LOGIQ e

K151028 · GE Medical Systems Ultrasound and Primary Care Diagnostics · IYN · Jun 18, 2015 · Radiology

Device Facts

• Record ID: K151028
• Device Name: LOGIQ e
• Applicant: GE Medical Systems Ultrasound and Primary Care Diagnostics
• Product Code: IYN · Radiology
• Decision Date: Jun 18, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

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 Story

LOGIQ e is a portable, laptop-style ultrasound console (approx. 70mm x 295mm x 346mm) featuring an integrated keyboard, color LCD display, and interchangeable electronic-array transducers. It performs digital acquisition, processing, and display of ultrasound signals for diagnostic imaging and fluid flow analysis. Operated by clinicians in various settings, the device supports multiple modes (B, M, PW/CW Doppler, Color Doppler, PDI, Harmonic Imaging, Coded Pulse). It aids clinical decision-making by providing real-time visualization, measurements, and analysis for diverse anatomical regions and interventional procedures. The system operates on an integrated battery or external power supply. The current version updates the operating system from Windows XP to Windows 7 and adds an Advanced Isolation Cart. Clinical benefits include non-invasive diagnostic imaging and guidance for procedures like nerve blocks and vascular access.

Clinical Evidence

No clinical studies were required to support substantial equivalence. The device relies on bench testing, including acoustic output measurements, biocompatibility, cleaning/disinfection effectiveness, and thermal/electrical/electromagnetic safety testing. Compliance with standards such as AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 2/UD 3, and ISO 10993 was demonstrated.

Technological Characteristics

Laptop-style ultrasound console with integrated keyboard and color LCD. Uses electronic-array transducers. Modes: B, M, PW/CW Doppler, Color Doppler, PDI, Harmonic Imaging, Coded Pulse. Connectivity: DICOM. Safety standards: AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 2/3. Biocompatible patient-contact materials per ISO 10993. Power: Integrated battery or external supply. OS: Windows 7.

Indications for Use

Indicated for ultrasound imaging, measurement, and analysis of human anatomy including ophthalmic, fetal/OB, abdominal (GYN/urology), pediatric, small organ (breast, testes, thyroid), neonatal/adult cephalic, cardiac, peripheral vascular, musculoskeletal (conventional/superficial), transrectal, transvaginal, transesophageal, and intraoperative applications. Includes interventional guidance for nerve blocks, vascular access, tissue biopsy, and fluid drainage.

Regulatory Classification

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.

Predicate Devices

• LOGIQ e (K133533)
• LOGIQ e (K113690)
• LOGIQ i (K113690)
• Vivid e (K113690)

Submission Summary (Full Text)

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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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely yours.

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)

| <span style="font-size: 10pt;"><input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</span> |
|----------------------------------------------------------------------------------------------------------------------------|
| <span style="font-size: 10pt;"><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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Image /page/3/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a circular frame. The letters and the frame are both blue. The background is white.

#### Diagnostic Ultrasound Indications for Use Form GE LOGIQ e Ultrasound System

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

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

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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<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color<br>M | PDI | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse• | Other |
|-----------------------------------|---|---|---------------|---------------|------------------|------------|-----|--------------------|---------------------|-----------------|-------|
| <i>Anatomy/Region of Interest</i> | | | | | | | | | | | |
| 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] | | | | | | | | | | | |
| <i>Exam Type, Means of Access</i> | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Intraoperative[6] | | | | | | | | | | | |
| <i>Interventional Guidance</i> | | | | | | | | | | | |
| 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.

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

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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 Application | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color<br>M | PDI | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse | Other |
| Anatomy/Region of Interest | | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | P1 | P1 | P1 | | P1 | | P1 | P1 | P1 | P1 | |
| Abdominal[1] | P1 | P1 | P1 | | P1 | | P1 | P1 | P1 | P1 | |
| Pediatric | P1 | P1 | P1 | | P1 | | P1 | P1 | P1 | P1 | |
| Small Organ [2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [3] | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | N | N | N | | N | | N | N | N | N | |
| Musculo-skeletal Superficial | N | N | N | | N | | N | N | N | N | |
| Thoracic/Pleural[4] | P1 | P1 | P1 | | P1 | | P1 | P1 | P1 | P1 | |
| Other[5] | P1 | P1 | P1 | | P1 | | P1 | P1 | P1 | P1 | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Intraoperative[6] | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Tissue Biopsy/Fluid Drainage | N | N | N | | N | | N | N | N | N | |
| Vascular Access (IV, PICC) | | | | | | | | | | | |
| Nerve Block | N | N | N | | N | | N | N | N | N | |

#### 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.

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

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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 Application | B | M | PW Doppler | CW Doppler | Color Doppler | Color M | PDI | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse | Other |
| Anatomy/Region of Interest | | | | | | | | | | | |
| Ophthalmic | P | P | P | | P | | P | P | P | | |
| Fetal / Obstetrics | | | | | | | | | | | |
| Abdominal[1] | P | P | P | | P | | P | P | P | | |
| Pediatric | P | P | P | | P | | P | P | P | | |
| Small Organ [2] | P | P | P | | P | | P | P | P | | |
| Neonatal Cephalic | P | P | P | | P | | P | P | P | | |
| Adult Cephalic | P | P | P | | P | | P | P | P | | |
| Cardiac [3] | P | P | P | | P | | P | P | P | | |
| Peripheral Vascular | P | P | P | | P | | P | P | P | | |
| Musculo-skeletal Conventional | P | P | P | | P | | P | P | P | | |
| Musculo-skeletal Superficial | P | P | P | | P | | P | P | P | | |
| Thoracic/Pleural [4] | 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 | | | | | | | | | | | |
| Vascular Access (IV, PICC) | P | P | P | | P | | P | P | P | | |
| 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.

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

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

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

{8}------------------------------------------------

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 Application | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color<br>M | PDI | Combined<br>Modes * | Harmonic<br>Imaging | Coded<br>Pulse | Other |
| Anatomy/Region of Interest | | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | |
| 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] | P | P | P | | P | | P | P | P | P | |
| Interventional Guidance | | | | | | | | | | | |
| Tissue Biopsy/Fluid Drainage | P | P | P | | P | | P | P | P | | |
| Vascular Access (IV, PICC) | P | P | P | | P | | P | P | P | | |
| Nerve Block | 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.

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

{9}------------------------------------------------

Image /page/9/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a circular 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<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color<br>M | PDI | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>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.

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

{10}------------------------------------------------

Image /page/10/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a circular 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 Application | B | M | PW<br>Doppler Doppler Doppler | CW | Color | Color<br>M | | PDI Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other | | |
| Anatomy/Region of Interest | | | | | | | | | | | | | |
| Ophthalmic | P | P | P | | P | | P | P | P | | | | |
| Fetal / Obstetrics | | | | | | | | | | | | | |
| Abdominal 11 | | | | | | | | | | | | | |
| Pediatric | P | P | P | | P | | P | P | P | | | | |
| Small Organ [2] | P | P | P | | P | | P | P | P | | | | |
| Neonatal Cephalic | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | |
| Cardiac!3] | | | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | | P | P | P | | | | |
| Musculo-skeletal Conventional | P | P | P | | P | | P | P | P | | | | |
| Musculo-skeletal Superficial | P | P | P | | P | | P | P | P | | | | |
| Thoracic/Pleural14] | 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 | lb | | | |
| 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.

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

{11}------------------------------------------------

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 Application | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color<br>M | PDI | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse' | Other | |
| Anatomy/Region of Interest | | | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | | |
| 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] | P | P | P | | P | | P | P | P | P | | |
| 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.

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

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

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 Application | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color<br>M | PDI | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse' | Other |
| <i>Anatomy/Region of Interest</i> | | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | |
| Abdominal[1] | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ [2] | P | P | P | | P | | P | P | P | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [3] | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | | P | P | P | | |
| Musculo-skeletal Conventional | P | P | P | | P | | P | P | P | | |
| Musculo-skeletal Superficial | 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 | | |
| Vascular Access (IV, PICC) | P | P | P | | P | | P | P | P | | |
| Nerve Block | 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.

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

{13}------------------------------------------------

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

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

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