GE LOGIQ I/E & VIVID E COMPACT ULTRASOUND

• K Number: K091374
• Device Name: GE LOGIQ I/E & VIVID E COMPACT ULTRASOUND
• Manufacturer: GE MEDICAL SYSTEMS CHINA CO., LTD.
• Date Cleared: 2009-05-26 ( 15 days)
• Product Code: IYO ITX IYN
• Regulation Number: 892.1560

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; Intra-operative (abdominal, thoracic and PV), Musculo-skeletal Conventional & Superficial, 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 market niche. It has an integrated keyboard, LCD display and several interchangeable electronic-array 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

K072797, K091164

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document does not mention AI, ML, or related terms, and the description focuses on standard ultrasound technology and image processing.

Therapeutic

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

Diagnostic

Yes

The device description explicitly states, "The GE Compact Ultrasound is a very compact and portable diagnostic ultrasound system." The Intended Use section also describes its purpose for "evaluation by ultrasound imaging or fluid flow analysis of the human body," which aligns with diagnostic functions.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "diagnostic ultrasound system" with "interchangeable electronic-array transducers," an "integrated keyboard," and an "LCD display," indicating it is a hardware device with integrated software.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
• Device Function: The description clearly states that this device is an ultrasound system used for imaging or fluid flow analysis of the human body. It uses ultrasonic waves to create images of internal structures and assess blood flow.
• No Specimen Analysis: There is no mention of the device analyzing any biological specimens taken from the patient.

Therefore, based on the provided information, this ultrasound system falls under the category of in vivo diagnostic imaging devices, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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 market niche. It has an integrated keyboard, LCD display and several interchangeable electronic-array 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.

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

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), Musculoskeletal Conventional & Superficial, Transrectal and Transvaginal, and Thoracic/Pleural for motion/sliding and fluid detection.

Diagnostic ultrasound imaging or fluid flow analysis of the human body for the following clinical applications/anatomy/region of interest:

• Fetal / Obstetrics
• Abdominal (including GYN and Urological)
• Pediatric
• Small Organ (including 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 (including Urology/Prostate)

Exam Types / Means of Access:

• Transrectal
• Transvaginal
• Intraoperative

Specific transducers (4C-RS, 8C-RS, E8C-RS, 8L-RS, 9L-RS, 12L-RS, 16L-RS, i12L-RS, i/t739-RS, 3S-RS, 6S-RS, P2D) have varying indicated applications detailed in the tables for each transducer.

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 market niche. It has an integrated keyboard, LCD display and several interchangeable electronic-array 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, "provides digital acquisition, processing and display capability."

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasonic Pulsed Echo Imaging System
Ultrasonic Pulsed Doppler Imaging System

Anatomical Site

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, Transrectal and Transvaginal, and Thoracic/Pleural for motion/sliding and fluid detection.

Indicated Patient Age Range

Neonatal and Adult Cephalic, Pediatric, Adult. (Fetal/OB indicates use throughout pregnancy, implying all ages from fetus to adult).

Intended User / Care Setting

Qualified physician. Care setting not explicitly stated but implied to be clinical.

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 thermal, 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K072797, K091164

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Summary

0

K091374

MAY 26 2009

GE Healthcare

Attachment B

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

| 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:	April 20, 2009
2.	Device Name:	GE LOGIQ i/e, 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-i/e & Vivid-e Compact Ultrasound, 510(k) No: K072797
(90-IYO/IYN/ITX) A device currently in commercial distribution.
		GE Venue 40 Compact Ultrasound, 510(k) No: K091164
(90-IYO/IYN/ITX) A device currently cleared and starting to 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 market niche. It has an integrated keyboard, LCD display and several interchangeable electronic-array 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; Intra-operative (abdominal, thoracic and PV), Musculo-skeletal Conventional & Superficial, Transrectal and Transvaginal, and Thoracic/Pleural for motion/sliding and fluid detection.

6. Comparison with Predicate Device: The modified device is of a comparable type and substantially equivalent to the current GE LOGIQ e and Venue 40 with overall performance in a small and compact package. It has the same overall characteristics, key safety and effectiveness features, physical overall construction, and materials. And all technological characteristics and safety and effectiveness features are equivalent.

Section b):

Nor-clinical Tests: The device has been evaluated for acoustic output, biocompatibility, cleaning and 1 disinfection effectiveness, electromagnetic compatibility, as well as thermal, electrical and mechanical safety, and has been found to conform with applicable medical device safety standards.

2. Clinical Tests: None required.

Intended uses and other key features are consistent with traditional clinical practice, FDA 3. Conclusion: 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 Diagnostic ultrasound has accumulated a long history of safe and effective ongoing factory surveillance. performance. Therefore, it is the opinion of GE Healthcare that the GE LOGIQ ife Vivid e Ultrasound imaging device is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

1

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of what appears to be an eagle or bird-like figure with three stylized lines representing its body and wings.

MAY 26 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

GE Medical Systems, Ultrasound and Primary Care Diagnostics, LLC % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25" Street NW BUFFALO MN 55313

Re: K091374

Trade/Device Name: GE LOGIQ i/e & Vivid e Compact Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: May 8, 2009 Received: May 11, 2009

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/e & Vivid e Compact Ultrasound System, as described in your premarket notification:

	Transducer Model Number
4C-RS	9L-RS	i/t739-RS
8C-RS	12L-RS	3S-RS
E8C-RS	16L-RS	6S-RS
8L-RS	i12L-RS	P2D

2

Enclosure(s)

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 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); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

If you have any questions regarding the content of this letter, please contact Lauren Hefner at [phone].

Sincerely yours,

Vorge M. Wkay

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

3

Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: GE LOGIQ i/e & Vivid e Compact Ultrasound

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), Musculoskeletal Conventional & Superficial, Transrectal and Transvaginal, and Thoracic/Pleural for motion/sliding and fluid detection.

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

hogu Khha

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices K691374 510(k) Number _

Page 1 of 1

4

Diagnostic Ultrasound Indications for Use Form

GE Compact Ultrasound System

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
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]	P	P	P	P	P	P	P	P	P	P
Neonatal Cephalic	P	P	P	P	P	P	P	P	P	P
Adult Cephalic	P	P	P	P	P	P	P	P	P	P
Cardiac[3]	P	P	P	P	P	P	P	P	P	P
Peripheral Vascular	P	P	P	P	P	P	P	P	P	P
Musculo-skeletal Conventional	P	P	P	P	P	P	P	P	P	P
Musculo-skeletal Superficial	N	N	N	N	N	N	N	N	N	N
Thoracic/Pleural (specify) [4]	N	N	N	N	N	N	N	N	N	N
Other [5]	P	P	P	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	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

[1] Outlet use includes are BM, B/PWD, B/Color/PWD, B/PowerfF100(K) Number

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 Device Evaluation (ODE

(Division Sign-Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

Division of Reproductive, Abdominal and

(Division Sign-Off)

Radiological Device

E-2

5

、・・・・・・・・

.. -- - -

··············································································································································································

GE Compact Ultrasound with 4C-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	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 (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac [3]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Thoracic/Pleural (specify) [4]	N	N	N		N		N	N	N	N
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

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*1 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 Device Evaluation (ODE)

e of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, and

Division of Reproductive, Abdominal and Radiological Device 510(k) Number

6

i

---

ﯩﺴﺮﯨ

Diagnostic Ultrasound Indications for Use Form

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 (specify)	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)	N	N	N		N		N	N	N
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 .

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
fo

Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

7

Diagnostic Ultrasound Indications for Use Form

GE Compact Ultrasound with E8C-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
Ophthalmic
Fetal / Obstetrics	P	P	P		P		P	P	P
Abdominal[1]	P	P	P		P		P	P	P
Pediatric
Small Organ (specify)
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

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 Device Evaluation (ØDE)

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Device 510(k) Number

Prescription User (Per 21 CFR 801.109)

.i -

E-S

8

Diagnostic Ultrasound Indications for Use Form

GE Compact Ultrasound with 8L-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	P
Pediatric	P	P	P		P		P	P	P	P
Small Organ (specify)[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

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 Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal and
Prescription User (Per 21 CFR 801.109)	Radiological Devices
510(k) Number	K091374

9

Diagnostic Ultrasound Indications for Use Form

GE Compact Ultrasound with 9L-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	P
Pediatric	P	P	P		P		P	P	P	P
Small Organ (specify)[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
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

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 Device Evaluation (ODE)

(Division Sign-Off)

Division of Reproductive, Abdominal a Radiological Devices 510(k) Number

E-7

10

Diagnostic Ultrasound Indications for Use Form

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	Mode of Operation
	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	N	N	N		N		N	N	N	N
Thoracic/Pleural (specify)[4]	N	N	N		N		N	N	N	N
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 Device Evaluation (ODE)

forn h. Wry

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Device 510(k) Number

11

Diagnostic Ultrasound Indications for Use Form

GE Compact Ultrasound with 16L-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*
Ophthalmic
Fetal / Obstetrics
Abdominal
Pediatric	E	E	E		E		E	E	E	E
Small Organ(2)	E	E	E		E		E	E	E	E
Neonatal Cephalic
Adult Cephalic
Cardiac
Peripheral Vascular	E	E	E		E		E	E	E	E
Musculo-skeletal Conventional	E	E	E		E		E	E	E	E
Musculo-skeletal Superficial	N	N	N		N		N	N	N	N
Thoracic/Pleural (specify)(4)
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 Device Evaluation (ODE)

f Device Evaluation (ODE)

(Division Sign-Off)

Division of Reproductive, Abdominal and Radiological Devic 510(k) Number

12

Diagnostic Ultrasound Indications for Use Form

GE Compact Ultrasound with i12L-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	P
Pediatric	P	P	P		P		P	P	P	P
Small Organ (specify)[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	N	N	N		N		N	N	N
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

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;

{51 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 Device Evaluation (ODE)

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Device 510(k) Number

13

Diagnostic Ultrasound Indications for Use Form

GE Compact Ultrasound with i/t739-RS Transducers

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 (specify)[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

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 Device Evaluation (ODE)
	(Division Sign-Off)
	Division of Reproductive, Abdominal and
Prescription User (Per 21 CFR 801.109)	Radiological Devices
510(k) Number

14

Diagnostic Ultrasound indications for Use Form

GE Compact Ultrasound with 3S-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	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 (specify)
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]	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

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 Device Evaluation (ODE)

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Device 510(k) Number

15

Diagnostic Ultrasound Indications for Use Form

GE Compact Ultrasound with 6S-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	P	P	P
Pediatric	P	P	P	P	P	P	P	P	P	P
Small Organ (specify)[2]
Neonatal Cephalic	P	P	P	P	P	P	P	P	P	P
Adult Cephalic	•	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
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

-ﺴﻪ .

[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 Device Evaluation (ODE

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K091314

16

Diagnostic Ultrasound Indications for Use Form

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 (specify)[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 Device Evaluation (ODE)

(Division Sign-Off)

Division of Reproductive, Abdominal and Radiological Device 510(k) Number

E-14