GE LOGIQ P5 MODEL H44662LD
Device Facts
| Record ID | K101878 |
|---|---|
| Device Name | GE LOGIQ P5 MODEL H44662LD |
| Applicant | GE Healthcare |
| Product Code | IYN · Radiology |
| Decision Date | Aug 31, 2010 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal; Abdominal (renal & GYN/pelvic); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal (TE); Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, vascular and neuro).
Device Story
Mobile ultrasound console with keyboard, specialized controls, and color LCD display; utilizes electronic-array transducers to acquire, process, and display real-time digital ultrasound images. Operates as a Track 3 general-purpose imaging and analysis system. Used by clinicians in radiology, cardiology, and vascular settings. Inputs include acoustic signals from transducers; system performs digital signal processing to generate B-mode, M-mode, Doppler (PW, CW, Color, Power), harmonic imaging, and 4D/real-time 3D outputs. Healthcare providers view images on the integrated display to evaluate anatomy and blood flow, supporting clinical decision-making for diagnosis and monitoring. Benefits include non-invasive visualization of internal structures and hemodynamics.
Clinical Evidence
Bench testing only. Device evaluated for acoustic output, biocompatibility, cleaning/disinfection effectiveness, and thermal, electrical, electromagnetic, and mechanical safety. Conforms to applicable medical device safety standards.
Technological Characteristics
Mobile console with color LCD display and electronic-array transducers. Supports B, M, PW/CW/Color/Power Doppler, harmonic imaging, coded pulse, and 4D/real-time 3D modes. Includes elastography imaging. Biocompatible patient-contact materials. Complies with voluntary safety standards for medical ultrasound systems.
Indications for Use
Indicated for diagnostic ultrasound imaging or fluid flow analysis in fetal, abdominal, pediatric, small organ, neonatal/adult cephalic, cardiac, peripheral vascular, musculoskeletal, urological, transesophageal, transrectal, transvaginal, and intraoperative applications.
Regulatory Classification
Identification
An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Predicate Devices
- LOGIQ P5/A5 Ultrasound System (K060993)
- LOGIQ E9 Ultrasound System (K092271)
Reference Devices
- LOGIQ 9 (K030934)
- LOGIQ 9 (K061129)
Related Devices
- K120741 — VOLUSON S6, VOLUSON S8 · GE Healthcare · Apr 27, 2012
- K221117 — RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound System · Samsung Medison Co., Ltd. · Jun 17, 2022
- K233697 — SonoMax Series Digital Color Doppler Ultrasound System · CHISON Medical Technologies Co., Ltd. · Aug 9, 2024
- K152164 — S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound System · Sonoscape Medical Corp. · Aug 28, 2015
- K101874 — GE LOGIQ P6/P6 PRO · GE Healthcare · Oct 5, 2010
Submission Summary (Full Text)
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K101878
.
:
Addi 31 2010
Section 5: 510(k) Summary
LOGIQ P5 BT11
Image /page/0/Picture/5 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The letters are stylized and connected in a flowing, cursive-like manner.
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Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circular shape. The letters are stylized and connected, giving the logo a distinctive and recognizable appearance. The logo is in black and white.
K101878
AUG 3 1 2010
## GE Healthcare
510(k) Premarket Notification Submission
#### 510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
July 1, 2010 Date:
Submitter: GE Healthcare [GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC] 9900 Innovation Dr Wauwatosa, WI 53226
Primary Contact Person:
## Bryan Behn Regulatory Affairs Manager
GE Healthcare, GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC.] T:(414)721-4214 F:(414)918-8275
Secondary Contact Person:
### Jim Turner
Regulatory Affairs Manager America's Service GE Healthcare, GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC
T:(262) 544-3359
F:(414)908-9225
Trade Name: LOGIQ P5 BT11 Ultrasound System
Device:
Common/Usual Name: LOGIQ P5 BT11
Classification Names: Class II
Product Code:
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
Predicate Device(s): K060993 LOGIQ P5/A5 Ultrasound System
K092271 LOGIO E9 Ultrasound System
The subject device consists of a mobile console with keyboard. Device Description: specialized controls, a color video LCD display with electronicarray transducers. It has the same general appearance, dimensions and weight as the unmodified 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 a general-purpose ultrasound system. Specific Intended Use: clinical applications and exam types include: Fetal; Abdominal
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Image /page/2/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and surrounded by a circular pattern. The logo is black and white and appears to be a vintage or older version of the GE logo.
(renal & GYN/pelvic); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal (TE); Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, vascular and neuro.
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Image /page/3/Picture/0 description: The image shows the text "GE Healthcare". The text is in a sans-serif font and is black. The background is white.
510(k) Premarket Notification Submission
### Technology:
Determination of Substantial Equivalence:
### The LOGIQ P5 BT11 employs the same fundamental scientific technology as its predicate devices.
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 with applicable medical device safety standards. The LOGIQ P5 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 P5, did not require clinical studies to support substantial equivalence.
Conclusion:
GE Healthcare considers the LOGIQ P5 to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).
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# DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Bryan Behn Regulatory Affairs Manager GE Healthcare 9900 Innovation Dr. WAUWATOSA WI 53226
AUG 3 1 2010
Re: K101878
Trade/Device Name: LOGIQ P5 BT11 Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: July 26, 2010 Received: July 27, 2010
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 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). 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 LOGIQ P5 BT11 Ultrasound System, as described in your premarket notification:
Transducer Model Number
| i12L |
|-------|
| BE9CS |
| 3CRF |
| 3Sp |
| 5Sp |
| 4D8C |
| 11L |
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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 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); 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.
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.htm 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/Safety/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 Lauren Hefner at (301) 796-6881.
Sincerely yours,
Donald St. Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure(s)
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Image /page/6/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The letters are enclosed within a circular border. The logo is black and white.
AUG 31
2010
510(k) Number (if known):
Device Name: LOGIQ P5 BT11
Indications for Use:
The device is a general-purpose ultrasound system. Specific clinical applications and exam types include: Fetal; Abdominal (renal & GYN/pelvic); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal (TE); Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, vascular and neuro).
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use NA (Part 21 CFR 801 Subpart C)
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Concurrence of CDRH, Office of Besiee
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Sat
510K K101878
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Image /page/7/Picture/0 description: The image shows a logo with the letters 'GE' intertwined within a circular border. The letters are stylized and connected, creating a monogram-like design. The logo appears to be a vintage or older version, as indicated by the slightly distressed or aged texture of the image. The overall impression is that of a classic brand emblem.
### Diagnostic Ultrasound Indications for Use Form
### GE LOGIQ P5 Uitrasound System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | | | | | |
|----------------------------------|---|-------------------|---------------|---------------|------------------|--------------------|------------------|--------------------|---------------------|----------------|-------------|--|
| Anatomy/Region of<br>Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes' | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>** | |
| Ophthalmic | P | P | P | P | P | P | P | P | P | P | P | |
| Fetal / Obstetrics | P | P | P | P | P | P | P | P | P | P | P | |
| Abdominal[1] | P | P | P | P | P | P | P | P | P | P | P,[6] | |
| Pediatric | P | P | P | P | P | P | P | P | P | P | P,[6] | |
| Small Organ[2] | P | P | P | P | P | P | P | P | P | P | [6] | |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | P | P | |
| Adult Cephalic | P | P | P | P | P | P | P | P | P | P | P | |
| Cardiac[3] | P | P | P | P | P | P | P | P | P | P | | |
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | P | [6] | |
| Musculo-skeletal<br>Conventional | P | P | P | P | P | P | P | P | P | P | [6] | |
| Musculo-skeletal<br>Superficial | P | P | P | P | P | P | P | P | P | P | [6] | |
| Other[4] | P | P | P | P | P | P | P | P | P | P | P | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transesophageal | P | P | P | P | P | P | P | P | P | P | | |
| Transrectal | P | P | P | | P | | P | P | P | P | | |
| Transvaginal | P | P | P | | P | | P | P | P | P | | |
| Transuretheral | | | | | | | | | | | | |
| Intraoperative[5] | P | P | P | | P | P | P | P | P | P | [6] | |
| Intraoperative<br>Neurological | P | P | P | | P | P | P | P | P | P | [6] | |
| Intravascular | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
[1] Abdominal includes renal, GYN/Pelvic Notes:
[2] Small organ includes breast, testes, and thyroid.
[3] Cardiac is Adult and Pediatric.
[4] Other use includes Urology/Prostate
[5] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).
[6] Elastography Imaging
[1] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
[**] Other mode is 4D / Realtime 3D
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17
Concurrence of CDRH, Office of Device-Evaluation (GBC)
Prescription User (Per 21 CFR 801.109)
uation(BSE) OIVID
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K101878
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Image /page/8/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 logo is depicted in black and white, with the letters and border appearing in black against a white background. The design has a vintage or classic feel due to its style and the slightly distressed appearance of the image.
## Diagnostic Ultrasound Indications for Use Form GE LOGIQ P6 with i12L Transducer
the time and place of trial.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | | |
|----------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|--------------------|---------------------|----------------|-------------|
| Anatomy/Region of<br>Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>** |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | |
| Abdominal[1] | | | | | | | | | | | |
| 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<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Other[4] | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative[5] | P | P | P | | P | P | P | P | P | P | |
| Intraoperative<br>Neurological | E | E | E | | E | E | E | E | E | E | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA (Logig 9 K030934); E = added under Appendix E
Notes: [1] Abdominal includes renal, GYN/Pelvic
[2] Small organ includes breast, testes, and thyroid.
[3] Cardiac is Adult and Pediatric.
[4] Other use includes Urology/Prostate
[5] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).
[1] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
[**] Other mode is 4D / Realtime 3D
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Concurrence of CDRH, Office of Device Exatuation (900) OLD VO
510K
Prescription User (Per 21 CFR 801.109)
AZVP
18
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
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Image /page/9/Picture/0 description: The image shows a logo with the letters 'GE' intertwined in a circular design. The letters are stylized and connected, creating a monogram-like appearance. The logo is black and white, with the letters and the outline of the circle appearing in black against a white background.
# Diagnostic Ultrasound Indications for Use Form
### GE LOGIQ P6 with BE9CS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | | | | |
|----------------------------------|---|-------------------|---------------|---------------|------------------|--------------------|------------------|-----------------------------|---------------------|----------------|-------------|
| Anatomy/Region of<br>Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined Harmonic<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>** |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | |
| Abdominal[1] | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ[2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[3] | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Other[4] | E | E | E | | E | E | E | E | E | E | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | E | E | E | | E | E | E | E | E | E | |
| Transvaginal | E | E | E | | E | E | E | E | E | E | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative[5] | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E(Minor modification to BE9C)
[1] Abdominal includes renal, GYN/Pelvic Notes:
[2] Small organ includes breast, testes, and 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 8/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
[**] Other mode is 4D / Realtime 3D
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Concurrence of CDRH, Office of Bevios Evatuation (005) C
. .
510K
Prescription User (Per 21 CFR 801.109)
19
(Division Sign-Off) Division of Radiological Devices Office of in Vitro Diagnostic Device Evaluatio
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Image /page/10/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circle. The letters are stylized with curved lines, giving the logo a classic and recognizable appearance.
## Diagnostic Ultrasound Indications for Use Form GE LOGIQ P6 with 3CRF Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | | | | | |
|----------------------------------|---|-------------------|---------------|---------------|------------------|--------------------|------------------|--------------------|---------------------|----------------|-------------|--|
| Anatomy/Region of<br>Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>** | |
| Ophthalmic | | P | P | | P | | P | | P | P | | |
| Fetal / Obstetrics | P | P | P | | P | P | P | P | P | P | | |
| Abdominal[1] | P | P | P | | P | P | P | P | P | P | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ(2) | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiacia | | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | | |
| Otherf4 | P | P | P | | P | P | P | P | P | P | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | | |
| Intraoperativel5) | | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA(LOGIQ E9 K092271); E = added under Appendix E
[1] Abdominal includes renal, GYN/Pelvic Notes:
[2] Small organ includes breast, testes, and 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/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
[**] Other mode is 4D / Realtime 3D
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Seviga Evaluation (ADE) OI
、・
510K
Prescription User (Per 21 CFR 801.109)
20
(Division Sign-OM) Division of Radiological Devices Vitro Diagnostic Device Evaluation and Safety Office of In
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Image /page/11/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 letters are stylized with curved lines and flourishes, giving the logo a classic and recognizable appearance.
### Diagnostic Ultrasound Indications for Use Form
### GE LOGIQ P6 with 3Sp Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | | | | | |
|----------------------------------|---|-------------------|---------------|---------------|------------------|--------------------|------------------|-----------------------------|---------------------|----------------|-------------|--|
| Anatomy/Region of<br>Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined Harmonic<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>** | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | | |
| Abdominal[1] | E | E | E | E | E | E | E | E | E | E | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ[2] | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | E | E | E | E | E | E | E | E | E | E | | |
| Cardiac[3] | E | E | E | E | E | E | E | E | E | E | | |
| Peripheral Vascular | | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | | |
| Other[4] | | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | | |
| Intraoperative[5] | | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| I anamennin | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [1] Abdominal includes renal, GYN/Pelvic
[2] Small organ includes breast, testes, and thyroid.
[3] Cardiac is Adult and Pediatric.
[4] Other use includes Urology/Prostate
[5] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).
[1] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
[**] Other mode is 4D / Realtime 3D
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IE NEEDEDI
Concurrence of CDRH, Office of Begines Pratmation (0BB
Prescription User (Per 21 CFR 801.109) ﺮ ﺍﻟﻤﺪﻳﻨﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K
{12}------------------------------------------------
Image /page/12/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circular border. The letters are stylized and connected, creating a distinctive and recognizable emblem for the company.
## Diagnostic Ultrasound Indications for Use Form
### GE LOGIQ P6 with 5Sp Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | | |
|----------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|--------------------|---------------------|----------------|-------------|
| Anatomy/Region of<br>Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes' | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>** |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | |
| Abdominal[1] | | | | | | | | | | | |
| Pediatric | E | E | E | E | E | E | E | E | E | E | |
| Small Organ[2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | E | E | E | E | E | E | E | E | E | E | |
| Cardiac[3] | E | E | E | E | E | E | E | E | E | E | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Other[4] | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative[5] | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [1] Abdominal includes renal, GYN/Pelvic
[2] Small organ includes breast, testes, and thyroid.
[3] 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/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
[**] Other mode is 4D / Realtime 3D
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Bowice Examation (0)B
Prescription User (Per 21 CFR 801.109)
OIC
(Division Sign-Off)
510K
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
{13}------------------------------------------------
Image /page/13/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circular border. The letters are stylized and appear to be hand-drawn or calligraphic. The logo is black and white, with the letters and border in black and the background in white.
## Diagnostic Ultrasound Indications for Use Form GE LOGIQ P6 with 4D8C Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | | |
|----------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-----------------------------|---------|----------------|-------------|
| Anatomy/Region of<br>Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined Harmonic<br>Modes* | Imaging | Coded<br>Pulse | Other<br>** |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | |
| Abdominal[1] | | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | P | P | P | P |
| Small Organ[2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[3] | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Other[4] | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative[5] | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA (LOGIQ 9 K061129); E = added under Appendix E
[1] Abdominal includes renal, GYN/Pelvic Notes:
[2] Small organ includes breast, testes, and thyroid.
[3] Cardiac is Adult and Pediatric.
[4] Other use includes Urology/Prostate
[5] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).
[1] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
[**] Other mode is 4D / Realtime 3D
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, GME of Desice Bruitiation (ABE
Prescription User (Per 21 CFR 801.109)
OIVO
(Division Sign-Off)
510K
23
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
{14}------------------------------------------------
Image /page/14/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 letters are stylized and appear to be hand-drawn or calligraphic. The logo is black and white.
## Diagnostic Ultrasound Indications for Use Form GE LOGIQ P6 with 11L Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | | |
|----------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|--------------------|---------------------|----------------|-------------|
| Anatomy/Region of<br>Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>** |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | |
| Abdominal[1] | P | P | P | | P | P | P | P | P | P | [6] |
| Pediatric | P | P | P | | P | P | P | P | P | P | [6] |
| Small Organ[2] | P | P | P | | P | P | P | P | P | P | [6] |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[3] | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Other[4] | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative[5] | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA(LOGIQ E9 K092271); E = added under Appendix E
[1] Abdominal includes renal, GYN/Petvic Notes:
[2] Small organ includes breast, testes, and thyroid.
[3] Cardiac is Adult and Pediatric.
[4] Other use includes Urology/Prostate
[5] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).
[6] Elastography Imaging
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
1**1 Other mode is 4D / Realtime 3D
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Beating Evelusion (GDG)
Prescription User (Per 21 CFR 801.109)
OIVD
(Division Sign-Off)
Division of Radiological Devices
. Office of In Vitro Diagnostic Device Evaluation and Safety
510K
24
