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; Cardiac (adult & pediatric); Peripheral Vascular; Musculoskeletal Conventional & Superficial; Transvaginal; 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 a separate power supply/charger.

AI/ML Overview

The GE LOGIQ e Diagnostic Ultrasound System is a Class II device intended for ultrasound imaging, measurement and analysis of the human body for multiple clinical applications.

1. Table of Acceptance Criteria and Reported Device Performance:

The document provided does not specify quantitative acceptance criteria or a direct performance study comparing the device against such criteria. Instead, the substantial equivalence determination is based on the device employing the "same fundamental scientific technology as its predicate devices" and being equivalent in "intended use, imaging capabilities, technological characteristics and safety and effectiveness."

The document details the device's intended uses and modes of operation for various clinical applications with different transducers. It indicates whether an indication is "new" (N) or "previously cleared by FDA" (P) with a predicate device. This implies that for "P" indications, the device performance is considered equivalent to the predicate, and for "N" indications, the performance meets established safety and effectiveness standards, likely through non-clinical testing.

2. Sample Size Used for the Test Set and Data Provenance:

The document states, "The subject of this premarket submission, LOGIQ e, did not require clinical studies to support substantial equivalence." This means there was no specific "test set" of patient data used in a clinical study to evaluate the device's performance against pre-defined acceptance criteria, as the assessment was primarily based on non-clinical evaluations and comparison to predicate devices. Therefore, there is no information on sample size or data provenance from a clinical test set.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Since no clinical studies were conducted to establish performance with a test set, there is no information on the number or qualifications of experts used to establish ground truth in this context.

4. Adjudication Method for the Test Set:

As no clinical studies were conducted, there is no mention of an adjudication method used for a test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was mentioned or conducted. The submission explicitly states that clinical studies were not required.

6. Standalone Performance:

Standalone performance (algorithm only without human-in-the-loop) in a clinical context was not directly assessed via a clinical study, as the device is an ultrasound system requiring human operation. However, the non-clinical tests assess the inherent performance of the system against various safety and technical standards (e.g., acoustic output, electrical safety).

7. Type of Ground Truth Used:

For the purpose of establishing substantial equivalence, the "ground truth" primarily relied on:

Comparison to Predicate Devices: The performance and safety characteristics of the GE LOGIQ e were compared against its predicate devices (LOGIQ i/e, Vivide - K113690; LOGIQ S8 - K131527; SonoSite Edge - K113156; Voluson S6/S8 - K120741). The assumption is that if the new device is technologically equivalent and intended for similar uses as a legally marketed device, its performance is also equivalent.
Compliance with Voluntary Standards: Non-clinical tests were conducted to ensure compliance with a range of safety and performance standards (e.g., AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, NEMA UD 3 & 2, ISO10993-1, ISO14971, DICOM). These standards act as a form of "ground truth" for technical, electrical, acoustic, and biological safety and efficacy.

8. Sample Size for the Training Set:

This information is not applicable as the submission discusses a medical device (ultrasound system), not an AI algorithm that would typically have a "training set" of data in the context of machine learning. The "development of the system" involved quality assurance measures such as risk analysis, requirements reviews, design reviews, unit-level testing, integration testing, performance testing, safety testing, and simulated use testing, but these activities do not involve a "training set" in the sense of machine learning.

9. How the Ground Truth for the Training Set Was Established:

This question is not applicable for the same reason as point 8.

Summary

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510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided: November 15, 2013 Date: Submitter: GE Healthcare 9900 Innovation Drive Wauwatosa, WI 53226 Primary Contact Person: Bryan Behn Regulatory Affairs Manager GE Healthcare T:(414)721-4214 F:(414)918-8275 Secondary Contact Person: Jiawei ZHANG Regulatory Affairs GE Healthcare T: +86 510 8527 8259 F: +86 510 8522 7347 LOGIQ e Diagnostic Ultrasound System Device: Trade Name: Common/Usual Name: LOGIO e Class II Classification Names: Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-IYN Product Code: Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-1YO Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX LOGIQ i/e, Vivide - K113690 Predicate Device(s): LOGIQ S8 -- K131527 SonoSite Edge - K113156 Voluson S6/S8 - K120741 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 a separate power supply/charger.

Ophthalmic; Fetal/OB; Abdominal (GYN & Urology); Pediatric; Intended Use: Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Musculoskeletal Conventional & Superficial; Transrectal; Transvaginal; Intraoperative (abdominal, thoracic and

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peripheral); Thoracic/Pleural for motion and fluid detection and imaging guidance of interventional procedures (e.g. Nerve Block; Vascular Access).

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

Determination of Substantial Equivalence:

Comparison to Predicate Devices

The LOGIQ e system is substantially equivalent to the predicate devices with regard to intended use, imaging capabilities, technological characteristics and safety and effectiveness.

. The systems are all intended for diagnostic ultrasound imaging and fluid flow analysis.
. The LOGIQ e and predicate LOGIQ e systems have the same clinical intended use with the exception of Ophthalmic which is substantially equivalent to Ophthalmic on the SonoSite Edge (K113156) and the transesophageal application has been removed from the new version of the LOGIQ e.
. The LOGIO e and predicate LOGIO e systems have the same imaging modes.
The LOGIQ e and predicate LOGIO e systems . transducers are identical accept for the C1-5-RS and 3Sc-RS which are the same transducers on predicate Voluson S6/S8 (K120741), and the L4-12t-RS and L10-22-RS. which are linear transducers similar to the L8-18i-RS.
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 similar capability in terms of performing measurements, capturing digital images, reviewing and reporting studies. TVD and High-Res PDI are similar to predicate LOGIQ S8 (K131527).
The LOGIQ e and predicate systems have been designed . in compliance with approved electrical and physical safety standards.

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Summary of Non-Clinical Tests:

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

1. AAMI/ANSI ES60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety
1. JEC60601-1-2. Medical Electrical Equipment -Part 1-2:General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility Requirements and Tests
1. IEC60601-2-37, Medical Electrical Equipment -Part 2-37:Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment
1. NEMA UD 3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
1. ISO10993-1, Biological Evaluation of Medical Devices- Part 1: Evaluation and Testing- Third Edition
1. NEMA UD 2. Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
1. ISO14971. Application of risk management to medical devices
1. NEMA. Digital Imaging and Communications in Medicine (DICOM) Sct. (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)

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K1335533
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Transducer material and other patient contact materials such as needle guidance kits 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).

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Public Health Service

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

February 12, 2014

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

Re: K133533

Trade/Device Name: GE LOGIQ e Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: January 3, 2014 Received: January 6, 2014

Dear Mr. Behn:

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

This determination of substantial equivalence applies to the following transducers intended for use with the LOGIQ e Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number
C1-5-RS	8C-RS
E8C-RS	9L-RS
12L-RS	L4-12t-RS
L8-18i-RS	L10-22-RS
3Sc-RS	6S-RS

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

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Page 2-Mr. Bryan Behn

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resources/or You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/Reportal?rgblem/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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours,

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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K133533 510(k) Number (if known):

Device Name: LOGIQ e

Indications for Use:

Prescription Use______________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use N/A (Part 21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Janningh. Marge

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(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health K133533 510(k)

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Diagnostic Ultrasound Indications for Use Form GE LOGIQ e Ultrasound

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

	Mode of Operation
Clinical Application	B	M	PW	CW	Color	ColorM	PDI	CombinedModes	HarmonicImaging	CodedPulse	Other
Anatomy/Region of Interest
Ophthalmic	N	N	N	N	N	N	N	N	N	N	N
Fetal / Obstetrics	P	P	P	P	P	P	P	P	P	P	P
Abdominal1	P	P	P	P	P	P	P	P	P	P	P
Pediatric	P	P	P	P	P	P	P	P	P	P	P
Small Organ [2]	P	P	P	P	P	P	P	P	P	P	P
Neonatal Cephalic	P	P	P	P	P	P	P	P	P	P	P
Adult Cephalic	P	P	P	P	P	P	P	P	P	P	P
Cardiac[3]	P	P	P	P	P	P	P	P	P	P	P
Peripheral Vascular	P	P	P	P	P	P	P	P	P	P	P
Musculo-skeletal Conventional	P	P	P	P	P	P	P	P	P	P	P
Musculo-skeletal Superficial	P	P	P	P	P	P	P	P	P	P	P
Thoracic/Pleural(specify)[4]	P	P	P	P	P	P	P	P	P	P	P
Other[5]	P	P	P	P	P	P	P	P	P	P	P
Exam Type, Means of Access
Transesophageal
Transrectal	P	P	P	P	P	P	P	P	P	P
Transvaginal	P	P	P	P	P	P	P	P	P	P
Intraoperative(specify)[4]	P	P	P	P	P	P	P	P	P	P
Interventional Guidance
Tissue Biopsy/Fluid Drainage	P	P	P	P	P	P	P	P	P	P	P
Vascular Access (IV, PICC)	P	P	P	P	P	P	P	P	P	P	P
Nerve Block	P	P	P	P	P	P	P	P	P	P	P

N = new indication: P = previously cleared by FDA KI13690

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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Prescription Use (Per 21 CFR 801.109)

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Diagnostic Ultrasound Indications for Use Form

GE LOGIQ e with C1-5-RS Transducer

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

	Mode of Operation
Clinical Application	B	M	PW	CW	Color	ColorM	PDI	CombinedModes	HarmonicImaging	CodedPulse	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	N	N	N		N		N	N	N	N
Thoracic/Pleural(specify)[4]
Other[5]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Intraoperative(specify)[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

N = new indication: P = previously cleared by FDA (K120741)

[ I ] Abdominal includes GYN and Urological: Notes:

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

[3] Cardiac is Adult and Pediatric:

[4] For detection of Nuid 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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Prescription Use (Per 21 CFR 801.109)

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Diagnostic Ultrasound Indications for Use Form

GE LOGIQ e with 8C-RS Transducer

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

	Mode of Operation
Clinical Application	B	M	PW	CW	Color	ColorM	PDI	CombinedModes	HarmonicImaging	CodedPulse	Other
Anatomy/Region of Interest
Ophthalmic	N	N	N		N		N	N	N
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	N	N	N		N		N	N	N
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(specify)[4]	P	P	P		P		P	P	P
Other[5]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Intraoperative(specify)[6]
Interventional Guidance
Tissue Biopsy/Fluid Drainage
Vascular Access (IV, PICC)	P	P	P		P		P	P	P
Nerve Block

N = new indication; P = previously cleared by FDA (KI 13690)

[1] Abdominal includes GYN and Urological: Notes:

[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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Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Prescription Use (Per 21 CFR 801.109)

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Diagnostic Ultrasound Indications for Use Form

GE LOGIO e with E8C-RS Transducer

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

	Mode of Operation
Clinical Application	B	M	PW	CW	Color	Colorિ	PDI	CombinedModes	HarmonicImaging	CodedPulse	Other
Anatomy/Region of Interest
Ophthalmic
Fetal / Obstetrics	P	P	P		P		P	P	P
Abdominal("I	P	P	P		P		P	P	P
Pediatric
Small Organ 121
Neonatal Cephalic
Adult Cephalic
Cardiacli
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Thoracic/Pleural(specify) 4)
Other 15	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(specify)[6]
Interventional Guidance
Tissue Biopsy/Fluid Drainage	P	P	P		P		P	P	P
Vascular Access (IV, PICC)
Maria Rinak

N = new indication: P = previously cleared by FDA(K113690)

[I] Abdominal includes GYN and Urological: Notes:

[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:

[0] : muuoperative modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD

*] Coded Pulse is for digitally encoded harmonics.

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Prescription Use (Per 21 CFR 801.109)

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Diagnostic Ultrasound Indications for Use Form

GE LOGIQ e with 9L-RS Transducer

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

	Mode of Operation
Clinical Application	B	M	PW	CW	Color	ColorM	PDI	CombinedModes	HarmonicImaging	CodedPulse	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[1]
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(specify)[4]	P	P	P		P		P	P	P	P
Other[5]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Intraoperative(specify)[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
Nenio Alack	P	P	P		P		P	P	P

N = new indication: P = previously cleared by FDA(K | 13690)

Notes: [1] Abdominal includes GYN and Urological:

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

[3] Cardiac is Adult and Pediatric:

[4] For detection of tluid 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.

IPLEASE DO NOT WRITE BELOW THIS I.INE - CONTINUI: ON ANOTHER PAGE IF NEEDED I

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Prescription Use (Per 21 CFR 801.109)

Page 6 of 12

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Image /page/12/Picture/0 description: The image shows a black and white logo of General Electric (GE). The logo consists of the letters 'G' and 'E' intertwined within a circular border. The letters are stylized with curved lines, giving the logo a classic and recognizable appearance. The image is simple and clear, focusing on the iconic GE brand symbol.

Diagnostic Ultrasound Indications for Use Form

GE LOGIO e with 12L-RS Transducer

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

Clinical Application	Mode of Operation
	B	M	PW	CW	Color	ColorM	PDI	CombinedModes	HarmonicImaging	CodedPulse	Other
Anatomy Region of Interest
Ophthalmic	N	N	N		N		N	N	N	N
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(specify)[4]	P	P	P		P		P	P	P	P
Other[5]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Intraoperative(specify)[4]
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

N = new indication: P = previously cleared by FDA (K113690)

| | | Abdominal includes (iYN and Urological: Noles:

[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/l'WD

['] Coded Pulse is for digitally encoded harmonics.

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Prescription Use (Per 21 CFR 801.109)

Page 7 of 12

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

Image /page/13/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The logo is in black and white and appears to be a vintage or classic version of the GE logo.

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ e with L4-12t-RS Transducer

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

Clinical Application	Mode of Operation
	B	M	PW	CW	Color	ColorM	PDI	CombinedModes	HarmonicImaging
Anatomy/Region of Interest
Ophthalmic	N	N	N		N		N	N	N
Fetal / Obstetrics
Abdominal1
Pediatric	N	N	N		N		N	N	N
Small Organ l2l	N	N	N		N		N	N	N
Neonatal Cephalic
Adult Cephalic
Cardiacl3l
Peripheral Vascular	N	N	N		N		N	N	N
Musculo-skeletal Conventional	N	N	N		N		N	N	N
Musculo-skeletal Superficial	N	N	N		N		N	N	N
Thoracic/Pleural(specify)l4l	N	N	N		N		N	N	N
Othersl5l
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Intraoperative(specify) l6
Interventional Guidance
Tissue Biopsy/Fluid Drainage	N	N	N		N		N	N	N
Vascular Access (IV, PICC)	N	N	N		N		N	N	N
Nerve Block	N	N	N		N		N	N	N

N = new indication

[1] Abdominal includes GYN and Urological: Notes:

[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, R/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 NEEDEDI

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Prescription Use (Per 21 CFR 801.109)

Page 8 of 12

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Image /page/14/Picture/0 description: The image shows a black and white logo. The logo is circular and contains the letters 'GE' in a stylized, cursive font. The letters are intertwined and surrounded by a circular border. The logo appears to be a vintage or classic design.

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ e with L8-18i-RS Transducer

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

Clinical Application	Mode of Operation
	B	M	PW	CW	Color	ColorM	PDI	CombinedModes	HarmonicImaging	CodedPulse	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(specify)[4]	P	P	P		P		P	P	P	P
Other[5]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Intraoperative(specify)[4]	N	N	N		N		N	N	N	N
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

N = new indication; P = previously cleared by FDA (KI 13690)

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;

JCombined 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)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Prescription Use (Per 21 CFR 801.109)

Page 9 of 12

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Image /page/15/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The design is simple and recognizable, representing the company's brand identity.

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ e with L10-22-RS Transducer

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

Clinical Application	Mode of Operation
	B	M	PW	CW	Color	ColorM	PDI	CombinedModes*	HarmonicImaging	CodedPulse*	Other
Anatomy/Region of Interest
Ophthalmic
Fetal / Obstetrics
Abdominal[1]
Pediatric
Small Organ[2]	N	N	N		N		N	N	N
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular	N	N	N		N		N	N	N
Musculo-skeletal Conventional	N	N	N		N		N	N	N
Musculo-skeletal Superficial	N	N	N		N		N	N	N
Thoracic/Pleural(specify)[4]
Other[5]
Exam Type. Means of Access
Transesophageal
Transrectal
Transvaginal
Intraoperative(specify)[4]
Interventional Guidance
Tissue Biopsy/Fluid Drainage	N	N	N		N		N	N	N
Vascular Access (IV, PICC)	N	N	N		N		N	N	N
Nerve Block	N	N	N		N		N	N	N

N = new indication

[ ] ] Abdominal includes GYN and Urological; Notes:

[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!

Concurrence of CDRH. Office of In Vitro Diagnostics and Radiological Health (OIR)

Prescription Use (Per 21 CFR 801.109)

Page 10 of 12

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Image /page/16/Picture/0 description: The image shows the General Electric (GE) logo. The logo is a circular design with the letters "GE" intertwined in the center. The logo is black and white and has a vintage look.

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ e with 3Sc-RS Transducer

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

Clinical Application	Mode of Operation
	B	M	PW	CW	Color	ColorM	PDI	CombinedModes	HarmonicImaging	CodedPulse	Other
Anatomy: Region of Interest
Ophthalmic	N	N	N	N	N	N	N	N	N	N
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(specify)[4]	N	N	N	N	N	N	N	N	N	N
Other[5]
Exam Type. Means of Access
Transesophageal
Transrectal
Transvaginal
Intraoperative(specify)[6]
Interventional Guidance
Tissue Biopsy/Fluid Drainage	N	N	N	N	N	N	N	N	N	N
Vascular Access (IV, PICC)	N	N	N	N	N	N	N	N	N	N
Nerve Block

N = new indication: P = previously cleared by FDA(K120741)

[1] Abdominal includes GYN and Urological: Notes:

[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)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Prescription Use (Per 21 CFR 801.109)

Page 11 of 12

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Image /page/17/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "G" and "E" intertwined within a circular border. The logo is in black and white, with the letters and border appearing in black against a white background.

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ e with 6S-RS Transducer

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

Clinical Application	Mode of Operation
	B	M	PW	CW	Color	ColorM	PDI	CombinedModes	HarmonicImaging	CodedPulse*	Other*
Anatomy/Region of Interest
Ophthalmic
Fetal / Obstetrics
Abdominal1	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	P	P	P	P	P	P	P	P	P	P
Adult Cephalic	P	P	P	P	P	P	P	P	P	P
Cardiac1	P	P	P	P	P	P	P	P	P	P
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Thoracic/Pleural(specify)[4]	P	P	P	P	P	P	P	P	P	P
Other[5]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Intraoperative(specify)[4]
Interventional Guidance
Tissue Biopsy/Fluid Drainage
Vascular Access (IV, PICC)	P	P	P	P	P	P	P	P	P	P

N = new indication: P = previously cleared by FDA (KI 13690)

[1] Abdominal includes GYN and Urological: Notes:

[3] Cardiac is Adult and Pediatric;

Prescription Use (Per 21 CFR 801.109)

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

(*)Combined modes are B/M. B/PWD, B/Color/PWD. B/Power/PWD. B/Power/PW/D

[4] Coded Pulse is for digitally encoded harmonics.

(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)

Page 12 of 12

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) Number

Janning H. Morse

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.