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K Number
K151028
Device Name
LOGIQ e
Manufacturer
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS
Date Cleared
2015-06-18

(62 days)

Product Code
IYNITXIYO
Regulation Number
892.1550
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LOGIQ e is intended for ultrasound imaging, measurement and analysis of the human body for multiple clinical applications including: ophthalmic: fetal/ob; abdominal (gyn & urology); pediatric; small organ (breast, testes, thyroid); neonatal and adult cephalic; cardiatric); peripheral vascular; musculosketal conventional & superficial; transrectal; transvaginal; transesophageal; intraoperative (abdominal, thoracic and peripheral); thoracic/pleural for motion and fluid detection and imaging guidance of interventional procedures (e.g. Nerve block; vascular access).
Device Description
The LOGIQ e device is a laptop ultrasound console approximately 70mm in height, 295mm in width and 346mm in length with integrated keyboard, a color video LCD type display and several interchangeable electronic-array transducers. It has digital acquisition, processing and display capability and operates from an integrated battery or separate power supply/charger.
More Information

K133533, K113690

Not Found

No
The document describes a general-purpose ultrasound system with digital processing capabilities but does not mention AI, ML, or related terms. The focus is on standard ultrasound imaging and analysis.

No
The device is an imaging system designed for diagnosis and measurement, not for treatment or therapy.

Yes
The "Intended Use / Indications for Use" states that the device is for "ultrasound imaging, measurement and analysis of the human body for multiple clinical applications", which directly implies its use in diagnosing medical conditions through imaging and analysis.

No

The device description explicitly states it is a "laptop ultrasound console" with integrated hardware components like a keyboard, display, and interchangeable transducers. It also mentions operating from an integrated battery or separate power supply/charger, all of which are hardware elements.

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

Here's why:

  • Intended Use: The intended use clearly states that the device is for "ultrasound imaging, measurement and analysis of the human body". This describes a device used on the human body for diagnostic imaging, not a device used to examine specimens from the human body (which is the definition of an IVD).
  • Device Description: The description details a "laptop ultrasound console" with transducers, designed for direct interaction with the patient.
  • Anatomical Site: The listed anatomical sites are all parts of the human body where ultrasound is applied externally or internally for imaging.
  • Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.) or performing tests on samples outside of the body.

Therefore, the LOGIQ e is a medical imaging device, specifically an ultrasound system, and does not fit the definition of an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

The LOGIQ e is intended for ultrasound imaging, measurement and analysis of the human body for multiple clinical applications including: ophthalmic: fetal/ob; abdominal (gyn & urology); pediatric; small organ (breast, testes, thyroid); neonatal and adult cephalic; cardiatric); peripheral vascular; musculosketal conventional & superficial; transrectal; transvaginal; transesophageal; intraoperative (abdominal, thoracic and peripheral); thoracic/pleural for motion and fluid detection and imaging guidance of interventional procedures (e.g. Nerve block; vascular access).

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

IYN, IYO, ITX

Device Description

The LOGIQ e device is a laptop ultrasound console approximately 70mm in height, 295mm in width and 346mm in length with integrated keyboard, a color video LCD type display and several interchangeable electronic-array transducers. It has digital acquisition, processing and display capability and operates from an integrated battery or separate power supply/charger.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Ophthalmic, Fetal, Obstetrics, Abdominal (GYN and Urology), Pediatric, Small Organ (breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (adult & pediatric), Peripheral Vascular, Musculoskeletal conventional & superficial, Transrectal, Transvaginal, Transesophageal, Intraoperative (abdominal, thoracic and peripheral), Thoracic/Pleural.

Indicated Patient Age Range

Neonatal, Pediatric, Adult

Intended User / Care Setting

Not Found

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

Not Found

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

Not Found

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

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

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. The LOGIQ e and its applications comply with voluntary standards:

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

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

  • Risk Analysis
  • Requirements Reviews
  • Design Reviews
  • Testing on unit level (Module verification)
  • Integration testing (System verification)
  • Performance testing (Verification)
  • Safety testing (Verification)
  • Simulated use Testing (Validation)
    Transducer materials and other patient contact materials are biocompatible.

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

Not Found

Predicate Device(s)

K133533, K113690

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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.

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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that overlap and create a sense of movement.

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

June 18, 2015

GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC % Ms. Tracey Ortiz Regulatory Affairs Director 9900 W. Innovation Drive WAUWATOSA WI 53226

Re: K151028

Trade/Device Name: LOGIO e Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: April 17, 2015 Received: April 20, 2015

Dear Ms. Ortiz:

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.

Michael D'Hara

For

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

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Indications for Use

510(k) Number (if known) K151028

Device Name LOGIQ e

Indications for Use (Describe)

The LOGIQ e is intended for ultrasound imaging, measurement and analysis of the human body for multiple clinical applications including: ophthalmic: fetal/ob; abdominal (gyn & urology); pediatric; small organ (breast, testes, thyroid); neonatal and adult cephalic; cardiatric); peripheral vascular; musculosketal conventional & superficial; transrectal; transvaginal; transesophageal; intraoperative (abdominal, thoracic and peripheral); thoracic/pleural for motion and fluid detection and imaging guidance of interventional procedures (e.g. Nerve block; vascular access).

Type of Use (Select one or both, as applicable)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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Diagnostic Ultrasound Indications for Use Form GE LOGIQ e Ultrasound System

Mode of Operation
Clinical ApplicationBMPW
DopplerCW
DopplerColor
DopplerColor
MPDICombined
Modes*Harmonic
ImagingCoded
PulseOther
Anatomy/Region of Interest
OphthalmicPPPPPPPPPP
Fetal / ObstetricsPPPPPPPPPP
Abdominal[1]PPPPPPPPPP
PediatricPPPPPPPPPP
Small Organ [2]PPPPPPPPPP
Neonatal CephalicPPPPPPPPPP
Adult CephalicPPPPPPPPPP
Cardiac [3]PPPPPPPPPP
Peripheral VascularPPPPPPPPPP
Musculo-skeletal ConventionalPPPPPPPPPP
Musculo-skeletal SuperficialPPPPPPPPPP
Thoracic/Pleural[4]PPPPPPPPPP
Other[5]PPPPPPPPPP
Exam Type, Means of Access
TransesophagealNNNNNNNNNN
TransrectalPPPPPPPPPP
TransvaginalPPPPPPPPPP
Intraoperative[6]PPPPPPPPPP
Interventional Guidance
Tissue Biopsy/Fluid DrainagePPPPPPPPPP
Vascular Access (IV, PICC)PPPPPPPPPP
Nerve BlockPPPPPPPPPP

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

N = new indication; P= previously cleared by FDA K133533 ; P= previously cleared by FDA K113690

Notes: [1] Abdominal includes GYN and Urological;

[2] Small Organ includes breast, testes, thyroid;

[3] Cardiac is Adult and Pediatric:

[4] For detection of fluid and pleural motion/sliding;

[5] Other use includes Urology/Prostate;

[6] Intraoperative includes abdominal, thoracic and peripheral;

[*]Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD;

] Coded Pulse is for digitally encoded harmonics.

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Image /page/4/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 inside. The letters are also blue, and they are surrounded by a white, decorative border. The logo is simple and recognizable, and it is often used to represent the company.

Diagnostic Ultrasound Indications for Use Form GE LOGIQ e with C1-5-RS Transducer

| Clinical Application | B | M | PW
Doppler | CW
Doppler | Color
Doppler | Color
M | PDI | Combined
Modes* | Harmonic
Imaging | Coded
Pulse• | Other |
|-----------------------------------|---|---|---------------|---------------|------------------|------------|-----|--------------------|---------------------|-----------------|-------|
| Anatomy/Region of Interest | | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | P | P | P | | P | | P | P | P | P | |
| Abdominal[1] | P | P | P | | P | | P | P | P | P | |
| Pediatric | P | P | P | | P | | P | P | P | P | |
| Small Organ [2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [3] | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | P | P | P | | P | | P | P | P | P | |
| Musculo-skeletal Superficial | P | P | P | | P | | P | P | P | P | |
| Thoracic/Pleural [4] | | | | | | | | | | | |
| Other[5] | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Intraoperative[6] | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Tissue Biopsy/Fluid Drainage | P | P | P | | P | | P | P | P | P | |
| Vascular Access (IV, PICC) | | | | | | | | | | | |
| Nerve Block | P | P | P | | P | | P | P | P | P | |

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

N = new indication; P= previously cleared by FDA K133533 ; P= previously cleared by FDA K113690

Notes: [1] Abdominal includes GYN and Urological;

[2] Small Organ includes breast, testes, thyroid;

[3] Cardiac is Adult and Pediatric;

[4] For detection of fluid and pleural motion/sliding;

[5] Other use includes Urology/Prostate;

[6] Intraoperative includes abdominal, thoracic and peripheral;

[*]Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD;

[ ] Coded Pulse is for digitally encoded harmonics.

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Image /page/5/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 inside. The letters are also blue, and they are surrounded by a white, decorative border. The logo is simple and recognizable, and it is often used to represent the company.

Diagnostic Ultrasound Indications for Use Form GE LOGIQ e with 4C-RS Transducer

Mode of Operation
Clinical ApplicationBMPW
DopplerCW
DopplerColor
DopplerColor
MPDICombined
Modes*Harmonic
ImagingCoded
PulseOther
Anatomy/Region of Interest
Ophthalmic
Fetal / ObstetricsP1P1P1P1P1P1P1P1
Abdominal[1]P1P1P1P1P1P1P1P1
PediatricP1P1P1P1P1P1P1P1
Small Organ [2]
Neonatal Cephalic
Adult Cephalic
Cardiac [3]
Peripheral Vascular
Musculo-skeletal ConventionalNNNNNNNN
Musculo-skeletal SuperficialNNNNNNNN
Thoracic/Pleural[4]P1P1P1P1P1P1P1P1
Other[5]P1P1P1P1P1P1P1P1
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Intraoperative[6]
Interventional Guidance
Tissue Biopsy/Fluid DrainageNNNNNNNN
Vascular Access (IV, PICC)
Nerve BlockNNNNNNNN

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

N = new indication; P= previously cleared by FDA K133533 ; P= previously cleared by FDA K113690

Notes: [1] Abdominal includes GYN and Urological;

[2] Small Organ includes breast, testes, thyroid;

[3] Cardiac is Adult and Pediatric;

[4] For detection of fluid and pleural motion/sliding;

[5] Other use includes Urology/Prostate;

[6] Intraoperative includes abdominal, thoracic and peripheral;

[*]Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD;

[ ] Coded Pulse is for digitally encoded harmonics.

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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 script, enclosed within a circular frame. The color of the logo is a light blue.

Diagnostic Ultrasound Indications for Use Form GE LOGIQ e with 8C-RS Transducer

Mode of Operation
Clinical ApplicationBMPW DopplerCW DopplerColor DopplerColor MPDICombined
Modes*Harmonic
ImagingCoded
PulseOther
Anatomy/Region of Interest
OphthalmicPPPPPPP
Fetal / Obstetrics
Abdominal[1]PPPPPPP
PediatricPPPPPPP
Small Organ [2]PPPPPPP
Neonatal CephalicPPPPPPP
Adult CephalicPPPPPPP
Cardiac [3]PPPPPPP
Peripheral VascularPPPPPPP
Musculo-skeletal ConventionalPPPPPPP
Musculo-skeletal SuperficialPPPPPPP
Thoracic/Pleural [4]PPPPPPP
Other [5]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Intraoperative[6]
Interventional Guidance
Tissue Biopsy/Fluid Drainage
Vascular Access (IV, PICC)PPPPPPP
Nerve Block

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

N = new indication; P= previously cleared by FDA K133533 ; P= previously cleared by FDA K113690

Notes: [1] Abdominal includes GYN and Urological;

  • [2] Small Organ includes breast, testes, thyroid;
  • [3] Cardiac is Adult and Pediatric;
  • [4] For detection of fluid and pleural motion/sliding;
  • [5] Other use includes Urology/Prostate;
  • [6] Intraoperative includes abdominal, thoracic and peripheral;
    • | Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD;
  • | Coded Pulse is for digitally encoded harmonics.

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Image /page/7/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 inside. The letters are also blue, and they are surrounded by a white, decorative border. The logo is simple and recognizable, and it is often used to represent the company.

Diagnostic Ultrasound Indications for Use Form GE LOGIQ e with E8C-RS Transducer

Mode of Operation
Clinical ApplicationBMPW
DopplerCW
DopplerColor
DopplerColor
MPDI*Combined
Modes*Harmonic
ImagingCoded
Pulse`Other
Anatomy/Region of Interest
Ophthalmic
Fetal / ObstetricsPPPPPPP
Abdominal[1]PPPPPPP
Pediatric
Small Organ [2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Thoracic/Pleural[4]
Other[5]PPPPPPP
Exam Type, Means of Access
Transesophageal
TransrectalPPPPPPP
TransvaginalPPPPPPP
Intraoperative[6]
Interventional Guidance
Tissue Biopsy/Fluid DrainagePPPPPPP
Vascular Access (IV, PICC)
Nerve Block

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

N = new indication; P= previously cleared by FDA K133533 ; P= previously cleared by FDA K113690

Notes: [1] Abdominal includes GYN and Urological;

  • [2] Small Organ includes breast, testes, thyroid;
  • [3] Cardiac is Adult and Pediatric;
  • [4] For detection of fluid and pleural motion/sliding;
  • [5] Other use includes Urology/Prostate;
  • [6] Intraoperative includes abdominal, thoracic and peripheral;
    • | Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD;
  • | Coded Pulse is for digitally encoded harmonics.

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Image /page/8/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 inside. The letters are also blue, and they are surrounded by a white, decorative border. The logo is simple and recognizable, and it is often used to represent the company.

Diagnostic Ultrasound Indications for Use Form GE LOGIQ e with 9L-RS Transducer

Mode of Operation
Clinical ApplicationBMPW
DopplerCW
DopplerColor
DopplerColor
MPDICombined
Modes *Harmonic
ImagingCoded
PulseOther
Anatomy/Region of Interest
Ophthalmic
Fetal / Obstetrics
Abdominal [1]PPPPPPPP
PediatricPPPPPPPP
Small Organ [2]PPPPPPPP
Neonatal Cephalic
Adult Cephalic
Cardiac [3]
Peripheral VascularPPPPPPPP
Musculo-skeletal ConventionalPPPPPPPP
Musculo-skeletal SuperficialPPPPPPPP
Thoracic/Pleural [4]PPPPPPPP
Other [5]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Intraoperative[6]PPPPPPPP
Interventional Guidance
Tissue Biopsy/Fluid DrainagePPPPPPP
Vascular Access (IV, PICC)PPPPPPP
Nerve BlockPPPPPPP

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

N = new indication; P= previously cleared by FDA K133533 ; P= previously cleared by FDA K113690

Notes: [1] Abdominal includes GYN and Urological;

[2] Small Organ includes breast, testes, thyroid;

[3] Cardiac is Adult and Pediatric;

[4] For detection of fluid and pleural motion/sliding;

[5] Other use includes Urology/Prostate;

[6] Intraoperative includes abdominal, thoracic and peripheral;

[*]Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD;

[*] Coded Pulse is for digitally encoded harmonics.

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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 frame is made up of a series of curved lines that resemble swirling patterns. The logo is colored in a shade of blue.

Diagnostic Ultrasound Indications for Use Form GE LOGIQ e with 12L-RS Transducer

| Clinical Application | B | M | PW
Doppler | CW
Doppler | Color
Doppler | Color
M | PDI | Combined
Modes* | Harmonic
Imaging | Coded
Pulse` | Other |
|-------------------------------|---|---|---------------|---------------|------------------|------------|-----|--------------------|---------------------|-----------------|-------|
| Anatomy/Region of Interest | | | | | | | | | | | |
| Ophthalmic | P | P | P | | P | | P | P | P | P | |
| Fetal / Obstetrics | P | P | P | | P | | P | P | P | P | |
| Abdominal[1] | P | P | P | | P | | P | P | P | P | |
| Pediatric | P | P | P | | P | | P | P | P | P | |
| Small Organ [2] | P | P | P | | P | | P | P | P | P | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [3] | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | | P | P | P | P | |
| Musculo-skeletal Conventional | P | P | P | | P | | P | P | P | P | |
| Musculo-skeletal Superficial | P | P | P | | P | | P | P | P | P | |
| Thoracic/Pleural[4] | P | P | P | | P | | P | P | P | P | |
| Other[5] | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Intraoperative[6] | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Tissue Biopsy/Fluid Drainage | P | P | P | | P | | P | P | P | P | |
| Vascular Access (IV, PICC) | P | P | P | | P | | P | P | P | P | |
| Nerve Block | P | P | P | | P | | P | P | P | P | |

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

N = new indication; P= previously cleared by FDA K133533 ; P= previously cleared by FDA K113690

Notes: [1] Abdominal includes GYN and Urological;

[2] Small Organ includes breast, testes, thyroid;

[3] Cardiac is Adult and Pediatric;

[4] For detection of fluid and pleural motion/sliding;

[5] Other use includes Urology/Prostate;

[6] Intraoperative includes abdominal, thoracic and peripheral;

[*]Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD;

["] Coded Pulse is for digitally encoded harmonics.

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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 shape. The circle is not a solid line but rather a series of curved, wave-like elements that create a sense of motion or energy around the letters. The color of the logo is a light blue.

Diagnostic Ultrasound Indications for Use Form GE LOGIQ e with L4-12t-RS Transducer

Mode of Operation
Clinical ApplicationBMPW
Doppler Doppler DopplerCWColorColor
MPDI Combined
ModesHarmonic
ImagingCoded
PulseOther
Anatomy/Region of Interest
OphthalmicPPPPPPP
Fetal / Obstetrics
Abdominal 11
PediatricPPPPPPP
Small Organ [2]PPPPPPP
Neonatal Cephalic
Adult Cephalic
Cardiac!3]
Peripheral VascularPPPPPPP
Musculo-skeletal ConventionalPPPPPPP
Musculo-skeletal SuperficialPPPPPPP
Thoracic/Pleural14]PPPPPPP
Other[5]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Intraoperative[6]
Interventional Guidance
Tissue Biopsy/Fluid DrainagePPPPPPPlb
Vascular Access (IV, PICC)PPPPPPPP
Nerve BlockPPPPPPPP

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

N = new indication; P= previously cleared by FDA K133533 ; P= previously cleared by FDA K113690

Notes: [1] Abdominal includes GYN and Urological;

  • [2] Small Organ includes breast, testes, thyroid;
  • [3] Cardiac is Adult and Pediatric;
  • [4] For detection of fluid and pleural motion/sliding;
  • [5] Other use includes Urology/Prostate;
  • [6] Intraoperative includes abdominal, thoracic and peripheral;
  • [*]Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD;
  • ] Coded Pulse is for digitally encoded harmonics.

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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 frame is made up of a series of curved lines that resemble swirling patterns. The logo is colored in a shade of blue.

Diagnostic Ultrasound Indications for Use Form GE LOGIQ e with L8-18i-RS Transducer

Mode of Operation
Clinical ApplicationBMPW
DopplerCW
DopplerColor
DopplerColor
MPDICombined
Modes*Harmonic
ImagingCoded
Pulse'Other
Anatomy/Region of Interest
Ophthalmic
Fetal / Obstetrics
Abdominal[1]PPPPPPPP
PediatricPPPPPPPP
Small Organ[2]PPPPPPPP
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral VascularPPPPPPPP
Musculo-skeletal ConventionalPPPPPPPP
Musculo-skeletal SuperficialPPPPPPPP
Thoracic/Pleural[4]PPPPPPPP
Other[5]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Intraoperative[6]PPPPPPPP
Interventional Guidance
Tissue Biopsy/Fluid DrainagePPPPPPPP
Vascular Access (IV, PICC)PPPPPPPP
Nerve BlockPPPPPPPP

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

N = new indication; P= previously cleared by FDA K133533 ; P= previously cleared by FDA K113690

Notes: [1] Abdominal includes GYN and Urological;

[2] Small Organ includes breast, testes, thyroid;

[3] Cardiac is Adult and Pediatric;

[4] For detection of fluid and pleural motion/sliding;

[5] Other use includes Urology/Prostate;

[6] Intraoperative includes abdominal, thoracic and peripheral;

[*]Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD;

[*] Coded Pulse is for digitally encoded harmonics.

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Image /page/12/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' written in a stylized script, enclosed within a blue circle. The circle has decorative elements resembling water droplets or stylized leaves around its perimeter.

Diagnostic Ultrasound Indications for Use Form GE LOGIQ e with L10-22-RS Transducer

Mode of Operation
Clinical ApplicationBMPW
DopplerCW
DopplerColor
DopplerColor
MPDICombined
Modes*Harmonic
ImagingCoded
Pulse'Other
Anatomy/Region of Interest
Ophthalmic
Fetal / Obstetrics
Abdominal[1]
Pediatric
Small Organ [2]PPPPPPP
Neonatal Cephalic
Adult Cephalic
Cardiac [3]
Peripheral VascularPPPPPPP
Musculo-skeletal ConventionalPPPPPPP
Musculo-skeletal SuperficialPPPPPPP
Thoracic/Pleural [4]
Other [5]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Intraoperative[6]
Interventional Guidance
Tissue Biopsy/Fluid DrainagePPPPPPP
Vascular Access (IV, PICC)PPPPPPP
Nerve BlockPPPPPPP

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

N = new indication; P= previously cleared by FDA K133533 ; P= previously cleared by FDA K113690

Notes: [1] Abdominal includes GYN and Urological;

[2] Small Organ includes breast, testes, thyroid;

[3] Cardiac is Adult and Pediatric;

[4] For detection of fluid and pleural motion/sliding;

[5] Other use includes Urology/Prostate;

[6] Intraoperative includes abdominal, thoracic and peripheral;

[*]Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD;

] Coded Pulse is for digitally encoded harmonics.

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Image /page/13/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 inside. The letters are also blue, and they are surrounded by a white, decorative border. The logo is simple and recognizable, and it is often used to represent the company.

Diagnostic Ultrasound Indications for Use Form GE LOGIQ e with 3Sc-RS Transducer

Mode of Operation
Clinical ApplicationBMPW
DopplerCW
DopplerColor
DopplerColor
MPDICombined
Modes*Harmonic
ImagingCoded
PulseOther
Anatomy/Region of Interest
OphthalmicPPPPPPPPPP
Fetal / ObstetricsPPPPPPPPPP
Abdominal[1]PPPPPPPPPP
PediatricPPPPPPPPPP
Small Organ[2]
Neonatal Cephalic
Adult CephalicPPPPPPPPPP
Cardiac[3]PPPPPPPPPP
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Thoracic/Pleural[4]PPPPPPPPPP
Other[5]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Intraoperative[6]
Interventional Guidance
Tissue Biopsy/Fluid DrainagePPPPPPPPPP
Vascular Access (IV, PICC)PPPPPPPPPP
Nerve Block

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

N = new indication; P= previously cleared by FDA K133533 ; P= previously cleared by FDA K113690

Notes: [1] Abdominal includes GYN and Urological;

  • [2] Small Organ includes breast, testes, thyroid;
    [3] Cardiac is Adult and Pediatric;

[4] For detection of fluid and pleural motion/sliding;

[5] Other use includes Urology/Prostate;

[6] Intraoperative includes abdominal, thoracic and peripheral;

[*]Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD;

] Coded Pulse is for digitally encoded harmonics.

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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 circular frame. The frame is made up of a series of curved lines that resemble swirling patterns. The logo is colored in a shade of blue.

Diagnostic Ultrasound Indications for Use Form GE LOGIQ e with LK760-RS Transducer

Mode of Operation
Clinical ApplicationBMPW
DopplerCW
DopplerColor
DopplerColor
MPDICombined
Modes*Harmonic
ImagingCoded
Pulse'Other
Anatomy/Region of Interest
Ophthalmic
Fetal / Obstetrics
Abdominal[1]
Pediatric
Small Organ [2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal ConventionalNNNNNNNNN
Musculo-skeletal SuperficialNNNNNNNNN
Thoracic/Pleural[4]
Other[5]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Intraoperative[6]
Interventional Guidance
Tissue Biopsy/Fluid Drainage
Vascular Access (IV, PICC)
Nerve Block

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

N = new indication; P= previously cleared by FDA K133533 ; P= previously cleared by FDA K113690

Notes: [1] Abdominal includes GYN and Urological;

  • [2] Small Organ includes breast, testes, thyroid;
    [3] Cardiac is Adult and Pediatric;

[4] For detection of fluid and pleural motion/sliding;

[5] Other use includes Urology/Prostate;

[6] Intraoperative includes abdominal, thoracic and peripheral;

[*]Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD;

] Coded Pulse is for digitally encoded harmonics.

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Image /page/15/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 color of the logo is a light blue.

Diagnostic Ultrasound Indications for Use Form GE LOGIQ e with 6S-RS Transducer

Mode of Operation
Clinical ApplicationBMPW
DopplerCW
DopplerColor
DopplerColor
MPDICombined
Modes*Harmonic
ImagingCoded
Pulse'Other
Anatomy/Region of Interest
Ophthalmic
Fetal / Obstetrics
Abdominal[1]PPPPPPPPPP
PediatricPPPPPPPPPP
Small Organ[2]
Neonatal CephalicPPPPPPPPPP
Adult CephalicPPPPPPPPPP
Cardiac[3]PPPPPPPPPP
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Thoracic/Pleural[4]PPPPPPPPPP
Other[5]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Intraoperative[6]
Interventional Guidance
Tissue Biopsy/Fluid Drainage
Vascular Access (IV, PICC)PPPPPPPPPP
Nerve Block

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

N = new indication; P= previously cleared by FDA K133533 ; P= previously cleared by FDA K113690

Notes: [1] Abdominal includes GYN and Urological;

  • [2] Small Organ includes breast, testes, thyroid;
  • [3] Cardiac is Adult and Pediatric;
  • [4] For detection of fluid and pleural motion/sliding;

[5] Other use includes Urology/Prostate;

  • [6] Intraoperative includes abdominal, thoracic and peripheral;
  • [*]Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD;
  • [*] Coded Pulse is for digitally encoded harmonics.

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Image /page/16/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 color of the logo is a light blue.

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

Mode of Operation
Clinical ApplicationBMPW
DopplerCW
DopplerColor
DopplerColor
MPDICombined
Modes*Harmonic
ImagingCoded
PulseOther
Anatomy/Region of Interest
Ophthalmic
Fetal / Obstetrics
Abdominal[1]
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]P1P1P1P1P1P1P1P1P1P1P1
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Thoracic/Pleural[4]
Other[5]
Exam Type, Means of Access
TransesophagealP1P1P1P1P1P1P1P1P1P1P1
Transrectal
Transvaginal
Intraoperative[6]
Interventional Guidance
Tissue Biopsy/Fluid Drainage
Vascular Access (IV, PICC)
Nerve Block

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

N = new indication; P = previously cleared by FDA K133533; P1= previously cleared by FDA K113690

Notes: [1] Abdominal includes GYN and Urological;

[2] Small Organ includes breast, testes, thyroid;

[3] Cardiac is Adult and Pediatric:

[4] For detection of fluid and pleural motion/sliding;

[5] Other use includes Urology/Prostate;

[6] Intraoperative includes abdominal, thoracic and peripheral;

[*]Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD;

[*] Coded Pulse is for digitally encoded harmonics.

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Image /page/17/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in white, stylized in a cursive font. The circle is surrounded by a swirling, wave-like pattern, also in white, which gives the logo a dynamic and fluid appearance.

510(k) Summary

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

April 15, 2015 Date: GE Medical Systems Ultrasound and Primary Care Diagnostics, Submitter: 9900 Innovation Drive Wauwatosa, WI 53226

Primary Contact Person:Tracey Ortiz
Regulatory Affairs Director
GE Healthcare
T:(414)721-6120
F:(414)918-8275
Secondary Contact Person: Jiawei Zhang
Regulatory Affairs
GE Medical Systems (China) Co, Ltd.
T: +86 510 8527 8259
F: +86 510 8522 7347
Device:Trade Name: LOGIQ e
--------------------------------

Common/Usual Name: Ultrasound system

  • Classification Names: Class II
    Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-IYN Product Code: Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX

  • LOGIQ e K133533 Predicate Device(s): LOGIQ e, LOGIQ i, Vivid e - K113690
    Device Description: The LOGIQ e device is a laptop ultrasound console approximately 70mm in height, 295mm in width and 346mm in length with integrated keyboard, a color video LCD type display and several interchangeable electronic-array transducers. It has digital acquisition, processing and display capability and operates from an integrated battery or separate power supply/charger.

The device is a general purpose ultrasound system intended for Intended Use: ultrasound imaging, measurement and analysis of the human body for multiple clinical applications including: Ophthalmic: Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Musculoskeletal

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Image /page/18/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 stylized and connected, and there are swirling designs around the letters. The blue color is a medium shade, and the white letters stand out clearly against the blue background.

GE Healthcare

510(k) Premarket Notification Submission

Conventional & Superficial: Transrectal: Transvaginal: Transesophageal: Intraoperative (abdominal. thoracic and peripheral); Thoracic/Pleural for motion and fluid detection and imaging guidance of interventional procedures (e.g. Nerve Block; Vascular Access).

The LOGIQ e employs the same fundamental scientific Technology: technology as its predicate devices.

Determination of Comparison to Predicates

Substantial Equivalence: The LOGIQ e is substantially equivalent to the predicate devices with regards to intended use, imaging capabilities, technologicial characteristics and safety and effectiveness.

  • . The systems are all intended for diagnostic ultrasound imaging and fluid flow analysis.
  • . The LOGIO e and predicate LOGIO e systems have the same clinical intended use with the addition of the transesophageal application
  • The LOGIO e and predicate LOGIO e systems have the same imaging modes.
  • . The transducers of LOGIO e and predicate LOGIO e system are the same except for:
    • o Adding 6Tc-RS. cleared in LOGIO e (K113690)
    • Adding 4C-RS, cleared in LOGIQ e (K113690), O expanding indications for use to include musculoskeletal(conventional & superficial), Tissue Biopsy/Fluid Drainage, Nerve Block
    • Adding new transducer for GE, LK760-RS, it is a o linear transducer similar to the 9L-RS that was cleared on the predicate LOGIQ e system (K133533).
  • 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 e and predicate LOGIQ e systems have the ● same capability in terms of performing measurements, capturing digital images, reviewing and reporting studies.
  • . The LOGIO e and predicate systems have been designed in compliance with approved electrical and physical safety standards.

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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 blue circle. The circle has a swirling design around the letters, giving it a dynamic and recognizable appearance. The logo is simple, yet distinctive, and is widely recognized as the symbol of the General Electric company.

  • The Advanced Isolation Cart is being added.
  • The embedded operating system has been changed from ● Windows XP to Windows 7.

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. The LOGIQ e and its applications comply with voluntary standards:

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

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

  • . Risk Analysis
  • Requirements Reviews ●
  • Design Reviews
  • Testing on unit level (Module verification) ●
  • Integration testing (System verification) ●

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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 circle. The circle has a wavy, water-like design around the letters. The logo is blue.

  • Performance testing (Verification) ●
  • Safety testing (Verification) .
  • Simulated use Testing (Validation) .

Transducer materials and other patient contact materials are biocompatible.

Summary of Clinical Tests:

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

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