stylized water droplets or clouds. The overall design is simple, clean, and recognizable as the GE brand.

Diagnostic Ultrasound Indications for Use Form

LOGIQ P9; LOGIQ P7 Ultrasound System

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

Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[Notes]
Ophthalmic
Fetal / Obstetrics[7]PPPPPPPPPP5,6
Abdominal[1]PPPPPPPPPP3,5,6,10
PediatricPPPPPPPPPP3,5,6
Small Organ[2]PPPPPPPPPP3,5,6,10
Neonatal CephalicPPPPPPPPPP5,6
Adult CephalicPPPPPPPPPP5,6
Cardiac Adult & PediatricPPPPPPPPPP
Peripheral VascularPPPPPPPPPP3,5,6
Musculo-skeletal ConventionalPPPPPPPPPP3,5,6,10
Musculo-skeletal SuperficialPPPPPPPPPP3,5,6,9,10
Other[4]PPPPPPPPP3,5,6
Exam Type, Means of Access
TransesophagealNNNNNNNNNN
Transrectal[8]PPPPPPPPPP3,5,6
TransvaginalPPPPPPPPPP3,5,6
Transuretheral
Intraoperative[8]PPPPPPPPPP3,5,6
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)

[9] Needle guidance with PinpointTM GT needle technology

[10] Shear Wave Elastography

[*] 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/5/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 frame. The letters and the frame are both blue, and the background is white. The logo is simple and recognizable, representing the well-known multinational corporation.

Diagnostic Ultrasound Indications for Use Form

LOGIQ P9; LOGIQ P7with L12n-RS Transducer

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

Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[Notes]
OphthalmicPPPPPP
Fetal / Obstetrics[7]
Abdominal[1]PPPPPP
PediatricPPPPPP
Small Organ[2]PPPPPP
Neonatal CephalicPPPPPP
Adult Cephalic
Cardiac Adult & Pediatric
Peripheral VascularPPPPPP
Musculo-skeletal ConventionalPPPPPP
Musculo-skeletal SuperficialPPPPPP[9]
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal[8]
Transvaginal
Transuretheral
Intraoperative[8]PPPPPP
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)

[9] Needle guidance with PinpointTM GT needle technology;

[*] 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/6/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 frame. The letters and the frame are both blue, and the background is white. The logo is simple and recognizable, representing the well-known multinational corporation.

Diagnostic Ultrasound Indications for Use Form

LOGIQ P9; LOGIQ P7 with P6D Transducer

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

Mode of Operation
Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[Notes]
Ophthalmic
Fetal / Obstetrics[7]
Abdominal[1]
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult CephalicPP
Cardiac Adult & PediatricPP
Peripheral VascularPP
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

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

  • [2] Small organ includes breast, testes and thyroid
    [3] Elastography Imaging - Elasticity.

  • [4] Other use includes Urology/Prostate
    [5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development

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

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

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

Concurrence of CDRH, Office of In Vitro 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" in a stylized, cursive font, enclosed within a circular frame. The logo is colored in blue, with the letters and the frame having the same shade of blue.

Diagnostic Ultrasound Indications for Use Form

LOGIQ P9; LOGIQ P7 with L4-12t-RS Transducer

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

Clinical ApplicationAnatomy/Region of InterestBMPW DopplerCW DopplerColor DopplerColor M DopplerPower DopplerCombined Modes*Harmonic ImagingCoded PulseOther [Notes)
Ophthalmic
Fetal / Obstetrics[7]
Abdominal[1]
PediatricPPPPPPPPP[3,6]
Small Organ[2]PPPPPPPPP[3,6]
Neonatal CephalicPPPPPPPPP[3,6]
Adult Cephalic
Cardiac Adult & Pediatric
Peripheral VascularPPPPPPPPP[3,6]
Musculo-skeletal ConventionalPPPPPPPPP[3,6]
Musculo-skeletal SuperficialPPPPPPPPP[3,6]
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal[8]
Transvaginal
Transurethral
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)

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Image /page/8/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a circular frame. The logo is colored in blue, with the letters and the frame having the same shade of blue.

Diagnostic Ultrasound Indications for Use Form

LOGIQ P9; 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 ApplicationAnatomy/Region of InterestBMPW DopplerCW DopplerColor DopplerColor M DopplerPower DopplerCombined Modes*Harmonic ImagingCoded PulseOther [Notes]
Ophthalmic
Fetal / Obstetrics[7]
Abdominal[1]
Pediatric
Small Organ[2]PPPPPPPPP
Neonatal CephalicPPPPPPPPP
Adult Cephalic
Cardiac Adult & Pediatric
Peripheral Vascular
Musculo-skeletal ConventionalPPPPPPPPP
Musculo-skeletal SuperficialPPPPPPPPP
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)

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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" in a stylized, cursive font, enclosed within a circular frame. The letters and the frame are both blue, and the background is white. The logo is simple and recognizable, representing the well-known multinational corporation.

Diagnostic Ultrasound Indications for Use Form

LOGIQ P9; LOGIQ P7 with L3-9i-RS Transducer

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

Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[Notes]
Ophthalmic
Fetal / Obstetrics[7]
Abdominal[1]
Pediatric
Small Organ[2]PPPPPPPPP
Neonatal Cephalic
Adult Cephalic
Cardiac Adult & Pediatric
Peripheral VascularPPPPPPPPP
Musculo-skeletal ConventionalPPPPPPPPP
Musculo-skeletal SuperficialPPPPPPPPP
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal[8]
Transvaginal
Transuretheral
Intraoperative[8]PPPPPPPPP
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/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 frame. The logo is colored in blue, with the letters and the frame having the same shade of blue.

Diagnostic Ultrasound Indications for Use Form

LOGIQ P9; LOGIQ P7 with E8CS-RS Transducer

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

Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[Notes]
Ophthalmic
Fetal / Obstetrics[7]PPPPPPPPP[3,6]
Abdominal[1]PPPPPPPPP[3,6]
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult & Pediatric
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]PPPPPPPPP[3,6]
Exam Type, Means of Access
Transesophageal
Transrectal[8]PPPPPPPPP[3,6]
TransvaginalPPPPPPPPP[3,6]
Transurethral
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)

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Image /page/11/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 frame. The letters and the frame are both blue, and the background is white. The logo is simple and recognizable, representing the well-known multinational corporation.

Diagnostic Ultrasound Indications for Use Form

LOGIQ P9; 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 ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[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]PPPPPPPPP[3,6]
Exam Type, Means of Access
Transesophageal
Transrectal[8]PPPPPPPPP[3,6]
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)

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

Image /page/12/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 frame. The letters and the frame are both blue, and the background is white. The logo is simple and recognizable, representing the well-known multinational corporation.

Diagnostic Ultrasound Indications for Use Form

LOGIQ P9; LOGIQ P7 with RIC5-9A-RS Transducer

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

Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[Notes]
Ophthalmic
Fetal / Obstetrics[7]PPPPPPPPP[5,6]
Abdominal[1]PPPPPPPPP[5,6]
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult & Pediatric
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]PPPPPPPPP[5,6]
Exam Type, Means of Access
Transesophageal
Transrectal[8]
TransvaginalPPPPPPPPP[5,6]
Transuretheral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA

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

[2] Small organ includes breast, testes and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development

[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 "GE" in a stylized, cursive font, enclosed within a circular frame. The logo is colored in blue, with the letters and the frame having the same shade of blue.

Diagnostic Ultrasound Indications for Use Form

LOGIQ P9; 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 ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[Notes]
Ophthalmic
Fetal / Obstetrics[7]
Abdominal[1]
PediatricPPPPPPPPPP
Small Organ[2]
Neonatal CephalicPPPPPPPPPP
Adult Cephalic
Cardiac Adult & Pediatric
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal[8]
Transvaginal
Transuretheral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA

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

[2] Small organ includes breast, testes and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development

[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 General Electric (GE) logo. The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a blue circle. The circle is surrounded by eight curved, white shapes that resemble stylized water droplets or clouds. The overall design is simple, clean, and recognizable as the GE brand.

Diagnostic Ultrasound Indications for Use Form

LOGIQ P9; 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 ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[Notes]
Ophthalmic
Fetal / Obstetrics[7]PPPPPPPPPP5,6
Abdominal[1]PPPPPPPPPP3,5,6,10
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

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)

[10] Shear Wave Elastography

[*] 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' written in a stylized script, enclosed within a circular frame. The frame has a swirling design around the letters. The logo is colored in blue.

Diagnostic Ultrasound Indications for Use Form

LOGIQ P9; 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 ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[Notes]
Ophthalmic
Fetal / Obstetrics[7]PPPPPPPPPP5,6
Abdominal[1]PPPPPPPPPP3,5,6,10
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

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)

[10] Shear Wave Elastography

[*] 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" in a stylized, cursive font, enclosed within a circular frame. The letters and the frame are both blue, and the background is white. The logo is simple and recognizable, representing the well-known multinational corporation.

Diagnostic Ultrasound Indications for Use Form

LOGIQ P9; LOGIQ P7 with 9L-RS Transducer

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

Clinical ApplicationAnatomy/Region of InterestMode of Operation
BMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[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

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 frame. The logo is colored in blue, with the letters and the frame having the same shade of blue.

Diagnostic Ultrasound Indications for Use Form

LOGIQ P9; 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 ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[Notes]
Ophthalmic
Fetal / Obstetrics[7]
Abdominal[1]
PediatricPPPPPPPPP3,5,6
Small Organ[2]PPPPPPPPP3,5,6
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]
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" intertwined in a stylized script, enclosed within a circular frame. The logo is colored in blue, with a white outline around the letters and the circular frame.

Diagnostic Ultrasound Indications for Use Form

LOGIQ P9; 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 ApplicationAnatomy/Region of InterestBMPW DopplerCW DopplerColor DopplerColor M DopplerPower DopplerCombined Modes*Harmonic ImagingCoded PulseOther [Notes]
Ophthalmic
Fetal / Obstetrics[7]PPPPPPPPP5,6
Abdominal[1]PPPPPPPPP
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult & Pediatric
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]PPPPPPPPP3,5,6
Exam Type, Means of Access
Transesophageal
Transrectal[8]PPPPPPPPP3,5,6
TransvaginalPPPPPPPPP3,5,6
Transuretheral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA

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

[2] Small organ includes breast, testes and thyroid

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D/4D Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development

[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, cursive font, enclosed within a circular frame. The letters and the frame are both blue, and the background is white. The logo is simple and recognizable, representing the well-known multinational corporation.

Diagnostic Ultrasound Indications for Use Form

LOGIQ P9; 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 ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[Notes]
Ophthalmic
Fetal / Obstetrics[7]
Abdominal[1]
PediatricPPPPPPPPP5,6
Small Organ[2]PPPPPPPPP
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

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)

{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, cursive font, enclosed within a circular frame. The letters and the frame are both blue, and the background is white. The logo is simple and recognizable, representing the well-known multinational corporation.

Diagnostic Ultrasound Indications for Use Form

LOGIQ P9; LOGIQ P7 with P8D Transducer

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

Clinical ApplicationAnatomy/Region of InterestMode of OperationOther [Notes]
BMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulse
Ophthalmic
Fetal / Obstetrics[7]
Abdominal[1]
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult CephalicPP
Cardiac Adult & PediatricPP
Peripheral VascularPP
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)

{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, cursive font, enclosed within a circular frame. The logo is colored in blue, with the letters and the frame having the same shade of blue.

Diagnostic Ultrasound Indications for Use Form

LOGIQ P9; 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 ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[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

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)

{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, cursive font, enclosed within a circular frame. The logo is colored in blue, with the letters and the frame having the same shade of blue.

Diagnostic Ultrasound Indications for Use Form

LOGIQ P9; 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 ApplicationBMPWCWColorColor MPowerCombinedModes*HarmonicImagingCodedPulseOther[Notes)
Anatomy/Region of InterestDopplerDopplerDopplerDopplerDoppler
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

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)

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

Image /page/23/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 frame. The letters and the frame are both blue, and the background is white. The logo is simple and recognizable, representing the well-known multinational corporation.

Diagnostic Ultrasound Indications for Use Form

LOGIQ P9; 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 ApplicationAnatomy/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

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)

{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, cursive font, enclosed within a circular frame. The letters and the frame are both blue, and the background is white. The logo is simple and recognizable, representing the well-known multinational corporation.

Diagnostic Ultrasound Indications for Use Form

LOGIQ P9; 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 ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[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

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)

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

Image /page/25/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 frame. The letters and the frame are both blue, and the background is white. The logo is simple and recognizable, representing the well-known multinational corporation.

Diagnostic Ultrasound Indications for Use Form

LOGIQ P9; 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 ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[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

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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Image /page/26/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 frame. The logo is colored in blue, with the letters and the frame having the same shade of blue.

Diagnostic Ultrasound Indications for Use Form

LOGIQ P9; LOGIQ P7 with 6S-RS Transducer

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

Clinical ApplicationAnatomy/Region of InterestMode of Operation
BMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[Notes]
Ophthalmic
Fetal / Obstetrics[7]
Abdominal[1]
PediatricPPPPPPPPPP
Small Organ[2]
Neonatal CephalicPPPPPPPPPPP
Adult Cephalic
Cardiac Adult & PediatricPPPPPPPPPPP
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal[8]
Transvaginal
Transuretheral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA

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

[2] Small organ includes breast, testes and thyroid

[3] Elastography Imaging – Elasticity.

[4] Other use includes Urology/Prostate

[5] 3D 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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Image /page/27/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 a swirling design around the letters. The logo is colored in blue.

Diagnostic Ultrasound Indications for Use Form

LOGIQ P9; LOGIQ P7 with L3-12-RS Transducer

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

Mode of Operation
Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[Notes]
Ophthalmic
Fetal / Obstetrics[7]NNNNNNNNNN5,6
Abdominal[1]NNNNNNNNNN3,5,6,10
PediatricNNNNNNNNNN3,5,6
Small Organ[2]NNNNNNNNNN3,5,6,10
Neonatal Cephalic
Adult Cephalic
Cardiac Adult & Pediatric
Peripheral VascularNNNNNNNNNN3,5,6
Musculo-skeletal ConventionalNNNNNNNNNN3,5,6,10
Musculo-skeletal SuperficialNNNNNNNNNN3,5,6,10
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 Imaging mode

[6] Needle guidance imaging

[7] Includes infertility monitoring of follicle development

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

[10] Shear Wave Elastography

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

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Image /page/28/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a circular frame. The letters and the frame are both blue, and the background is white. The logo is simple and recognizable, representing the well-known multinational corporation.

Diagnostic Ultrasound Indications for Use Form

LOGIQ P9; LOGIQ P7 with IC9-RS Transducer

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

Mode of Operation
Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[Notes]
Ophthalmic
Fetal / Obstetrics[7]*P*P*P*P*P*P*P*P*P6
Abdominal[1]*P*P*P*P*P*P*P*P*P6
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult & Pediatric
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal[8]
Transvaginal*P*P*P*P*P*P*P*P*P6
Transuretheral*P*P*P*P*P*P*P*P*P6
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; *P = previously cleared by FDA in (K160162)

[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.

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Image /page/29/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a circular frame. The letters and the frame are both blue, and the background is white. The logo is simple and recognizable, representing the well-known multinational corporation.

Diagnostic Ultrasound Indications for Use Form

LOGIQ P9; LOGIQ P7 with 6Tc-RS Transducer

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

Mode of Operation
Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[Notes]
Ophthalmic
Fetal / Obstetrics[7]
Abdominal[1]
Pediatric
Small Organ[2]
Neonatal Cephalic
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*P*P*P*P*P*P*P*P*P*P
Transrectal[8]
Transvaginal
Transuretheral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; *P = previously cleared by FDA in K170445

[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.

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Image /page/30/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a circular frame. The logo is colored in blue, with the letters and the frame having the same shade of blue.

Diagnostic Ultrasound Indications for Use Form

LOGIQ P9; LOGIQ P7 with P2D Transducer

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

Mode of Operation
Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[Notes]
Ophthalmic
Fetal / Obstetrics[7]
Abdominal[1]
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic*P
Cardiac Adult & Pediatric*P
Peripheral Vascular*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 in K170445

[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.

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Image /page/31/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a circular frame. The color of the logo is a light blue.

510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:
Date:July 2, 2018
Submitter:GE Healthcare9900 Innovation DrWauwatosa, WI 53226
Primary Contact Person:Bryan BehnRegulatory Affairs DirectorGE HealthcareT:(262-247-5502)F:(414)918-8275
Secondary Contact Person:Soyoung ParkRegulatory Affairs SpecialistGE HealthcareGE Ultrasound Korea, Ltd.T: +82-31-740-6136
Device: Trade Name:LOGIQ P9; LOGIQ P7
Common/Usual Name:LOGIQ P9; LOGIQ P7
Classification Names:Class II
Product Code:Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-IYNUltrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYODiagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX
Primary Predicate Device:K163596 LOGIQ P9; LOGIQ P7 Diagnostic Ultrasound System
Reference Predicate Device(s):K170445 LOGIQ S8 Diagnostic Ultrasound SystemK160162 Voluson P6 And Voluson P8K173555 LOGIQ E10
Device Description:The LOGIQ P9; LOGIQ P7 is a full featured, general purposediagnostic ultrasound system which consists of a mobile consoleapproximately 53 cm wide, 74 cm deep and 157 cm high thatprovides digital acquisition, processing and display capability.The user interface includes a computer keyboard, specializedcontrols, 10.4 inch LCD touch screen and color 21.5 inch LCD
New technology added:Shear wave elastography on the LOGIQ P9; LOGIQ P7 is anultrasound imaging mode in which shear waves are generated in-vivo acoustically via the imaging ultrasound transducer. Themotion of the shear waves is then tracked to determine theirvelocity of propagation as an indicator of the mechanicalproperties of the tissue.HDlive allows the user can alter the position of the light source toget a more natural image display.Connectivity to LOGIQ P Apps which allows the user to take apicture of scanning area with a smart device to attach to thepatient record and duplicate the UI of the touch panel onto asmart device to control the touch panel UI from the smart device.HRes contrast imaging is used for developing harmonic signals ofthe contrast agent. Additionally, LOGIQ P9; LOGIQ P7 enhanceContrast imaging, B steer+ and B-flow/B-flow color previouslyon the system.
Intended Use:The device is intended for use by a qualified physician forultrasound evaluation of Fetal; Abdominal; Pediatric; SmallOrgan (breast, testes, thyroid); Neonatal Cephalic; AdultCephalic; Cardiac (adult and pediatric); Peripheral Vascular;Musculo-skeletal Conventional and Superficial; Urology(including prostate); Transrectal; Transvaginal; Transesophagealand Intraoperative (abdominal, thoracic, vascular).When Pinpoint™ GT Technology, from C.R. Bard, Inc., isincluded with the system, the Indications for Use include:Pinpoint GT Technology is intended to provide clinicians withvisual tools for passive magnetic tracking of a needle with respectto ultrasound image data.
Technology:The LOGIQ P9; LOGIQ P7 employs the same fundamentalscientific technology as its predicate devices
Determination ofSubstantial Equivalence:Comparison to Predicate DevicesThe LOGIQ P9; LOGIQ P7 systems are substantially equivalentto the predicate devices with regard to intended use, imagingcapabilities, technological characteristics and safety andeffectiveness.
● The systems are all intended for diagnostic ultrasoundimaging and fluid flow analysis.

image display.

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

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Image /page/33/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 logo is colored in a light blue hue, and the frame has decorative flourishes around it.

  • o The LOGIO P9; LOGIO P7and predicate LOGIO P9; LOGIQ P7 systems have the same clinical intended uses.
  • The LOGIQ P9; LOGIQ P7 and predicate LOGIQ P9; . LOGIO P7systems have the same imaging modes except Shearwave Elastography which is migrated from LOGIQ S8 (K170445).
  • The LOGIQ P9; LOGIQ P7 and predicate LOGIQ P9; LOGIQ P7 systems transducers are identical except for the addition of 4 new transducers L3-12-RS (smilar to L3-12-D on predicate LOGIQ S8 K170445, only change os the connector type D to RS). 6Tc-RS and P2D (identical to LOGIQ S8 K170445) and IC9-RS on predicate Voluson P6/P8 (K160162)
  • . The LOGIQ P9; LOGIQ P7 and predicate LOGIQ P9; LOGIQ P7 systems have the same indications for use with the addition of Transesophageal exams
  • The systems are manufactured with materials which have ● been evaluated and found to be safe for the intended use of the device.
  • . The systems have acoustic power levels which are below the applicable FDA limits.
  • The LOGIQ P9; LOGIQ P7 and predicate LOGIQ P9; ● LOGIQ P7 systems have similar capability in terms of performing measurements, capturing digital images, reviewing and reporting studies.
  • The LOGIO P9; LOGIO P7 and predicate LOGIO P9; LOGIO P7systems have been designed in compliance with approved electrical and physical safety standards.
  • . The following feature has been migrated from Voluson P6/P8 (K180535) HD live.
  • The following features have been migrated from LOGIQ E10 (K173555) Tricefy and LOGIO P Apps.
  • The following feature has been migrated from LOGIQ S8 (K170445) Hres contrast mode.
  • The LOGIQ P9; LOGIQ P7 extends supportable probes on contrast image mode and B steer+ mode. And it enhances B-flow/B-flow color mode with high definition color as a minor change.
  • . The systems can recall non-ultrasound DICOM images on the image history page and provides probe light on probe holder.

Summary of Non-Clinical Performance Tests:

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Image /page/34/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 logo is colored in a light blue hue, and the frame has decorative flourishes around it.

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
  • o IEC60601-2-37, Medical Electrical Equipment - Part 2-37:Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment, 2007
  • 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 proposed LOGIQ P9; LOGIQ P7 Ultrasound Systems also comply with the FDA ultrasound specific guidance. Guidance for Industry and FDA Staff - Information for manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers (September 9, 2008).

Non-Clinical verification testing has been performed to cover system level requirements and the risk control measures. Non-Clinical validation testing covered the intended use and commercial claims as well as usability testing with representative intended users.

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Image /page/35/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. The circle is bordered by a series of curved, wave-like lines, also in blue, that give the impression of motion or energy surrounding the central letters.

All these tests were used to support substantial equivalence of the subject device and demonstrate that the proposed LOGIO P9; LOGIQ P7 Ultrasound Systems comply with international and FDA-recognized consensus standards and FDA ultrasound guidance document and meet the acceptance criteria and are adequate for their intended use.

Therefore, the proposed LOGIQ P9; LOGIQ P7 Diagnostic Ultrasound Systems are substantially equivalent to the predicate in terms of safety and effectiveness.

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, LOGIQ P9; LOGIQ P7, did not require clinical studies to support substantial equivalence.

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

§ 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.