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.

AI/ML Overview

This is a 510(k) premarket notification for a diagnostic ultrasound system (GE LOGIQ i/e, Vivid e Ultrasound) and does not contain detailed acceptance criteria and performance study results in the way a clinical trial submission for a novel device might.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria or detailed reported device performance metrics (e.g., sensitivity, specificity, accuracy, image quality scores). Instead, it relies on a "substantial equivalence" argument to predicate devices. The "performance" is implicitly deemed equivalent to the predicate devices.

Acceptance Criteria (Not explicitly stated/quantified)	Reported Device Performance (Implicitly equivalent to predicate)
Safety:	Conforms with applicable medical device safety standards.
- Acoustic output	Evaluated and conforms.
- Biocompatibility	Evaluated and conforms.
- Cleaning and disinfection effectiveness	Evaluated and conforms.
- Electromagnetic compatibility	Evaluated and conforms.
- Thermal, electrical, and mechanical safety	Evaluated and conforms.
Effectiveness:
- Overall performance	Comparable to predicate GE LOGIQ e and Venue 40.
- Key safety and effectiveness features	Same as predicate devices.
- Physical overall construction and materials	Same as predicate devices.
- Technological characteristics	Equivalent to predicate devices.

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

No specific test set or clinical data is mentioned. The submission states: "Clinical Tests: None required." Therefore, there is no sample size for a test set and no data provenance (country of origin, retrospective/prospective). The rationale is that "Intended uses and other key features are consistent with traditional clinical practice, FDA guidelines, and established methods of patient examination. Diagnostic ultrasound has accumulated a long history of safe and effective performance."

3. Number of Experts Used to Establish Ground Truth and Qualifications

Since no clinical tests or test sets were used, no experts were involved in establishing ground truth for a test set.

4. Adjudication Method

Not applicable, as no test set or clinical data requiring adjudication was used.

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

No MRMC comparative effectiveness study was done. The submission explicitly states "Clinical Tests: None required." The device is cleared based on demonstrating substantial equivalence to predicate devices, not on proving improved effectiveness through head-to-head clinical trials with human readers.

6. Standalone Performance Study

No standalone performance study (algorithm only, without human-in-the-loop) was conducted or reported in this 510(k) submission. This device is a diagnostic ultrasound system, not an AI algorithm requiring standalone performance evaluation in the typical sense for medical imaging AI. Its performance is inherent in its imaging capabilities and user-controlled operation.

7. Type of Ground Truth Used

The ground truth for the device's performance, as argued in this 510(k), is essentially the established safe and effective performance of its predicate devices in clinical practice, along with compliance to recognized standards. There isn't a "ground truth" derived from expert consensus, pathology, or outcomes data for this specific submission's evaluation.

8. Sample Size for the Training Set

Not applicable. The GE LOGIQ i/e and Vivid e Ultrasound system is a conventional diagnostic ultrasound device, not an AI/machine learning model in the modern sense that requires a training set of data.

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

Not applicable, as there is no training set for this conventional diagnostic ultrasound device.

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., LtdNo. 19 Changjiang Road, National Hi-Tech Development ZoneWuxi, 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 RegulatoryTelephone: 86-510-85278652; Fax: 86-510-85227347
	Date Prepared:	April 20, 2009
2.	Device Name:	GE LOGIQ i/e, Vivid e UltrasoundUltrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYOUltrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYNDiagnostic 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.

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.
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.
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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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 (240) 276-3666.

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

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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 ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	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 ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	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}------------------------------------------------

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 ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	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 ApplicationAnatomy/ Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse
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 ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	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 ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse*	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 ApplicationAnatomy/Region of Interest	Mode of Operation
	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse
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 ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse*
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 ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	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 ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	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 Devices510(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 ApplicationAnatomy/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 ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse*	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 ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	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

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.