LOGIQ P9 and LOGIQ P7
Device Facts
| Record ID | K161047 |
|---|---|
| Device Name | LOGIQ P9 and LOGIQ P7 |
| Applicant | GE Healthcare |
| Product Code | IYN · Radiology |
| Decision Date | May 5, 2016 |
| 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; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, vascular).
Device Story
The LOGIQ P9 and LOGIQ P7 are mobile, general-purpose diagnostic ultrasound systems. They acquire, process, and display ultrasound data using a mobile console with a 21.5-inch LCD display and 10.4-inch touch screen. The system supports various imaging modes (B, M, PW/CW Doppler, Color/Power Doppler, Harmonic, Coded Pulse, 3D/4D) and needle guidance. It is operated by qualified physicians in clinical settings. New features include battery-powered off-line scanning, STIC (Spatio-Temporal Image Correlation), OmniView, Cardiac AFI (Automated Function Imaging), and SMTP-based email for image/text transmission. The system processes acoustic signals from transducers to provide real-time diagnostic images and measurements, aiding clinical decision-making in diverse anatomical regions.
Clinical Evidence
No clinical studies were required to support substantial equivalence. Evidence is based on bench testing, including acoustic output measurements, biocompatibility, cleaning/disinfection effectiveness, and thermal, electrical, electromagnetic, and mechanical safety testing in compliance with standards such as AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 2, NEMA UD 3, and ISO 10993-1.
Technological Characteristics
Mobile console (53x69x157 cm) with 21.5-inch LCD display and 10.4-inch touch screen. Supports multiple transducers (L4-12t-RS, L10-22-RS, L3-9i-RS, BE9CS-RS, E8CS-RS, RIC5-9A-RS, 12S-RS). Imaging modes: B, M, PW/CW Doppler, Color/Power Doppler, Harmonic, Coded Pulse, 3D/4D. Connectivity: DICOM, SMTP email. Safety standards: AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 2/3, ISO 10993-1.
Indications for Use
Indicated for diagnostic ultrasound imaging or fluid flow analysis in fetal, abdominal, pediatric, small organ (breast, testes, thyroid), neonatal/adult cephalic, cardiac (adult/pediatric), peripheral vascular, musculoskeletal (conventional/superficial), urological (prostate), transrectal, transvaginal, 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 P9/P7 Diagnostic Ultrasound System (K143452)
Reference Devices
- LOGIQ S7 Expert Diagnostic Ultrasound System (K160182)
- LOGIQ e Diagnostic Ultrasound System (K151028)
- LOGIQ E9 Diagnostic Ultrasound System (K152309)
- LOGIQ F Series Diagnostic Ultrasound System (K160277)
- VOLUSON S Series Diagnostic Ultrasound System (K160184)
Related Devices
- K160182 — LOGIQ S7 Expert · GE Healthcare · Feb 26, 2016
- K163596 — LOGIQ P9 and LOGIQ P7 · GE Healthcare · Feb 10, 2017
- K141261 — LOGIQ S7 EXPERT, LOGIQ S7 PRO · GE Healthcare · Jun 5, 2014
- K181783 — LOGIQ P9; LOGIQ P7 · GE Healthcare · Sep 20, 2018
- K152309 — LOGIQ E9, LOGIQ E9 XDClear 2.0 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Sep 14, 2015
Submission Summary (Full Text)
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of human profiles facing to the right, with three distinct head shapes stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 5, 2016
GE Healthcare % Mr. Bryan Behn Regulatory Affairs Director 9900 Innovation Drive WAUWATOSA WI 53226
Re: K161047
Trade/Device Name: LOGIO P9 and LOGIO P7 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: April 12, 2016 Received: April 13, 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,
Robert Oals
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)
K161047
Device Name LOGIQ P9 and LOGIQ P7
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; and Intraoperative (abdominal, thoracic, vascular).
| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| <span style="font-size: 10pt;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> | |
| | <span style="font-size: 10pt;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
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{3}------------------------------------------------
Image /page/3/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, wave-like elements around its perimeter, giving it a distinctive and recognizable appearance.
### Diagnostic Ultrasound Indications for Use Form
#### GE LOGIQ P9 and LOGIQ P7 Ultrasound System
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] | P | P | P | P | P | P | P | P | P | P | 5,6 |
| 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 | P | P | P | P | P | P | P | P | P | P | 5,6 |
| Adult Cephalic | P | P | P | P | P | P | P | P | P | P | 5,6 |
| Cardiac Adult & 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 |
| 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] | P | P | P | P | P | P | P | P | P | P | 3,5,6 |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal[8] | P | P | P | P | P | P | P | P | P | P | 3,5,6 |
| Transvaginal | P | P | P | P | P | P | P | P | P | P | 3,5,6 |
| Transuretheral | | | | | | | | | | | |
| Intraoperative[8] | P | P | P | P | P | P | P | P | P | P | 3,5,6 |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA
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)
[*] 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)
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' written in a stylized script, enclosed within a blue circle. The circle has decorative swirls around the letters, giving it a classic and recognizable appearance. The logo is simple, yet distinctive, representing the brand identity of General Electric.
### Diagnostic Ultrasound Indications for Use Form
#### GE LOGIQ P9 and LOGIQ P7 with L4-12t-RS 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 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 | [3,6] |
| Small Organ[2] | *P | *P | *P | | *P | *P | *P | *P | *P | *P | [3,6] |
| Neonatal Cephalic | *P | *P | *P | | *P | *P | *P | *P | *P | *P | [3,6] |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac Adult & Pediatric | | | | | | | | | | | |
| Peripheral Vascular | *P | *P | *P | | *P | *P | *P | *P | *P | *P | [3,6] |
| Musculo-skeletal Conventional | *P | *P | *P | | *P | *P | *P | *P | *P | *P | [3,6] |
| Musculo-skeletal Superficial | *P | *P | *P | | *P | *P | *P | *P | *P | *P | [3,6] |
| 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 in (K151028)
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)
[*] 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)
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' written in a stylized script, enclosed within a blue circle. The circle has decorative swirls around the letters, giving it a classic and recognizable appearance. The logo is simple, yet distinctive, representing the brand identity of General Electric.
### Diagnostic Ultrasound Indications for Use Form
#### GE LOGIQ P9 and LOGIQ P7 with L10-22-RS 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 | |
| Neonatal Cephalic | *P | *P | *P | | *P | *P | *P | *P | *P | *P | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac Adult & Pediatric | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | *P | *P | *P | | *P | *P | *P | *P | *P | *P | |
| Musculo-skeletal Superficial | *P | *P | *P | | *P | *P | *P | *P | *P | *P | |
| 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 in (K151028)
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)
[*] 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 'GE' written in a stylized script, enclosed within a circular frame. The color of the logo is blue, and the background is white.
### Diagnostic Ultrasound Indications for Use Form
#### GE LOGIQ P9 and LOGIQ P7 with L3-9i-RS 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 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 | | | | | | | | | | | |
| Small Organ[2] | N | N | N | | N | N | N | N | N | N | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac Adult & Pediatric | | | | | | | | | | | |
| Peripheral Vascular | N | N | N | | N | N | N | N | N | N | |
| Musculo-skeletal Conventional | N | N | N | | N | N | N | N | N | N | |
| Musculo-skeletal Superficial | N | N | N | | N | N | N | N | N | N | |
| Other[4] | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal[8] | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative[8] | N | N | N | | N | N | N | N | N | N | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA
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)
[*] 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' written in a stylized script, enclosed within a circular frame. The frame has decorative swirls or flourishes around the letters. The logo is presented in a blue color.
### Diagnostic Ultrasound Indications for Use Form
#### GE LOGIQ P9 and LOGIQ P7 with E8CS--RS 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 | [3,6] |
| Abdominal[1] | *P | *P | *P | | *P | *P | *P | *P | *P | *P | [3,6] |
| Pediatric | | | | | | | | | | | |
| Small Organ[2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac Adult & Pediatric | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other[4] | *P | *P | *P | | *P | *P | *P | *P | *P | *P | [3,6] |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal[8] | *P | *P | *P | | *P | *P | *P | *P | *P | *P | [3,6] |
| Transvaginal | *P | *P | *P | | *P | *P | *P | *P | *P | *P | [3,6] |
| Transuretheral | | | | | | | | | | | |
| Intraoperative[8] | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication; *P = previously cleared by FDA in (K160184)
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)
[*] 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 'GE' written in a stylized script, enclosed within a blue circle. The circle has decorative swirls around the letters, giving it a classic and recognizable appearance. The logo is simple, yet distinctive, and is widely associated with the multinational conglomerate.
### Diagnostic Ultrasound Indications for Use Form
#### GE LOGIQ P9 and LOGIQ P7 with BE9CS-RS 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 | | | | | | | | | | | |
| Cardiac Adult & Pediatric | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other[4] | *P | *P | *P | | *P | *P | *P | *P | *P | *P | [3,6] |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal[8] | *P | *P | *P | *P | *P | *P | *P | *P | *P | *P | [3,6] |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative[8] | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication; *P = previously cleared by FDA in (K160277)
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)
[*] 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" written in a stylized script, enclosed within a blue circle. The circle has three curved lines emanating from it, giving the impression of movement or energy.
### Diagnostic Ultrasound Indications for Use Form
#### GE LOGIQ P9 and LOGIQ P7 with RIC5-9A-RS 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] | |
| Abdominal[1] | *P | *P | *P | | *P | *P | *P | *P | *P | *P | [5,6] | |
| Pediatric | | | | | | | | | | | | |
| Small Organ[2] | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac Adult & Pediatric | | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | | |
| Other[4] | *P | *P | *P | | *P | *P | *P | *P | *P | *P | [5,6] | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal[8] | | | | | | | | | | | | |
| Transvaginal | *P | *P | *P | | *P | *P | *P | *P | *P | *P | [5,6] | |
| Transuretheral | | | | | | | | | | | | |
| Intraoperative[8] | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
N = new indication; *P = previously cleared by FDA in (K160184)
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)
[*] 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 logo is colored in a shade of blue, and the background is white.
### Diagnostic Ultrasound Indications for Use Form
#### GE LOGIQ P9 and LOGIQ P7 with 12S-RS 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 | |
| Small Organ[2] | | | | | | | | | | | |
| Neonatal Cephalic | *P | *P | *P | *P | *P | *P | *P | *P | *P | *P | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac Adult & Pediatric | | | | | | | | | | | |
| 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 in (K160184)
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)
[*] 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' written in a stylized script, enclosed within a circular frame. The color of the logo is blue, and the background is white.
### Diagnostic Ultrasound Indications for Use Form
#### GE LOGIQ P9 and LOGIQ P7 with C1-5-RS 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 | |
| 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] | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac Adult & Pediatric | | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | P | P | 3,5,6 |
| Musculo-skeletal Conventional | | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | | |
| Other[4] | P | P | P | P | P | P | P | P | P | P | P | 3,5,6 |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal[8] | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | | |
| Intraoperative[8] | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA (K141639, K143452)
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)
[*] 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' intertwined in a stylized script, enclosed within a blue circle. The circle is surrounded by a decorative, swirling pattern, also in blue, giving the logo a classic and recognizable appearance.
# Diagnostic Ultrasound Indications for Use Form GE LOGIQ P9 and LOGIQ P7 with 4C-RS 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 | |
| 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] | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac Adult & Pediatric | | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | P | 3,5,6 | |
| Musculo-skeletal Conventional | | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | | |
| Other[4] | P | P | P | P | P | P | P | P | P | P | 3,5,6 | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal[8] | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | | |
| Intraoperative[8] | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA (K141639)
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)
[*] 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 'g' and 'e' intertwined in a stylized script, enclosed within a blue circle. There are three stylized swirls around the circle.
### Diagnostic Ultrasound Indications for Use Form
#### GE LOGIQ P9 and LOGIQ P7 with 9L-RS 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 | 3,5,6 | |
| Pediatric | P | P | P | | P | P | P | P | P | P | 3,5,6 | |
| Small Organ[2] | P | P | P | | P | P | P | P | P | P | 3,5,6 | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac Adult & Pediatric | | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | P | P | P | 3,5,6 | |
| Musculo-skeletal Conventional | | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | | |
| Other[4] | | |…
