LOGIQ E9, LOGIQ E9 XDClear 2.0
Device Facts
| Record ID | K152309 |
|---|---|
| Device Name | LOGIQ E9, LOGIQ E9 XDClear 2.0 |
| Applicant | GE Medical Systems Ultrasound and Primary Care Diagnostics |
| Product Code | IYN · Radiology |
| Decision Date | Sep 14, 2015 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
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; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transvaginal; Transesophageal and Intraoperative (abdominal, thoracic and vascular).
Device Story
The LOGIQ E9 and LOGIQ E9 XDclear 2.0 are mobile, general-purpose diagnostic ultrasound systems. They acquire, process, and display ultrasound data for clinical evaluation. The system includes a console with a keyboard, specialized controls, a 10-inch LCD touch screen, and a color wide-screen display. It utilizes various transducers to perform imaging in modes including B, M, PW/CW Doppler, Color/Power Doppler, and 3D/4D. The device is operated by qualified physicians in clinical settings. It supports digital image acquisition, review, and reporting. The system incorporates software features like AutoEF and AFI (migrated from the Vivid E9). By providing real-time visualization and fluid flow analysis, the device assists clinicians in diagnostic decision-making across multiple anatomical regions, potentially improving patient management through enhanced diagnostic accuracy.
Clinical Evidence
No clinical studies were required to support substantial equivalence. The device's safety and effectiveness were established through non-clinical bench testing, including acoustic output, biocompatibility, and electrical/mechanical safety verification.
Technological Characteristics
Mobile console (approx. 58cm x 87cm x 130cm) with 10-inch LCD touch screen and wide-screen display. Uses ultrasonic pulsed Doppler/echo imaging. Complies with AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, NEMA UD 2, NEMA UD 3, ISO 10993-1, and ISO 14971. Supports DICOM interoperability. Software includes AutoEF and AFI features.
Indications for Use
Indicated for ultrasound evaluation of fetal, abdominal, pediatric, small organ (breast, testes, thyroid), neonatal/adult cephalic, cardiac (adult/pediatric), peripheral vascular, musculoskeletal (conventional/superficial), urological (including prostate), transrectal, transvaginal, transesophageal, and intraoperative (abdominal, thoracic, vascular) applications. Prescription use only.
Regulatory Classification
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.
Predicate Devices
- GE LOGIQ E9 Diagnostic Ultrasound System (K142160)
- GE LOGIQ S8 Diagnostic Ultrasound System (K131527)
- GE Vivid E9 Diagnostic Ultrasound System (K131514)
Related Devices
- K123564 — LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM · GE Healthcare · Dec 18, 2012
- K163077 — LOGIQ E9, LOGIQ E9 XDClear 2.0 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Nov 17, 2016
- K110943 — LOGIQ E9 · GE Healthcare · Jul 22, 2011
- K173555 — LOGIQ E10 · GE Healthcare · Dec 20, 2017
- K142160 — LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM · GE Healthcare · Oct 10, 2014
Submission Summary (Full Text)
{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" arranged around the perimeter. Inside the circle is a stylized representation of a caduceus, a symbol often associated with medicine and healthcare.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 08, 2015
GE Medical Systems Ultrasound and Primary Care Diagnostics % Mr. Brvan Behn Sr. Regulatory Affairs Manager 9900 Innovation Drive WAUWATOSA WI 53226
Re: K152309
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: August 14, 2015 Received: August 17, 2015
Dear Mr. Behn:
This letter corrects our substantially equivalent letter of September 14. 2015.
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/ResourcesforYou/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,
erely yours,
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) K152309
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}------------------------------------------------
# Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9, LOGIQ E9 XDclear 2.0 Ultrasound System
| | Mode of Operation | | | | | | | | | | |
|-------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|--------------------|---------------------|----------------|------------------|
| Clinical Application | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[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 | [3,5,6,9,10] |
| 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 | [3,5,6,9,10] |
| 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 | | | | | | | | | | | |
| 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
[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 2 of 36
{4}------------------------------------------------
## Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9, LOGIQ E9 XDclear 2.0 with 3CRF Transducer
| | | | | | | | Mode of Operation | | | | |
|----------------------------------------------------|---|---|---------------|---------------|------------------|--------------------|-------------------|--------------------|---------------------|-----------------|------------------|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse* | Other<br>[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
{5}------------------------------------------------
# Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9, LOGIQ E9 XDclear 2.0 with 3CRF-D Transducer
| | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|--------------------|---------------------|-----------------|------------------|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse* | Other<br>[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 4 of 36
{6}------------------------------------------------
# Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9, LOGIQ E9 XDclear 2.0 with 6S-D Transducer
| | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|--------------------|---------------------|-----------------|------------------|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse* | Other<br>[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
{7}------------------------------------------------
# Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9, LOGIQ E9 XDclear 2.0 with 6Tc Transducer
| | | | | | | | Mode of Operation | | | | | |
|-------------------------------|---|---|---------|---------|---------|---------|-------------------|--------------------|---------------------|-----------------|------------------|--|
| Clinical Application | B | M | PW | CW | Color | Color M | Power | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse* | Other<br>[Notes] | |
| Anatomy/Region of Interest | | | Doppler | Doppler | Doppler | Doppler | Doppler | | | | | |
| 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)
Page 6 of 36
{8}------------------------------------------------
# Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9, LOGIQ E9 XDclear 2.0 with 9L-D Transducer
| | Mode of Operation | | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|--------------------|---------------------|----------------|------------------|--|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[Notes] | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal/Obstetrics[7] | P | P | P | P | P | P | P | P | P | P | [5,6,9] | |
| Abdominal[1] | P | P | P | P | P | P | P | P | P | P | [3,5,6,9,10] | |
| 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 | [3,5,6,9,10] | |
| 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 | | | | | | | | | | | | |
#### 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
{9}------------------------------------------------
# Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9, LOGIQ E9 XDclear 2.0 with 11L-D Transducer
| | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|--------------------|---------------------|----------------|------------------|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[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 | | | | | | | | | | | |
# 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
{10}------------------------------------------------
# Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9, LOGIQ E9 XDclear 2.0 with C1-5-D Transducer
| | Mode of Operation | | | | | | | | | | | |
|-------------------------------|-------------------|---|---------|---------|---------|---------|---------|----------|----------|-------|---------|--|
| Clinical Application | B | M | PW | CW | Color | Color M | Power | Combined | Harmonic | Coded | Other | |
| Anatomy/Region of Interest | | | Doppler | Doppler | Doppler | Doppler | Doppler | Modes* | Imaging | Pulse | [Notes] | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal/Obstetrics[7] | P | P | P | P | P | P | P | P | P | P | [5,6,9] | |
| Abdominal[1] | P | P | P | P | P | P | P | P | P | P | [5,6,9] | |
| Pediatric | P | P | P | P | P | P | P | P | P | P | [5,6,9] | |
| Small Organ[2] | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | P | [5,6,9] | |
| Musculo-skeletal Conventional | | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | | |
| Other [4] | P | P | P | P | P | P | P | P | P | P | [5,6,9] | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intraoperative[8] | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
#### 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
{11}------------------------------------------------
# Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9, LOGIQ E9 XDclear 2.0 with IC5-9-D Transducer
| | Mode of Operation | | | | | | | | | | |
|-------------------------------|-------------------|---|---------|---------|---------|---------|---------|----------|----------|--------|-----------|
| Clinical Application | B | M | PW | CW | Color | Color M | Power | Combined | Harmonic | Coded | Other |
| Anatomy/Region of Interest | | | Doppler | Doppler | Doppler | Doppler | Doppler | Modes* | Imaging | Pulse* | [Notes] |
| Ophthalmic | | | | | | | | | | | |
| Fetal/Obstetrics[7] | P | P | P | | P | P | P | P | P | P | [5,6,9] |
| Abdominal[1] | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ[2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other[4] | 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 | | | | | | | | | | | |
# 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
{12}------------------------------------------------
# Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9, LOGIQ E9 XDclear 2.0 with L8-18i-D Transducer
| | Mode of Operation | | | | | | | | | | |
|-------------------------------|-------------------|---|---------|---------|---------|---------|---------|----------|----------|-------|-----------|
| Clinical Application | B | M | PW | CW | Color | Color M | Power | Combined | Harmonic | Coded | Other |
| Anatomy/Region of Interest | | | Doppler | Doppler | Doppler | Doppler | Doppler | Modes* | Imaging | Pulse | [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
{13}------------------------------------------------
# Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9, LOGIQ E9 XDclear 2.0 with M4S-D Transducer
| | Mode of Operation | | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|--------------------|---------------------|----------------|------------------|--|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[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 | | | | | | | | | | | | |
#### 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
{14}------------------------------------------------
# Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9, LOGIQ E9 XDclear 2.0 with M5S-D Transducer
| | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|--------------------|---------------------|-----------------|------------------|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse® | Other<br>[Notes] |
| Ophthalmic | | | | | | | | | | | |
| Fetal/Obstetrics[7] | P | P | P | P | P | P | P | P | P | P | [5,6,9] |
| Abdominal[1] | P | P | P | P | P | P | P | P | P | P | [5,6,9] |
| Pediatric…
