LOGIQ S8
Device Facts
| Record ID | K170445 |
|---|---|
| Device Name | LOGIQ S8 |
| Applicant | GE Healthcare |
| Product Code | IYN · Radiology |
| Decision Date | Apr 11, 2017 |
| Decision | SESE |
| Submission Type | Traditional |
| 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/Obstetrics; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (abdominal, thoracic, vascular).
Device Story
The LOGIQ S8 is a mobile, general-purpose diagnostic ultrasound system. It acquires, processes, and displays ultrasound images and fluid flow data. The system features a console with a keyboard, specialized controls, a 10.1-inch LCD touch screen, and a color widescreen monitor. It is operated by qualified physicians in clinical settings. The device uses various transducers to perform B-mode, M-mode, Doppler (PW, CW, Color, Power), harmonic imaging, and coded pulse imaging. It supports advanced features like 3D/4D imaging, volume navigation, needle guidance, and elastography (including FibroScan and shear wave). The system aids clinicians in diagnostic evaluation, measurement, and reporting. It benefits patients by providing non-invasive diagnostic imaging across a wide range of anatomical regions and clinical applications.
Clinical Evidence
No clinical data. Substantial equivalence is supported by non-clinical bench testing, including acoustic output, biocompatibility, cleaning/disinfection effectiveness, and thermal, electrical, electromagnetic, and mechanical safety testing in compliance with standards such as AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, ISO10993-1, and NEMA UD 2/UD 3.
Technological Characteristics
Mobile console ultrasound system with 10.1-inch LCD touch screen and color monitor. Employs pulsed Doppler, B-mode, M-mode, and harmonic imaging. Supports various transducers. Materials are biocompatible (ISO 10993-1). Complies with electrical/safety standards (AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37). Connectivity includes DICOM.
Indications for Use
Indicated for ultrasound evaluation of fetal/obstetrics, abdominal, pediatric, small organ (breast, testes, thyroid), neonatal/adult cephalic, cardiac (adult/pediatric), peripheral vascular, musculoskeletal (conventional/superficial), urology (prostate), transrectal, transvaginal, transesophageal, and intraoperative (abdominal, thoracic, vascular) applications.
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
- LOGIQ S8 Diagnostic Ultrasound System (K152195)
Reference Devices
- LOGIQ E9 Diagnostic Ultrasound System (K163077)
- VIVID E90/E95 Diagnostic Ultrasound System (K150087)
- FibroScan 530 Compact Ultrasonic Pulsed Echo Imaging System (K160524)
- VOLUSON S6/S8/S10 Diagnostic Ultrasound System (K160184)
- LOGIQ P7/P9 Diagnostic Ultrasound System (K161047)
- LOGIQ S7 EXPERT Diagnostic Ultrasound System (K160182)
Related Devices
- K152195 — LOGIQ S8 · GE Healthcare · Sep 29, 2015
- K131527 — LOGIQ S8 · GE Healthcare · Aug 26, 2013
- K111582 — LOGIQ S8 · GE Healthcare · Jul 26, 2011
- K170277 — DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Mar 23, 2017
- K123564 — LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM · GE Healthcare · Dec 18, 2012
Submission Summary (Full Text)
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is a stylized symbol consisting of three overlapping human profiles facing to the right, with flowing lines above them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 11, 2017
GE Healthcare % Mr. Bryan Behn Regulatory Affairs Director 9900 Innovation Drive WAUWATOSA WI 53226
Re: K170445 Trade/Device Name: LOGIO S8 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: February 13, 2017 Received: February 14, 2017
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.
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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
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## Indications for Use
510(k) Number (if known) K170445
Device Name LOGIO 88
Indications for Use (Describe)
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/Obstetrics; Abdominal; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transvaginal; Transesophageal and Intraoperative (abdominal, thoracic, vascular).
Type of Use (Select one or both, as applicable)
| <span style="font-size: 10pt;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> |
|--------------------------------------------------------------------------------------|
| <span style="font-size: 10pt;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |
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Image /page/3/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, enclosed within a blue circle. The circle has a decorative border with swirling patterns, giving it a classic and recognizable appearance.
GE Healthcare 510(k) Premarket Notification Submission
## Indications for Use Forms
The following forms represent indications with clinical applications and exam types along with the modes of operation for the LOGIQ S8 system and for all of its probe/mode combinations. Combinations identified by "P" represent those previously cleared with the unmodified LOGIQ S8. "N" is 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.
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Image /page/4/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The letters are enclosed within a blue circle, and there are decorative white swirls around the perimeter of the circle.
### Diagnostic Ultrasound Indications for Use Form GE LOGIQ S8 Ultrasound System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | 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 | 3,5,6,9,10,11,12, 13 |
| Pediatric | P | P | P | P | P | P | P | P | P | P | 3,5,6,9,10, 11, 13 |
| 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 | 3,5,6,9 |
| Adult Cephalic | P | P | P | P | P | P | P | P | P | P | 3,5,6,9 |
| Cardiac | P | P | P | P | P | P | P | P | P | P | |
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | P | 3,5,6,9,10 |
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P | P | P | 3,5,6,9,10 |
| Musculo-skeletal Superficial | P | P | P | P | P | P | P | P | P | P | 3,5,6,9,10 |
| Other[4] | P | P | P | P | P | P | P | P | P | P | 3,5,6,9,10 |
| 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 | 3,5,6,7,9 |
| Transuretheral | | | | | | | | | | | |
| Intraoperative[8] | P | P | P | P | P | P | P | P | P | P | 3,5,6,9 |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
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
[11] FibroScan elastography
[12] Controlled Attenuation Parameter at 3.5MHz
[13] A Mode
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
(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)
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Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a circular border. The border has decorative swirls or flourishes around the letters. The logo is presented in a blue color.
### GE LOGIQ S8 with C1-5-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | 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 |
| Pediatric | P | P | P | P | P | P | P | P | P | P | 3,5,6,9 |
| Small Organ[2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | P | 3,5,6,9 |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other[4] | P | P | P | P | P | P | P | P | P | P | 3,5,6,9 |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative[8] | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
[1] Abdominal includes Renal, GYN/Pelvic. Notes:
[2] Small organ includes breast, testes and thyroid
[3] Elastography Imaging - Elasticity.
[4] Other use includes Urology/Prostate
[5] 3D/4D Imaqing 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
[11] FibroScan elastography
[12] Controlled Attenuation Parameter at 3.5MHz
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
(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)
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The letters are enclosed within a circular border, and there are decorative swirls or flourishes surrounding the circle, giving it a classic and recognizable appearance.
### GE LOGIQ S8 with 9L-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | 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 | | 5,6,9 |
| Abdominal[1] | P | P | P | | P | P | P | P | P | P | 3,5,6,9,10 |
| Pediatric | P | P | P | | P | P | P | P | P | P | 3,5,6,9,10 |
| Small Organ[2] | P | P | P | | P | P | P | P | P | P | 3,5,6,9,10 |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | P | P | P | 3,5,6,9,10 |
| Musculo-skeletal Conventional | P | P | P | | P | P | P | P | P | P | 3,5,6,9,10 |
| Musculo-skeletal Superficial | P | P | P | | P | P | P | P | P | P | 3,5,6,9,10 |
| Other[4] | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal[8] | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative[8] | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
[1] Abdominal includes Renal, GYN/Pelvic. Notes:
[2] Small organ includes breast, testes 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
[11] FibroScan elastography
[12] Controlled Attenuation Parameter at 3.5MHz
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
(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)
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a circular border. The color of the logo is a light blue. The logo is simple and recognizable, representing the General Electric brand.
### GE LOGIQ S8 with ML6-15-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| 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] | | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | P | P | P | 3,5,6,9 |
| Small Organ[2] | P | P | P | | P | P | P | P | P | P | 3,5,6,9 |
| Neonatal Cephalic | P | P | P | | P | P | P | P | P | P | 9 |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| 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[8] | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative[8] | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [1] Abdominal includes Renal, GYN/Pelvic.
[2] Small organ includes breast, testes 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
[11] FibroScan elastography
[12] Controlled Attenuation Parameter at 3.5MHz
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
(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)
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The letters are enclosed within a blue circle, and there are decorative white swirls around the perimeter of the circle.
### Diagnostic Ultrasound Indications for Use Form GE LOGIQ S8 with M5S-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | | |
|-------------------------------|-------------------|---|---------|---------|---------|---------|---------|----------|----------|-------|---------|--|
| Clinical Application | B | M | PW | CW | Color | Color M | Power | Combined | Harmonic | Coded | Other | |
| Anatomy/Region of Interest | | | Doppler | Doppler | Doppler | Doppler | Doppler | Modes | Imaging | Pulse | [Notes] | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal / Obstetrics[7] | | | | | | | | | | | | |
| Abdominal[1] | P | P | P | P | P | P | P | P | P | P | 5,9 | |
| Pediatric | | | | | | | | | | | | |
| Small Organ[2] | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | P | P | P | P | P | P | P | P | P | P | 5,9 | |
| Cardiac | 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[8] | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | | |
| Intraoperative[8] | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
[1] Abdominal includes Renal, GYN/Pelvic. Notes:
[2] Small organ includes breast, testes 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
[11] FibroScan elastography
[12] Controlled Attenuation Parameter at 3.5MHz
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
(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)
{9}------------------------------------------------
Image /page/9/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a circular border. The border has decorative swirls or flourishes around the letters. The logo is presented in a blue color.
### GE LOGIQ S8 with IC5-9-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|--------------------|---------------------|----------------|------------------|
| Clinical Application<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 | 3,5,9 |
| Pediatric | | | | | | | | | | | |
| Small Organ[2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| 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[8] | P | P | P | | P | P | P | P | P | P | 3,5,6,9 |
| Transvaginal | P | P | P | | P | P | P | P | P | P | 3,5,6,7,9 |
| Transuretheral | | | | | | | | | | | |
| Intraoperative[8] | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [1] Abdominal includes Renal, GYN/Pelvic.
[2] Small organ includes breast, testes 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
[11] FibroScan elastography
[12] Controlled Attenuation Parameter at 3.5MHz
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
(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)
{10}------------------------------------------------
Image /page/10/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a circular border. The border has decorative swirls or flourishes around the letters. The logo is presented in a blue color.
### GE LOGIQ S8 with 3CRF-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | 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 | 5,6,9 |
| Pediatric | P | P | P | | P | P | P | P | P | P | 5,6,9 |
| Small Organ[2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other[4] | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal[8] | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative[8] | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [1] Abdominal includes Renal, GYN/Pelvic.
[2] Small organ includes breast, testes 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
[11] FibroScan elastography
[12] Controlled Attenuation Parameter at 3.5MHz
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
(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)
{11}------------------------------------------------
Image /page/11/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a circular border. The color of the logo is a light blue. The logo is simple and recognizable, representing the General Electric brand.
#### GE LOGIQ S8 with L8-18i-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|--------------------|---------------------|----------------|------------------|--|
| Clinical Application<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] | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ[2] | P | P | P | | P | P | P | P | P | P | 5,9 | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | P | P | P | 5,9 | |
| Musculo-skeletal Conventional | P | P | P | | P | P | P | P | P | P | 5,9 | |
| Musculo-skeletal Superficial | P | P | P | | P | P | P | P | P | P | 5,9 | |
| Other[4] | | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal[8] | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | | |
| Intraoperative[8] | P | P | P | | P | P | P | P | P | P | 5,9 | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
[1] Abdominal includes Renal, GYN/Pelvic. Notes:
[2] Small organ includes breast, testes and thyroid
[3] Elastography Imaging - Elasticity.
[4] Other use includes Urology/Prostate
[5] 3D/4D Imaqing 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
[11] FibroScan elastography
[12] Controlled Attenuation Parameter at 3.5MHz
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
(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)
{12}------------------------------------------------
Image /page/12/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a circular border. The color of the logo is a light blue. The logo is simple and recognizable, representing the General Electric brand.
### GE LOGIQ S8 with S4-10-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | 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] | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | P | P | P | 5,9 | |
| Small Organ[2] | | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | P | 5,9 | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac | 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[8] | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | | |
| Intraoperative[8] | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [1] Abdominal includes Renal, GYN/Pelvic.
[2] Small organ includes breast, testes 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
[11] FibroScan elastography
[12] Controlled Attenuation Parameter at 3.5MHz
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
(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)
{13}------------------------------------------------
Image /page/13/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a circular border. The color of the logo is a light blue. The logo is simple and recognizable, representing the General Electric brand.
### GE LOGIQ S8 with P2D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | 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] | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ[2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | P | | | | | | | |
| Cardiac | | | | P | | | | | | | |
| Peripheral Vascular | | | | P | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other[4] | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal[8] | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative[8] | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
[1] Abdominal includes Renal, GYN/Pelvic. Notes:
[2] Small organ includes breast, testes and thyroid
[3] Elastography Imaging - Elasticity.
[4] Other use includes Urology/Prostate
[5] 3D/4D Imaqing 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
[11] FibroScan elastography
[12] Controlled Attenuation Parameter at 3.5MHz
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
(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)
{14}------------------------------------------------
Image /page/14/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a circular border. The color of the logo is a light blue. The logo is simple and recognizable, representing the General Electric brand.
### GE LOGIQ S8 with P6D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | 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] | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ[2] | | | |…
