LOGIQ P9, LOGIQ P7
Device Facts
| Record ID | K143452 |
|---|---|
| Device Name | LOGIQ P9, LOGIQ P7 |
| Applicant | GE Healthcare |
| Product Code | IYN · Radiology |
| Decision Date | Jan 29, 2015 |
| 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; 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
Mobile ultrasound console (53x69x157 cm) with digital acquisition, processing, and display. Inputs: ultrasound signals from various compatible transducers. Processing: digital signal processing, image mapping, spatial/time filtering, and enhancement. Outputs: B-mode, M-mode, Color/Power Doppler, PW/CW Doppler, harmonic imaging, coded pulse, 3D/4D, and elastography displayed on 21.5-inch LCD. User interface includes keyboard, controls, and 10.4-inch touch screen. Used in clinical settings by physicians for diagnostic evaluation. Features include auto-optimization, needle guidance, and automated measurement tools (e.g., Auto EF, breast/OB measure assistants). Benefits: provides real-time diagnostic imaging to support clinical decision-making across multiple anatomical regions.
Clinical Evidence
No clinical studies were required to support substantial equivalence. Evidence is based on bench testing, including acoustic output, biocompatibility, thermal, electrical, electromagnetic, and mechanical safety testing, and compliance with recognized standards (AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, NEMA UD 3, ISO 10993-1, NEMA UD 2).
Technological Characteristics
Mobile console with 21.5-inch LCD and 10.4-inch touch screen. Supports multiple transducers (C1-5-RS, 4C-RS, 8C-RS, E8C-RS, 9L-RS, 12L-RS, L6-12-RS, ML6-15-RS, L8-18i-RS, RAB2-6-RS, 3Sc-RS, 6S-RS, P8D, P6D). Imaging modes: B, M, Color M, Color/Power Doppler, PW/CW Doppler, Harmonic, Coded Pulse, 3D/4D, Elastography, B-flow. Connectivity: DICOM. Biocompatible patient-contact materials.
Indications for Use
Indicated for diagnostic ultrasound imaging or fluid flow analysis of the human body, including fetal, abdominal, pediatric, small organ, neonatal/adult cephalic, cardiac, peripheral vascular, musculoskeletal, urological, transrectal, transvaginal, and intraoperative applications. Used by qualified physicians.
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 S7 Diagnostic Ultrasound System (K141261)
- LOGIQ e Diagnostic Ultrasound System (K133533)
- Voluson S6/S8 Diagnostic Ultrasound System (K141639)
- LOGIQ F Series Diagnostic Ultrasound System (K133034)
Related Devices
- K253370 — LOGIQ Totus · GE Medical Systems Ultrasound and Primary Care Diagnostics · Jan 8, 2026
- K233841 — HD80 Series Ultrasound Diagnostic System · Qingdao Hisense Medical Equipment Co., Ltd. · May 16, 2024
- K260673 — LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 Power · GE Medical Systems Ultrasound and Primary Care Diagnostics · Mar 24, 2026
- K201768 — Voluson E10 · GE Healthcare · Oct 22, 2020
- K233692 — Voluson Signature 20, Voluson Signature 18 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Mar 7, 2024
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 features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected by a flowing line that resembles a ribbon or wave. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 29, 2015
GE Healthcare % Mr. Bryan Behn Regulatory Affairs Manager 9900 Innovation Drive WAUWATOSA WI 53226
Re: K143452 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: December 1, 2014 Received: December 2, 2014
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 A Ochs
Robert Ochs. Ph.D. Acting 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)
#### K143452
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) | |
|----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| <div> <span> </span> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> </span> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
#### 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}------------------------------------------------
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 circular frame. The color of the logo is a light blue.
#### 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<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] | N | N | N | N | N | N | N | N | N | N | 5,6 |
| Abdominal[1] | N | N | N | N | N | N | N | N | N | N | 3,5,6 |
| Pediatric | N | N | N | N | N | N | N | N | N | N | 3,5,6 |
| Small Organ[2] | N | N | N | N | N | N | N | N | N | N | 3,5,6 |
| Neonatal Cephalic | N | N | N | N | N | N | N | N | N | N | 5,6 |
| Adult Cephalic | N | N | N | N | N | N | N | N | N | N | 5,6 |
| Cardiac Adult & Pediatric | N | N | N | N | N | N | N | N | N | N | |
| Peripheral Vascular | N | N | N | N | N | N | N | N | N | N | 3,5,6 |
| Musculo-skeletal Conventional | N | N | N | N | N | N | N | N | N | N | 3,5,6 |
| Musculo-skeletal Superficial | N | N | N | N | N | N | N | N | N | N | 3,5,6 |
| Other[4] | N | N | N | N | N | N | N | N | N | N | 3,5,6 |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal[8] | N | N | N | N | N | N | N | N | N | N | 3,5,6 |
| Transvaginal | N | N | N | N | N | N | N | N | N | N | 3,5,6 |
| Transuretheral | | | | | | | | | | | |
| Intraoperative[8] | N | N | N | N | N | N | N | N | N | N | 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 quidance 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)
Prescription User (Per 21 CFR 801.109)
Page 2 of 15
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" in a stylized script, enclosed within a circular frame. The frame has a decorative, swirling pattern around the letters. The logo is presented in a blue color.
GE Healthcare 510(k) Premarket Notification Submission
### 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 | 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, K141261)
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)
Prescription User (Per 21 CFR 801.109)
Page 3 of 15
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a blue circle. The circle has decorative swirls around the perimeter, giving it a classic and recognizable appearance. The blue color is consistent throughout the logo, providing a clean and professional look.
GE Healthcare 510(k) Premarket Notification Submission
## 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)
Prescription User (Per 21 CFR 801.109)
Page 4 of 15
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a blue circle. The circle has decorative swirls around the perimeter, giving it a classic and recognizable appearance.
GE Healthcare 510(k) Premarket Notification Submission
## 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] | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal[8] | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative[8] | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA (K133533)
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)
Prescription User (Per 21 CFR 801.109)
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" in a stylized script, enclosed within a circular frame. The frame has a decorative, swirling pattern around the letters. The logo is presented in a blue color.
GE Healthcare 510(k) Premarket Notification Submission
### Diagnostic Ultrasound Indications for Use Form GE LOGIQ P9 and LOGIQ P7 with ML6-15-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 | 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 | 3,5,6 |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac Adult & 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[8] | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative[8] | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA (K141639, K141261)
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)
Prescription User (Per 21 CFR 801.109)
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" in a stylized script, enclosed within a circular frame. The frame has a decorative, swirling pattern around the letters. The logo is presented in a blue color.
GE Healthcare 510(k) Premarket Notification Submission
### Diagnostic Ultrasound Indications for Use Form GE LOGIQ P9 and LOGIQ P7 with E8C-RS 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 | | |
| 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 | 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] | | | | | | | | | | | | |
| 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 (K133533)
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)
Prescription User (Per 21 CFR 801.109)
{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 letters and the border are both a light blue color, set against a white background. The logo is simple and recognizable, representing the well-known multinational corporation.
GE Healthcare 510(k) Premarket Notification Submission
### Diagnostic Ultrasound Indications for Use Form GE LOGIQ P9 and LOGIQ P7 with L8-18i-RS 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] | | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | P | P | P | 5,6 |
| Small Organ[2] | P | P | P | | P | P | P | P | P | P | 5,6 |
| Neonatal Cephalic | P | P | P | | P | P | P | P | P | P | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac Adult & Pediatric | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | P | P | P | 3,5,6 |
| Musculo-skeletal Conventional | P | P | P | | P | P | P | P | P | P | 3,5,6 |
| Musculo-skeletal Superficial | P | P | P | | P | P | P | P | P | P | 3,5,6 |
| Other[4] | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal[8] | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative[8] | P | P | P | | P | P | P | P | P | P | 3,5,6 |
| 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 (K133533)
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)
Prescription User (Per 21 CFR 801.109)
Page 8 of 15
{10}------------------------------------------------
Image /page/10/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" in a stylized script, enclosed within a circular frame. The frame has a decorative, swirling pattern around the letters. The logo is presented in a blue color.
GE Healthcare 510(k) Premarket Notification Submission
### Diagnostic Ultrasound Indications for Use Form GE LOGIQ P9 and LOGIQ P7 with P8D 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 | | | N | N | | | | | | | |
| Cardiac Adult & Pediatric | | | N | N | | | | | | | |
| Peripheral Vascular | | | N | N | | | | | | | |
| 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
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)
Prescription User (Per 21 CFR 801.109)
Page 9 of 15
{11}------------------------------------------------
Image /page/11/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" in a stylized script, enclosed within a circular frame. The frame has a decorative, swirling pattern around the letters. The logo is presented in a blue color.
### Diagnostic Ultrasound Indications for Use Form GE LOGIQ P9 and LOGIQ P7 with RAB2-6-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 | | | | | | | | | | | | |
| 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) Prescription User (Per 21 CFR 801.109)
Page 10 of 15
{12}------------------------------------------------
Image /page/12/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" in a stylized script, enclosed within a circular frame. The frame has a decorative, swirling pattern around the letters. The logo is presented in a blue color, which is a common branding element for GE.
GE Healthcare 510(k) Premarket Notification Submission
### Diagnostic Ultrasound Indications for Use Form GE LOGIQ P9 and LOGIQ P7 with L6-12-RS 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] | 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 | P | P | P | | P | P | P | P | P | P | 3,5,6 |
| Musculo-skeletal Superficial | P | P | P | | P | P | P | P | P | P | 3,5,6 |
| Other[4] | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal[8] | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative[8] | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA (K133034)
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)
Prescription User (Per 21 CFR 801.109)
Page 11 of 15
{13}------------------------------------------------
Image /page/13/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" in a stylized script, enclosed within a circular frame. The frame has a decorative, swirling pattern around the letters. The logo is presented in a blue color.
GE Healthcare 510(k) Premarket Notification Submission
### Diagnostic Ultrasound Indications for Use Form GE LOGIQ P9 and LOGIQ P7 with 12L-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…
