(41 days)
None
No
The document does not mention AI, ML, or related terms, and the device description focuses on standard ultrasound technology.
No
The provided text indicates the device is for "Diagnostic ultrasound imaging or fluid flow analysis," and explicitly states its purpose for "evaluation of Fetal/Obstetrics, Abdominal...". A therapeutic device would be used for treatment, not just evaluation or diagnosis.
Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body".
No
The device description explicitly states it consists of a "mobile console with keyboard, specialized controls, a color video LCD display with electronic array transducers," indicating it includes significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "ultrasound evaluation" and "Diagnostic ultrasound imaging or fluid flow analysis of the human body." This describes a device used to image the internal structures and functions of the body, not to perform tests on samples taken from the body (like blood, urine, or tissue).
- Device Description: The description details a "mobile console with keyboard, specialized controls, a color video LCD display with electronic array transducers." This is consistent with an ultrasound imaging system.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples, reagents, or any other components typically associated with in vitro diagnostic testing.
In vitro diagnostics are tests performed on samples taken from the human body to provide information about a person's health. This device is used for in vivo imaging and analysis of the body itself.
N/A
Intended Use / Indications for Use
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/Obstetrics, Abdominal (including GYN), Pediatric, Small Organ (including breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (adult and pediatric), Peripheral Vascular, Intraoperative (abdominal, thoracic and peripheral), Musculoskeletal Conventional, Urology (including prostate), Transrectal and Transvaginal.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Product codes
IYN, IYO, ITX
Device Description
The subject device consists of a mobile console with keyboard, specialized controls, a color video LCD display with electronicarray transducers. The proposed device is a console based device but predicated is a laptop based device. It is a Track 3 generalpurpose imaging and analysis system providing real-time digital acquisition, processing and display capability intended for general radiology imaging and evaluation with some cardiology and vascular applications.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal/Obstetrics, Abdominal (including GYN), Pediatric, Small Organ (including breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (adult and pediatric), Peripheral Vascular, Intraoperative (abdominal, thoracic and peripheral), Musculo-sketal Conventional, Urology (including prostate), Transrectal and Transvaginal.
Indicated Patient Age Range
Fetal, Neonatal, Pediatric, Adult
Intended User / Care Setting
Qualified physician / Not Found
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 subject of this premarket submission, LOGIQ P3, did not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The logo is black and white.
K112371 SEP 2 7 2011
GE Healthcare 510(k) Premarket Notification Submission
Section 5: 510(k) Summary
LOGIQ P3
1
Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The border has decorative swirls or flourishes at regular intervals around the circle.
SEP 2 7 2011 K112371
GE Healthcare 510(k) Premarket Notification Submission
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided: August 15, 2011 Date: GE Healthcare Submitter: 9900 Innovation Dr Wauwatosa, WI 53226 Bryan Behn Primary Contact Person: Regulatory Affairs Manager GE Healthcare T:(414)721-4214 F:(414)918-8275 TC Mohanmurthy Secondary Contact Person: Regulatory Affairs Leader GE Healthcare T: +91 80408 95020 LOGIQ P3 Ultrasound System Device: Trade Name: Common/Usual Name: LOGIO P3 Classification Names: Class II Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-IYN Product Code: Ultrasonic Pulsed Echo Imaging System. 21CFR 892.1560, 90-IYO Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX K102256 LOGIQ e Predicate Device(s): K102104 Vivid P3 The subject device consists of a mobile console with keyboard, Device Description: specialized controls, a color video LCD display with electronicarray transducers. The proposed device is a console based device but predicated is a laptop based device. It is a Track 3 generalpurpose imaging and analysis system providing real-time digital acquisition, processing and display capability intended for general radiology imaging and evaluation with some cardiology and vascular applications. The device is intended for use by a qualified physician for
Intended Use: ultrasound evaluation of Fetal/Obstetrics. Abdominal (including GYN). Pediatric, Small Organ (including breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (adult and pediatric),
2
Image /page/2/Picture/0 description: The image shows the General Electric (GE) logo, which consists of the letters 'GE' intertwined within a circular frame. The letters are stylized with curved lines, giving them a flowing appearance. The circular frame has decorative elements resembling swirls or stylized leaves at four points around its circumference. The logo is presented in black and white, with the letters and frame in black against a white background.
Peripheral Vascular, Intraoperative (abdominal, thoracic and peripheral), Musculo-sketal Conventional, Urology (including prostate), Transrectal and Transvaginal.
The LOGIQ P3 employs the same fundamental scientific Technology: technology as its predicate devices
Determination of Substantial Equivalence:
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. LOGIO P3 and its applications comply with voluntary standards as detailed in Section 9, 11 and 17 of this premarket submission. The following quality assurance measures were applied to the development of the system:
- Risk Analysis ●
- . Requirements Reviews
- . Design Reviews
- . Testing on unit level (Module verification)
- . Integration testing (System verification)
- Final Acceptance Testing (Validation) .
- 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, LOGIQ P3, did not require clinical studies to support substantial equivalence.
- GE Healthcare considers the LOGIQ P3 to be as safe, as Conclusion: effective, and performance is substantially equivalent to the predicate device(s).
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol of medicine, with three figures in profile forming the staff. The text "U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circle around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Mr. Brvan Behn Regulatory Affairs Manager GE Healtheare 9900 W. Innovations Dr WAUWATOSA WI 53226
SEP 27 2011
Re: K112371
Trade/Device Name: GE LOGIQ P3 Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: TYN, IYO. and ITX Dated: August 15, 2011 Received: August 17, 2011
Dear Mr. Behn:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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 Mav 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). 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.
This determination of substantial equivalence applies to the following transducers intended for use with the GE LOGIQ P3 Ultrasound System, as described in your premarket notification:
Transducer Model Number
| 4C | 3S |
|---|---|
| E8C | 8C |
| E8Cs | T739 |
| 5Cs | 6S |
| 8L | 3.8CA |
| 11L | 7.5LA |
4
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. In addition, FDA may publish further announcements concerning vour 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/Safetv/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
If you have any questions regarding the content of this letter, please contact Shahram Vaezy at (301) 796-6242.
Sincerely Yours.
Mary S. Postet
Mary S. Pastel. Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure(s)
5
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510(k) Number (if known):
Device Name: LOGIQ P3
Indications for Use:
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/Obstetrics, Abdominal (including GYN), Pediatric, Small Organ (including breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (adult and pediatric), Peripheral Vascular, Intraoperative (abdominal, thoracic and peripheral), Musculoskeletal Conventional, Urology (including prostate), Transrectal and Transvaginal.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use NA (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mary S Postol
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Number
Number K112371
6
Image /page/6/Picture/0 description: The image shows a black and white logo of General Electric (GE). The logo consists of the letters 'GE' intertwined within a circular border. The image quality is somewhat degraded, with some pixelation and artifacts visible, particularly around the edges of the logo.
Diagnostic Ultrasound Indications for Use Form GE LOGIQ P3 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 | N | N | N | N | N | N | N | N | N | ||
| Abdominal[1] | N | N | N | N | N | N | N | N | N | ||
| Pediatric | |||||||||||
| N | N | N | N | N | N | N | N | N | |||
| Small Organ[2] | |||||||||||
| N | N | N | N | N | N | N | N | ||||
| Neonatal Cephalic | N | N | N | N | N | N | N | N | N | ||
| Adult Cephalic | N | N | N | N | N | N | N | N | N | ||
| Cardiac[3] | N | N | N | N | N | N | N | N | N | ||
| Peripheral Vascular | N | N | N | N | N | N | N | N | |||
| Musculo-skeletal Conventional | N | N | N | N | N | N | N | N | |||
| Musculo-skeletal Superficial | |||||||||||
| Other[4] | N | N | N | N | N | N | N | N | |||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | 1 | ||||||||||
| Transrectal | N | N | N | N | N | N | N | ||||
| Transvaginal | N | N | N | N | N | N | N | ||||
| Transuretheral | |||||||||||
| Intraoperative[5] | N | N | N | N | N | N | N | N | |||
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic | -4 |
N = new indication; P = previously cleared by FDA
Notes: [1] Abdominal includes renal, GYN/Pelvic
. [2] Small organ includes breast, testes, thyroid.
[3] Cardiac is Adult and Pediatric.
[4] Other use includes Urology/Prostate
[5] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).
[*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD.
"] Coded Pulse is for digitally encoded harmonics and B-flow.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Prescription User (Per 21 CFR 801.109)
Mary Slatel
(Division Sign-Off)
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
18
510K
7
Image /page/7/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "G" and "E" intertwined within a circular border. The logo is in black and white.
Diagnostic Ultrasound Indications for Use Form GE LOGIQ P3 with 4C Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PW | CW | Color | Color M | Power | Combined | Harmonic | Coded | Other |
| Anatomy/Region of Interest | Doppler | Doppler | Doppler | Doppler | Doppler | Modes | Imaging | Pulse | [Notes) | ||
| Ophthalmic | |||||||||||
| Fetal / Obstetrics | P | P | P | P | P | P | P | P | |||
| Abdominal[1] | P | P | P | P | P | P | P | P | |||
| Pediatric | P | P | P | P | P | P | P | P | |||
| Small Organ(2) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac [3] | |||||||||||
| Peripheral Vascular | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other[4] | P | P | P | P | P | P | P | P | |||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperative | |||||||||||
| 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, thyroid.
[3] Cardiac is Adult and Pediatric.
[4] Other use includes Urology/Prostate
[*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD.
["] Coded Pulse is for digitally encoded harmonics and B-flow.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mary Patel
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Division Office Evaluation and Safety
510K K112321
8
Image /page/8/Picture/0 description: The image shows a logo of the General Electric (GE) company. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The logo is in black and white and has a vintage look.
Diagnostic Ultrasound Indications for Use Form GE LOGIQ P3 with E8C 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 | P | P | P | P | P | P | P | ||||
| Abdominal[1] | P | P | P | P | P | P | P | ||||
| Pediatric | |||||||||||
| Small Organ[2] | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac[3] | - | ||||||||||
| Peripheral Vascular | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other[4] | P | P | P | P | P | P | P | ||||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | P | P | P | P | P | P | P | ||||
| Transvaginal | P | P | P | P | P | P | P | ||||
| Transuretheral | |||||||||||
| Intraoperative | |||||||||||
| 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
Notes: [1] Abdominal includes renal, GYN/Pelvic
[2] Small organ includes breast, testes, thyroid.
[3] Cardiac is Adult and Pediatric.
[4] Other use includes Urology/Prostate
[*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD.
*] Coded Pulse is for digitally encoded harmonics and B-flow.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Prescription User (Per 21 CFR 801.109)
Mary Patel
(Division Sign-Off)
(Division of Radiological Devices Division of Aadiological Device Evaluation and Safety
Office of In Vitro Diag.
510K. K112371
20
9
Image /page/9/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The logo is black and white and has a vintage look.
Diagnostic Ultrasound Indications for Use Form GE LOGIQ P3 with E8Cs 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 | P | P | P | P | P | P | P | ||||
| Abdominal[1] | P | P | P | P | P | P | P | ||||
| Pediatric | |||||||||||
| Small Organ[2] | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac[3] | |||||||||||
| Peripheral Vascular | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other[4] | P | P | P | P | P | P | P | ||||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | P | P | P | P | P | P | P | ||||
| Transvaginal | P | P | P | P | P | P | P | ||||
| Transuretheral | |||||||||||
| Intraoperative | |||||||||||
| 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
Notes: [1] Abdominal includes renal, GYN/Pelvic
[2] Small organ includes breast, testes, thyroid.
[3] Cardiac is Adult and Pediatric.
[4] Other use includes Urology/Prostate
[*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD.
Coded Pulse is for digitally encoded harmonics and B-flow.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mary S Patel
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K112371
10
Image /page/10/Picture/0 description: The image shows a logo of the company General Electric (GE). The logo is a circular shape with the letters "GE" in the center. The letters are stylized and intertwined. The logo is black and white.
Diagnostic Ultrasound Indications for Use Form GE LOGIQ P3 with 5Cs 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 | P | P | P | P | P | P | P | P | |||
| Abdominal[1] | P | P | P | P | P | P | P | P | |||
| Pediatric | P | P | P | P | P | P | P | P | |||
| Small Organ[2] | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac[3] | |||||||||||
| Peripheral Vascular | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other[4] | P | P | P | P | P | P | P | P | |||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperative | |||||||||||
| 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, thyroid.
[3] Cardiac is Adult and Pediatric.
[4] Other use includes Urology/Prostate
*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD.
Coded Pulse is for digitally encoded harmonics and B-flow.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Maisy Powell
on Sign-Offi (Divis Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K. K112371
11
Image /page/11/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, circular design. The logo is black and white and has a vintage look.
Diagnostic Ultrasound Indications for Use Form GE LOGIQ P3 with 8L 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 | |||||||||||
| Abdominal[1] | P | P | P | P | P | P | P | P | P | ||
| Pediatric | P | P | P | P | P | P | P | P | P | ||
| Small Organ[2] | P | P | P | P | P | P | P | P | P | ||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac[3] | |||||||||||
| 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 | |||||||||||
| Other[4] | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperative[5] | 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, thyroid.
[3] Cardiac is Adult and Pediatric.
[4] Other use includes Urology/Prostate ·
[5] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).
[*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD.
'] Coded Pulse is for digitally encoded harmonics and B-flow.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
23
Mura Stow
Division of Radiological Device: Office of In Vitro Diagnostic Device Evaluation and Safety
510K. K112321
12
Image /page/12/Picture/0 description: The image shows a vintage logo of General Electric (GE). The logo consists of the letters 'G' and 'E' intertwined in a stylized, circular design. The letters are rendered in a cursive font, and the entire logo is enclosed within a textured circle, giving it a classic and recognizable appearance.
Diagnostic Ultrasound Indications for Use Form GE LOGIQ P3 with 11L 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 | |||||||||||
| Abdominal(1) | P | P | P | P | P | P | P | P | |||
| Pediatric | P | P | P | P | P | P | P | P | |||
| Small Organ[2] | P | P | P | P | P | P | P | P | |||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac[3] | |||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | P | |||
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P | |||
| Musculo-skeletal Superficial | |||||||||||
| Other[4] | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperative | 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
ﺮﮐﻠﯿﻨﮉ ﮈﺍﺋ
[2] Small organ includes breast, testes, thyroid.
[3] Cardiac is Adult and Pediatric.
[4] Other use includes Urology/Prostate
[*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD.
'] Coded Pulse is for digitally encoded harmonics and B-flow.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Prescription User (Per 21 CFR 801.109)
Mary Spader
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K//237/
24
13
Image /page/13/Picture/0 description: The image shows the General Electric (GE) logo, which consists of the letters 'G' and 'E' intertwined within a circular border. The letters are stylized with curved lines and loops, creating a distinctive and recognizable design. The logo is presented in black and white, with the letters and border appearing in black against a white background.
Diagnostic Ultrasound Indications for Use Form GE LOGIQ P3 with 3S 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 | |||||||||||
| Abdominal[1] | P | P | P | P | P | P | P | P | P | ||
| Pediatric | P | P | P | P | P | P | P | P | P | ||
| Small Organ[2] | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | P | P | P | P | P | P | P | P | P | ||
| Cardiac[3] | P | P | P | P | P | P | P | P | P | ||
| Peripheral Vascular | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other[4] | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperative | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic |
くなり
N = new indication; P = previously cleared by FDA
Notes: [1] Abdominal includes renal, GYN/Pelvic
[2] Small organ includes breast, testes, thyroid.
[3] Cardiac is Adult and Pediatric.
[4] Other use includes Urology/Prostate
*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD.
] Coded Pulse is for digitally encoded harmonics and B-flow.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Prescription User (Per 21 CFR 801.109)
Mary Patel
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K
14
Image /page/14/Picture/0 description: The image shows a black and white logo. The logo is circular and contains the letters 'GE' in a stylized, intertwined font. The letters are surrounded by a circular border, giving the logo a classic and recognizable appearance.
Diagnostic Ultrasound Indications for Use Form GE LOGIQ P3 with 8C 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 | |||||||||||
| Abdominal(1) | P | P | P | P | P | P | P | P | P | ||
| Pediatric | P | P | P | P | P | P | P | P | P | ||
| 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[3] | |||||||||||
| Peripheral Vascular | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other(4) | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperative | |||||||||||
| 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, thyroid.
[3] Cardiac is Adult and Pediatric.
[4] Other use includes Urology/Prostate
[*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD.
[*] Coded Pulse is for digitally encoded harmonics and B-flow.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Prescription User (Per 21 CFR 801.109)
Mury S. Paster
(Division Sign Off)
- 2011 - 12:44
Division of Reddiological D Office of In Vitro Diagnostic Device Evaluation and Safety
510K K112371
15
Image /page/15/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a circular design. The logo is black and white and has a vintage look.
Diagnostic Ultrasound Indications for Use Form GE LOGIQ P3 with T739 Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PW | CW | Color | Color M | Power | Combined | Harmonic | Coded | Other |
| Anatomy/Region of Interest | Doppler | Doppler | Doppler | Doppler | Doppler | Modes | Imaging | Pulse | [Notes] | ||
| Ophthalmic | |||||||||||
| Fetal / Obstetrics | |||||||||||
| Abdominal[1] | |||||||||||
| Pediatric | |||||||||||
| Small Organ(2) | P | P | P | P | P | P | P | P | P | ||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac[3] | |||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | P | |||
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P | |||
| Musculo-skeletal Superficial | |||||||||||
| Other(4) | |||||||||||
| Exam Type. Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperative(5) | 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, thyroid.
[3] Cardiac is Adult and Pediatric.
[4] Other use includes Urology/Prostate
[5] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).
[*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD.
"] Coded Pulse is for digitally encoded harmonics and B-flow.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Murs. S. Patel
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K112371
16
Image /page/16/Picture/0 description: The image shows a black and white logo of General Electric (GE). The logo consists of the letters "GE" intertwined in a circular design. The letters are stylized with curved lines and flourishes, giving them a vintage or classic appearance. The logo is surrounded by a textured or patterned border, adding to its overall visual appeal.
Diagnostic Ultrasound Indications for Use Form GE LOGIQ P3 with 6S 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 | |||||||||||
| Abdominal[1] | P | P | P | P | P | P | P | P | P | P | |
| Pediatric | P | P | P | P | P | P | P | P | P | P | |
| Small Organ[2] | |||||||||||
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | P | |
| Adult Cephalic | P | P | P | P | P | P | P | P | P | P | |
| Cardiac[3] | P | P | P | P | P | P | P | P | P | P | |
| Peripheral Vascular | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other[4] | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperative | |||||||||||
| 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, thyroid.
[3] Cardiac is Adult and Pediatric.
[4] Other use includes Urology/Prostate
*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD.
Coded Pulse is for digitally encoded harmonics and B-flow.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Prescription User (Per 21 CFR 801.109)
Mary S. Patel
(Division Sign-Off Division of Radiological Devices Office of In ce Evaluation and Safety
28
210K
17
Image /page/17/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "G" and "E" intertwined within a circular border. The logo is in black and white and has a vintage look.
Diagnostic Ultrasound Indications for Use Form GE LOGIQ P3 with 3.8CA Transducer
Mode of Operation Clinical Application pw CW Color Color M Power Combined Harmonic Coded Other B M Doppler Doppler Doppler Doppler Doppler Modes Imaging Pulse [Notes) Anatomy/Region of Interest Ophthalmic Fetal / Obstetrics N N N N N N N N Abdominal[1] N N N N N N N N Pediatric N N N N N N N N Small Organ(21 . Neonatal Cephalic Adult Cephalic Cardiac[J] Peripheral Vascular Musculo-skeletal Conventional Musculo-skeletal Superficial Other(4) N N N N N N N N Exam Type, Means of Access Transesophageal Transrectal Transvaginal Transuretheral Intraoperative Intraoperative Neurological Intravascular Laparoscopic
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Laparoscopic
N = new indication; P = previously cleared by FDA
Notes: [1] Abdominal includes renal, GYN/Pelvic
[2] Small organ includes breast, testes, thyroid.
[3] Cardiac is Adult and Pediatric.
[4] Other use includes Urology/Prostate
[*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD.
"] Coded Pulse is for digitally encoded harmonics and B-flow.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mace S. Padell
(Division Sign-Off)
Division of Radiological Devices Office of In fitro Diagnostic Device Evaluation and Safety
18
Image /page/18/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The logo is in black and white and appears to be a slightly pixelated or low-resolution image.
Diagnostic Ultrasound Indications for Use Form GE LOGIQ P3 with 7.5LA 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 | |||||||||||
| Abdominal[1] | N | N | N | N | N | N | N | N | |||
| Pediatric | N | N | N | N | N | N | N | N | |||
| Small Organ[2] | N | N | N | N | N | N | N | N | |||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac[3] | |||||||||||
| Peripheral Vascular | N | N | N | N | N | N | N | N | |||
| Musculo-skeletal Conventional | N | N | N | N | N | N | N | N | |||
| Musculo-skeletal Superficial | |||||||||||
| Other[4] | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperative | N | N | N | N | N | N | N | N | |||
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA
Notes: [1] Abdominal includes renal, GYN/Pelvic
[2] Small organ includes breast, testes, thyroid.
[3] Cardiac is Adult and Pediatric.
[4] Other use includes Urology/Prostate
[*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD.
["] Coded Pulse is for digitally encoded harmonics and B-flow.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Prescription User (Per 21 CFR 801.109)
Mary Stotts
(Division Siar Divisi on of Rediological D Office of In Vitro D stic Dos Evaluation and Safety
30
SIOK