LogoFDA 510(k) Search
K Number
K163077
Device Name
LOGIQ E9, LOGIQ E9 XDClear 2.0
Manufacturer
GE Medical Systems Ultrasound and Primary Care Diagnostics,
Date Cleared
2016-11-17

(14 days)

Product Code
IYNITXIYO
Regulation Number
892.1550
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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 and vascular).
Device Description
The LOGIQ E9 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 58 cm wide, 87cm deep and 130 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 wide screen image display.
More Information

K152309

Not Found

No
The summary does not mention AI, ML, or related terms, and the performance studies focus on safety and standards compliance, not AI/ML performance metrics.

No.
The device's intended use is for "ultrasound evaluation" and it is described as a "diagnostic ultrasound system," indicating its purpose is to diagnose conditions rather than treat them.

Yes

The "Device Description" explicitly states, "The LOGIQ E9 is a full featured, general purpose diagnostic ultrasound system".

No

The device description clearly states it is a "full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 58 cm wide, 87cm deep and 130 cm high". This indicates a physical hardware component beyond just software. The performance studies also mention evaluations for acoustic output, biocompatibility, thermal, electrical, electromagnetic, and mechanical safety, which are all related to hardware components.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use describes the device as being used for "ultrasound evaluation" of various anatomical sites. This is a diagnostic imaging procedure performed directly on the patient, not a test performed on a sample taken from the patient.
  • Device Description: The description details a "diagnostic ultrasound system" that provides "digital acquisition, processing and display capability." This aligns with the function of an ultrasound machine used for imaging the body.
  • Lack of IVD Characteristics: There is no mention of the device being used to test biological samples (like blood, urine, tissue, etc.) or to provide information about a patient's health status based on the analysis of such samples.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a diagnostic imaging system that uses ultrasound waves to create images of internal structures.

N/A

Intended Use / 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; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transvaginal; Transesophageal and Intraoperative (abdominal, thoracic and vascular).

Product codes

IYN, IYO, ITX

Device Description

The LOGIQ E9 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 58 cm wide, 87cm deep and 130 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 wide screen image display.

Mentions image processing

digital acquisition, processing and display capability.

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

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 and vascular).

Indicated Patient Age Range

Adult, Pediatric, Neonatal, Fetal

Intended User / Care Setting

qualified physician / Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K152309

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 17, 2016

GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC % Mr. Bryan Behn Regulatory Affairs Director 9900 Innovation Drive WAUWATOSA WI 53226

Re: K163077

Trade/Device Name: LOGIQ E9, LOGIQ E9 XDClear 2.0 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: November 2, 2016 Received: November 3, 2016

Dear Mr. Behn:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

1

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael O'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known)

K163077

Device Name LOGIQ E9, LOGIQ E9 XDClear 2.0

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

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Indications for Use Forms

The following forms represent indications with clinical applications and exam types along with the modes of operation for the LOGIQ E9 system and for all of its probe/mode combinations. Combinations identified by "P" represents those previously cleared with the unmodified LOGIQ E9, "N" are new in this submission and "E" have been added by Appendix E of the FDA Ultrasound Guidance. The subject modification does not alter the previously cleared system level indications and clinical applications.

4

Diagnostic Ultrasound Indications for Use Form LOGIQ E9, LOGIQ E9 XDclear 2.0 Ultrasound System

Mode of Operation
Clinical ApplicationBMPW
DopplerCW
DopplerColor
DopplerColor M
DopplerPower
DopplerCombined
Modes*Harmonic
ImagingCoded
PulseªOther
[Notes]
Anatomy/Region of Interest
Ophthalmic
Fetal/Obstetrics[7]PPPPPPPPPP[5,6,9]
Abdominal[1]PPPPPPPPPP[3,5,6,9,10]
PediatricPPPPPPPPPP[3,5,6,9,10]
Small Organ[2]PPPPPPPPPP[3,5,6,9,10]
Neonatal CephalicPPPPPPPPPP[5,6,9]
Adult CephalicPPPPPPPPPP[5,6,9]
Cardiac AdultPPPPPPPPPP
Cardiac PediatricPPPPPPPPPP
Peripheral VascularPPPPPPPPPP[3,5,6,9]
Musculo-skeletal ConventionalPPPPPPPPPP[3,5,6,9]
Musculo-skeletal SuperficialPPPPPPPPPP[3,5,6,9]
Other[4]PPPPPPPPPP[3,5,6,9]
Exam Type, Means of Access
TransesophagealPPPPPPPPPP
TransrectalPPPPPPPPPP[3,5,6,9]
TransvaginalPPPPPPPPPP[3,5,6,9]
Transurethral
Intraoperative[8]PPPPPPPPPP[3,5,6,9]
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 orqan 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, Gyn

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

[9] Volume navigation

[10] Shear wave elastography

[*] 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)

Page 2 of 36

5

Diagnostic Ultrasound Indications for Use Form LOGIQ E9, LOGIQ E9 XDclear 2.0 with 3CRF Transducer

| Clinical Application
Anatomy/Region of Interest | B | M | PW
Doppler | CW
Doppler | Color
Doppler | Color M
Doppler | Power
Doppler | Combined
Modes* | Harmonic
Imaging | Coded
Pulse* | Other
[Notes] |
|----------------------------------------------------|---|---|---------------|---------------|------------------|--------------------|------------------|--------------------|---------------------|-----------------|------------------|
| 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 | | | | | | | | | | | |

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)

Page 3 of 36

6

Diagnostic Ultrasound Indications for Use Form LOGIQ E9, LOGIQ E9 XDclear 2.0 with 3CRF-D Transducer

Mode of Operation
Clinical ApplicationBMPW
DopplerCW
DopplerColor
DopplerColor M
DopplerPower
DopplerCombined
Modes*Harmonic
ImagingCoded
PulseOther
[Notes]
Anatomy/Region of Interest
Ophthalmic
Fetal/Obstetrics[7]PPPPPPPPP[5,6,9]
Abdominal[1]PPPPPPPPP[5,6,9]
PediatricPPPPPPPPP[5,6,9]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other [4]PPPPPPPPP[5,6,9]
Exam Type, Means of Access
Transesophageal
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)

Page 4 of 36

7

Diagnostic Ultrasound Indications for Use Form LOGIQ E9, LOGIQ E9 XDclear 2.0 with 6S-D Transducer

| Clinical Application
Anatomy/Region of Interest | B | M | PW
Doppler | CW
Doppler | Color
Doppler | Color M
Doppler | Power
Doppler | Combined
Modes* | Harmonic
Imaging | Coded
Pulse® | Other
[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 | | | | | | | | | | | |

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)

Page 5 of 36

8

Diagnostic Ultrasound Indications for Use Form LOGIQ E9, LOGIQ E9 XDclear 2.0 with 6Tc Transducer

Mode of Operation
Clinical Application
Anatomy/Region of InterestBMPW
DopplerCW
DopplerColor
DopplerColor M
DopplerPower
DopplerCombined
Modes*Harmonic
ImagingCoded
Pulse°Other
[Notes]
Ophthalmic
Fetal/Obstetrics[7]
Abdominal[1]
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac AdultPPPPPPPPPP
Cardiac Pediatric
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
TransesophagealPPPPPPPPPP
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)

Page 6 of 36

9

Diagnostic Ultrasound Indications for Use Form LOGIQ E9, LOGIQ E9 XDclear 2.0 with 9L-D Transducer

Mode of Operation
Clinical ApplicationBMPWCWColorColor MPowerCombinedHarmonicCodedOther
Anatomy/Region of InterestDopplerDopplerDopplerDopplerDopplerModes*ImagingPulse*[Notes]
Ophthalmic
Fetal/Obstetrics[7]PPPPPPPPP[5,6,9]
Abdominal[1]PPPPPPPPP[3,5,6,9,10]
PediatricPPPPPPPPP[3,5,6,9,10]
Small Organ[2]PPPPPPPPP[3,5,6,9,10]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral VascularPPPPPPPPP[3,5,6,9]
Musculo-skeletal ConventionalPPPPPPPPP[3,5,6,9]
Musculo-skeletal SuperficialPPPPPPPPP[3,5,6,9]
Other [4]PPPPPPPPP[3,5,6,9]
Exam Type, Means of Access
Transesophageal
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

[10] Shear wave elastography

[*] 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)

Page 7 of 36

10

Diagnostic Ultrasound Indications for Use Form LOGIQ E9, LOGIQ E9 XDclear 2.0 with 11L-D Transducer

Mode of Operation
Clinical Application
Anatomy/Region of InterestBMPW
DopplerCW
DopplerColor
DopplerColor M
DopplerPower
DopplerCombined
Modes*Harmonic
ImagingCoded
Pulse®Other
[Notes]
Ophthalmic
Fetal/Obstetrics [7]
Abdominal [1]PPPPPPPPPP[3,5,6]
PediatricPPPPPPPPPP[3,5,6]
Small Organ[2]PPPPPPPPPP[3,5,6]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral VascularPPPPPPPPPP[3,5,6]
Musculo-skeletal ConventionalPPPPPPPPPP[3,5,6]
Musculo-skeletal SuperficialPPPPPPPPPP[3,5,6]
Other [4]
Exam Type, Means of Access
Transesophageal
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)

Page 8 of 36

11

Diagnostic Ultrasound Indications for Use Form LOGIQ E9, LOGIQ E9 XDclear 2.0 with C1-5-D Transducer

Mode of Operation
Clinical Application
Anatomy/Region of InterestBMPW DopplerCW DopplerColor DopplerColor M DopplerPower DopplerCombined Modes*Harmonic ImagingCoded PulseOther [Notes]
Ophthalmic
Fetal/Obstetrics[7]PPPPPPPPPP[5,6,9]
Abdominal[1]PPPPPPPPPP[5,6,9]
PediatricPPPPPPPPPP[5,6,9]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral VascularPPPPPPPPPPP[5,6,9]
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]PPPPPPPPPPP[5,6,9]
Exam Type, Means of Access
Transesophageal
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)

Page 9 of 36

12

Diagnostic Ultrasound Indications for Use Form LOGIQ E9, LOGIQ E9 XDclear 2.0 with IC5-9-D Transducer

Mode of Operation
Clinical Application
Anatomy/Region of InterestBMPW
DopplerCW
DopplerColor
DopplerColor M
DopplerPower
DopplerCombined
Modes*Harmonic
ImagingCoded
Pulse*Other
[Notes]
Ophthalmic
Fetal/Obstetrics [7]PPPPPPPPP[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]PPPPPPPPP[3,5,6,9]
Exam Type, Means of Access
Transesophageal
TransrectalPPPPPPPPP[3,5,6,9]
TransvaginalPPPPPPPPP[3,5,6,9]
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, Gyn

[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)

Page10 of 36

13

Diagnostic Ultrasound Indications for Use Form LOGIQ E9, LOGIQ E9 XDclear 2.0 with L8-18i-D Transducer

| Clinical Application
Anatomy/Region of Interest | B | M | PW
Doppler | CW
Doppler | Color
Doppler | Color M
Doppler | Power
Doppler | Combined
Modes* | Harmonic
Imaging | Coded
Pulse | Other
[Notes] |
|----------------------------------------------------|---|---|---------------|---------------|------------------|--------------------|------------------|--------------------|---------------------|----------------|------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal/Obstetrics[7] | | | | | | | | | | | |
| Abdominal[1] | | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | P | P | P | [3,5,6,9] |
| Small Organ[2] | P | P | P | | P | P | P | P | P | P | [3,5,6,9] |
| Neonatal Cephalic | 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 | [3,5,6,9] |
| Musculo-skeletal Conventional | P | P | P | | P | P | P | P | P | P | [3,5,6,9] |
| Musculo-skeletal Superficial | P | P | P | | P | P | P | P | P | P | [3,5,6,9] |
| Other [4] | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intraoperative[8] | P | P | P | | P | P | P | P | P | P | [3,5,6,9] |
| 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)

Page 11 of 36

14

Diagnostic Ultrasound Indications for Use Form LOGIQ E9, LOGIQ E9 XDclear 2.0 with M4S-D Transducer

Mode of Operation
Clinical ApplicationBMPWCWColorColor MPowerCombinedHarmonicCodedOther
Anatomy/Region of InterestDopplerDopplerDopplerDopplerDopplerModes*ImagingPulse*[Notes]
Ophthalmic
Fetal/Obstetrics[7]PPPPPPPPPP[5,6]
Abdominal[1]PPPPPPPPPP[5,6]
PediatricPPPPPPPPPP[5,6]
Small Organ[2]
Neonatal Cephalic
Adult CephalicPPPPPPPPPP
Cardiac AdultPPPPPPPPPP
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

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)

Page 12 of 36

15

Diagnostic Ultrasound Indications for Use Form LOGIQ E9, LOGIQ E9 XDclear 2.0 with M5S-D Transducer

Mode of Operation
Clinical Application
Anatomy/Region of InterestBMPW
DopplerCW
DopplerColor
DopplerColor M
DopplerPower
DopplerCombined
Modes*Harmonic
ImagingCoded
Pulse®Other
[Notes]
Ophthalmic
Fetal/Obstetrics[7]PPPPPPPPPP[5,6,9]
Abdominal[1]PPPPPPPPPP[5,6,9]
PediatricPPPPPPPPPP[5,6,9]
Small Organ[2]
Neonatal Cephalic
Adult CephalicPPPPPPPPPP[9]
Cardiac AdultPPPPPPPPPP
Cardiac PediatricPPPPPPPPPP
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

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)

Page13 of 36

16

Diagnostic Ultrasound Indications for Use Form LOGIQ E9, LOGIQ E9 XDclear 2.0 with M6C-D Transducer

Mode of Operation
Clinical Application
Anatomy/Region of InterestBMPW
DopplerCW
DopplerColor
DopplerColor M
DopplerPower
DopplerCombined
Modes*Harmonic
ImagingCoded
Pulse®Other
[Notes]
Ophthalmic
Fetal/Obstetrics[7]PPPPPPPPPP[5,6]
Abdominal[1]PPPPPPPPPP[5,6]
PediatricPPPPPPPPPP[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

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)

Page14 of 36

17

Diagnostic Ultrasound Indications for Use Form LOGIQ E9, LOGIQ E9 XDclear 2.0 with ML6-15-D Transducer

Mode of Operation
Clinical Application
Anatomy/Region of InterestBMPW
DopplerCW
DopplerColor
DopplerColor M
DopplerPower
DopplerCombined
Modes*Harmonic
ImagingCoded
Pulse"Other
[Notes]
Ophthalmic
Fetal/Obstetrics[7]
Abdominal[1]
PediatricPPPPPPPPP[3,5,6,9]
Small Organ[2]PPPPPPPPP[3,5,6,9]
Neonatal CephalicPPPPPPPPP[9]
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral VascularPPPPPPPPP[3,5,6,9]
Musculo-skeletal ConventionalPPPPPPPPP[3,5,6,9]
Musculo-skeletal SuperficialPPPPPPPPP[3,5,6,9]
Other[4]
Exam Type, Means of Access
Transesophageal
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)

Page 15 of 36

18

Diagnostic Ultrasound Indications for Use Form LOGIQ E9, LOGIQ E9 XDclear 2.0 with P2D

Mode of Operation
Clinical Application
Anatomy/Region of InterestBMPW DopplerCW DopplerColor DopplerColor M DopplerPower DopplerCombined Modes*Harmonic ImagingCoded Pulse®Other [Notes]
Ophthalmic
Fetal/Obstetrics[7]
Abdominal[1]
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult CephalicPP
Cardiac AdultPP
Cardiac PediatricPP
Peripheral VascularPP
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
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)

Page 16 of 36

19

Diagnostic Ultrasound Indications for Use Form LOGIQ E9, LOGIQ E9 XDclear 2.0 with P6D Transducer

Mode of Operation
Clinical Application
Anatomy/Region of InterestBMPW DopplerCW DopplerColor DopplerColor M DopplerPower DopplerCombined Modes*Harmonic ImagingCoded Pulse*Other [Notes]
Ophthalmic
Fetal/Obstetrics[7]
Abdominal[1]
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult CephalicPP
Cardiac AdultPP
Cardiac PediatricPP
Peripheral VascularPP
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
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)

Page 17 of 36

20

Diagnostic Ultrasound Indications for Use Form LOGIQ E9, LOGIQ E9 XDclear 2.0 with RAB2-5-D Transducer

Mode of Operation
Clinical Application
Anatomy/Region of InterestBMPW
DopplerCW
DopplerColor
DopplerColor M
DopplerPower
DopplerCombined
Modes*Harmonic
ImagingCoded
Pulse*Other
[Notes]
Ophthalmic
Fetal/Obstetrics [7]PPPPPPPPP[5,6]
Abdominal [1]PPPPPPPPP[5,6]
PediatricPPPPPPPPP[5,6]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral Vascular
Musculo-skeletal ConventionalPPPPPPPPP[5,6]
Musculo-skeletal Superficial
Other [4]PPPPPPPPP[5]
Exam Type, Means of Access
Transesophageal
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)

Page 18 of 36

21

Diagnostic Ultrasound Indications for Use Form LOGIQ E9, LOGIQ E9 XDclear 2.0 with RAB4-8-D Transducer

Mode of Operation
Clinical Application
Anatomy/Region of InterestBMPW DopplerCW DopplerColor DopplerColor M DopplerPower DopplerCombined Modes*Harmonic ImagingCoded Pulse®Other [Notes]
Ophthalmic
Fetal/Obstetrics [7]PPPPPPPPPP[5,6]
Abdominal [1]PPPPPPPPPP[5,6]
PediatricPPPPPPPPPP[5,6]
Small Organ [2]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral Vascular
Musculo-skeletal ConventionalPPPPPPPPP[5,6]
Musculo-skeletal Superficial
Other [4]
Exam Type, Means of Access
Transesophageal
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)

Page 19 of 36

22

Diagnostic Ultrasound Indications for Use Form LOGIQ E9, LOGIQ E9 XDclear 2.0 with RIC5-9-D Transducer

Mode of Operation
Clinical Application
Anatomy/Region of InterestBMPW
DopplerCW
DopplerColor
DopplerColor M
DopplerPower
DopplerCombined
Modes*Harmonic
ImagingCoded
Pulse*Other
[Notes]
Ophthalmic
Fetal/Obstetrics [7]PPPPPPPPPP[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]PPPPPPPPPP[3,5,6]
Exam Type, Means of Access
Transesophageal
TransrectalPPPPPPPPPP[3,5,6]
TransvaginalPPPPPPPPPP[3,5,6]
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, Gyn

[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)

Page 20 of 36

23

Diagnostic Ultrasound Indications for Use Form LOGIQ E9, LOGIQ E9 XDclear 2.0 with RNA5-9-D Transducer

Mode of Operation
Clinical ApplicationBMPWCWColorColor MPowerCombinedHarmonicCodedOther
Anatomy/Region of InterestDopplerDopplerDopplerDopplerDopplerModes*ImagingPulse®[Notes]
Ophthalmic
Fetal/Obstetrics[7]PPPPPPPPPP[5,6]
Abdominal[1]PPPPPPPPPP[5,6]
PediatricPPPPPPPPPP[5,6]
Small Organ[2]PPPPPPPPPP[5,6]
Neonatal CephalicPPPPPPPPPP[5]
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral VascularPPPPPPPPPP[5,6]
Musculo-skeletal ConventionalPPPPPPPPPP[5,6]
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
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)

Page 21 of 36

24

Diagnostic Ultrasound Indications for Use Form LOGIQ E9, LOGIQ E9 XDclear 2.0 with RSP6-16-D Transducer

Mode of Operation
Clinical Application
Anatomy/Region of InterestBMPW DopplerCW DopplerColor DopplerColor M DopplerPower DopplerCombined Modes*Harmonic ImagingCoded Pulse®Other [Notes]
Ophthalmic
Fetal/Obstetrics[7]
Abdominal[1]
PediatricPPPPPPPPP[3,5,6]
Small Organ[2]PPPPPPPPP[3,5,6]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral VascularPPPPPPPPP[3,5,6]
Musculo-skeletal ConventionalPPPPPPPPP[3,5,6]
Musculo-skeletal SuperficialPPPPPPPPP[3,5,6]
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative[8]PPPPPPPPP
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)

Page 22 of 36

25

Diagnostic Ultrasound Indications for Use Form LOGIQ E9, LOGIQ E9 XDclear 2.0 with S1-5 Transducer

Mode of Operation
Clinical ApplicationBMPW
DopplerCW
DopplerColor
DopplerColor M
DopplerPower
DopplerCombined
Modes*Harmonic
ImagingCoded
PulseOther
[Notes]
Anatomy/Region of Interest
Ophthalmic
Fetal/Obstetrics[7]PPPPPPPPPP[5,6,9]
Abdominal[1]PPPPPPPPPP[5,6,9]
PediatricPPPPPPPPPP[5,6,9]
Small Organ[2]
Neonatal Cephalic
Adult CephalicPPPPPPPPPP[5,6,9]
Cardiac AdultPPPPPPPPPP
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

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)

Page 23 of 36

26

Diagnostic Ultrasound Indications for Use Form LOGIQ E9, LOGIQ E9 XDclear 2.0 with S4-10 Transducer

Mode of Operation
Clinical Application
Anatomy/Region of InterestBMPW
DopplerCW
DopplerColor
DopplerColor M
DopplerPower
DopplerCombined
Modes*Harmonic
ImagingCoded
Pulse®Other
[Notes]
Ophthalmic
Fetal/Obstetrics[7]PPPPPPPPPP[5,6,9]
Abdominal[1]PPPPPPPPPP[5,6,9]
PediatricPPPPPPPPPP[5,6,9]
Small Organ[2]PPPPPPPPPP[5,6,9]
Neonatal CephalicPPPPPPPPPP[5,6,9]
Adult Cephalic
Cardiac Adult
Cardiac PediatricPPPPPPPPPP
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

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)

Page 24 of 36

27

Diagnostic Ultrasound Indications for Use Form LOGIQ E9, LOGIQ E9 XDclear 2.0 with S4-10-D Transducer

Mode of Operation
Clinical ApplicationBMPWCWColorColor MPowerCombinedHarmonicCodedOther
Anatomy/Region of InterestDopplerDopplerDopplerDopplerDopplerModes*ImagingPulse°[Notes]
Ophthalmic
Fetal/Obstetrics[7]PPPPPPPPPP[5,6,9]
Abdominal[1]PPPPPPPPPP[5,6,9]
PediatricPPPPPPPPPP[5,6,9]
Small Organ[2]PPPPPPPPPP[5,6,9]
Neonatal CephalicPPPPPPPPPP[5,6,9]
Adult Cephalic
Cardiac Adult
Cardiac PediatricPPPPPPPPPPP
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

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)

Page 25 of 36

28

Diagnostic Ultrasound Indications for Use Form LOGIQ E9, LOGIQ E9 XDclear 2.0 with C2-9-D Transducer

Mode of Operation
Clinical Application
Anatomy/Region of InterestBMPW
DopplerCW
DopplerColor
DopplerColor M
DopplerPower
DopplerCombined
Modes*Harmonic
ImagingCoded
Pulse®Other
[Notes]
Ophthalmic
Fetal/Obstetrics[7]PPPPPPPPPP[5,6,9]
Abdominal[1]PPPPPPPPPP[3,5,6,9]
PediatricPPPPPPPPPP[3,5,6,9]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral VascularPPPPPPPPPP[3,5,6,9]
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other [4]PPPPPPPPPP[3,5,6,9]
Exam Type, Means of Access
Transesophageal
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)

Page 26 of 36

29

Diagnostic Ultrasound Indications for Use Form LOGIQ E9, LOGIQ E9 XDclear 2.0 with RAB6-D Transducer

Mode of Operation
Clinical Application
Anatomy/Region of InterestBMPW
DopplerCW
DopplerColor
DopplerColor M
DopplerPower
DopplerCombined
Modes*Harmonic
ImagingCoded
PulseOther
[Notes]
Ophthalmic
Fetal/Obstetrics[7]PPPPPPPPP[5,6]
Abdominal[1]PPPPPPPPP[5,6]
PediatricPPPPPPPPP[5,6]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral Vascular
Musculo-skeletal ConventionalPPPPPPPPP[5,6]
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
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)

Page 27 of 36

30

Diagnostic Ultrasound Indications for Use Form LOGIQ E9, LOGIQ E9 XDclear 2.0 with S1-5-D Transducer

Mode of Operation
Clinical Application
Anatomy/Region of InterestBMPW
DopplerCW
DopplerColor
DopplerColor M
DopplerPower
DopplerCombined
Modes*Harmonic
ImagingCoded
Pulse®Other
[Notes]
Ophthalmic
Fetal/Obstetrics[7]PPPPPPPPPP[5,6,9]
Abdominal[1]PPPPPPPPPP[5,6,9]
PediatricPPPPPPPPPP[5,6,9]
Small Organ[2]
Neonatal Cephalic
Adult CephalicPPPPPPPPPP[5,6,9]
Cardiac AdultPPPPPPPPPP
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

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)

Page 28 of 36

31

Diagnostic Ultrasound Indications for Use Form LOGIQ E9, LOGIQ E9 XDclear 2.0 with C1-6-D Transducer

Mode of Operation
Clinical ApplicationBMPWCWColorColor MPowerCombinedHarmonicCodedOther
Anatomy/Region of InterestDopplerDopplerDopplerDopplerDopplerModes*ImagingPulse°[Notes]
Ophthalmic
Fetal/Obstetrics[7]PPPPPPPPPP[5,6,9]
Abdominal[1]PPPPPPPPPP[3,5,6,9,10]
PediatricPPPPPPPPPP[3,5,6,9,10]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral VascularPPPPPPPPPP[3,5,6,9]
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]PPPPPPPPPP[3,5,6,9]
Exam Type, Means of Access
Transesophageal
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

[10] Shear wave elastoqraphy

[*] 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)

Page 29 of 36

32

Diagnostic Ultrasound Indications for Use Form LOGIQ E9, LOGIQ E9 XDclear 2.0 with C2-9VN-D Transducer

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

Mode of Operation
Clinical ApplicationBMPWCWColorColor MPowerCombinedHarmonicCodedOther
Anatomy/Region of InterestDopplerDopplerDopplerDopplerDopplerModes'ImagingPulse^[Notes]
Ophthalmic
Fetal/Obstetrics[7]PPPPPPPPPP[5,6,9]
Abdominal[1]PPPPPPPPPP[3,5,6,9]
PediatricPPPPPPPPPP[3,5,6,9]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral VascularPPPPPPPPPP[3,5,6,9]
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]PPPPPPPPPP[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 orqan 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)

Page 30 of 36

33

Diagnostic Ultrasound Indications for Use Form LOGIQ E9, LOGIQ E9 XDclear 2.0 with C1-6VN-D Transducer

Mode of Operation
Clinical ApplicationBMPW
DopplerCW
DopplerColor
DopplerColor M
DopplerPower
DopplerCombined
Modes*Harmonic
ImagingCoded
Pulse°Other
[Notes]
Anatomy/Region of Interest
Ophthalmic
Fetal/Obstetrics[7]PPPPPPPPPP[5,6,9]
Abdominal[1]PPPPPPPPPP[3,5,6,9,10]
PediatricPPPPPPPPPP[3,5,6,9,10]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral VascularPPPPPPPPPP[3,5,6,9]
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other [4]PPPPPPPPPP[3,5,6,9]
Exam Type, Means of Access
Transesophageal
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

[10] Shear wave elastography

[*] 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)

Page 31 of 36

34

Diagnostic Ultrasound Indications for Use Form LOGIQ E9, LOGIQ E9 XDclear 2.0 with C2-7-D Transducer

Mode of Operation
Clinical ApplicationBMPWCWColorColor MPowerCombinedHarmonicCodedOther
Anatomy/Region of InterestDopplerDopplerDopplerDopplerDopplerModes*ImagingPulse[Notes]
Ophthalmic
Fetal/Obstetrics[7]
Abdominal[1]PPPPPPPP[5,6]
PediatricPPPPPPPP[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

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

[10] Shear wave elastography

[*] 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)

Page 32 of 36

35

Diagnostic Ultrasound Indications for Use Form LOGIQ E9, LOGIQ E9 XDclear 2.0 with C2-7VN-D Transducer

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

Mode of Operation
Clinical ApplicationBMPW
DopplerCW
DopplerColor
DopplerColor M
DopplerPower
DopplerCombined
Modes*Harmonic
ImagingCoded
Pulse®Other
[Notes]
Anatomy/Region of Interest
Ophthalmic
Fetal/Obstetrics[7]
Abdominal[1]PPPPPPPP[5,6,9]
PediatricPPPPPPPP[5,6,9]
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

[10] Shear wave elastoqraphy

[*] 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)

Page 33 of 36

36

Diagnostic Ultrasound Indications for Use Form LOGIQ E9, LOGIQ E9 XDclear 2.0 with L3-9i-D Transducer

Mode of Operation
Clinical Application
Anatomy/Region of InterestBMPW DopplerCW DopplerColor DopplerColor M DopplerPower DopplerCombined Modes*Harmonic ImagingCoded Pulse*Other [Notes]
Ophthalmic
Fetal/Obstetrics[7]
Abdominal[1]
Pediatric
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]PPPPPPPP[5]
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
  • [10] Shear wave elastography
  • [*] 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)

Page 34 of 36

37

Diagnostic Ultrasound Indications for Use Form LOGIQ E9, LOGIQ E9 XDclear 2.0 with C3-10-D Transducer

Mode of Operation
Clinical Application
Anatomy/Region of InterestBMPW DopplerCW DopplerColor DopplerColor M DopplerPower DopplerCombined Modes*Harmonic ImagingCoded Pulse*Other [Notes]
Ophthalmic
Fetal/Obstetrics[7]
Abdominal[1]
PediatricPPPPPPPP[5,9]
Small Organ[2]PPPPPPPP[5,9]
Neonatal CephalicPPPPPPPP[5,9]
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral VascularPPPPPPPP[5,9]
Musculo-skeletal Conventional
Musculo-skeletal SuperficialPPPPPPPP[5,6,9]
Other[4]
Exam Type, Means of Access
Transesophageal
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

[10] Shear wave elastography

[*] 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)

Page 35 of 36

38

Diagnostic Ultrasound Indications for Use Form LOGIQ E9, LOGIQ E9 XDclear 2.0 with C2-6b-D Transducer

Mode of Operation
Clinical Application
Anatomy/Region of InterestBMPW
DopplerCW
DopplerColor
DopplerColor M
DopplerPower
DopplerCombined
Modes*Harmonic
ImagingCoded
Pulse*Other
[Notes]
Ophthalmic
Fetal/Obstetrics[7]
Abdominal[1]PPPPPPPP[5,6,9]
Pediatric
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

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

N = new indication; P = previously cleared;

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

[10] Shear wave elastography

[*] 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)

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Image /page/39/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 frame. The letters and the frame are both a light blue color. The logo is simple and recognizable, representing the well-known multinational corporation.

510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:
Date:November 2, 2016
Submitter/Manufacturer:GE Healthcare, GE Medical Systems Ultrasound and Primary
Care Diagnostics, LLC.
9900 Innovation Dr.
Wauwatosa, WI 53226
Contact Person:Bryan Behn
Regulatory Affairs Director
GE Healthcare, GE Medical Systems Ultrasound and Primary
Care Diagnostics, LLC.
Phone: 414-721-4214
Fax: 414-918-8275
Device:
Trade Name:LOGIQ E9, LOGIQ E9 XDClear 2.0
Common/Usual Name:LOGIQ E9, LOGIQ E9 XDClear 2.0
Classification Names:Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYN
Ultrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYO
Product Code:Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX
Predicate Device(s):K152309 LOGIQ E9 Diagnostic Ultrasound System
Device Description:The LOGIQ E9 is a full featured, general purpose diagnostic
ultrasound system which consists of a mobile console
approximately 58 cm wide, 87cm deep and 130 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 wide screen image
display.
Intended 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 and vascular).
Technology:The LOGIQ E9 employs the same fundamental scientific
technology as its predicate device(s).

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Image /page/40/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a blue circle. The circle has decorative swirls around its perimeter, giving it a classic and recognizable appearance.

Comparison to Predicates Determination of

Substantial Equivalence: The LOGIQ E9 is substantially equivalent to the predicate devices with regard to intended use, imaging capabilities, technological characteristics and safety and effectiveness.

  • The systems are all intended for diagnostic ultrasound o imaging and fluid flow analysis.
  • The LOGIQ E9 and predicate LOGIQ E9 systems have the same clinical intended use.
  • The LOGIQ E9 and predicate LOGIQ E9 systems have ● the same imaging modes.
  • The systems are manufactured with materials which have ● been evaluated and found to be safe for the intended use of the device.
  • . The systems have acoustic power levels which are below the applicable FDA limits.
  • The LOGIQ E9 and predicate LOGIQ E9 systems have similar capability in terms of performing measurements, capturing digital images, reviewing and reporting studies.
  • The LOGIQ E9 and predicate systems have been designed in compliance with approved electrical and physical safety standards.
  • The LOGIQ E9 and predicate LOGIQ E9 systems transducers are identical.
  • The LOGIO E9 adds software feature Parametric Imaging that was not available on the predicate LOGIQ E9. Parametric Imaging is an evolution of the previously cleared TIC feature on LOGIQ E9.

Summary of Non-Clinical Tests:

The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic and mechanical safety, and has been found to conform with applicable medical device safety standards. The LOGIQ E9 and its applications comply with voluntary standards:

    1. AAMI/ANSI ES60601-1. Medical Electrical Equipment - Part 1: General Requirements for Safety, 2005
    1. IEC60601-1-2, Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral

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Image /page/41/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined in a stylized script. The letters are enclosed within a circular border, and there are decorative swirls or flourishes around the border, giving it a classic and recognizable appearance. The color scheme is primarily blue.

Standard: Electromagnetic Compatibility Requirements and Tests 2007

    1. IEC60601-2-37, Medical Electrical Equipment Part 2-37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment, 2007
    1. NEMA UD 3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment:2004
    1. ISO10993-1, Biological Evaluation of Medical Devices- Part 1: Evaluation and Testing- 2009
    1. NEMA UD 2, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment:2004
    1. ISO14971, Application of risk management to medical devices: Second edition 2007
    1. NEMA PS 3.1 3.20 (2011), Digital Imaging and Communications in Medicine (DICOM) Set. (Radiology)

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

  • Risk Analysis ●
  • Requirements Reviews ●
  • Design Reviews ●
  • Testing on unit level (Module verification)
  • o 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).