GE LOGIQ I, LOGIQ E AND VIVID E

• K Number: K113690
• Device Name: GE LOGIQ I, LOGIQ E AND VIVID E
• Manufacturer: GE HEALTHCARE
• Date Cleared: 2011-12-29 ( 14 days)
• Product Code: IYN ITX IYO
• Regulation Number: 892.1550

Intended Use

The LOGIQ i/e & Vivid e is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Intra-operative (abdominal, thoracic and PV), Musculo-skeletal Conventional & Superficial, Transesophageal, Transrectal and Transvaginal, and Thoracic/Pleural for motion/sliding and fluid detection.

Device Description

The LOGIQ ife & Vivid e is a full-featured, compact and extremely portable ultrasound system consisting of a main console chassis 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. It is used primarily where portability, size and convenience are essential and is available in three variations: LOGIQ e is for general purpose radiology imaging having a variety of options to tailor it for use by the medical specialist for use in various departments and patient care areas (e.g., OR, ER & outpatient care). Accordingly it has various configurations (Software option/standard and probes supporting) for different packages (Nerve, ED, and GI). LOGIO i is a full-featured premium radiology system suitable for physician rounds in a hospital, nursing home where a broader range of high performance is needed. Vivid e is similar to the LOGIO e with an emphasis on cardiology examinations.

Predicate Devices

K102256, K110943

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard digital image processing capabilities but does not mention AI, ML, or any related terms.

Therapeutic

No
The device is described as an ultrasound system intended for imaging and fluid flow analysis, which are diagnostic purposes, not therapeutic.

Diagnostic

Yes

Explanation: The device is an ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body, indicating its use in diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "full-featured, compact and extremely portable ultrasound system consisting of a main console chassis with integrated keyboard, a color video LCD type display and several interchangeable electronic-array transducers." This indicates it is a hardware device with integrated software, not a software-only device.

IVD (In Vitro Diagnostic)

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

Here's why:

• IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body ("in vitro").
• Device Description: The description clearly states that the LOGIQ i/e & Vivid e is an ultrasound system. Ultrasound is an imaging modality that uses sound waves to create images of internal body structures. This is an in vivo (within the living body) diagnostic method, not an in vitro one.
• Intended Use: The intended use describes the system being used for "evaluation by ultrasound imaging or fluid flow analysis of the human body." This directly involves examining the body internally, not analyzing samples taken from the body.

Therefore, the LOGIQ i/e & Vivid e is a medical imaging device used for in vivo diagnosis, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The LOGIQ i/e & Vivid e is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Intra-operative (abdominal, thoracic and PV), Musculo-skeletal Conventional & Superficial, Transesophageal, Transrectal and Transvaginal, and Thoracic/Pleural for motion/sliding and fluid detection.

Product codes

IYN, IYO, ITX

Device Description

The LOGIQ i/e & Vivid e is a full-featured, compact and extremely portable ultrasound system consisting of a main console chassis 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. It is used primarily where portability, size and convenience are essential and is available in three variations: LOGIQ e is for general purpose radiology imaging having a variety of options to tailor it for use by the medical specialist for use in various departments and patient care areas (e.g., OR, ER & outpatient care). Accordingly it has various configurations (Software option/standard and probes supporting) for different packages (Nerve, ED, and GI). LOGIQ i is a full-featured premium radiology system suitable for physician rounds in a hospital, nursing home where a broader range of high performance is needed. Vivid e is similar to the LOGIQ e with an emphasis on cardiology examinations.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Musculo-skeletal Conventional & Superficial; Thoracic/Pleural.

Indicated Patient Age Range

Fetal, Neonatal, Pediatric, Adult

Intended User / Care Setting

Qualified physician. Various departments and patient care areas (e.g., OR, ER & outpatient care), hospital, nursing home.

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 i/e & Vivid e, did not require clinical studies to support substantial equivalence.

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

Not Found

Predicate Device(s)

LOGIQ i, LOGIQ e, Vivid e, K102256, LOGIQ E9 K110943

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

K113690

DEC 2 9 2011

GE Healthcare 510(k) Premarket Notification Submission

510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided: December 14, 2011 Date: Submitter: GE Healthcare 9900 W. Innovation Dr. Wauwatosa, WI 53226 Primary Contact Person: Brvan Behn Regulatory Affairs Manager GE Healthcare T:[phone] F:[phone] Secondary Contact Person: Yalan Wu Regulatory Affairs Manager GE Healthcare T: [phone] F: [phone] Device: Trade Name: LOGIQ i, LOGIQ e, Vivid e Common/Usual Name: LOGIQ i, LOGIQ e, Vivid e Classification Names: Class II Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-Product Code: IYN Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560. 90-IYO Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX Predicate Device(s): LOGIQ i, LOGIQ e, Vivid e, K102256 LOGIO E9 K110943 Device Description: The LOGIQ ife & Vivid e is a full-featured, compact and extremely portable ultrasound system consisting of a main console chassis 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. It is used primarily where portability, size and convenience are essential and is available in three variations: LOGIQ e is for general purpose radiology imaging having a variety of options to tailor it for use by the medical specialist

for use in various departments and patient care areas (e.g., OR,

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GE Healthcare 510(k) Premarket Notification Submission

ER & outpatient care). Accordingly it has various configurations (Software option/standard and probes supporting) for different packages (Nerve, ED, and GI). LOGIO i is a full-featured premium radiology system suitable for physician rounds in a hospital, nursing home where a broader range of high performance is needed. Vivid e is similar to the LOGIO e with an emphasis on cardiology examinations. The LOGIO i/e & Vivid e is a general purpose ultrasound Intended Use: system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Intra-operative (abdominal, thoracic and PV), Musculo-skeletal Conventional & Superficial, Transesophageal, Transrectal and Transvaginal, and Thoracic/Pleural for motion/sliding and fluid detection.

The LOGIQ i/e & Vivid e employs the same fundamental Technology: scientific technology as its predicate.

Determination of Summary of Non-Clinical Tests: Substantial Equivalence: The LOGIQ i/e & Vivid e and its applications comply with voluntary standards as detailed in Section 9, 11 and 17 of this premarket submission. 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 material and other patient contact materials such as needle guidance kits are biocompatible.

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Image /page/2/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 letters are stylized with curved lines and a vintage design, and the border has a decorative pattern.

GE Healthcare 510(k) Premarket Notification Submission

Summary of Clinical Tests:

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

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

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" written around it. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing. The overall design is simple and conveys a sense of professionalism and authority.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

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

JAN 1 9 2012

Re: K113690

Trade/Device Name: GE LOGIQ I, LOGIQ e and Vivid e Diagnostic Ultrasound Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: December 14, 2011 Received: December 15, 2011

Dear Mr. Behn:

This letter corrects our substantially equivalent letter of December 29, 2011.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). 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.

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

Transducer Model Number

4C-RS	12L-RS	6S-RS
8C-RS	16L-RS	P2D
E8C-RS	i12L-RS	6Tc-RS
8L-RS	i/t739-RS	L8-18i-RS
9L-RS	3S-RS

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If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. 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); 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.

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

If you have any questions regarding the content of this letter, please contact Michael O'Hara at [phone].

Sincerely Yours,

Michael D'Antoni for

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

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GE Healthcare ー 510(k) Premarket Notification Submission

510(k) Number (if known):

GE LOGIQ I, LOGIQ e and Vivid e Diagnostic Ultrasound Device Name:

Indications for Use:

The LOGIQ i/e & Vivid e is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Intraoperative (abdominal, thoracic and PV), Musculo-skeletal Conventional & Superficial, Transesophageal, Transrectal and Transvaginal, and Thoracic/Pleural for motion/sliding and fluid detection.

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

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

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary S. Patil

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) Number

Page 1 of 1

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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" intertwined within a circle. The letters are stylized and connected, with the "G" looping around the "E". The logo is black and white.

GE Healthcare 510(k) Premarket Notification Submission

Indications For Use Forms

The following Indication for Use forms are attached.

System: GE LOGIQ ile & Vivid e Transducer: 4C-RS Transducer: 8C-RS Transducer: E8C-RS Transducer: 8L-RS Transducer: 9L-RS Transducer: 12L-RS Transducer: 16L-RS Transducer: i12L-RS Transducer: i/t739-RS Transducer: 3S-RS Transducer: 6S-RS Transducer: P2D Transducer: 6Tc-RS Transducer: L8-18i-RS

The following forms represent indications with clinical applications and exam types along with the modes of operation for the LOGIQ i/e & Vivid e system and for all of its probe/mode combinations. Combinations identified by "N" are new while "P" represents those previously cleared with the unmodified LOGIO i/e & Vivid e. The subject modification does not alter the previously cleared system level indications or clinical applications.

Mary's Protel

DIVISION SIGH:OH
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K. K113690

Confidential and Privileged. This document continential and privileged under . information of General Electric Co. and as such may not be disclosed to others not employed by General Electic Co. All rights reserved

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GE Compact Ultrasound System LOGIO i, LOGIO e, Vivid e

Mode of Operation Power Combined Harmonic Coded Other Color M Clinical Application CW Color PW M B Imaging Pulse Doppler Doppler Modes Doppler Doppler Doppler Anatomy/Region of Interest Ophthalmic P P P P P P P P P P Fetal / Obstetrics P P P P Abdomina[1] P P P P P P P P P P P P P P P P Pediatric P P P Small Organ 121 P P P p P 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 Cardiaclif P P P P P Peripheral Vascular P P P P P P P P P P P P P Musculo-skeletal Conventional P P P P Musculo-skeletal P P P P Superficial P P P P Thoracic/Pleural(specify)41 P P P P P P P P Other الموار P p P P P P P P Exam Type, Means of Access P P P P P P P P P P Transesophageal Transectal P P P P P P P P P P P P P P Transvaginal Transurethral Intraoperative(specify)(6) P P P P P P P P Intraoperative Neurological Intravascular Laparoscopic

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

N = new indication; P = previously cleared by FDA; E = added under Appendix E

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

of fluid and pleural thickening,
includes Urology/Prostate
Office of in Ve

[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.

Marr S/Pratt
(Division Sign-Off)

Division of Radiological Devices Offica of In Vitro Diagnostic Device Evaluation and Safety

810K

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

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GE Compact Ultrasound LOGIQ i, LOGIO e, Vivid e with 4C-RS Transducer

Mode of Operation Color M Power Other Combined Coded Clinical Application CW Color Harmonic PW B ખ Pulse Modes Imaging Doppler Doppler Doppler Doppler Doppler Anatomy/Region of Interest Ophthalmic P P P P P Fetal / Obstetrics P P P P P P P Abdominal!!! P P P P P P P P P P P P Pediatric Small Organ (2) Neonatal Cephalic Adult Cephalic Cardiad II Peripheral Vascular Musculo-skeletal Conventional Musculo-skeletal Superficial P P Thoracic/Pleural(specify) (4) P P P P P P Other 151 P P P P P P P P Exam Type, Means of Access Transesophageal Transrectal Transvaginal Transurethral Intraoperative (specify)[6] Intraoperative Neurological Intravascular Laparoscopic

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

N = new indication; P = previously cleared by FDA; E = added under Appendix E

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; 1*1 Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD.

[""] Combined modes are B/M, B/P WD, B/Color* WD,
Q.S.A.P.L. - Spatially encoded harmonics

[*] Coded Pulse is for digitally encoded harmonics.

Mary Shady

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Sefety

610K K113690

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

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GE Compact Ultrasound LOGIQ i, LOGIQ e, Vivid e with 8C-RS Transducer

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

	Mode of Operation
Clinical Application
Anatomy/Region of
Interest	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M
Doppler	Power
Doppler	Combined
Modes'	Harmonic
Imaging	Coded
Pulse	Other
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	P	P	P		P		P	P	P	P
Adult Cephalic
Cardiac[3]	P	P	P		P		P	P	P	P
Peripheral Vascular	P	P	P		P		P	P	P	P
Musculo-skeletal
Conventional	P	P	P		P		P	P	P	P
Musculo-skeletal
Superficial	N	N	N		N		N	N	N	N
Thoracic/Pleura(specify) [4]	P	P	P		P		P	P	P	P
Other[5]
Exam Type, Means of
Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative (specify) [6]
Intraoperative
Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA; E = added under Appendix E

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/PWF30K

{"} Coded Pulse is for digitally encoded harmonics .

Mary S Patil

---

(Division Sign-Off)

Division of Redictories De Office of In Vitro

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GE Compact Ultrasound LOGIO i, LOGIO e, Vivid e with E8C-RS Transducer

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

	Mode of Operation
Clinical Application
Anatomy/ Region of
Interest	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M
Doppler	Power
Doppler	Combined
Modes	Harmonic
Imaging	Coded
Pulse
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
Peripheral Vascular
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Thoracic/Pleura(specify) (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
Transurethral
Intraoperative (specify) (6)
Intraoperative
Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Notes: [1] Abdominal includes GYN and Urological

[2] Small organ includes breast, testes, thyroid.

[3] Cardiac is Adult and Pediatric.

Mary S Patel

Division Sign-Off

Division of Radiological Devices

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

[5] Other use includes Urology/Prostate

510K

[6] Intraoperative includes abdominal, thoracic and peripheral;

["] Coded Pulse is for digitally encoded harmonics.

(Division Sign-On)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

[] Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD.
[] Coded Pulse is for digitally encoded harmonics.

(PLEASED ON NOT WRITE BELOW THIS LINE _ CONTINUE ON ANOTHER PAGE IE NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

11

GE Compact Ultrasound LOGIQ i, LOGIQ e, Vivid e with 8L-RS Transducer

Mode of Operation Other Power Combined Harmonic Coded Clinical Application PW CW Color Color M B M Imaging Pulse Doppler Modes Doppler Doppler Doppler Doppler Anatomy/Region of Interest Ophthalmic Fetal / Obstetrics P P P P Abdominal™ P P P P P P P P P Pediatric P P P P P P Small Organ 121 P P P P P Neonatal Cephalic Adult Cephalic Cardiac [3] P P P P P P P P P P P P P Peripheral Vascular P P P P P P P P P Musculo-skeletal Conventional Musculo-skeletal Superficial Thoracic/Pleural(specify) [4] Other 151 Exam Type, Means of Access Transesophageal Transrectal Transvaginal Transurethral Intraoperative (specify) (6) P P P P P P P Intraoperative Neurological Intravascular Laparoscopic

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

N = new indication; P = previously cleared by FDA; E = added under Appendix E

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

Mory Spath
(Division Sign-Off)

Division of Rediological Devices Office of In Vitro Diagnostic Device Evaluation and Satety

510K

[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.

['] 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 Diagnostic Devices (OIVD)

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GE Compact Ultrasound LOGIQ i, LOGIQ e, Vivid e with 9L-RS Transducer

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

	Mode of Operation
Clinical Application
Anatomy/Region of
Interest	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M
Doppler	Power
Doppler	Combined
Modes*	Harmonic
Imaging	Coded
Pulse*	Other
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	N	N	N		N		N	N	N	N
Thoracic/Pleural(specify) [4]	N	N	N		N		N	N	N	N
Other [5]
Exam Type, Means of
Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative (specify) [6]	P	P	P		P		P	P	P	P
Intraoperative
Neurological
Intravascular
Laparoscopic

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; 610K

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

["] Coded Pulse is for digitally encoded harmonics.

Image /page/12/Figure/12 description: The image shows a signature, presumably of a person. The signature appears to read "Mary Stott". Below the signature is the text "(Division Sign-Off)" in a smaller font size. A horizontal line is drawn beneath the signature and above the text.

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

13

GE Compact Ultrasound LOGIQ i, LOGIO e, Vivid e with 12L-RS Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Mode of Operation Clinical Application CW Color Color M Power Combined Harmonio Coded PW B M Imaging Pulse Doppler Doppler Dopple Modes Doppler Doppler Anatomy/Region of Interest Ophthalmic Fetal / Obstetrics N N N N N N Abdominal N N P P P P P Pediatric P P P Small Organ 121 P P P P P P P P Neonatal Cephalic Adult Cephalic Cardiac P P P P P Peripheral Vascular P P P P P Musculo-skeleta! P P P P P P Conventional Musculo-skeletal P P P P P P P P Superficial Thoracic/Pleural(specify) (41 P P P P P P P P Other (specify) [3] Exam Type, Means of Access Transesophageal Transrectal Transvaginal Transurethrai Intraoperative(specify) 161 Intraoperative Neurological Intravascular Laparoscopic N = new indication; P = previously cleared by FDA; E = added under Appendix E

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

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

[5] Other use includes Urology/Prostate

Mary Stastil

610K

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

[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.

(19).E.A.SE.D.O.NOT WRITE.BELOW THIS LINE_CONTINUE.ON ANOTHER JAGE (ENEFOD)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

14

GE Compact Ultrasound LOGIQ i, LOGIO e, Vivid e with 16L-RS Transducer

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

	Mode of Operation
Clinical Application
Anatomy/Region of
Interest	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M
Doppler	Power
Doppler	Combined
Modes	Harmonic
Imaging	Coded
Pulse*
Ophthalmic
Fetal / Obstetrics
Abdominal
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
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]
Other (specify) [5]
Exam Type, Means of
Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative(specify) [6]
Intraoperative
Neurological
Intravascular
Laparoscopic
N = new indication; P = previously cleared by FDA; E = added under Appendix E
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

HURST PI

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

・・

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

[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.

15

GE Compact Ultrasound LOGIO i, LOGIO e, Vivid e with i12L-RS Transducer

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

| Clinical Application
Anatomy/Region of
Interest | B | M | PW
Doppler | CW
Doppler | Color
Doppler | Color M
Doppler | Power
Doppler | Combined
Modes | Harmonic
Imaging | Coded
Pulse* | Other |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|-----------------|-------|
| 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] | P | P | P | | P | | P | P | P | | |
| Peripheral Vascular | P | 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] | | | | | | | | | | | |
| Other[5] | | | | | | | | | | | |
| Exam Type, Means of
Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intraoperative (specify)[6] | P | P | P | | P | | P | P | P | | |
| Intraoperative
Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| N = new indication; P = previously cleared by FDA; E = added under Appendix E | | | | | | | | | | | |
| 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) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

16

GE Compact Ultrasound LOGIQ i, LOGIQ e, Vivid e with i/t739-RS Transducers

	Mode of Operation
Clinical Application
Anatomy/Region of
Interest	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M
Doppler	Power
Doppler	Combined
Modes	Harmonic
Imaging	Coded
Pulse	Other
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]	P	P	P		P		P	P	P	P
Peripheral Vascular	P	P	P		P		P	P	P	P
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Thoracic/Pleural(specify)[4]
Other[4]
Exam Type, Means of
Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative (specify)[6]	P	P	P		P		P	P	P	P
Intraoperative
Neurological
Intravascular
Laparoscopic
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Clinical Application
Anatomy/Region of
Interest	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M
Doppler	Power
Doppler	Combined
Modes*	Harmonic
Imaging	Coded
Pulse	Other
Ophthalmic
Fetal / Obstetrics	P	P	P	P	P	P	P	P	P	P	P
Abdominal[1]	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]
Neonatal Cephalic
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	N	N	N	N	N	N	N	N	N	N	N
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
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
Transvaginal
Transurethral
Intraoperative (specify)[6]
Intraoperative
Neurological
Intravascular
Laparoscopic
N = new indication; P = previously cleared by FDA; E = added under Appendix E
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.
Clinical Application
Anatomy/Region of Interest	Mode of Operation
	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M
Doppler	Power
Doppler	Combined
Modes	Harmonic
Imaging	Coded
Pulse	Other
Ophthalmic
Fetal / Obstetrics
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	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
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Thoracic/Pleural(specify)[4]
Other[5]	P	P	P	P	P	P	P	P	P	P
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative (specify)[6]
Intraoperative
Neurological
Intravascular
Laparoscopic
Clinical Application
Anatomy/Region of
Interest	Mode of Operation									Other
	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M
Doppler	Power
Doppler	Combined
Modes*	Harmonic
Imaging		Coded
Pulse*
Ophthalmic
Fetal / Obstetrics
Abdominal[1]
Pediatric
Small Organ [2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]				P
Peripheral Vascular				P
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Thoracic/Pleural (specify)[4]
Other[5]
Exam Type, Means of
Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative (specify)[6]
Intraoperative
Neurological
Intravascular
Laparoscopic

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

minal 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

Mam S. Postl
(Division Sign-Off)
Division of Radiological Devices

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Sellety

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.

Office of In Vitro Diagnostic Device Evaluation and Safety
510K. K113690

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IE NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

17

GE Compact Ultrasound LOGIQ i, LOGIQ e, Vivid e with 3S-RS Transducer

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

18

GE Compact Ultrasound LOGIQ i, LOGIQ e, Vivid e with 6S-RS Transducer

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

Image /page/18/Figure/4 description: The image shows a line of text that reads "(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IS NEEDED)". The text is in all caps and is underlined. The purpose of the text is to instruct the reader not to write below the line and to continue on another page if needed.

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

19

GE Compact Ultrasound LOGIO i, LOGIO e, Vivid e with P2D Transducer

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

N = new indication; P = previously cleared by FDA; E = added under Appendix E

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

[1] Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD, B/Power/PWD, 10/2

• "] Coded Pulse is for digitally encoded harmonics.
  Mary S. Patel
  (Division Sign-Off)

Division of Rediological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

igitally encoded harmonics.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

20

GE Compact Ultrasound LOGIQ i, LOGIO e, Vivid e with 6Tc-RS Transducer

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

	Mode of Operation
Clinical Application
Anatomy/Region of Interest	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M
Doppler	Power
Doppler	Combined
Modes	Harmonic
Imaging	Coded
Pulse*	Other
Ophthalmic
Fetal / Obstetrics
Abdominal (1)
Pediatric
Small Organ (2)
Neonatal Cephalic
Adult Cephalic
Cardiac (3)	P	P	P	P	P	P	P	P	P	P
Peripheral Vascular
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Thoracic/Pleural (specify) (4)
Other (5)
Exam Type, Means of
Access
Transesophageal	P	P	P	P	P	P	P	P	P	P
Transrectal
Transvaginal
Transurethral
Intraoperative (specify) (6)
Intraoperative
Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA; E = added under Appendix E

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;

Mary S Pastel

(Division Sign-Off)

Division of Radiological Devices

Office of In Vitro Diagnostic Device Evaluation and Safety

510K. K113690

[*] 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 Diagnostic Devices (OIVD)

21

GE Compact Ultrasound LOGIQ i, LOGIQ e, Vivid e with L8-18i-RS Transducer

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

	Mode of Operation
Clinical Application
Anatomy/Region of
Interest	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M
Doppler	Power
Doppler	Combined
Modes*	Harmonic
Imaging	Coded
Pulse	Other
Ophthalmic
Fetal / Obstetrics
Abdominal[1]	N	N	N	N	N	N	N	N	N	N	N
Pediatric	N	N	N	N	N	N	N	N	N	N	N
Small Organ [2]	N	N	N	N	N	N	N	N	N	N	N
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular	N	N	N	N	N	N	N	N	N	N	N
Musculo-skeletal
Conventional	N	N	N	N	N	N	N	N	N	N	N
Musculo-skeletal
Superficial	N	N	N	N	N	N	N	N	N	N	N
Thoracic/Pleural(specify)[4]	N	N	N	N	N	N	N	N	N	N	N
Other[5]
Exam Type, Means of
Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative (specify)[6]
Intraoperative
Neurological
Intravascular
Laparoscopic

previously cleared by FDA; E indication; F

Notes: [I] 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; 510K

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

[*] Coded Pulse is for digitally encoded harmonics.

Mace S. Patil
(Division Sign-Off)

Division of Rediological Devices Offica of In Vitro Diagnostic Device Evaluation and Safaty

K113690

(PLEASE DO NOT WRITE BELOW THIS LINE_CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)