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); 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, 86cm 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.

AI/ML Overview

The provided document is a 510(k) Premarket Notification Submission for the GE LOGIQ E9 Diagnostic Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through novel clinical studies against acceptance criteria.

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

Because no clinical studies were performed, it is not possible to extract the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies.

The document instead focuses on:

Summary of Non-Clinical Tests: Evaluation for acoustic output, biocompatibility, cleaning and disinfection effectiveness, and thermal, electrical, electromagnetic, and mechanical safety.
Compliance with Voluntary Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 3, ISO 10993-1, NEMA UD 2, ISO 14971, and NEMA DICOM Set.
Quality Assurance Measures: Risk Analysis, Requirements Reviews, Design Reviews, Testing on unit level (Module verification), Integration testing (System verification), Performance testing (Verification), Safety testing (Verification), and Final Acceptance testing (Validation).
Intended Use: A broad range of diagnostic ultrasound evaluations for various anatomical regions and clinical applications, with specific modes of operation (B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse, and other features like 3D/4D imaging and needle guidance) listed for each supported transducer.

In summary, the provided text does not contain the information required to populate the table or answer the questions as it pertains to clinical acceptance criteria and a study demonstrating performance against those criteria. The device's clearance was based on demonstrating equivalence, not on de novo clinical performance studies with acceptance criteria.

Summary

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Image /page/0/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a circular border. The border has decorative elements resembling stylized lightning bolts or arcs. The logo is black and white.

EC 1 8 2012

GE Healthcare

510(k) Premarket Notification Submission

510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

November 19, 2012 Date:

GE Healthcare, GE Medical Systems Ultrasound and Primary Submitter: Care Diagnostics, LLC. 9900 Innovation Dr.

Wauwatosa, WI 53226

Bryan Behn Contact Person:

Regulatory Affairs Manager GE Healthcare, GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC. Phone: 414-721-4214

GE LOGIO E9 Diagnostic Ultrasound System

Fax: 414-918-8275

Trade Name: Device: Common/Usual Name: Classification Names: Product Code:

Predicate Device(s):

LOGIO E9

Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYN Ultrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYO

Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX

K110943, K092271 GE LOGIQ E9 Diagnostic Ultrasound System

K 122327 GE Voluson E6/E8/E8ExpertE 10 Diagnostic :Ultrasound System

K113690 GE LOGIQ e Diagnostic Ultrasound System

Device Description:

Intended Use:

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

GE Healthcare

510(k) Premarket Notification Submission

and Intraoperative (abdominal, thoracic, vascular and neurosurgical).

The LOGIQ E9 employs the same fundamental scientific technology as its predicate device(s).

Summary of Non-Clinical Tests: Determination of

Technology:

Substantial Equivalence:

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 and its applications comply with voluntary standards:

1 . IEC60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety
IEC60601-1-2,Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility Requirements and Tests
IEC60601-2-37, Medical Electrical Equipment -Part 2-37:Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment
NEMA UD 3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
1. ISO10993-1, Biological Evaluation of Medical Devices- Part 1: Evaluation and Testing- Third Edition
1. NEMA UD 2, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
ISO14971, Application of risk management to medical 7. devices
NEMA, Digital Imaging and Communications in Medicine (DICOM) Set. (Radiology)

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

GE Healthcare

. . : . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

510(k) Premarket Notification Submission

The following quality assurance measures were applied to the development of the system:

. : Risk Analysis
- Requirements Reviews
Design Reviews
Testing on unit level (Module verification)
Integration testing (System verification)
Performance testing (Verification)
· Safety testing (Verification)
Final Acceptance testing (Validation)

Summary of Clinical Tests:

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

GE Healthcare considers the LOGIQ E9 to be as safe, as Conclusion: effective, and performance is substantially equivalent to the predicate device(s).

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

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle-like symbol with three curved lines representing its body and wings.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

December 18, 2012

Mr. Bryan Behn Regulatory Affairs Manager GE Healthcare 9900 Innovation Drive WAUWATOSA WI 53226

Re: K123564

Trade/Device Name: GE LOGIQ E9 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasound pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: November 19, 2012 Received: November 20, 2012

Dear Mr. Behn:

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 Ultrasound System, as described in your premarket notification:

	Transducer Model Number
3CRF	M5S-D	RSP6-16-D
6S-D	M6C-D	S1-5
6Tc	ML6-15-D	S4-10
9L-D	P2D	S4-10-D
11L-D	P6D	C2-9-D
C1-5-D	RAB2-5D	RAB6-D
IC5-9-D	RAB4-8-D	S1-5-D
L8-18i-D	RIC5-9-D	C1-6-D
M4S-D	RNA5-9-D

If your device is classified (see above) into either class II (Special Controls) or class III (PMA),

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

it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

If you have any questions regarding the content of this letter, please contact Shahram Vaezy at (301) 796-6242.

Sincerely Yours,

Janine M. Morris -S

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure(s)

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Indications for Use

510(k) Number (if known): K123564

Device Name: 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); Transrectal; Transvaginal; Transesophageal and Intraoperative (abdominal, thoracic, vascular and neurosurgical).

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

Over-The-Counter Use N/A (21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of In Vitho Diagnostics and Radiological Health (OIR)

allet

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510(k)_K123564

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Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9 Ultrasound System

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

	Mode of Operation
Clinical Application	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes*	HarmonicImaging	CodedPulse†	Other[Notes]
Anatomy/Region of Interest
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	[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 and 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

item provided real time QS and to acquisition finish time QS that specifies to process.

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Prescription User (Per 21 CFR 801.109)

eal Health (SWR)

(Division Sign Off)

Division of Radiological Health

fice of in Vitro

510(k) K123564

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

Diagnostic Ultrasound Indications for Use Form 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 Application	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes*	HarmonicImaging	CodedPulse*	Other[Notes]
Anatomy/Region of Interest
Ophthalmic
Fetal/Obstetrics[7]	P	P	P		P	P	P	P	P	P	[5,6,9]
Abdominal[1]	P	P	P		P	P	P	P	P	P	[5,6,9]
Pediatric	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	[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 and 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 In Vitro Diagnostics and Radiological Health (OIR)

Prescription User (Per 21 CFR 801.109)

(Division Sign Off)

Division of Radiological Hea

Office of In Vitro Diagnostics and Ra

510(k) K123564

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

Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9 with 6S-D Transducer

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

Clinical Application	Mode of Operation
Anatomy/Region of Interest	B	M	PW Doppler	CW Doppler	Color Doppler	Color M Doppler	Power Doppler	Combined Modes*	Harmonic Imaging	Coded Pulse^	Other [Notes]
Ophthalmic
Fetal/Obstetrics[7]	P	P	P	P	P	P	P	P	P	P
Abdominal[1]	P	P	P	P	P	P	P	P	P	P
Pediatric	P	P	P	P	P	P	P	P	P	P
Small Organ(2)
Neonatal Cephalic	P	P	P	P	P	P	P	P	P	P
Adult Cephalic
Cardiac Adult
Cardiac Pediatric	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
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 and thyroid

131 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 In Vitro Diagnostics and Radiological Health (OlR)

Prescription User (Per 21 CFR 801.109)

ical Health (Off)

(Division Sign Off)

Division of Radiological Health

Office of In Vitro Diagnostics and Radiological Health

510(k) K123564

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

Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9 with 6Tc Transducer

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	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	P	P	P	P	P	P	P	P	P	P
Transrectal
Transvaginal
Transurethral
Intraoperative(8)
· Intraoperative Neurological
Intravascular
Laparoscopic

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

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

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

[2] Small organ includes breast, testes and 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 In Vitro Diagnostics and Radiological Health (OIR)

Prescription User (Per 21 CFR 801.109)

(Division Sign Off)

iston of Radiological Hea D

Office of In Vitro Diaguostics a

510(k) K12564

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

Diagnostic Ultrasound Indications for Use Form 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 Application	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes"	HarmonicImaging	CodedPulse*	Other[Notes]
Anatomy/Region of Interest
Ophthalmic
Fetal/Obstetrics[7]	P	P	P		P	P	P	P	P	P	[5,6,9]
Abdominal[1]	P	P	P		P	P	P	P	P	P	[3,5,6,9]
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
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	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
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 and 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 In Vitro Diagnostics and Radiological Health (OlR)

Prescription User (Per 21 CFR 801 109)

iological Health (OIR)

(Division Sign Off)

Division of Radiological Health

Office of In Vitro Diagnostics and Radiological Heatth

510(k) K123564

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

Diagnostic Ultrasound Indications for Use Form 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]	P	P	P	P	P	P	P	P	P	P	[3,5,6]
Pediatric	P	P	P	P	P	P	P	P	P	P	[3,5,6]
Small Organ[2]	P	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	P	[3,5,6]
Musculo-skeletal Conventional	P	P	P	P	P	P	P	P	P	P	[3,5,6]
Musculo-skeletal Superficial	P	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

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

[2] Small organ includes breast, testes and 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 BIM, 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 In Vitro Diagnostics and Radiological Health (OIR)

Prescription User (Per 21 CFR 801.109)

(Division Sign Off)

Division of Radfological Health

Office of In vitro Diagnostics and Radiological Health

510(k) K123564

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

Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9 with C1-5-D Transducer

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

Clinical Application	Mode of Operation
	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes*	HarmonicImaging	CodedPulse*	Other[Notes]
Anatomy/Region of Interest
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]	P	P	P	P	P	P	P	P	P	P	[5,6,9]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
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 and 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)

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

Diagnostic Ultrasound Indications for Use Form 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 Application	B	M	PW	CW	Color	Color M	Power	Combined	Harmonic	Coded	Other[Notes]
Anatomy/Region of Interest			Doppler	Doppler	Doppler	Doppler	Doppler	Modes'	Imaging	Pulse'
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]	P	P	P		P	P	P	P	P	P	[3,5,6,9]
Exam Type, Means of Access
Transesophageal
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 and 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)

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

Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9 with L8-18i-D Transducer

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

	Mode of Operation
Clinical Application	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes'	HarmonicImaging	CodedPulse	Other[Notes]
Anatomy/Region of Interest
Ophthalmic
Fetal/Obstetrics[7]
Abdominal[1]
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
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	P	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]	P	P	P	P	P	P	P	P	P	P	[3,5,6,9]
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 and 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)

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

Diagnostic Ultrasound Indications for Use Form 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

ostic Ultrasound imaging or fluid flow analysis of the human body as follow

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 and 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)

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

Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9 with M5S-D Transducer

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

Clinical Application	Mode of Operation
	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse
Anatomy/Region of Interest
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	[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
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 and 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)

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

Diagnostic Ultrasound Indications for Use Form 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	PW Doppler	CW Doppler	Color Doppler	Color M Doppler	Power Doppler	Combined Modes1	Harmonic Imaging	Coded Pulse2	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 and 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)

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

Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9 with ML6-15-D Transducer

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

Clinical ApplicationAnatomy/Region of Interest	Mode of Operation									Other[Notes]
	B	M	PW Doppler	CW Doppler	Color Doppler	Color M Doppler	Power Doppler	Combined Modes'	Harmonic Imaging		Coded Pulse*
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	P	P	P	P	P	P	P	P	P	[9]
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	P	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 and 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)

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

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			P	P
Cardiac Adult			P	P
Cardiac Pediatric			P	P
Peripheral Vascular			P	P
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 and 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)

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

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 Application	B	M	PW Doppler	CW Doppler	Color Doppler	Color M Doppler	Power Doppler	Combined Modes*	Harmonic Imaging	Coded Pulse*	Other [Notes]
Anatomy/Region of Interest
Ophthalmic
Fetal/Obstetrics[7]
Abdominal[1]
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic			P	P
Cardiac Adult			P	P
Cardiac Pediatric			P	P
Peripheral Vascular			P	P
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
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 and 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)

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

Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9 with RAB2-5D 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	CodedPulse²	Other[Notes]
Ophthalmic
Fetal/Obstetrics⁷	P	P	P		P	P	P	P	P	P	[5,6]
Abdominal¹	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 Adult
Cardiac Pediatric
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	[5]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative[5]
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 and 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)

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Dan Shan
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{22}------------------------------------------------

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:

Clinical Application	Mode of Operation
Anatomy/Region of Interest	B	M	PW Doppler	CW Doppler	Color Doppler	Color M Doppler	Power Doppler	Combined Modes	Harmonic Imaging	Coded Pulse	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 Adult
Cardiac Pediatric
Peripheral Vascular
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
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 and 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)

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

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:

Clinical Application	Mode of Operation
	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes*	HarmonicImaging	CodedPulse*
Anatomy/Region of Interest
Ophthalmic
Fetal/Obstetrics[7]	P	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]	P	P	P	P	P	P	P	P	P	P	[3,5,6]
Exam Type, Means of Access
Transesophageal
Transrectal	P	P	P	P	P	P	P	P	P	P	[3,5,6]
Transvaginal	P	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

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

(2) Small organ includes breast, testes and 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

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

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

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:

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

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

[2] Small organ includes breast, testes and 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)

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

Diagnostic Ultrasound Indications for Use Form 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]
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

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

[2] Small organ includes breast, testes and 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 In Vitro Diagnostics and Radiological Health (OIR)

Prescription User (Per 21 CFR 801.109)

Radiological Health (OIR)

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ivision of Radiological Health

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510(k) K123564

રૂર્

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

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:

Clinical Application	Mode of Operation										Other[Notes]
	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes'	HarmonicImaging	CodedPulse'
Anatomy/Region of Interest
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 and 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 In Vitro Diagnostics and Radiological Health (OIR)

Prescription User (Per 21 CFR 801.109)

Rann Thoren
(Division Sign-Off)

Division of Radiological Health

Office of In Vitro Diagnostics and Radiological Heatth

510(k) K123564

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

Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9 with S4-10 Transducer

Clinical ApplicationAnatomy/Region of Interest	Mode of Operation
	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse
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]	P	P	P	P	P	P	P	P	P	P	[5,6,9]
Neonatal Cephalic	P	P	P	P	P	P	P	P	P	P	[5,6,9]
Adult Cephalic
Cardiac Adult

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

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

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

[2] Small organ includes breast, testes and 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

Cardiac Pediatric

Other 41

Peripheral Vascular

Transesophageal Transrectal Transvaginal Transurethral Intraoperative(8)

Intravascular Laparoscopic

Musculo-skeletal Conventional Musculo-skeletal Superficial

Exam Type, Means of Access

Intraoperative Neurological

[*] 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)

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Prescription User (Per 21 CFR 801.109)

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Division of Radiological Hea

રૂક

Office of In Vitro Diagnostics and

510(k) K123564

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

Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9 with S4-10-D Transducer

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

Clinical Application	Mode of Operation
		B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes*	HarmonicImaging	CodedPulse*	Other[Notes]
Anatomy/Region of Interest
Ophthalmic
Fetal/Obstetrics(7)	E	E	E	E	E	E	E	E	E	E	[5,6,9]
Abdominal(1)	E	E	E	E	E	E	E	E	E	E	[5,6,9]
Pediatric	E	E	E	E	E	E	E	E	E	[5,6,9]
Small Organ(2)	E	E	E	E	E	E	E	E	E	E	[5,6,9]
Neonatal Cephalic	E	E	E	E	E	E	E	E	E	E	[5,6,9]
Adult Cephalic
Cardiac Adult
Cardiac Pediatric	E	E	E	E	E	E	E	E	E	E
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 (previously cleared K111582)

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

[2] Small organ includes breast, testes and 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 In Vitro Diagnostics and Radiological Health (OIR)

Prescription User (Per 21 CFR 801.109)

(Division Sign Off)

Division of Radiological He

Office of In Vitm Dian

510(k) K123564

રૂપ

{29}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9 with C2-9-D Transducer

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

Clinical ApplicationAnatomy/Region of Interest	Mode of Operation
	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes'	HarmonicImaging	CodedPulse'	Other[Notes]
	Ophthalmic
Fetal/Obstetrics(7)	E	E	E	E	E	E	E	E	E	E	[5,6,9]
Abdominal(1)	E	E	E	E	E	E	E	E	E	E	[3,5,6,9]
Pediatric	E	E	E	E	E	E	E	E	E	E	[3,5,6,9]
Small Organ (2)
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral Vascular	E	E	E	E	E	E	E	E	E	E	[3,5,6,9]
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other(4)	E	E	E	E	E	E	E	E	E	E	[3,5,6,9]
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 (previously cleared K122515)

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

[2] Small organ includes breast, testes and 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 In Vitro Diagnostics and Radiological Health (OlR)

Prescription User (Per 21 CFR 801.109)

(Division Sign Off)

Division of Radiological Ho

Office of In Vitro Diagnostics and Radiological

510(k) K.123564

{30}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9 with RAB6-D Transducer

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

Clinical ApplicationAnatomy/Region of Interest	Mode of Operation
	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes*	HarmonicImaging	CodedPulse*	Other[Notes]
	Ophthalmic
Fetal/Obstetrics[7]	E	E	E		E	E	E	E	E	E	[5,6]
Abdominal[1]	E	E	E		E	E	E	E	E	E	[5,6]
Pediatric	E	E	E		E	E	E	E	E	E	[5,6]
Small Organ(2)
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral Vascular
Musculo-skeletal Conventional	E	E	E		E	E	E	E	E	E	[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 (previously cleared K122327)

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

[2] Small organ includes breast, testes and 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 In Vitro Diagnostics and Radiological Health (OlR)

Prescription User (Per 21 CFR 801.109)

(Division Sign Off)

Division of Radiological He

Office of In Vitro Diagnostics and

510(k) K123564

{31}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9 with S1-5-D Transducer

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

Clinical Application	Mode of Operation
	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes*	HarmonicImaging	CodedPulse*	Other[Notes]
Anatomy/Region of Interest
Ophthalmic
Fetal/Obstetrics[7]	E	E	E	E	E	E	E	E	E	E	[5,6,9]
Abdominal[1]	E	E	E	E	E	E	E	E	E	E	[5,6,9]
Pediatric	E	E	E	E	E	E	E	E	E	E	[5,6,9]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic	E	E	E	E	E	E	E	E	E	E	[5,6,9]
Cardiac Adult	E	E	E	E	E	E	E	E	E	E
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

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

[2] Small organ includes breast, testes and 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 In Vitro Diagnostics and Radiological Health (OIR)

Prescription User (Per 21 CFR 801.109)

(Division Sign Off)

Division of Radiological Health

Office of in Vitro Diagnostics and Radiological Heatth

510(k) K123564

{32}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9 with C1-6-D Transducer

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

Clinical Application	Mode of Operation
	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes*	HarmonicImaging	CodedPulse*	Other[Notes]
Anatomy/Region of Interest
Ophthalmic
Fetal/Obstetrics(7)	E	E	E	E	E	E	E	E	E	E	[5,6,9]
Abdominal(1)	E	E	E	E	E	E	E	E	E	E	[3,5,6,9]
Pediatric	E	E	E	E	E	E	E	E	E	E	[3,5,6,9]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral Vascular	E	E	E	E	E	E	E	E	E	E	[3,5,6,9]
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other(4)	E	E	E	E	E	E	E	E	E	E	[3,5,6,9]
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 (previously cleared K122921)

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

[2] Small organ includes breast, testes and 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 In Vitro Diagnostics and Radiological Health (OIR)
Prescription User (Per 21 CFR 801.109)

escription Osc. (Pt. 2 of Pt. 001.103)

Division of Radiological Health

(Division Sign

Office of In Vitro Diagnostics and Radiological Health

510(k) K123564

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.