The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thvroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (abdominal, thoracic, vascular and neurosurgical).

Device Description

The LOGIQ E9 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 58 cm wide, 86 cm deep and 141 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 10-inch LCD touch screen and color 19-inch LCD image display. This modification will provide users with 8 additional transducers, an additional optional feature called Elastography Imaging and an enhanced version of the commercially available Volume Navigation (V Nav) optional feature. These modifications all lead to overall quality and image enhancement.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the GE LOGIQ E9 BT2010 Diagnostic Ultrasound System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary (K092271) for the GE LOGIQ E9 BT2010 system does not specify quantitative acceptance criteria or specific device performance metrics in a readily extractable table format for individual features (like Elastography or Volume Navigation).

Instead, the documentation relies on a general statement of compliance and equivalence:

Acceptance Criteria Category	Reported Device Performance (Summary)
General Safety and Effectiveness Standards	Conforms with applicable medical device safety standards (acoustic output, biocompatibility, cleaning/disinfection, thermal, electrical, electromagnetic, mechanical safety).
	Complies with voluntary standards detailed in Sections 9, 11, 15, and 17 of the premarket submission.
Elastography Imaging Mode	The elasticity imaging algorithm can differentiate different structures with different stiffness.
Volume Navigation (V Nav) Feature	The V Nav feature functions according to requirements and specifications.
Substantial Equivalence to Predicate Devices	The LOGIQ E9 BT2010 is of a comparable type and substantially equivalent to the GE LOGIQ E9, GE Vivid E9, and the Elastography Imaging feature from SonixTouch Ultrasound Scanner. It has the same technological characteristics, key safety and effectiveness features, and is similar in physical design, construction, materials, intended uses, and basic operating modes as the predicate devices.

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

The document explicitly states: "The subject of this premarket submission, LOGIQ E9 BT2010, did not require clinical studies to support substantial equivalence."

This indicates that clinical test data (and thus a "test set" with a corresponding sample size and data provenance as would be customary for a clinical study) was not used to demonstrate the substantial equivalence of the modified device. The submission relies on non-clinical tests and comparison to predicate devices.

However, for the specific features:

Elastography Imaging: The submission includes "DOC0605013 Verification Results Summary for Elastography Imaging". The document does not specify the sample size or provenance of data used in this verification, but it is implied to be non-clinical (e.g., phantom studies or controlled material tests) given the statement about not requiring clinical studies.
Volume Navigation: The submission includes "DOC0631792 Verification Results Summary for Volume Navigation". Similar to Elastography, details on sample size and provenance are not provided, but it is implied to be non-clinical verification.

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

Since clinical studies were not required and new features were validated through non-clinical verification, there is no mention of human experts being used to establish ground truth for a clinical test set. The "ground truth" for the non-clinical verification studies (e.g., for Elastography and V Nav) would likely be physical measurements, known properties of test materials (phantoms), or engineering specifications, rather than expert consensus on clinical images.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set was utilized for human expert review and thus no adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Improvement with AI vs. Without AI Assistance

Not applicable. The document describes a diagnostic ultrasound system and its features, not an AI-assisted diagnostic tool in the sense of image analysis that would typically involve MRMC studies to assess human reader improvement. The "Elastography imaging algorithm" is mentioned, but its performance is verified against the ability to differentiate stiffness, not as an AI assistant to human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

For the specific features mentioned:

Elastography Imaging: A standalone algorithm verification was done, as evidenced by the "DOC0605013 Verification Results Summary for Elastography Imaging" which provides evidence that the algorithm can differentiate different structures with different stiffness. This verifies the algorithm's capability independent of human interpretation for basic feature function.
Volume Navigation: A standalone verification was done for the V Nav feature, as evidenced by "DOC0631792 Verification Results Summary for Volume Navigation," which confirms it functions according to requirements and specifications.

7. The Type of Ground Truth Used

Elastography Imaging: The ground truth for the Elastography imaging algorithm verification likely involved physical properties/measurements of materials with known varying stiffness (e.g., phantoms). The goal was to prove the algorithm could differentiate stiffness, implying a controlled environment with established ground truth for stiffness levels.
Volume Navigation: The ground truth for Volume Navigation verification would be based on engineering requirements and specifications for tracking movement and needle tracking accuracy, verified against known positions or trajectories.
Overall System: For the overall substantial equivalence claim, the "ground truth" implicitly refers to the performance and characteristics of the predicate devices (GE LOGIQ E9, GE Vivid E9, and SonixTouch Ultrasound Scanner's Elastography feature). The new device is determined to be equivalent based on having the same technological characteristics, safety, effectiveness, physical design, construction, materials, and intended uses.

8. The Sample Size for the Training Set

Not applicable. The document describes a medical device with updated features (additional transducers, enhanced Volume Navigation, and Elastography imaging functionality), not a machine learning or AI model trained on a dataset. Therefore, there is no "training set" in the context of machine learning. The verification studies for the new features (Elastography, V Nav) would involve test data specific to their function, but not "training data."

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

Not applicable, as there was no training set described.

Summary

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pg. 1 of 3

NOV 1 7 2009

510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided: 2009-July-24 Date: K092271 510(k): Number: GE Healthcare, GE Medical Systems Ultrasound and Primary Care Submitter: Diagnostics, LLC. 9900 Innovation Drive Wauwatosa, WI, USA 53226 Nicole Landreville, Eng. RAC Primary Contact Person: USA Premarket Requlatory Affairs Leader GE Healthcare 3000 North Grandview Boulevard #W450 Waukesha, WI, USA 53188 Telephone: 289-208-2365 Fax: 414-918-4498 James T. Turner, MS, RAC Secondary Contact Person: USA Premarket Requlatory Affairs Leader GE Healthcare 3000 North Grandview Boulevard #W450 Waukesha, WI, USA 53188 Telephone: 262-544-3359 Fax: 414-908-9225 GE LOGIQ E9 BT2010 Diagnostic Ultrasound System Device/Trade Name: LOGIO Eg Common/Usual Name: Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYN Classification Names and Ultrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYO Product Code: Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX Class II Classification: K082185 GE LOGIQ E9 Diagnostic Ultrasound System Predicate Device(s): K081921 GE Vivid E9 Diagnostic Ultrasound System K083095 SonixTouch Ultrasound Scanner The LOGIQ E9 is a full featured, general purpose diagnostic ultrasound Device Description: system which consists of a mobile console approximately 58 cm wide, 86 cm deep and 141 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 10-inch LCD touch screen and color 19-inch LCD image display. This modification will provide users with 8 additional transducers, an additional optional feature called Elastography Imaging and an enhanced version of the commercially available Volume Navigation (V Nav) optional feature. These modifications all lead to overall quality and image enhancement.

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K092271
Pg. 2 of 3

The device is intended for use by a qualified physician for ultrasound Intended Use: evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thvroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (abdominal, thoracic, vascular and neurosurgical).

The LOGIQ E9 BT2010 employs the same fundamental scientific technology Technology: as its predicate devices. In addition to the 13 transducers commercially released: 3CRF, 9L-D, 11L-D, C1-5-D, IC5-9-D, M4S-D, M6C-D, ML6-15-D, RAB2-5-D, RIC5-9-D, RNA5-9-D, RSP6-16-D, S1-5, the LOGIQ E9 Diagnostic Ultrasound System will be released with these additional 8 transducers: 6S-D, 6Tc, L8-18i-D, M5S-D, P2D, P6D, RAB4-8-D and S4-10.

Additional Features Description:

Elastography imaging mode on the LOGIO E9 is similar to the Elastography imaging mode on the Ultrasonix SonixTouch Ultrasound Scanner. Elastography is a method to extract and display the mechanical properties of tissue.

This imaging method involves applying a manual pressure with the hand on the transducer. The actual imaging sequence is similar to the B-mode sequence except that the system will acquire the RF signal instead of acquiring B-mode dota. The acoustic output transmission is identical to Bmode data. The algorithm extracts a strain value information for every point on the image. The Elastography image then color-codes the stiff versus softer structures. The clinical benefits of elastography imaging are still under evaluation. This feature allows the user to be able to determine whether or not a structure inside the patient is stiffer than another one; no clinical diagnostic claims are being made.

This submission includes a document "DOC0605013 Verification Results Summary for Elastography Imagina". The report provides evidence that the elasticity imaging algorithm can differentiate different structures with different stiffness.

Volume Navigation (V Nav) feature was modified from its previous version cleared under 510(k) K082185. The Volume Navigation feature is enhanced with needle tracking. Volume Navigation uses one or more Electromagnetic (EM) position sensors attached to the transducer to track its movement. Needle Tracking is achieved by using an additional EM sensor attached to the needle.

This submission includes a document "DOC0631792 Verification Results Summary for Volume Navigation". The report provides evidence that the V Nav feature functions according to requirements and specifications.

Determination of Substantial Equivalence:

Summary of Non-Clinical Tests:

The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic and mechanical safety, and has been found to conform with applicable medical device safety standards. The LOGIQ E9 BT2010 and its applications comply with voluntary standards as detailed in Section 9, 11, 15 and 17 of this premarket submission. The following quality assurance measures were applied to the development of the system:

Risk Management .
Requirements Reviews

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K092271/
Pg. 3 of 3

Design Reviews ●
Testing on unit level (Module verification) .
Integration testing (System verification) .
Final acceptance testing (Validation) .
. Performance testing (Verification)
. Safety testing (Verification)

Transducer material and other patient contact materials such as needle guidance kits are biocompatible.

Summary of Clinical Tests:

The subject of this premarket submission, LOGIQ E9 BT2010, did not require clinical studies to support substantial equivalence.

The GE LOGIQ E9 BT2010 is of a comparable type and substantially Conclusion: equivalent to the current GE LOGIQ E9, GE Vivid E9 and the Elastography Imaging feature from SonixTouch Ultrasound Scanner. It has the same technological characteristics, key safety and effectiveness features, and is similar in physical design, construction and materials and has the same intended uses and basic operating modes as the predicate devices.

Intended uses and other key features are consistent with traditional clinical practice, FDA quidelines, and established methods of patient examination. The design and development process of the manufacturer conforms to 21 CFR 820, ISO 9001 and ISO 13485 quality management 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 LOGIQ E9 BT2010 is as safe, as effective, and performance is substantially equivalent to the predicate devices(s).

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

NOV 1 7 2009

Ms. Nicole Landreville USA Premarket RA Leader GE Healthcare 3000 N. Grandview Blvd., W450 WAUKESHA WI 53188

Re: K092271

Trade/Device Name: GE LOGIQ E9 Diagnostic 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: October 15, 2009 Received: October 26, 2009

Dear Ms. Landreville:

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 E9 Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number
3CRF	11L-D	M4S-D
6S-D	C1-5-D	M5S-D
6Tc	IC5-9-D	M6C-D
9L-D	L8-18i-D	ML6-15-D

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Page 2 - Ms. Landreville

DAT	-Carles Can Mar------------------------------------------------------------------------------------------------------------------------------------------------------------------------------.	non/ 1/ n----
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DO	11-.	1House, News1

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 (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 i 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 (301) 796-6242.

Sincerely yours,

Heidi Luman

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

Enclosure(s)

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Indications for Use

510(k) Number (if known): K092271

GE LOGIQ E9 Diagnostic Ultrasound System Device Name:

Indications For Use:

The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Cardia; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (abdominal, thoracic, vascular and neurosurgical}.

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

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)
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Herreim

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

Prescription Use (Per 21 CFR 801.109)

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K092271

Indications for Use Forms

The following forms represent indications with clinical applications and exam types along with the modes of operation for the LOGIQ E9 system and for all of its probe/mode combinations. Combinations identified by "N" are new while "P" represents those previously cleared with the unmodified LOGIQ E9. In a similar manner, "E" represents combinations added to the unmodified LOGIQ E9 via Appendix E of the 510(k) Guidance. The subject modification does not alter the previously cleared system level indications, clinical applications or modes of operation.

{7}------------------------------------------------

GE LOGIQ E9 Ultrasound System

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[Notes]
Ophthalmic	P	P	P	P	P	P	P	P	P	P	[5, 6, 9]
Fetal / Obstetrics (7)	P	P	P	P	P	P	P	P	P	P	[3, 5, 6, 9]
Abdominal(1)	P	P	P	P	P	P	P	P	P	P	[3, 5, 6, 9]
Pediatric	P	P	P	P	P	P	P	P	P	P	[3, 5, 6, 9]
Small Organ [2]	P	P	P	P	P	P	P	P	P	P	[3, 5, 6, 9]
Neonatal Cephalic	P	P	P	P	P	P	P	P	P	P	[5, 6, 9]
Adult Cephalic	P	P	P	P	P	P	P	P	P	P	[5, 6, 9]
Cardiac Adult	P	P	P	P	P	P	P	P	P	P
Cardiac Pediatric	P	P	P	P	P	P	P	P	P	P
Peripheral Vascular	P	P	P	P	P	P	P	P	P	P	[3, 5, 6, 9]
Musculo-skeletal Conventional	P	P	P	P	P	P	P	P	P	P	[3, 5, 6, 9]
Musculo-skeletal Superficial	P	P	P	P	P	P	P	P	P	P	[3, 5, 6, 9]
Other [4]	P	P	P	P	P	P	P	P	P	P	[3, 5, 6, 9]
Exam Type, Means of Access
Transesophageal	P	P	P	P	P	P	P	P	P	P
Transrectal	P	P	P	P	P	P	P	P	P	P	[3, 5, 6, 9]
Transvaginal	P	P	P	P	P	P	P	P	P	P	[3, 5, 6, 9]
Transurethral
Intraoperative[8]	P	P	P	P	P	P	P	P	P	P	[3, 5, 6, 9]
Intraoperative Neurological	P	P	P	P	P	P	P	P	P	P
Intravascular
Laparoscopic

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

[1] Abdominal includes renal, GYN/Pelvic. Notes:

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

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate.

[5] 3D/4D Imaging Mode.

[6] Needle guidance imaging.

[7] Includes infertility monitoring of follicle development.

[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).

[9] Volume Navigation.

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

System provides real-time 3D and 4D acquisition when used with special 4D probes.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)
---------------------------------------	--

	(Division Sign-Off)
	Division of Reproductive, Abdominal, and
	Radiological Devices
510(k) Number	K092271

4-3

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GE LOGIQ E9 with 3CRF Transducer

lntended 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	Other[Notes]
Ophthalmic
Fetal / Obstetrics[7]	N	N	N	N	N	N	N	N	N	N	[5, 6, 9]
Abdominal[1]	P	P	P	P	P	P	P	P	P	P	[5, 6, 9]
Pediatric	P	P	P	P	P	P	P	P	P	P	[5, 6, 9]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]	P	P	P	P	P	P	P	P	P	P	[5, 6, 9]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [1] Abdominal includes renal, GYN/Pelvic.

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

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate.

[5] 3D/4D Imaging Mode.

[6] Needle guidance imaging.

[7] Includes infertility monitoring of follicle development.

[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).

(9) Volume Navigation.

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD. System provides real-time 3D and 4D acquisition when used with special 4D probes.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription User (Per 21 CFR 801.109)	4-4
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(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number	K092271

{9}------------------------------------------------

GE LOGIQ E9 with 6S-D Transducer

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[Notes]
Ophthalmic
Fetal / Obstetrics[7]	N	N	N	N	N	N	N	N	N	N
Abdominal[1]	N	N	N	N	N	N	N	N	N	N
Pediatric	N	N	N	N	N	N	N	N	N	N
Small Organ[2]
Neonatal Cephalic	N	N	N	N	N	N	N	N	N	N
Adult Cephalic
Cardiac Adult
Cardiac Pediatric	N	N	N	N	N	N	N	N	N	N
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [1] Abdominal includes renal, GYN/Pelvic.

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

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate.

[5] 3D/4D Imaging Mode.

[6] Needle guidance imaging.

[7] Includes infertility monitoring of follicle development.

[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).

[9] Volume Navigation.

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

System provides real-time 3D and 4D acquisition when used with special 4D probes.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
	(Division Sigh-Off)
	Division of Reproductive, Abdominal, and

Radiological Devices

510(k) Number

Prescription User (Per 21 CFR 801.109)

{10}------------------------------------------------

GE LOGIQ E9 with 6Tc Transducer

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[Notes]
Ophthalmic
Fetal / Obstetrics[7]
Abdominal[1]
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult	N	N	N	N	N	N	N	N	N	N
Cardiac Pediatric
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal	N	N	N	N	N	N	N	N	N	N
Transrectal
Transvaginal
Transurethral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

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

[1] Abdominal includes renal, GYN/Pelvic. Notes:

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

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate.

[5] 3D/4D Imaging Mode.

[6] Needle guidance imaging.

[7] Includes infertility monitoring of follicle development.

[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV),

[9] Volume Navigation.

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD. System provides real-time 3D and 4D acquisition when used with special 4D probes.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (QDE)

(Division Sign-Off)

510(k) Ni

Radiological Devices

Division of Reproductive, Abdominal, and

Prescription User (Per 21 CFR 801.109)

4-6

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GE LOGIQ E9 with 9L-D Transducer

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[Notes]
Ophthalmic
Fetal / Obstetrics[7]	N	N	N	N	N	N	N	N	N	N	[5, 6, 9]
Abdominal[1]	N	N	N	N	N	N	N	N	N	N	[3, 5, 6, 9]
Pediatric	P	P	P	P	P	P	P	P	P	P	[3, 5, 6, 9]
Small Organ[2]	P	P	P	P	P	P	P	P	P	P	[3, 5, 6, 9]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral Vascular	P	P	P	P	P	P	P	P	P	P	[3, 5, 6, 9]
Musculo-skeletal Conventional	P	P	P	P	P	P	P	P	P	P	[3, 5, 6, 9]
Musculo-skeletal Superficial	N	N	N	N	N	N	N	N	N	N	[3, 5, 6, 9]
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [1] Abdominal includes renal, GYN/Pelvic.

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

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate.

[5] 3D/4D Imaging Mode.

[6] Needle guidance imaging.

[7] Includes infertility monitoring of follicle development.

[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).

[9] Volume Navigation.

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD. System provides real-time 3D and 4D acquisition when used with special 4D probes.

(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

Prescription User (Per 21 CFR 801.109)

4-7

510(k) Number

{12}------------------------------------------------

GE LOGIQ E9 with 11L-D Transducer

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[Notes]
Ophthalmic
Fetal / Obstetrics[7]
Abdominal(1)	N	N	N		N	N	N	N	N	N	[3, 5, 6]
Pediatric	P	P	P		P	P	P	P	P	P	[3, 5, 6]
Small Organ(2)	P	P	P		P	P	P	P	P	P	[3, 5, 6]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral Vascular	P	P	P		P	P	P	P	P	P	[3, 5, 6]
Musculo-skeletal Conventional	P	P	P		P	P	P	P	P	P	[3, 5, 6]
Musculo-skeletal Superficial	P	P	P		P	P	P	P	P	P	[3, 5, 6]
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

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

[1] Abdominal includes renal, GYN/Pelvic. Notes:

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

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate.

[5] 3D/4D Imaging Mode.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[6] Needle guidance imaging.

[7] Includes infertility monitoring of follicle development.

[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).

[9] Volume Navigation.

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD. System provides real-time 3D and 4D acquisition when used with special 4D probes.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription User (Per 21 CFR 801.109)
	4-8

(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number	K092271

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

GE LOGIQ E9 with C1-5-D Transducer

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[Notes]
Ophthalmic
Fetal / Obstetrics[7]	P	P	P	P	P	P	P	P	P	P	[5, 6, 9]
Abdominal[1]	P	P	P	P	P	P	P	P	P	P	[5, 6, 9]
Pediatric	P	P	P	P	P	P	P	P	P	P	[5, 6, 9]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral Vascular	P	P	P	P	P	P	P	P	P	P	[5, 6, 9]
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]	N	N	N	N	N	N	N	N	N	N	[5, 6, 9]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

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

[1] Abdominal includes renal, GYN/Pelvic. Notes:

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

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate.

[5] 3D/4D Imaging Mode.

[6] Needle guidance imaging.

[7] Includes infertility monitoring of follicle development.

[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).

[9] Volume Navigation.

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

System provides real-time 3D and 4D acquisition when used with special 4D probes.

(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
Prescription User (Per 21 CFR 801.109)
	4-9
510(k) Number	2092271

{14}------------------------------------------------

GE LOGIQ E9 with IC5-9-D Transducer

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(Notes)
Ophthalmic
Fetal / Obstetrics[7]	P	P	P		P	P	P	P	P	P	[5, 6, 9]
Abdominal[1]
Pediatric
Small Organ [2]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]	N	N	N		N	N	N	N	N	N	[3, 5, 6, 9]
Exam Type, Means of Access
Transesophageal	P	P	P		P	P	P	P	P	P	[3, 5, 6, 9]
Transrectal	P	P	P		P	P	P	P	P	P	[3, 5, 6, 9]
Transvaginal	P	P	P		P	P	P	P	P	P	[3, 5, 6, 9]
Transurethral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [1] Abdominal includes renal, GYN/Pelvic.

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

(3) Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate.

[5] 3D/4D Imaging Mode.

[6] Needle guidance imaging.

[7] Includes infertility monitoring of follicle development.

[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).

[9] Volume Navigation.

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD. System provides real-time 3D and 4D acquisition when used with special 4D probes.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription User (Per 21 CFR 801.109)	4-10
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number	K092271

{15}------------------------------------------------

GE LOGIQ E9 with L8-18i-D Transducer

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

Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other[Notes]
Ophthalmic
Fetal / Obstetrics7
Abdominal[1]
Pediatric	N	N	N	N	N	N	N	N	N	[3, 5, 6, 9]
Small Organ[2]	N	N	N	N	N	N	N	N	N	[3, 5, 6, 9]
Neonatal Cephalic	N	N	N	N	N	N	N	N	N	[5, 6, 9]
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral Vascular	N	N	N	N	N	N	N	N	N	[3, 5, 6, 9]
Musculo-skeletal Conventional	N	N	N	N	N	N	N	N	N	[3, 5, 6, 9]
Musculo-skeletal Superficial	N	N	N	N	N	N	N	N	N	[3, 5, 6, 9]
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative[8]	N	N	N	N	N	N	N	N	N	[3, 5, 6, 9]
Intraoperative Neurological
Intravascular
Laparoscopic

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

[1] Abdominal includes renal, GYN/Pelvic. Notes:

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

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate.

[5] 3D/4D Imaging Mode.

[6] Needle guidance imaging.

[7] Includes infertility monitoring of follicle development.

[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).

[9] Volume Navigation.

ﻟﻤﺮﻳﺮ

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

System provides real-time 3D and 4D acquisition when used with special 4D probes.

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

	Concurrence of CDRH, Office of Device Evaluation (ODE)

		(Division Sign-Off)
Prescription User (Per 21 CFR 801.109)		Division of Reproductive, Abdominal, and
		Radiological Devices
	4-11	510(k) Number

{16}------------------------------------------------

GE LOGIQ E9 with M4S-D Transducer

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[Notes]
Ophthalmic
Fetal / Obstetrics[7]	P	P	P	P	P	P	P	P	P	P	[5, 6]
Abdominal[1]	P	P	P	P	P	P	P	P	P	P	[5, 6]
Pediatric	P	P	P	P	P	P	P	P	P	P	[5, 6]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic	P	P	P	P	P	P	P	P	P	P
Cardiac Adult	P	P	P	P	P	P	P	P	P	P
Cardiac Pediatric
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [1] Abdominal includes renal, GYN/Pelvic.

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

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate.

[5] 3D/4D Imaging Mode.

. . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[6] Needle guidance imaging.

[7] Includes infertility monitoring of follicle development.

[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).

[9] Volume Navigation.

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD. System provides real-time 3D and 4D acquisition when used with special 4D probes.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Prescription User (Per 21 CFR 801.109)

4-12

ivision of Reproductive, Abdominal, and gical Devices

{17}------------------------------------------------

GE LOGIQ E9 with M5S-D Transducer

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

Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other[Notes]
Ophthalmic
Fetal / Obstetrics[7]	N	N	N	N	N	N	N	N	N	N	[5, 6, 9]
Abdominal[1]	N	N	N	N	N	N	N	N	N	N	[5, 6, 9]
Pediatric	N	N	N	N	N	N	N	N	N	N	[5, 6, 9]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic	N	N	N	N	N	N	N	N	N	N	[9]
Cardiac Adult	N	N	N	N	N	N	N	N	N	N
Cardiac Pediatric	N	N	N	N	N	N	N	N	N	N
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [1] Abdominal includes renal, GYN/Pelvic.

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

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate.

[5] 3D/4D Imaging Mode ..

[6] Needle guidance imaging.

[7] Includes infertility monitoring of follicle development.

[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).

[9] Volume Navigation.

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

System provides real-time 3D and 4D acquisition when used with special 4D probes.

(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 4-13

Prescription User (Per 21 CFR 801.109)

. --

{18}------------------------------------------------

GE LOGIQ E9 with M6C-D Transducer

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

Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other[Notes]
Ophthalmic
Fetal / Obstetrics[7]	P	P	P	P	P	P	P	P	P	P	[5, 6]
Abdominal[1]	P	P	P	P	P	P	P	P	P	P	[5,6]
Pediatric	P	P	P	P	P	P	P	P	P	P	[5, 6]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: ' [1] Abdominal includes renal, GYN/Pelvic.

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

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate.

[5] 3D/4D Imaging Mode.

[6] Needle guidance imaging.

[7] Includes infertility monitoring of follicle development.

[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).

[9] Volume Navigation.

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

System provides real-time 3D and 4D acquisition when used with special 4D probes.

(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

Prescription User (Per 21 CFR 801.109)

4-14

{19}------------------------------------------------

GE LOGIQ E9 with ML6-15-D Transducer

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[Notes]
Ophthalmic
Fetal / Obstetrics[7]
Abdominal[1]
Pediatric	P	P	P		P	P	P	P	P	P	[3, 5, 6, 9]
Small Organ[2]	P	P	P		P	P	P	P	P	P.	[3, 5, 6, 9]
Neonatal Cephalic	N	N	N		N	N	N	N	N	N	[9]
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral Vascular	P	P	P		P	P	P	P	P	P	[3, 5, 6, 9]
Musculo-skeletal Conventional	P	P	P		P	P	P	P	P	P	[3, 5, 6, 9]
Musculo-skeletal Superficial	P	P	P		P	P	P	P	P	P	[3, 5, 6, 9]
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [1] Abdominal includes renal, GYN/Pelvic.

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

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate.

[5] 3D/4D Imaging Mode.

[6] Needle guidance imaging.

[7] Includes infertility monitoring of follicle development.

[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).

[9] Volume Navigation.

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD. System provides real-time 3D and 4D acquisition when used with special 4D probes.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE),

Het
(Division Sign-Off)

Prescription User (Per 21 CFR 801.109)

. 4-15

Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number

{20}------------------------------------------------

K092271

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ E9 with P2D Transducer

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[Notes]
Ophthalmic
Fetal / Obstetrics[7]
Abdominal [1]
Pediatric
Small Organ [2]
Neonatal Cephalic
Adult Cephalic		N	N	N
Cardiac Adult		N	N	N
Cardiac Pediatric		N	N	N
Peripheral Vascular		N	N	N
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [1] Abdominal includes renal, GYN/Pelvic.

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

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate.

[5] 3D/4D Imaging Mode.

[6] Needle guidance imaging.

[7] Includes infertility monitoring of follicle development.

[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).

[9] Volume Navigation.

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

System provides real-time 3D and 4D acquisition when used with special 4D probes.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE).

(Division Sign-Off)

Prescription User (Per 21 CFR 801.109)

4-16

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

{21}------------------------------------------------

:K092271

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ E9 with P6D Transducer

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[Notes]
Ophthalmic
Fetal / Obstetrics[7]
Abdominal[1]
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic			N	N
Cardiac Adult			N	N
Cardiac Pediatric			N	N
Peripheral Vascular			N	N
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

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

[1] Abdominal includes renal, GYN/Pelvic. Notes:

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

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate.

[5] 3D/4D Imaging Mode.

[6] Needle guidance imaging.

[7] Includes infertility monitoring of follicle development.

[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).

[9] Volume Navigation.

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

System provides real-time 3D and 4D acquisition when used with special 4D probes.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription User (Per 21 CFR 801.109)
	4-17

(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number	K092271

{22}------------------------------------------------

GE LOGIQ E9 with RAB2-5-D Transducer

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[Notes]
Ophthalmic
Fetal / Obstetrics[7]	P	P	P	P	P	P	P	P	P	P	[5, 6]
Abdominal[1]	P	P	P	P	P	P	P	P	P	P	[5, 6]
Pediatric	P	P	P	P	P	P	P	P	P	P	[5, 6]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral Vascular
Musculo-skeletal Conventional	P	P	P	P	P	P	P	P	P	P	[5, 6]
Musculo-skeletal Superficial
Other[4]	P	P	P	P	P	P	P	P	P	P	[5]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [1] Abdominal includes renal, GYN/Pelvic.

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

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate.

[5] 3D/4D Imaging Mode.

. İ

[6] Needle guidance imaging.

[7] Includes infertility monitoring of follicle development.

[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).

[9] Volume Navigation.

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

System provides real-time 3D and 4D acquisition when used with special 4D probes.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Prescription Use (Per 21 CFR 801.109)

4-18

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

{23}------------------------------------------------

K092271

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ E9 with RAB4-8-D Transducer

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[Notes]
Ophthalmic
Fetal / Obstetrics[7]	N	N	N	N	N	N	N	N	N	N	[5, 6]
Abdominal[1]	N	N	N	N	N	N	N	N	N	N	[5, 6]
Pediatric	N	N	N	N	N	N	N	N	N	N	[5, 6]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral Vascular
Musculo-skeletal Conventional	N	N	N	N	N	N	N	N	N	N	[5, 6]
Musculo-skeletal Superficial
Other [4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [1] Abdominal includes renal, GYN/Pelvic.

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

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate.

[5] 3D/4D Imaging Mode.

[6] Needle guidance imaging.

[7] Includes infertility monitoring of follicle development.

[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).

[9] Volume Navigation.

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

System provides real-time 3D and 4D acquisition when used with special 4D probes.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)	4-19
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number	K092271

{24}------------------------------------------------

K092271

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ E9 with RIC5-9-D Transducer

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[Notes]
Ophthalmic
Fetal / Obstetrics[7]	P	P	P		P	P	P	P	P	P	[5, 6]
Abdominal[1]
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]	N	N	N	N	N	N	N	N	N	N	[3, 5, 6]
Exam Type, Means of Access
Transesophageal	P	P	P		P	P	P	P	P	P	[3, 5, 6]
Transrectal	P	P	P		P	P	P	P	P	P	[3, 5, 6]
Transvaginal	P	P	P		P	P	P	P	P	P	[3, 5, 6]
Transurethral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

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

[1] Abdominal includes renal, GYN/Pelvic. Notes:

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

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate.

[5] 3D/4D Imaging Mode.

[6] Needle guidance imaging.

[7] Includes infertility monitoring of follicle development.

[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).

[9] Volume Navigation.

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

System provides real-time 3D and 4D acquisition when used with special 4D probes.

(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

Prescription User (Per 21 CFR 801.109)

{25}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9 with RNA5-9-D Transducer

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[Notes]
Ophthalmic
Fetal / Obstetrics[7]	P	P	P	P	P	P	P	P	P	P	[5,6]
Abdominal[1]	P	P	P	P	P	P	P	P	P	P	[5,6]
Pediatric	P	P	P	P	P	P	P	P	P	P	[5,6]
Small Organ[2]	P	P	P	P	P	P	P	P	P	P	[5,6]
Neonatal Cephalic	P	P	P	P	P	P	P	P	P	P	[5]
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral Vascular	P	P	P	P	P	P	P	P	P	P	[5,6]
Musculo-skeletal Conventional	P	P	P	P	P	P	P	P	P	P	[5,6]
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

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

[1] Abdominal includes renal, GYN/Pelvic. Notes:

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

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate.

[5] 3D/4D Imaging Mode.

[6] Needle guidance imaging.

[7] Includes infertility monitoring of follicle development.

[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).

[9] Volume Navigation.

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

System provides real-time 3D and 4D acquisition when used with special 4D probes.

(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

Prescription User (Per 21 CFR 801.109)

{26}------------------------------------------------

GE LOGIQ E9 with RSP6-16-D Transducer

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[Notes]
Ophthalmic
Fetal / Obstetrics [7]
Abdominal[1]	P	P	P		P	P	P	P	P	P
Pediatric	P	P	P		P	P	P	P	P	P	[3, 5, 6]
Small Organ[2]	P	P	P		P	P	P	P	P	P	[3, 5, 6]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral Vascular	P	P	P		P	P	P	P	P	P	[3, 5, 6]
Musculo-skeletal Conventional	P	P	P		P	P	P	P	P	P	[3, 5, 6]
Musculo-skeletal Superficial	P	P	P		P	P	P	P	P	P	[3, 5, 6]
Other [4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative[8]	P	P	P		P	P	P	P	P	P
Intraoperative Neurological	P	P	P		P	P	P	P	P	P
Intravascular
Laparoscopic

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

[1] Abdominal includes renal, GYN/Pelvic. Notes:

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

[3] Elastography Imaging - Elasticity.

(4) Other use includes Urology/Prostate

[5] 3D/4D Imaging Mode.

[6] Needle guidance imaging.

[7] Includes infertility monitoring of follicle development.

[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).

[9] Volume Navigation.

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

System provides real-time 3D and 4D acquisition when used with special 4D probes.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Prescription User (Per 21 CFR 801.109)

sion of Reproductive, Abdominal, and

{27}------------------------------------------------

GE LOGIQ E9 with S1-5 Transducer

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[Notes]
Ophthalmic
Fetal / Obstetrics[7]	P	P	P	P	P	P	P	P	P	P	[5, 6, 9]
Abdominal[1]	P	P	P	P	P	P	P	P	P	P	[5, 6, 9]
Pediatric	P	P	P	P	P	P	P	P	P	P	[5, 6, 9]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic	P	P	P	P	P	P	P	P	P	P	[5, 6, 9]
Cardiac Adult	P	P	P	P	P	P	P	P	P	P
Cardiac Pediatric
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [1] Abdominal includes renal, GYN/Pelvic.

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

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate.

[5] 3D/4D Imaging Mode.

[6] Needle guidance imaging.

[7] Includes infertility monitoring of follicle development.

[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).

[9] Volume Navigation.

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD. System provides real-time 3D and 4D acquisition when used with special 4D probes.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sidn-Off)

Prescription User (Per 21 CFR 801.109)

4-23

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

{28}------------------------------------------------

GE LOGIQ E9 with S4-10 Transducer

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[Notes]
Ophthalmic
Fetal / Obstetrics[7]	N	N	N	N	N	N	N	N	N	N	[5, 6, 9]
Abdominal[1]	N	N	N	N	N	N	N	N	N	N	[5, 6, 9]
Pediatric	N	N	N	N	N	N	N	N	N	N	[5, 6, 9]
Small Organ[2]	N	N	N	N	N	N	N	N	N	N	[5, 6, 9]
Neonatal Cephalic	N	N	N	N	N	N	N	N	N	N	[5, 6, 9]
Adult Cephalic
Cardiac Adult
Cardiac Pediatric	N	N	N	N	N	N	N	N	N	N
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

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

[1] Abdominal includes renal, GYN/Pelvic. Notes:

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

[3] Elastography Imaging - Elasticity.

[4] Other use includes Urology/Prostate.

[5] 3D/4D Imaging Mode.

[6] Needle guidance imaging.

[7] Includes infertility monitoring of follicle development.

[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).

[9] Volume Navigation.

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

System provides real-time 3D and 4D acquisition when used with special 4D probes.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

GE IF NEEDED)
(ODE)

(Division Sign-Off)

Prescription User (Per 21 CFR 801.109)

ﻧ

4-24

vision of Reproductive, Abdominal, & Radiological Devices 510(k) Number

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.