GE LOGIQ I/E & VIVID E COMPACT DIAGNOSTIC ULTRASOUND

• K Number: K102256
• Device Name: GE LOGIQ I/E & VIVID E COMPACT DIAGNOSTIC ULTRASOUND
• Manufacturer: GE MEDICAL SYSTEMS CHINA CO., LTD.
• Date Cleared: 2010-10-05 ( 56 days)
• Product Code: IYN ITX IYO
• Regulation Number: 892.1550

Intended Use

The subject modified device 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.

Device Description

The GE Compact Ultrasound is a very compact and portable diagnostic ultrasound system having three variations: LOGIQ e and Vivid e, each with options and features suited for its It has an integrated keyboard, LCD display and several interchangeable electronic-array market niche. transducers with an approximate size of 34 cm wide, 29 cm deep and 6 cm high in transport configuration and provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, an intuitive layout of specialized controls, color GUI display and Doppler audio.

Predicate Devices

K091374

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard ultrasound system with digital processing, but there is no mention of AI or ML capabilities in the device description, intended use, or performance studies.

Therapeutic

No.
The device is described as a "diagnostic ultrasound system" intended for "evaluation by ultrasound imaging or fluid flow analysis," indicating its purpose is for diagnosis rather than treatment.

Diagnostic

Yes
The 'Intended Use / Indications for Use' section states the device is "intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body." The 'Device Description' also explicitly calls it a "diagnostic ultrasound system". These phrases clearly indicate its role in diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "diagnostic ultrasound system having three variations" and includes hardware components like an "integrated keyboard, LCD display and several interchangeable electronic-array transducers."

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 to provide information for diagnosis, monitoring, or screening.
• Device Function: The description clearly states that this is an ultrasound system used for imaging or fluid flow analysis of the human body. This is an in vivo diagnostic method, meaning it is performed directly on the living body, not on samples taken from the body.
• Intended Use: The intended use describes various clinical applications and exam types that involve scanning different parts of the body using ultrasound waves. This aligns with in vivo imaging, not in vitro testing.

Therefore, the GE Compact Ultrasound system described is a diagnostic imaging device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The LOGIQ ile & 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/OG; 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.

Each transducer also specifies its own intended uses:

• GE Compact Ultrasound System LOGIQ i, LOGIQ e, Vivid e: Diagnostic ultrasound imaging or fluid flow analysis of the human body
• GE Compact Ultrasound with 4C-RS Transducer LOGIQ i, LOGIQ e, Vivid e: Diagnostic ultrasound imaging or fluid flow analysis of the human body
• GE Compact Ultrasound with 8C-RS Transducer LOGIQ i, LOGIQ e, Vivid e: Diagnostic ultrasound imaging or fluid flow analysis of the human body
• GE Compact Ultrasound with E8C-RS Transducer LOGIQ i, LOGIQ e, Vivid e: Diagnostic ultrasound imaging or fluid flow analysis of the human body
• GE Compact Ultrasound with 8L-RS Transducer LOGIQ i, LOGIQ e, Vivid e: Diagnostic ultrasound imaging or fluid flow analysis of the human body
• GE Compact Ultrasound with 9L-RS Transducer LOGIQ i, LOGIQ e, Vivid e: Diagnostic ultrasound imaging or fluid flow analysis of the human body
• GE Compact Ultrasound with 12L-RS Transducer LOGIQ i, LOGIQ e, Vivid e: Diagnostic ultrasound imaging or fluid flow analysis of the human body
• GE Compact Ultrasound with 16L-RS Transducer LOGIQ i, LOGIQ e, Vivid e: Diagnostic ultrasound imaging or fluid flow analysis of the human body
• GE Compact Ultrasound with i12L-RS Transducer LOGIQ i, LOGIQ e, Vivid e: Diagnostic ultrasound imaging or fluid flow analysis of the human body
• GE Compact Ultrasound with i/t739-RS Transducers LOGIQ i, LOGIQ e, Vivid e: Diagnostic ultrasound imaging or fluid flow analysis of the human body
• GE Compact Ultrasound with 3S-RS Transducer LOGIQ i, LOGIQ e, Vivid e: Diagnostic ultrasound imaging or fluid flow analysis of the human body
• GE Compact Ultrasound with 6S-RS Transducer LOGIQ i, LOGIQ e, Vivid e: Diagnostic ultrasound imaging or fluid flow analysis of the human body
• GE Compact Ultrasound with P2D Transducer LOGIQ i, LOGIQ e, Vivid e: Diagnostic ultrasound imaging or fluid flow analysis of the human body
• GE Compact Ultrasound with 6Tc-RS Transducer LOGIQ i, LOGIQ e, Vivid e: Diagnostic ultrasound imaging or fluid flow analysis of the human body

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

IYN, IYO, ITX

Device Description

The GE Compact Ultrasound is a very compact and portable diagnostic ultrasound system having three variations: LOGIQ e and Vivid e, each with options and features suited for its It has an integrated keyboard, LCD display and several interchangeable electronic-array market niche. transducers with an approximate size of 34 cm wide, 29 cm deep and 6 cm high in transport configuration and provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, an intuitive layout of specialized controls, color GUI display and Doppler audio.

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; Intraoperative (abdominal, thoracic and PV), Musculo-skeletal Conventional & Superficial, Transesophageal, Transrectal and Transvaginal, and Thoracic/Pleural for motion/sliding and fluid detection.

More specific anatomical sites are listed per transducer:

• Ophthalmic
• Fetal / Obstetrics
• Abdominal (includes GYN and Urological)
• Pediatric
• Small Organ (includes breast, testes, thyroid)
• Neonatal Cephalic
• Adult Cephalic
• Cardiac (Adult and Pediatric)
• Peripheral Vascular
• Musculo-skeletal Conventional
• Musculo-skeletal Superficial
• Thoracic/Pleural (for detection of fluid and pleural motion/sliding)
• Other (includes Urology/Prostate)

Indicated Patient Age Range

Adult and Pediatric

Intended User / Care Setting

qualified physician

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)

Non-clinical Tests: The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, electromagnetic compatibility, as well as themal, electrical and mechanical safety, and has been found to conform with applicable medical device safety standards.
Clinical Tests: None required.

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

Not Found

Predicate Device(s)

K091374

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

OCT 5 2010

142

Attachment B

510(k) Summary of Safety and Effectiveness Prepared in accordance with 21 CFR Part 807.92(c).

GE Healthcare GE Medical Systems (China) Co., Ltd No. 19 Changjiang Road, National Hi-Tech Development Zone Wuxi, Jiangsu Province, CHINA 214028 Section a): 1. Submitter: GE Medical Systems (China) Co., Ltd. No. 19 Changjiang Road, National Hi-Tech Development Zone, Wuxi, Jiangsu Province, CHINA 214028 Contact Person: Yalan Wu, Manager, Safety and Regulatory Telephone: [phone]; Fax: [phone] Date Prepared: June 20, 2010 2. Device Name: GE LOGIQ ille, Vivid e Ultrasound Ultrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYO Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYN Diagnostic Ultrasonic Transducer, 21 CFR 892.1570, 90-ITX 3. Marketed Device: GE LOGIQ-ile & Vivid-e Compact Ultrasound, 510(k) No: K091374 (90-IYO/IYN/ITX) A device currently in commercial distribution.

4. Device Description: The GE Compact Ultrasound is a very compact and portable diagnostic ultrasound system having three variations: LOGIQ e and Vivid e, each with options and features suited for its It has an integrated keyboard, LCD display and several interchangeable electronic-array market niche. transducers with an approximate size of 34 cm wide, 29 cm deep and 6 cm high in transport configuration and provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, an intuitive layout of specialized controls, color GUI display and Doppler audio.

5. Indications for Use: The subject modified device 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.

6. Companison with Predicate Device: The modified Compact Ultrasound devices are virually identical having the same design, construction, materials, brand names and intended uses. All technological characteristics and safety and effectiveness features are equivalent. The modified device has additional Transesophageal indication for use and Intima Media Thickness (IMT) measurement with Vascular.

Section b):

Non-clinical Tests: The device has been evaluated for acoustic output, biocompatibility, cleaning and 1. disinfection effectiveness, electromagnetic compatibility, as well as themal, electrical and mechanical safety, and has been found to conform with applicable medical device safety standards.

• 2. Clinical Tests: None required.

3. Conclusion: Intended uses and other key features are consistent with traditional clinical practice, FDA guidelines, and established methods of patient examination. The design and development process of the manufacturer conforms with 21 CFR 820, ISO 9001:2000 and ISO 13485 quality systems. The device conforms to applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. Diagnostic ultrasound has accumulated a long history of safe and effective performance. Therefore, it is the opinion of GE Healthcare that the GE LOGIQ ile Vivid e Ultrasound imaging device is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

1

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

GE Medical Systems, Ultrasound and Primary Care Diagnostics, LLC % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 2510 Street NW BUFFALO MN 55313

OCT 5 2010

Re: K102256

Trade/Device Name: GE LOGIQ i, LOGIQ e and Vivid e Diagnostic Ultrasound Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasound pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: September 27, 2010 Received: September 28, 2010

Dear Mr. Job:

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-S	16L-RS	P2D
E8C-RS	i12L-RS	6Tc-RS
8L-RS	i/t739-RS
9L-RS	3S-RS

2

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 Shahram Vaezy at [phone].

Sincerely yours,

Mach. A.D.O. Then for

David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

3

Indications for Use Form

510(k) Number (if known):

Device Name: __GE LOGIQ i, LOGIQ e and Vivid e Diagnostic Ultrasound

Indications For Use:

The LOGIQ ile & 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/OG; 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.

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

Over-The-Counter Use (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 Diagnostics

MuhaMD.D.M. David 6, Brown
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K102056

Page 1 of 1

4

GE Compact Ultrasound System

LOGIQ i, LOGIQ e, Vivid e

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

| 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	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]	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	N	N	N	N	N	N	N	N	N	N	N
Transrectal	P	P	P	P	P	P	P	P	P
Transvaginal	P	P	P	P	P	P	P	P	P
Transuretheral
Intraoperative	P	P	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

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

[*] 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 (OIVD)

Nuhal D. O'Kee for David C. Brown
Division Sign Off

510(k) K102256

Office of In Vitro Diagnostic Device Evaluation and Safety

5

GE Compact Ultrasound with 4C-RS Transducer

LOGIQ i, LOGIQ e, Vivid e

	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	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
Musculo-skeletal Superficial
Thoracic/Pleural (specify) [4]	P	P	P		P		P	P	P	P
Other[5]	P	P	P		P		P	P	P	P
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
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

[*] 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 (OIVD)

Mudand D. O'K. Go. David b. Brown
Division Sign-Off

Prescription Use (21 CFR 801 Subpart D)

Office of In Vitro Diagnostic Device Evaluation and Safe

510(k) K102256

6

GE Compact Ultrasound with 8C-RS Transducer

LOGIQ i, LOGIQ e, Vivid e

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
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
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
Thoracic/Pleural (specify) [4]	P	P	P		P		P	P	P
Other[5]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
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

(*) 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 (OIVD)

Mhll.D.O'K. for David C. Brown
Division Sign-Off

Prescription Use (21 CFR 801 Subpart D)

Office of In Vitro Diagnostic Device Evaluation and S

510(k) K102256

7

GE Compact Ultrasound with E8C-RS Transducer

LOGIQ İ, LOGIQ e, Vivid e

		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/Pleural (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
Transuretheral
Intraoperative (specify)
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

[*] 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 (OIVD)

Andrew D. Kirk for David G. Brown
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K102256

8

GE Compact Ultrasound with 8L-RS Transducer

LOGIQ İ, LOGIQ e, Vivid e

	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
Peripheral Vascular	P	P	P		P		P	P	P	P
Musculo-skeletal Conventional	P	P	P		P		P	P	P
Musculo-skeletal Superficial
Thoracic/Pleural (specify) [4]
Other [5]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)[5]	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

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

[1] 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 (OIVD)

Andrew D. Thoms for David C. Brown
Division Sign Off

Prescription Use (21 CFR 801 Subpart D)

Office of In Vitro Diagnostic Device Evaluation and Safe

510(k) K102256

9

GE Compact Ultrasound with 9L-RS Transducer

LOGIQ İ, LOGIQ e, Vivid e

Mode of Operation Clinical Application PW CW Color Color M B Power Combined M Harmonic Coded Other Anatomy/Region of Interest Doppler Doppler Doppler Doppler Doppler Modes lmaging Pulse® Ophthalmic Fetal / Obstetrics Abdominal [1] P P P P P P P P Pediatric P P P P P P P P Small Organ 같 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 Thoracic/Pleural (specify) [4] Other (5) Exam Type, Means of Access Transesophageal Transrectal Transvaginal Transuretheral Intraoperative (specify)[5] 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

[*] 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 (OIVD)

Michal D. O'Shea Lisa David G. Brown
Division Sign-Off

Prescription Use (21 CFR 801 Subpart D)

ce of In Vitro Diagnostic Device Evaluation and Safety

510(k) K102256

10

GE Compact Ultrasound with 12L-RS Transducer

LOGIQ i, LOGIQ e, Vivid e

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* |
|----------------------------------------------------|---|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|-----------------|
| 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] | P | P | P | | P | | P | P | P | P |
| Other (specify) [5] | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transuretheral | | | | | | | | | | |
| Intraoperative [5] (specify) | | | | | | | | | | |
| 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

[*] 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 (OIVD)

Andra D'Oliveira for David 6 Brown
Division Sign Off

510(k) K102256

Office of In Vitro Diagnostic Device Evaluation and Safety

11

GE Compact Ultrasound with 16L-RS Transducer

LOGIQ İ, LOGIQ e, Vivid e

Mode of Operation Clinical Application bM CM B Color Power Combined Color M M Harmonic Coded Anatomy/Region of Interest Doppler Doppler Doppler Doppler Modes Doppler Imaging Pulse® Ophthalmic Fetal / Obstetrics Abdominal Pediatric P P P p P P P P Small Organ 121 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) 15) Exam Type, Means of Access Transesophageal Transrectal Transvaginal Transuretheral Intraoperative [3] (specify) 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

[*] 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 (OIVD)

Aayyad Dothan Lan David 6. Boiso
Division Sign Off

office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K102256

12

GE Compact Ultrasound with i12L-RS Transducer

LOGIQ i, LOGIQ e, Vivid e

	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
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
Transuretheral
Intraoperative (specify)[5]	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

[*] Combined modes are B/M, B/PWD, B/Color/PWD, 8/Power/PWD.

[1] Coded Pulse is for digitally encoded harmonics .

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

nce of CDRH, Office of In Vitro Diagnostics (OIVD)

Auhul 1052K for David b Brown
Division Sign-Off

fice of In Vitro Diagnostic Device Evaluation and Safety

510(k) K102256

13

GE Compact Ultrasound with i/t739-RS Transducers

LOGIQ i, LOGIQ e, Vivid e

	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
Pediatric	P	P	P		P		P	P	P
Small Organ [2]	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
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Thoracic/Pleural (specify) (4)
Other (4)
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)[5]	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

[*] 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 (OIVD)

Ardd DDK for David b. Brown
Division Sign Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K102256

14

GE Compact Ultrasound with 3S-RS Transducer

LOGIQ i, LOGIQ e, Vivid 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 | |
| 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] | P | P | P | P | P | P | P | P | P | P | |
| Other [5] | P | P | P | P | P | P | P | P | P | P | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| 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

[*] 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 (OIVD)

Nuhad D. Khawam for David 6. Brown
Division Sign-Off

Prescription Use (21 CFR 801 Subpart D)

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K102256

15

GE Compact Ultrasound with 6S-RS Transducer

LOGIQ İ, LOGIQ e, Vivid e

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
Pulse¹	Other
Ophthalmic
Fetal / Obstetrics
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	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
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Thoracic/Pleural (specify) [4]
Other [5]	P	P	P	P	P	P	P	P	P	P	P
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)[5]
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

["] 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 (OIVD)

Ahaland D. K. for David G. Brown
Division Sign Off

510(k) K102256

Office of In Vitro Diagnostic Device Evaluation and Safety

16

GE Compact Ultrasound with P2D Transducer

LOGIQ i, LOGIQ e, Vivid e

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
Peripheral Vascular				P
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Thoracic/Pleural (specify) [4]
Other [5]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)[5]
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

[*] 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 (OIVD)

Andrew D. Klee for David 6 Brown
Division Sign Off

Office of In Vitro Diagnostic Device Evaluation and Safe

510(k) K102256

17

GE Compact Ultrasound with 6Tc-RS Transducer

LOGIQ i, LOGIQ e, Vivid e

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)	N	N	N	N	N	N	N	N	N	N	N
Peripheral Vascular									N	N
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Thoracic/Pleural (specify) (4)
Other [5]
Exam Type, Means of Access
Transesophageal	N	N	N	N	N	N	N	N	N	N
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify) [5]
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

["] 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 (OIVD)

ha D.M. for David 6. Browns
Division Sign Off

510(k) K102556

Office of In Vitro Diagnostic Device Evaluation and Safety