The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); 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 includes a computer keyboard. specialized controls, 10-inch LCD touch screen and color 19-inch LCD image display. This modification will provide users with additional probe options, additional software options (V Nav and Scan Assistant) leading to overall quality and image enhancement. The LOGIQ E9 Diagnostic Ultrasound System is initially released with the following 13 probes: S1-5, C1-5-D, 3CRF, 9L-D, 11L-D, IC5-9-D, M4S-D, M6C-D, ML6-15-D, RAB2-5-D, RIC5-9-D, RNA5-9-D, RSP6-16-D.

AI/ML Overview

The GE LOGIQ E9 Diagnostic Ultrasound System is a general-purpose diagnostic ultrasound system. Its acceptance criteria and proof of meeting those criteria are established through a predicate device comparison rather than specific performance metrics like sensitivity or specificity.

Acceptance Criteria and Reported Device Performance

The core acceptance criterion for the GE LOGIQ E9 Diagnostic Ultrasound System is Substantial Equivalence to a legally marketed predicate device, specifically the GE LOGIQ BT08 Diagnostic Ultrasound System (K073408).

The reported device performance, which supports this acceptance criterion, is based on the claim that the GE LOGIQ E9:

Has the same technological characteristics as the predicate device.
Possesses key safety and effectiveness features similar to the predicate device.
Is similar in physical design, construction, and materials to the predicate device.
Has the same intended uses and basic operating modes as the predicate device.
Conforms with applicable medical device safety standards (acoustic output, biocompatibility, cleaning and disinfection effectiveness, thermal, electrical, and mechanical safety).
Its design and development process conform to 21 CFR 820, ISO 9001, and ISO 13485 quality management systems.

The FDA's letter (Attachment {2}) confirms this determination of substantial equivalence.

Study Information

Sample Size Used for the Test Set and Data Provenance:
- Not Applicable. The document explicitly states: "Clinical Tests: None required" (Attachment {1}). The device's substantial equivalence is based on non-clinical tests and comparison to a predicate device, not on clinical performance metrics derived from a test set of patient data.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not Applicable. As no clinical tests were required or performed to establish novel performance claims, there was no test set requiring ground truth established by experts for performance evaluation.
Adjudication Method for the Test Set:
- Not Applicable. No clinical test set was utilized.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not Applicable. No MRMC study was conducted. The clearance is based on substantial equivalence to a predicate device, not on demonstrating improved human reader performance with or without AI assistance.
Standalone (i.e., algorithm only without human-in-the-loop performance) Study:
- Not Applicable. This device is an ultrasound system, not an AI algorithm. Its performance is inherent in its hardware and software for image acquisition and display, which are deemed substantially equivalent to a predicate.
Type of Ground Truth Used:
- Not Applicable. No clinical ground truth (e.g., pathology, outcomes data) was used to assess the device's performance, as no clinical performance study was conducted. The ground truth for substantial equivalence is the safety and effectiveness profile of the predicate device, K073408.
Sample Size for the Training Set:
- Not Applicable. This submission is for a diagnostic ultrasound system (hardware and associated software features), not a machine learning or AI model that requires a "training set" of data in the typical sense. The 'training' for this type of device would involve engineering design, component testing, and adherence to quality standards.
How the Ground Truth for the Training Set Was Established:
- Not Applicable. As there is no "training set" for an AI model, this question does not apply. The development is based on established engineering principles, regulatory standards, and the performance characteristics of the predicate device.

Summary

{0}------------------------------------------------

KOR2185

Special 510(k) Premarket Notification GE LOGIQ E9 Ultrasound System July 24, 2008

Attachment B:

AUG 1 5 2008

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

	GE Healthcare
	General Electric CompanyP.O. Box 414, Milwaukee, WI 53201
Section a):
1. Submitter:	GE Healthcare, Ultrasound and Primary Care Diagnostics, LLCPO Box 414, Milwaukee, WI 53201
Contact Person:	Nicole Landreville, Eng. RACLeader, Diagnostic Ultrasound Regulatory AffairsTelephone: 414-721-2272; Fax: 414-918-4498
Date Prepared:	July 29, 2008
2. Device Name:	GE LOGIQ E9 Diagnostic Ultrasound SystemUltrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYOUltrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYN
3. Marketed Device:	GE LOGIOBT08 Diagnostic Ultrasound System K073408

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 includes a computer keyboard. specialized controls, 10-inch LCD touch screen and color 19-inch LCD image display. This modification will provide users with additional probe options, additional software options (V Nav and Scan Assistant) leading to overall quality and image enhancement. The LOGIQ E9 Diagnostic Ultrasound System is initially released with the following 13 probes: $1-5, C1-5-D, 3CRF, 9L-D, 11L-D, IC5-9-D, M4S-D, M6C-D, ML6-15-D, RAB2-5-D, RIC5-9-D, RNA5-9-D, RSP6-16-D.
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; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transvaginal; Transesophageal and Intraoperative (abdominal, thoracic, vascular and neurosurgical).
Comparison with Predicate Devices: The GE LOGIQ E9 is of a comparable type and substantially equivalent to the current GE LOGIQ BT08. 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 device.

Section b):

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

{1}------------------------------------------------

Special 510(k) Premarket Notification GE LOGIQ E9 Ultrasound System July 24, 2008

Clinical Tests: None required.
Conclusion: Intended uses and other key features are consistent with traditional clinical practice, FDA guidelines, and established methods of patient examination. The design and development process of the manufacturer conforms 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 GE LOGIQ E9 Diagnostic Ultrasound is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus. The seal is presented in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 5 2008

Nicole Landreville, RAC Leader, Diagnostic Ultrasound Regulatory Affairs General Electric Company GE Medical Systems, Ultrasound and Primary Care Diagnostics, LLC 9900 Innovation Drive WAUWATOSA WI 53226

Re: K082185

Trade/Device Name: GE LOGIQ E9 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO and IYN Dated: July 29, 2008 Received: August 1, 2008

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

S1-5
C1-5-D
3CRF
9L-D
11L-D

{3}------------------------------------------------

IC5-9-D
M4S-D
M6C-D
ML6-15-D
RAB2-5-D
RIC5-9-D
RNA5-9-D
RSP6-16-D

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 determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

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.

{4}------------------------------------------------

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.l.ttml

If you have any questions regarding the content of this letter, please contact Andrew Kang, M.D. at (240) 276-3666.

Sincerely yours,

Helene Leinen

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

{5}------------------------------------------------

Indications for Use

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: GE LOGIQ E9 Diagnostic Ultrasound System

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; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transvaginal; 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)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hebert Leeman

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

{6}------------------------------------------------

Kora 185

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
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	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	[5, 6]
Musculo-skeletal Conventional	P	P	P	P	P	P	P	P	P	P	[5, 6]
Musculo-skeletal Superficial	P	P	P	P	P	P	P	P	P	P	[5, 6]
Other[4]	P	P	P	P	P	P	P	P	P	P
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	[5, 6]
Transvaginal	P	P	P	P	P	P	P	P	P	P	[5, 6]
Transuretheral
Intraoperative[8]	P	P	P	P	P	P	P	P	P	P
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

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

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

[3] Cardiac is Adult and Pediatric.

[4] Other use includes Urology/Prostate.

[5] 3D/4D Imaging Mode.

[6] Includes imaging of guidance of biopsy (3D/4D).

[7] Includes infertility monitoring of follicle development.

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

[9] Volume Navigation / Image Fusion / GPS /

[*] 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)

(ODE)

Prescription Use (Per 21 CFR 801.109)

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

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

K082185

Diagnostic Ultrasound Indications for Use Form

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]	N	N	N	N	N	N	N	N	N	N	[6]
Abdominal[1]	N	N	N	N	N	N	N	N	N	N	[6]
Pediatric	N	N	N	N	N	N	N	N	N	N	[6]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic	N	N	N	N	N	N	N	N	N	N	[6]
Cardiac[3]	N	N	N	N	N	N	N	N	N	N	[6]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
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] Cardiac is Adult and Pediatric.

[4] Other use includes Urology/Prostate.

[5] 3D/4D Imaging Mode.

[6] Includes imaging of guidance of biopsy (3D/4D).

[7] Includes infertility monitoring of follicle development.

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

[*] 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)

evice Evaluation (ODE)

(Division Sign-Off)

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

{8}------------------------------------------------

K082185 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]	N	N	N	N	N	N	N	N	N	N	[6]
Abdominal[1]	N	N	N	N	N	N	N	N	N	N	[6]
Pediatric	N	N	N	N	N	N	N	N	N	N	[6]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular	N	N	N	N	N	N	N	N	N	N	[6]
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
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] Cardiac is Adult and Pediatric.

[4] Other use includes Urology/Prostate.

[5] 3D/4D Imaging Mode.

[6] Includes imaging of guidance of biopsy (3D/4D).

[7] Includes infertility monitoring of follicle development.

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

[*] 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)

ice Evaluation (ODE)

Division Sign-Off)

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

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

Koga185 GE LOGIQ E9 with 3CRF 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	[5, 6]
Pediatric	P	P	P		P	P	P	P	P	P	[5, 6]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]	P	P	P		P	P	P	P	P	P
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
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] Cardiac is Adult and Pediatric.

[4] Other use includes Urology/Prostate.

[5] 3D/4D Imaging Mode.

[6] Includes imaging of guidance of biopsy (3D/4D).

[7] Includes infertility monitoring of follicle development.

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

[*] 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 ANQTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

NUE ON ANOTHER PAGE IF NEEDED)

evice Evaluation (ODE)

sugion Sign Offl

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

Radiological Devices
510(k) Number K082185

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

-042185

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]
Abdominal[1]
Pediatric	P	P	P		P	P	P	P	P	P	[5, 6]
Small Organ[2]	P	P	P		P	P	P	P	P	P	[6]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular	P	P	P		P	P	P	P	P	P	[5, 6]
Musculo-skeletal Conventional	P	P	P		P	P	P	P	P	P	[5, 6]
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
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] Cardlac Is Adult and Pedlatric.

[4] Other use includes Urology/Prostate.

[5] 3D/4D Imaging Mode.

[6] Includes imaging of guidance of biopsy (3D/4D).

[7] Includes infertility monitoring of follicle development,

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

[*] 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)

Helmut Lehner

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

{11}------------------------------------------------

KOB2185

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]
Pediatric	P	P	P		P	P	P	P	P	P	[5, 6]
Small Organ[2]	P	P	P		P	P	P	P	P	P	[5, 6]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular	P	P	P		P	P	P	P	P	P	[5, 6]
Musculo-skeletal Conventional	P	P	P		P	P	P	P	P	P	[5, 6]
Musculo-skeletal Superficial	P	P	P		P	P	P	P	P	P	[5, 6]
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
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] Cardlac Is Adult and Pedlatric.

[4] Other use includes Urology/Prostate.

[5] 3D/4D Imaging Mode.

[6] Includes imaging of guidance of biopsy (3D/4D).

[7] Includes infertility monitoring of follicle development.

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

[*] 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)

vice Evaluation (ODE)

Sign Off)

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

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

GE LOGIQ E9 with IC5-9-D Transducer 082185

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[3]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal	P	P	P		P	P	P	P	P	P	[5, 6]
Transvaginal	P	P	P		P	P	P	P	P	P	[5, 6]
Transuretheral
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] Cardiac is Adult and Pediatric.

[4] Other use includes Urology/Prostate.

[5] 3D/4D Imaging Mode.

[6] Includes imaging of guidance of biopsy (3D/4D).

[7] Includes infertility monitoring of follicle development.

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

[*] 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 TF NEEDED)

Concurrence of CDRH, Office of Device Evaluation ODE

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

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

Ko82185 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[3]	P	P	P	P	P	P	P	P	P	P
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
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] Cardiac is Adult and Pediatric.

[4] Other use includes Urology/Prostate.

[5] 3D/4D Imaging Mode.

[6] Includes imaging of guidance of biopsy (3D/4D).

[7] Includes infertility monitoring of follicle development.

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

[*] 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 (ODF)

(Dilbion Sign-Off)

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

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

1002185 GE LOGIQ E9 with M6C-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	OtherNotes
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[3]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
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] Cardiac is Adult and Pedialric.

[4] Other use includes Urology/Prostate.

[5] 3D/4D Imaging Mode.

[6] Includes imaging of guidance of biopsy (3D/4D).

[7] Includes infertility monitoring of follicle development.

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

[*] 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 K082/85

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

K082185 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	Combined HarmonicModes	Imaging	CodedPulse	Other[Notes]
Ophthalmic
Fetal / Obstetrics [7]
Abdominal [1]
Pediatric	P	P	P		P	P	P	P	P	P	[5, 6]
Small Organ[2]	P	P	P		P	P	P	P	P	P	[5, 6]
Neonatal Cephalic
Adult Cephalic
Cardiac [3]
Peripheral Vascular	P	P	P		P	P	P	P	P	P	[5, 6]
Musculo-skeletal Conventional	P	P	P		P	P	P	P	P	P	[5, 6]
Musculo-skeletal Superficial	P	P	P		P	P	P	P	P	P	[5, 6]
Other [4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
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] Cardiac is Adult and Pediatric.

[4] Other use includes Urology/Prostate.

[5] 3D/4D Imaging Mode.

[6] Includes imaging of guidance of biopsy (3D/4D).

[7] Includes Infertility monitoring of follicle development.

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

[*] 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 Radlological Device 510(k) Number

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

Kod2185 GE LOGIQ E9 with RAB2-5-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 / Obstetrics[7]	P	P	P	P	P	P	P	P	P	[5, 6]
Abdominal[1]	P	P	P	P	P	P	P	P	P	[5, 6]
Pediatric	P	P	P	P	P	P	P	P	P	[5, 6]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal Conventional	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
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative[6]
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] Cardiac is Adult and Pediatric.

[4] Other use includes Urology/Prostate.

[5] 3D/4D Imaging Mode.

[6] Includes imaging of guidance of biopsy (3D/4D).

[7] Includes infertility monitoring of follicle development.

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

["] 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

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

K082185 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	Combined HarmonicModes	Imaging	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[3]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other [4]
Exam Type, Means of Access
Transesophageal
Transrectal	P	P	P		P	P	P	P	P	P	[5,6]
Transvaginal	P	P	P		P	P	P	P	P	P	[5,6]
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] Cardiac is Adult and Pediatric.

[4] Other use includes Urology/Prostate.

[5] 3D/4D Imaging Mode.

[6] Includes imaging of guidance of biopsy (3D/4D).

[7] Includes infertility monitoring of follicle development.

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

[*] 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)

Device Evaluation (ODE)

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

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

K082185 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[3]	P	P	P	P	P	P	P	P	P	P	[ 5]
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
Transuretheral
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] Cardiac is Adult and Pediatric.

[4] Other use includes Urology/Prostate.

[5] 3D/4D Imaging Mode.

[6] Includes imaging of guidance of biopsy (3D/4D).

[7] Includes infertility monitoring of follicle development.

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

[*] 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

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

Ko82185 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	[5,6]
Small Organ(2)	P	P	P		P	P	P	P	P	P	[5,6]
Neonatal Cephalic
Adult Cephalic
Cardiac [3]
Peripheral Vascular	P	P	P		P	P	P	P	P	P	[5,6]
Musculo-skeletal Conventional	P	P	P		P	P	P	P	P	P	[5,6]
Musculo-skeletal Superficial	P	P	P		P	P	P	P	P	P	[5,6]
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
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

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

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

[3] Cardiac is Adult and Pediatric.

[4] Other use includes Urology/Prostate.

[5] 3D/4D Imaging Mode.

[6] Includes imaging of guidance of biopsy (3D/4D).

[7] Includes infertility monitoring of follicle development.

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

[*] 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)

ON ANOTHER PAGE IF NEEDED)

ce Evaluation (ODE)

ivision Sign-Off)

(Division Sian-Off) Division of Reproductive, Abd Radiological Devices 510(k) Number

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.