(51 days)
No
The document does not mention AI, ML, or related terms, nor does it describe features or performance metrics typically associated with AI/ML in medical imaging.
No
The device is described as a "general purpose diagnostic ultrasound system" and its intended use is for "ultrasound evaluation" and "passive magnetic tracking of a needle with respect to ultrasound image data," all of which are diagnostic functions, not therapeutic.
Yes
The Device Description explicitly states: "The LOGIQ P9 and LOGIQ P7 is a full featured, general purpose diagnostic ultrasound system".
No
The device description clearly states it is a "full featured, general purpose diagnostic ultrasound system which consists of a mobile console" with physical components like a keyboard, touch screen, and image display. This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for ultrasound evaluation of various anatomical sites. This is a form of in vivo imaging, meaning it's used to visualize structures within a living body.
- Device Description: The description details a mobile console with digital acquisition, processing, and display capabilities for ultrasound images. This aligns with the characteristics of an ultrasound system used for imaging the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide diagnostic information. IVDs are typically used in laboratories or point-of-care settings to analyze biological samples.
Therefore, the device described is a diagnostic ultrasound system used for medical imaging, which is distinct from an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transvaginal; and Intraoperative (abdominal, thoracic, vascular).
When PinpointTM GT Technology, from C.R. Bard, Inc., is included with the system, the Indications for Use include: Pinpoint GT Technology is intended to provide clinicians with visual tools for passive magnetic tracking of a needle with respect to ultrasound image data.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
The LOGIQ P9 and LOGIQ P7 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 53 cm wide, 69 cm deep and 157 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 10.4-inch LCD touch screen and color 21.5-inch LCD image display.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal; Intraoperative (abdominal, thoracic, vascular).
Indicated Patient Age Range
Adult and pediatric (age range not explicitly defined, but implied by "Fetal", "Neonatal Cephalic", "Pediatric", and "Adult Cephalic" clinical applications)
Intended User / Care Setting
qualified physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic, and mechanical safety, and has been found to conform to applicable medical device safety standards. LOGIQ P9 and LOGIQ P7 and its applications comply with voluntary standards:
- AAMI/ANSI ES60601-1, Medical Electrical Equipment -● Part 1: General Requirements for Safety, 2005/C1:2012
- IEC60601-1-2, Medical Electrical Equipment - Part 1-2:General Requirements for Safety – Collateral Standard: Electromagnetic Compatibility Requirements and Tests 2007
- IEC60601-2-37, Medical Electrical Equipment - Part 2-37:Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment, 2007
- NEMA UD 3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment:2004
- ISO10993-1, Biological Evaluation of Medical Devices-● Part 1: Evaluation and Testing- Third Edition, 2009
- NEMA UD 2, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment:2004
- ISO14971, Application of risk management to medical devices: Second edition 2007
- NEMA PS 3.1 3.20 (2011), Digital Imaging and ● Communications in Medicine (DICOM) Set. (Radiology)
The following quality assurance measures are applied to the development of the system:
- Risk Analysis
- Requirements Reviews
- Design Reviews
- Testing on unit level (Module verification)
- Integration testing (System verification)
- o Performance testing (Verification)
- Safety testing (Verification)
The subject of this premarket submission, LOGIO P9 and LOGIO P7, did not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K161047 LOGIQ P9/P7 Diagnostic Ultrasound System
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K152758 Venue 50 Diagnostic Ultrasound System, K160182 LOGIQ S7 Expert Diagnostic Ultrasound System
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 10, 2017
GE Healthcare % Mr. Bryan Behn Regulatory Affairs Director 9900 Innovation Drive WAUWATOSA WI 53226
Re: K163596 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 20, 2016 Received: December 21, 2016
Dear Mr. Behn:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D. O'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K163596
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).
When PinpointTM GT Technology, from C.R. Bard, Inc., is included with the system, the Indications for Use include: Pinpoint GT Technology is intended to provide clinicians with visual tools for passive magnetic tracking of a needle with respect to ultrasound image data
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Indications for Use Forms
The following forms represent indications with clinical applications and exam types along with the modes of operation for the LOGIQ P9 and LOGIQ P7 system. Combinations identified "P" for the transducers represents those previously cleared with LOGIQ P9 and LOGIQ P7 and *P for those cleared on another GE Ultrasound system and those identified and "N" are new. Please see section 11 Table 11.2.1 for information on previous clearance information on these transducers.
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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 letters are white, creating a contrast against the blue background.
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 | ||||||||||||
| Anatomy/Region of Interest | B | M | PW | |||||||||
| Doppler | CW | |||||||||||
| Doppler | Color | |||||||||||
| Doppler | Color M | |||||||||||
| Doppler | Power | |||||||||||
| Doppler | Combined | |||||||||||
| Modes* | Harmonic | |||||||||||
| Imaging | Coded | |||||||||||
| Pulse | Other | |||||||||||
| [Notes] | ||||||||||||
| Ophthalmic | ||||||||||||
| Fetal / Obstetrics[7] | P | P | P | P | P | P | P | P | P | P | 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 | 3,5,6,9 | |
| 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)
[9]Needle guidance with Pinpoint™ GT needle technology;
[*] 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' written in a stylized, cursive font. The letters are enclosed within a circular border. The logo is colored in blue, with the letters and the border in the same shade of blue.
Diagnostic Ultrasound Indications for Use Form
GE LOGIQ P9 and LOGIQ P7 with L12n-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | |||||||||||
| Anatomy/Region of Interest | B | M | PW Doppler | CW Doppler | Color Doppler | Color M Doppler | Power Doppler | Combined Modes | Harmonic Imaging | Coded Pulse | Other [Notes] |
| Ophthalmic | N | N | N | N | N | N | |||||
| Fetal / Obstetrics[7] | |||||||||||
| Abdominal[1] | N | N | N | N | N | N | |||||
| Pediatric | N | N | N | N | N | N | |||||
| Small Organ[2] | N | N | N | N | N | N | |||||
| Neonatal Cephalic | N | N | N | N | N | N | |||||
| Adult Cephalic | |||||||||||
| Cardiac Adult & Pediatric | |||||||||||
| Peripheral Vascular | N | N | N | N | N | N | |||||
| Musculo-skeletal Conventional | N | N | N | N | N | N | |||||
| Musculo-skeletal Superficial | N | N | N | N | N | N | [9] | ||||
| Other[4] | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal[8] | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperative[8] | 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)
[9]Needle guidance with Pinpoint™ GT needle technology;
[*] 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/6/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" written in a stylized script, enclosed within a blue circle. The letters are white, creating a contrast against the blue background. The logo is simple and recognizable, representing the company's brand identity.
GE LOGIQ P9 and LOGIQ P7 with P6D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | ||||||||||||
| Anatomy/Region of Interest | B | M | PW | |||||||||
| Doppler | CW | |||||||||||
| Doppler | Color | |||||||||||
| Doppler | Color M | |||||||||||
| Doppler | Power | |||||||||||
| Doppler | Combined | |||||||||||
| Modes* | Harmonic | |||||||||||
| Imaging | Coded | |||||||||||
| Pulse | Other | |||||||||||
| [Notes] | ||||||||||||
| Ophthalmic | ||||||||||||
| Fetal / Obstetrics[7] | ||||||||||||
| Abdominal[1] | ||||||||||||
| Pediatric | ||||||||||||
| Small Organ[2] | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | *P | *P | ||||||||||
| Cardiac Adult & Pediatric | *P | *P | ||||||||||
| Peripheral Vascular | *P | *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 in (K160182)
[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
[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" in a stylized font, enclosed within a circular frame. The frame has decorative swirls or flourishes around the letters. The logo is blue.
GE LOGIQ P9 and LOGIQ P7 with L4-12t-RS Transducer
| Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | ||||||||||||
| Anatomy/Region of Interest | B | M | PW Doppler | CW Doppler | Color Doppler | Color M Doppler | Power Doppler | Combined Modes | Harmonic Imaging | Coded Pulse | Other [Notes] | |
| Ophthalmic | ||||||||||||
| Fetal / Obstetrics[7] | ||||||||||||
| Abdominal[1] | ||||||||||||
| Pediatric | P | P | P | P | P | P | P | P | P | [3,6] | ||
| 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 |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA
[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
[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" intertwined in a stylized script, enclosed within a blue circle. The circle has decorative swirls around the perimeter, giving it a classic and recognizable appearance.
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:
| Clinical Application
Anatomy/Region of Interest | Mode of Operation | | | | | | | | | | Other
[Notes] |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|--------------------|---------------------|----------------|------------------|
| | B | M | PW
Doppler | CW
Doppler | Color
Doppler | Color M
Doppler | Power
Doppler | Combined
Modes* | Harmonic
Imaging | Coded
Pulse | |
| 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
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" in a stylized, cursive font, enclosed within a circular frame. The letters and the frame are both in a blue color. The logo is simple and recognizable, representing the brand identity of General Electric.
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:
| Clinical Application
Anatomy/Region of Interest | B | M | PW
Doppler | CW
Doppler | Color
Doppler | Color M
Doppler | Power
Doppler | Combined
Modes* | Harmonic
Imaging | Coded
Pulse | Other
[Notes] |
|----------------------------------------------------|---|---|---------------|---------------|------------------|--------------------|------------------|--------------------|---------------------|----------------|------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics[7] | | | | | | | | | | | |
| Abdominal[1] | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ[2] | P | P | P | | P | P | P | P | P | P | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac Adult & Pediatric | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | P | P | P | |
| 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] | P | P | P | | P | P | P | P | P | P | |
| 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)
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 blue circle. The circle has decorative swirls or flourishes around the perimeter, giving it a vintage or classic appearance. The logo is simple, recognizable, and represents the brand identity of General Electric.
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 | ||||||||||||
| Anatomy/Region of Interest | B | M | PW | |||||||||
| Doppler | CW | |||||||||||
| Doppler | Color | |||||||||||
| Doppler | Color M | |||||||||||
| Doppler | Power | |||||||||||
| Doppler | Combined | |||||||||||
| Modes* | Harmonic | |||||||||||
| Imaging | Coded | |||||||||||
| Pulse | Other | |||||||||||
| [Notes] | ||||||||||||
| Ophthalmic | ||||||||||||
| Fetal / Obstetrics[7] | P | P | P | P | P | P | P | P | P | [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
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 logo for General Electric (GE). The logo consists of the letters "GE" in a stylized script, enclosed within a blue circle. The circle has decorative swirls or flourishes around the perimeter, giving it a vintage or classic appearance.
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:
| Clinical Application
| Anatomy/Region of Interest | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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] | ||||||||||||
| 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 | ||||||||||||
| 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)
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 blue circle. The circle has decorative swirls or flourishes around the perimeter, giving it a vintage or classic appearance.
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 | |||||||||||
| Anatomy/Region of Interest | B | M | PW Doppler | CW Doppler | Color Doppler | Color M Doppler | Power Doppler | Combined Modes* | Harmonic Imaging | Coded Pulse | Other [Notes] |
| Ophthalmic | |||||||||||
| Fetal / Obstetrics[7] | P | P | P | P | P | P | P | P | P | [5,6] | |
| 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
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 "GE" in a stylized, cursive font, enclosed within a circular frame. The letters and the frame are both in a blue color. The logo is simple and recognizable, representing the brand identity of General Electric.
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:
| Clinical Application
Anatomy/Region of Interest | B | M | PW
Doppler | CW
Doppler | Color
Doppler | Color M
Doppler | Power
Doppler | Combined
Modes* | Harmonic
Imaging | Coded
Pulse | Other
[Notes] |
|----------------------------------------------------|---|---|---------------|---------------|------------------|--------------------|------------------|--------------------|---------------------|----------------|------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics[7] | | | | | | | | | | | |
| Abdominal[1] | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | P | P | 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
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)
14
Image /page/14/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 shape. The circle is light blue, and there are small white flourishes around the perimeter of the circle.
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 | ||||||||||||
| Anatomy/Region of Interest | B | M | PW Doppler | CW Doppler | Color Doppler | Color M Doppler | Power Doppler | Combined Modes* | Harmonic Imaging | Coded Pulse | Other [Notes] | |
| Ophthalmic | ||||||||||||
| Fetal / Obstetrics[7] | P | P | P | P | P | P | P | P | P | P | 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
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)
15
Image /page/15/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a blue circle. The letters are stylized and connected, giving the logo a distinctive and recognizable appearance. The blue color of the circle and letters provides a clean and professional look.
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 | |||||||||||
| Anatomy/Region of Interest | B | M | PW | ||||||||
| Doppler | CW | ||||||||||
| Doppler | Color | ||||||||||
| Doppler | Color M | ||||||||||
| Doppler | Power | ||||||||||
| Doppler | Combined | ||||||||||
| Modes* | Harmonic | ||||||||||
| Imaging | Coded | ||||||||||
| Pulse | Other | ||||||||||
| [Notes] | |||||||||||
| Ophthalmic | |||||||||||
| Fetal / Obstetrics[7] | P | P | P | P | P | P | P | P | P | P | 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
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)
16
Image /page/16/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' written in a stylized, cursive font. The letters are enclosed within a circular border. The logo is colored in blue, with the letters and the border in the same shade of blue.
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 | ||||||||||||
| 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] | 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
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)
17
Image /page/17/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a circular design with the letters "GE" intertwined in the center. The logo is blue and has a white outline.
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 | ||||||||||||
| Anatomy/Region of Interest | B | M | PW Doppler | CW Doppler | Color Doppler | Color M Doppler | Power Doppler | Combined Modes* | Harmonic Imaging | Coded Pulse | Other [Notes] | |
| Ophthalmic | ||||||||||||
| Fetal / Obstetrics[7] | ||||||||||||
| Abdominal[1] | ||||||||||||
| Pediatric | P | P | P | P | P | P | P | P | P | 3,5,6 | ||
| Small Organ[2] | P | P | P | P | P | P | P | P | P | 3,5,6 | ||
| 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] | ||||||||||||
| 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)
18
Image /page/18/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 border. The logo is colored in a light blue hue, which is consistent with the company's branding.
Diagnostic Ultrasound Indications for Use Form
GE LOGIQ P9 and LOGIQ P7 with E8C-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PW | ||||||||
| Doppler | CW | ||||||||||
| Doppler | Color | ||||||||||
| Doppler | Color M | ||||||||||
| Doppler | Power | ||||||||||
| Doppler | Combined | ||||||||||
| Modes | Harmonic | ||||||||||
| Imaging | Coded | ||||||||||
| Pulse | Other | ||||||||||
| [Notes] | |||||||||||
| Anatomy/Region of Interest | |||||||||||
| 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 | ||
| 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 | 3,5,6 | |
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal[8] | P | P | P | P | P | P | P | P | P | 3,5,6 | |
| Transvaginal | P | P | P | P | P | P | P | P | P | 3,5,6 | |
| Transuretheral | |||||||||||
| Intraoperative[8] | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA
[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 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)
19
Image /page/19/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 flourishes around its perimeter, giving it a classic and recognizable appearance. The logo is simple, yet distinctive, and is widely recognized as the symbol of the General Electric company.
Diagnostic Ultrasound Indications for Use Form
GE LOGIQ P9 and LOGIQ P7 with L8-18i-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | ||||||||||||
| Anatomy/Region of Interest | B | M | PW | |||||||||
| Doppler | CW | |||||||||||
| Doppler | Color | |||||||||||
| Doppler | Color M | |||||||||||
| Doppler | Power | |||||||||||
| Doppler | Combined | |||||||||||
| Modes* | Harmonic | |||||||||||
| Imaging | Coded | |||||||||||
| Pulse | Other | |||||||||||
| [Notes) | ||||||||||||
| Ophthalmic | ||||||||||||
| Fetal / Obstetrics[7] | ||||||||||||
| Abdominal[1] | ||||||||||||
| Pediatric | P | P | P | P | P | P | P | P | P | 5,6 | ||
| 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 | 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 |
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)
20
Image /page/20/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 letters are white, creating a contrast against the blue background of the circle.
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 | ||||||||||||
| 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] | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | P | P | ||||||||||
| Cardiac Adult & Pediatric | P | P | ||||||||||
| Peripheral Vascular | P | 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
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)
21
Image /page/21/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 blue circle. The circle has decorative swirls or flourishes around the perimeter, giving it a vintage or classic appearance.
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:
| Clinical Application
Anatomy/Region of Interest | Mode of Operation | | | | | | | | Other
[Notes] | | |
|----------------------------------------------------|-------------------|---|------------|------------|---------------|-----------------|---------------|-----------------|------------------|-------------|-----|
| | B | M | PW Doppler | CW Doppler | Color Doppler | Color M Doppler | Power Doppler | Combined Modes* | Harmonic Imaging | Coded Pulse | |
| 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
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)
22
Image /page/22/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a circular design with the letters "GE" intertwined in the center. The logo is blue and has a white outline.
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:
| Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | ||||||||||||
| Anatomy/Region of Interest | B | M | PW Doppler | CW Doppler | Color Doppler | Color M Doppler | Power Doppler | Combined Modes* | Harmonic Imaging | Coded Pulse | Other [Notes] | |
| Ophthalmic | ||||||||||||
| Fetal / Obstetrics[7] | ||||||||||||
| Abdominal[1] | P | P | P | P | P | P | P | P | P | P | 3,5,6 | |
| Pediatric | P | P | P | P | P | P | P | P | P | P | 3,5,6 | |
| Small Organ[2] | P | P | P | P | P | P | P | P | P | P | 3,5,6 | |
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Cardiac Adult & 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
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)
23
Image /page/23/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 circle. The logo is blue, and the background is white.
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 | ||||||||||||
| 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] | 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
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)
24
Image /page/24/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 shape. The circle is light blue, and there are small white flourishes around the perimeter of the circle.
GE LOGIQ P9 and LOGIQ P7 with 8C-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | |||||||||||
| Anatomy/Region of Interest | B | M | PW Doppler | CW Doppler | Color Doppler | Color M Doppler | Power Doppler | Combined Modes* | Harmonic Imaging | Coded Pulse | Other [Notes] |
| Ophthalmic | |||||||||||
| Fetal / Obstetrics[7] | |||||||||||
| Abdominal[1] | P | P | P | P | P | P | P | P | P | 5 | |
| Pediatric | P | P | P | P | P | P | P | P | P | 5 | |
| Small Organ[2] | P | P | P | P | P | P | P | P | P | 5 | |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | 5 | |
| 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
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 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)
25
Image /page/25/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 shape. The logo is colored in a light blue hue. The logo is simple and recognizable.
GE LOGIQ P9 and LOGIQ P7 with 3Sc-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | |||||||||||
| Anatomy/Region of Interest | B | M | PW | ||||||||
| Doppler | CW | ||||||||||
| Doppler | Color | ||||||||||
| Doppler | Color M | ||||||||||
| Doppler | Power | ||||||||||
| Doppler | Combined | ||||||||||
| Modes* | Harmonic | ||||||||||
| Imaging | Coded | ||||||||||
| Pulse | Other | ||||||||||
| [Notes] | |||||||||||
| Ophthalmic | |||||||||||
| Fetal / Obstetrics[7] | P | P | P | P | P | P | P | P | P | P | 5,6 |
| Abdominal[1] | P | P | P | P | P | P | P | P | P | P | 5,6 |
| Pediatric | P | P | P | P | P | P | P | P | P | P | 5,6 |
| Small Organ[2] | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | P | P | P | P | P | P | P | P | P | P | |
| Cardiac Adult & Pediatric | P | P | P | P | P | P | P | P | P | P | |
| Peripheral Vascular | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other[4] | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal[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 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)
26
Image /page/26/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 letters are white, creating a contrast against the blue background of the circle.
Diagnostic Ultrasound Indications for Use Form
GE LOGIQ P9 and LOGIQ P7 with 6S-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | ||||||||||||
| Anatomy/Region of Interest | B | M | PW Doppler | CW Doppler | Color Doppler | Color M Doppler | Power Doppler | Combined | ||||
| Modes* | Harmonic | |||||||||||
| Imaging | Coded | |||||||||||
| Pulse | Other | |||||||||||
| [Notes] | ||||||||||||
| Ophthalmic | ||||||||||||
| Fetal / Obstetrics[7] | ||||||||||||
| Abdominal[1] | ||||||||||||
| Pediatric | P | P | P | P | P | P | P | P | P | P | ||
| Small Organ[2] | ||||||||||||
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | P | ||
| Adult Cephalic | ||||||||||||
| Cardiac Adult & Pediatric | P | P | P | P | P | P | P | P | P | P | ||
| Peripheral Vascular | ||||||||||||
| Musculo-skeletal Conventional | ||||||||||||
| Musculo-skeletal Superficial | ||||||||||||
| Other[4] | ||||||||||||
| Exam Type, Means of Access | ||||||||||||
| Transesophageal | ||||||||||||
| Transrectal[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 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)
27
Image /page/27/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 blue circle. Three curved shapes surround the circle, giving the impression of movement or energy.
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | Dec 20, 2016 |
|---|---|
| Submitter: | GE Healthcare |
| 9900 Innovation Dr | |
| Wauwatosa, WI 53226 | |
| Primary Contact Person: | Bryan Behn |
| Regulatory Affairs Director | |
| GE Healthcare | |
| T:(414)721-4214 | |
| F:(414)918-8275 | |
| Secondary Contact Person: | Chan Sook Kim |
| Regulatory Affairs Leader | |
| GE Healthcare | |
| GE Ultrasound Korea, Ltd. | |
| T: +82 31 740 6307 | |
| Device: Trade Name: | LOGIQ P9 and LOGIQ P7 |
| Common/Usual Name: | LOGIQ P9 and LOGIQ P7 |
| Classification Names: | |
| Product Code: | Class II |
| Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-IYN | |
| Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO | |
| Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX | |
| Primary Predicate Device: | K161047 LOGIQ P9/P7 Diagnostic Ultrasound System |
| Reference Predicate | |
| Device(s): | K152758 Venue 50 Diagnostic Ultrasound System |
| K160182 LOGIQ S7 Expert Diagnostic Ultrasound System | |
| Device Description: | |
| Intended Use: | The LOGIQ P9 and LOGIQ P7 is a full featured, general purpose |
| diagnostic ultrasound system which consists of a mobile console | |
| approximately 53 cm wide, 69 cm deep and 157 cm high that | |
| provides digital acquisition, processing and display capability. | |
| The user interface includes a computer keyboard, specialized | |
| controls, 10.4-inch LCD touch screen and color 21.5-inch LCD | |
| image display. | |
| The device is intended for use by a qualified physician for | |
| ultrasound evaluation of Fetal; Abdominal; Pediatric; Small |
28
Image /page/28/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 border. The color of the logo is a light blue.
| 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). | |
|---|---|
| When Pinpoint™ GT Technology, from C.R. Bard, Inc., is included with the system, the Indications for Use include: Pinpoint GT Technology is intended to provide clinicians with visual tools for passive magnetic tracking of a needle with respect to ultrasound image data. | |
| Technology: | The LOGIQ P9 and LOGIQ P7 employs the same fundamental scientific technology as its predicate devices |
| Determination of | |
| Substantial Equivalence: | Comparison to Predicate Devices The LOGIQ P9 and P7 systems are substantially equivalent to the predicate devices with regard to intended use, imaging capabilities, technological characteristics and safety and effectiveness. The systems are all intended for diagnostic ultrasound imaging and fluid flow analysis. The LOGIQ P9/P7 and predicate LOGIQ P9/P7 systems have the same clinical intended uses. The LOGIQ P9/P7 and predicate LOGIQ P9/P7 systems have the same imaging modes. The LOGIQ P9/P7 and predicate LOGIQ P9/P7 systems transducers are identical except for the addition of 2 new transducers L12n-RS (similar to L12n-SC on predicate Venue50 K152758) and P6D (identical to LOGIQ S7 Expert K160182) The LOGIQ P9/P7 and predicate LOGIQ P9/P7 systems have the same indications for use The systems are manufactured with materials which have been evaluated and found to be safe for the intended use of the device. The systems have acoustic power levels which are below the applicable FDA limits. |
- The LOGIQ P9/P7 and predicate LOGIQ P9/P7 systems . have similar capability in terms of performing measurements, capturing digital images, reviewing and reporting studies.
- The LOGIQ P9/P7 and predicate LOGIQ P9/P7 systems .
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have been designed in compliance with approved electrical and physical safety standards.
- Migration of the Pinpoint GT Technology from C.R. ● Bard, which allows the user to track the needle location during interventional guidance. This technology is equivalent to that cleared by C.R. Bard, Inc. (previously cleared with Venue 50 K152758).
- o The LOGIO P9/P7 adds an scanning parameter of image rotation for 90° and 270° as a minor change to the 180° rotation already cleared.
Summary of Non-Clinical Tests:
The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic, and mechanical safety, and has been found to conform to applicable medical device safety standards. LOGIQ P9 and LOGIQ P7 and its applications comply with voluntary standards:
- AAMI/ANSI ES60601-1, Medical Electrical Equipment -● Part 1: General Requirements for Safety, 2005/C1:2012
- IEC60601-1-2, Medical Electrical Equipment - Part 1-2:General Requirements for Safety – Collateral Standard: Electromagnetic Compatibility Requirements and Tests 2007
- IEC60601-2-37, Medical Electrical Equipment - Part 2-37:Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment, 2007
- NEMA UD 3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment:2004
- ISO10993-1, Biological Evaluation of Medical Devices-● Part 1: Evaluation and Testing- Third Edition, 2009
- NEMA UD 2, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment:2004
- ISO14971, Application of risk management to medical devices: Second edition 2007
- NEMA PS 3.1 3.20 (2011), Digital Imaging and ●
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Communications in Medicine (DICOM) Set. (Radiology)
The following quality assurance measures are applied to the development of the system:
- Risk Analysis
- Requirements Reviews
- Design Reviews
- Testing on unit level (Module verification)
- Integration testing (System verification)
- o Performance testing (Verification)
- Safety testing (Verification)
Transducer materials and other patient contact materials are biocompatible.
Summary of Clinical Tests:
The subject of this premarket submission, LOGIO P9 and LOGIO P7, did not require clinical studies to support substantial equivalence.
- GE Healthcare considers the LOGIQ P9 and LOGIQ P7 to be as Conclusion: safe, as effective, and performance is substantially equivalent to the predicate device(s).