(95 days)
No
The document does not mention AI, ML, deep learning, or any related terms in the device description, intended use, or performance studies. The description focuses on standard ultrasound technology and image processing.
No.
The device is described as a "general-purpose ultrasound system" intended for "diagnostic ultrasound imaging or fluid flow analysis," indicating its purpose is for imaging and analysis, not treatment.
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, and 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/Indications for Use: The intended use clearly describes the device as a general-purpose ultrasound system for diagnostic imaging and fluid flow analysis of the human body. This involves visualizing internal structures and processes within the body.
- Device Description: The description details a mobile console with transducers, a display, and controls, consistent with an ultrasound imaging system.
- Input Imaging Modality: The input is Ultrasound, which is a non-invasive imaging technique applied externally or internally to the body, not a method for analyzing samples in vitro (outside the body).
- Anatomical Site: The listed anatomical sites are all locations within the human body.
- Summary of Performance Studies: The non-clinical tests focus on safety, performance, and compliance with medical device standards related to imaging and physical interaction with the body. There are no mentions of tests related to analyzing biological samples.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) in vitro to provide information for diagnosis, monitoring, or screening. This ultrasound system does not perform such analysis.
N/A
Intended Use / 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).
Product codes
90-IYN, 90-IYO, 90-ITX
Device Description
The subject device consists of a mobile console with keyboard, specialized controls, a color video LCD display with electronic-array transducers. It has the same general appearance, dimensions and weight as the unmodified device, it is a Track 3 general purpose 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
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fetal; Abdominal (renal & GYN/pelvic); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate)
Indicated Patient Age Range
Adult, Pediatric, Neonatal, Fetal
Intended User / Care Setting
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 P6/P6 Pro, did not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K073297 GE LOGIQ P6 Ultrasound System, K092271 GE LOGIQ E9 Diagnostic Ultrasound System
Reference Device(s)
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 a black and white logo. The logo is circular and contains the letters 'GE' in a stylized font. The letters are intertwined and appear to be in a bold, sans-serif typeface. The logo is surrounded by a slightly jagged or pixelated edge, suggesting it may be a low-resolution image or a scan of an older print.
SIO(k) Premarket Notification Submission
OCT - 5 2010 K101874
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | June 28, 2010 |
|---|---|
| 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 |
| Device: Trade Name: | LOGIQ P6/P6 Pro BT11 Ultrasound System |
| Common/Usual Name: | LOGIQ P6/P6 Pro 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): | K073297 GE LOGIQ P6 Ultrasound System K092271 GE LOGIQ E9 Diagnostic Ultrasound System |
| Device Description: | The subject device consists of a mobile console with keyboard, specialized controls, a color video LCD display with electronic- array transducers. It has the same general appearance, dimensions and weight as the unmodified device, it is a Track 3 general- purpose 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. |
| Intended 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. |
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 letters and the border are depicted in black, creating a strong contrast against the white background.
SIO(k) Premarket Notification Submission
thyroid); Neonatal Cephalic; Adult Cophalic; Cardiac (adult and Peripheral Vascular pediatric): (PV); Musculo-skeletal Conventional and Superficial; Urology (including prossate); Transesophageal (TE); Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracie, vascular and neuro.
The LOGIQ P6 BT11 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 with applicable medical device safety standards. The LOGIO P6/P6 Pro 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 (Verifieation)
- Safety testing (Verification)
Transducer materials and other patient contact materials are biocompatible.
Summary of Clinical Tests:
The subject of this premarket submission. LOGIQ P6/P6 Pro, did not require clinical studies to support substantial equivalence.
GE Healthcare considers the LOGIQ P6/P6 Pro to be as safe, as Conclusion: effective, and performance is substantially equivalent to the predicate device(s).
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle or bird with three curved lines representing its wings or body. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in capital letters. The text is arranged around the circumference of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
OCT - 5 2010
Mr. Bryan Behn Regulatory Affairs Manager GE Healthcare GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC 9900 Innovation Dr. WAUWATOSA WI 53226
Re: K101874
Trade/Device Name: LOGIQ P6/P6 Pro 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: September 10, 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 P6/P6 Pro BT11 Ultrasound, System as described in your premarket notification:
Transducer Model Number
| i12L | 3Sp |
|---|---|
| ML6-15 | 5Sp |
| 4D8C | 6Tc |
| 4D5C-L | 11L |
| 3CRF | BE9CS |
3
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 Eederal 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. 4
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/ReportaProblem/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,
Mahal O'Hara Lin
David G. Brown. Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure(s)
4
Image /page/4/Picture/0 description: The image shows a black and white drawing of a circular object. The object has a swirling pattern on its surface, with darker areas contrasting against lighter ones. The overall impression is that of a stylized or abstract representation of a sphere or similar rounded form.
0CT - 5 2010
510(k) Number (if known): K101874
Device Name: LOGIQ P6/P6 Pro BT11
Indications for Use:
The device is a general-purpose ultrasound system. Specific elinical 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, thoracie, vascular and neuro).
Prescription Use X AND/OR (Part 2) CFR 801 Subpart D)
Over-The-Counter Use_NA (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Coneurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Michael D. O'Rear for David b. Brown
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Number K101874
Page 1 of 1
5
Image /page/5/Picture/0 description: The image shows a black and white logo. The logo is circular and contains the letters 'GE' in a stylized font. The letters are intertwined and appear to be in a sans-serif typeface. The logo is surrounded by a circular border.
Diagnostic Ultrasound Indications for Use Form
GE LOGIQ P6/P6 Pro Ultrasound System
Inlended Use: Diagnostic ultrasound maging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Anatomy/Region of | |||||||||||
| Interest | B | M | PW | ||||||||
| Doppler | CW | ||||||||||
| Doppler | Color | ||||||||||
| Doppler | Color M | ||||||||||
| Doppler | Power | ||||||||||
| Doppler | Combined | ||||||||||
| Modes* | Harmonic | ||||||||||
| Imaging | Coded | ||||||||||
| Pulse | Other** | ||||||||||
| Ophthalmic | |||||||||||
| Fetal / Obstetrics | P | P | P | P | P | P | P | P | P | P | |
| Abdominal" | 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 | [6] | |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | ||
| Adult Cephalic | P | P | P | P | P | P | P | P | P | P | |
| Cardiac5 | P | P | P | P | P | P | P | P | P | P | |
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | [6] | |
| Musculo-skeletal | |||||||||||
| Conventional | P | P | P | P | P | P | P | P | P | [6] | |
| Musculo-skeletal | |||||||||||
| Superficial | P | P | P | P | P | P | P | P | P | [6] | |
| Other4 | 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 | P | ||
| Transvaginal | P | P | P | P | P | P | P | P | P | ||
| Transuretheral | |||||||||||
| Intraoperative1 | P | P | P | P | P | P | P | P | [6] | ||
| Intraoperative | |||||||||||
| Neurological | P | P | P | P | P | P | P | P | P | [6] | |
| Intravascular | |||||||||||
| Laparoscopic | |||||||||||
- new indication. P = previously cleared by FDA: E = added under Appendix E Notes.
[1] Abdominal indudes renal, GYN/Pelvic
(2) Small organ includes breast, testes, and thyoid.
[3] Cardiac is Adult and Pediatric
[4] Other use includes Urology/Prostate
[5] Intraoperative indudes abdominal, thoracic (cardiac), and vascular (PV).
[6] Elastography Imaging
[1] Combined modes are BiM, BiColor M, BiPWD or CWD, BlColoriPWD or CWD, BiPower/PWD.
(""| Other mode is 4D / Realtime 3D
IPLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IE NEEDED)
Concurrance of CDRH, Office of Device Evaluation (ODE)
Prescription User (Per 21 C(FR 801.109)
Mark A. O'Dea for David 6. Brown
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K. K101874
6
Image /page/6/Picture/0 description: The image shows a logo of General Electric (GE). The logo is a circular shape with the letters "GE" intertwined in the center. The logo is black and white, with the letters "GE" being white and the background being black. The logo is a well-known symbol of the General Electric company.
510(k) Premarket Notification Submission
Diagnostic Uitrasound Indications for Use Form GE LOGIQ P6 with i121, Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Anatomy/Region of | |||||||||||
| Interest | B | M | PW | ||||||||
| Doppler | CW | ||||||||||
| Doppler | Color | ||||||||||
| Doppler | Color M | ||||||||||
| Doppler | Power | ||||||||||
| Doppler | Combined | ||||||||||
| Modes* | Harmonic | ||||||||||
| Imaging | Coded | ||||||||||
| Pulse | Other** | ||||||||||
| Ophthalmic | |||||||||||
| Fetal / Obstetrics | |||||||||||
| Abdominal[1] | 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 | |||||||||||
| 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 | E | E | E | E | E | E | E | E | |||
| Intravascular | |||||||||||
| Laparoscopic |
N = new indication: P = previously desred by FDA (Logiq V K030934); E = added under Approadix H
Notes. [1] Abdominal includes renal, GYN/Pelvic
[2] Small organ includes breast, lesles, 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 BIM, B/Color M, B/PWD or CWO. B/Color/PWD or CWD, B/Power/PWD.
[™] Other mode is 4D / Reall:me 3D
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IE MEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription User (Per 21 CFR 801,109)
Michael D'Them for David G Brown
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K101874/
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 black and white, with the letters and border appearing in black against a white background.
Diagnostic Ultrasound Indications for Use Form
GE LOGIO P6 with ML6-15 Transducar
Intended Use: Diagnostic with as und imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Anatomy/Region of | |||||||||||
| Interest | B | M | PW | ||||||||
| Doppler | CW | ||||||||||
| Doppler | Color | ||||||||||
| Doppler | Color M | ||||||||||
| Doppler | Power | ||||||||||
| Doppler | Combined | ||||||||||
| Modes' | Harmonic | ||||||||||
| Imaging | Coded | ||||||||||
| Pulse | Other | ||||||||||
| ** | |||||||||||
| Ophthalmic | |||||||||||
| Fetal / Obstetrics | |||||||||||
| Abdominal1 | |||||||||||
| Pediatric | P | P | P | P | P | P | P | P | P | [6] | |
| Small Organ2 | P | P | P | P | P | P | P | P | P | [6] | |
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac3 | |||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | [6] | |
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | |||||||||||
| Other4 | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperative5 | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic |
Noles: [1] Abdominal includes renal. GYN/Pelvic
[7] Small organ includes breast, testes, and thyroid.
(J) Cardiac Is Adult and Pediatac
[4] Other use includes Uralogy: Prosiste
[5] intraoperative includes abdominal. thoracic (canthac), and vascular (PV)
[6] Elastography unaging
[0] Elibstograph| This and
[ 7] Ovner mode is 4D / Reallime JD
ISTEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOIRER FAGE IE NEEDEDI Cancurrence of CORH. Office of Device Evaluation (DDE)
Prescription User (Per 21 CFR 801.109)
Michael D'Ollone for David G. Brown
(Division Sign-Off) (Division of Radiological Devices
510K. K161874
8
Image /page/8/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 textured or dotted pattern, giving the logo a vintage or slightly distressed appearance. The overall design is simple yet recognizable.
Diagnostic Ultrasound Indications for Use Form
GE LOGIO 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 | |||||||||||
| Interest | B | M | PW | ||||||||
| Doppler | CW | ||||||||||
| Doppler | Color | ||||||||||
| Doppler | Color M | ||||||||||
| Doppler | Power | ||||||||||
| Doppler | Combined | ||||||||||
| Modes' | Harmonic | ||||||||||
| Imaging | Coded | ||||||||||
| Pulse | Other- | ||||||||||
| Ophthalmic | |||||||||||
| Fetal / Obstetrics | |||||||||||
| Abdominall | |||||||||||
| Pediatric | P | P | P | P | P | P | P | P | P | P | |
| Small Organl | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Peripheral Vascular | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | |||||||||||
| Otherl | |||||||||||
| Exam Type Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperativeli | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic | |||||||||||
| N = new indication; P - previously cleared by FDA (LOGIQ 9 Ku61129); E = added under Appendix F | |||||||||||
| Notes (1) Abdominal includes renal, GYN/Pelvic |
(2) Small organ includes breast, testes, and thyrou
(3) Cardian is Adult and Pediatine
[4] Other use includes Urology/Prostate
[5] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).
( 1 Combined modes are 8/M, B/Color M, B/PND ar CWD, B/Color/PWD or CWD, B/Power/PWD
[*] Other mode is 4D / Reallime 3D
IPLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANDIHER PAGE IE NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription User (Per 21 CFR 801.109)
Murdock D'Ochler for David 6 Brown
(District Sign Off)
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K101874
9
Image /page/9/Picture/0 description: The image shows a logo with the letters 'GE' inside a circle. The letters are stylized and intertwined. The logo is black and white and appears to be slightly distressed or aged.
Diagnostic Ultrasound Indications for Use Form
GE LOGIO P6 with 4D5C-L Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Anatomy/Region of | |||||||||||
| Interest | B | M | PW | ||||||||
| Doppler | CW | ||||||||||
| Doppler | Color | ||||||||||
| Doppler | Color M | ||||||||||
| Doppler | Power | ||||||||||
| Doppler | Combined | ||||||||||
| Modes | Harmonic | ||||||||||
| Imaging | Coded | ||||||||||
| Pulse | Other | ||||||||||
| ** | |||||||||||
| Ophthalmic | E | E | E | E | E | E | E | E | E | E | |
| Fetal / Obstetrics | E | E | E | E | E | E | E | E | E | E | |
| Abdominal(1) | E | E | E | E | E | E | E | E | E | E | |
| Pediatric | E | E | E | E | E | E | E | E | E | E | |
| Small Organ(2) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac(3) | |||||||||||
| Peripheral Vascular | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | |||||||||||
| Other (4) | E | E | E | E | E | E | E | E | E | E | |
| Exam Type. Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperative(5) | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic | |||||||||||
| N = new indication, P = previously cleared by FDA; E = added under Appendix E |
[1] Abdominal includes renal, GYN!Petric Noles.
[2] Small organ includes breast, testes, and thyroid.
[3] Cardiac is Adult and Pediatric
[4] Other use includes Urology:Proslate
- intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).
(v) miraoperative linduss Blashinal, the book (conode). 6-x) - Institution (r 7).
["] Combined modes are B/M, B/Color M. B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD
[**] Other mode is 40 / Realtime 3D
(BLEASE DO NOT WRITE BELOW THIS LINE . CONTINUE ON ANOTHER PAGE IE NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Preseription User (Per 21 CFR 801.109)
Michael D. O'Hern for David G. Brown
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K101874
10
Image /page/10/Picture/0 description: The image shows a black and white logo. The logo is a circular shape with the letters 'GE' intertwined in the center. The letters are stylized and appear to be in a cursive font. The logo is surrounded by a dashed line, suggesting it may be part of a larger image or document.
5 10(k) Premarket Notification Submission
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 | |||||||||||
| Interest | B | M | PW | ||||||||
| Doppler | CW | ||||||||||
| Doppler | Color | ||||||||||
| Doppler | Color M | ||||||||||
| Doppler | Power | ||||||||||
| Doppler | Combined | ||||||||||
| Modes' | Harmonic | ||||||||||
| Imaging | Coded | ||||||||||
| Pulse | Other** | ||||||||||
| Ophthalmic | |||||||||||
| 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 | |||||||||||
| Cardiac(3) | |||||||||||
| Peripheral Vascular | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | |||||||||||
| Other(4) | P | P | P | P | P | P | P | P | P | ||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperative(5) | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic | |||||||||||
| N = new indication; P - previously cleared by FDA(LOGIQ F9 KU92271); E = added under Appendix E | |||||||||||
| Notes: (1) Abdominal includes renal, GYN/Pelvic |
- Abdominal includes renal, GYN/pelvic
(2) Small organ includes breast, lestes, and thyroid.
(3) Cardiac is Adull and Pediatric
14] Other use includes UrologyProsiate
- Intraoperative includes abdominal. thorecic (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.
1™| Other mode is 4D / Realtime 3D
(P) EASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IE NEEDED) Concurrence of CDRH, Office of Device Evakuation (ODE)
Preseription User (Per 2) CFR 801.109)
Michael D. O'Hern for David C. Brown
Division of Rediological Devices
510K K101874
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 manner. The logo is enclosed within a dotted circle.
510(k) Premarket Notification Submission
Diagnostic Ultrasound Indications for Use Form GE LOGIO P8 with 3Sp Transducer
Intended Use: Diagnostic ultrasound imaging or fluid thow analysis of the human body as lollows:
| Clinical Application | Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Anatomy/Region of | |||||||||||
| Interest | B | M | PW | ||||||||
| Doppler | CW | ||||||||||
| Doppler | Color | ||||||||||
| Doppler | Color M | ||||||||||
| Doppler | Power | ||||||||||
| Doppler | Combined | ||||||||||
| Modes' | Harmonic | ||||||||||
| Imaging | Coded | ||||||||||
| Pulse | Other** | ||||||||||
| Ophthalmic | |||||||||||
| Fetal / Obstetrics | |||||||||||
| Abdominal1 | E | E | E | E | E | E | E | E | E | E | |
| Pediatric | |||||||||||
| Small Organ2 | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | E | E | E | E | E | E | E | E | E | E | |
| Cardiac3 | E | E | E | E | E | E | E | E | E | E | |
| Peripheral Vascular | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | |||||||||||
| Other4 | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperative5 | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic |
previously clear cd by ( ation; P DA: I:
Notes: (1) Abdominal includes renal, GYN/Pelvic
[2] Small organ includes breast, testes, and thyroid.
[3] Cardrac is Adult and Pediatric.
[4] Other use includes UrologyProstate
[5] Intracperative includes abdominal, thoracic (cardiac), and vascular (PV),
[1] Combined modes are BiM. BIColor M. BiPWD or CWD, B/Color/PWD or CWD, B/Power/PWD
| " | Other mode is 40 / Realume 30
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON PHOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription User (Per 21 L'FR 801.109)
Fletcher D. Hannon G- David b. Brown
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K161874
12
Image /page/12/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized manner. The logo is surrounded by a circular pattern, giving it a distinctive and recognizable appearance.
510(k) Premarket Notification Submission
Diagnostic Ultrasound Indications for Use Form
GE LOGIO 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 | |||||||||||
| Interest | B | M | PW | ||||||||
| Doppler | CW | ||||||||||
| Doppler | Color | ||||||||||
| Doppler | Color M | ||||||||||
| Doppler | Power | ||||||||||
| Doppler | Combined | ||||||||||
| Modes* | Harmonic | ||||||||||
| Imaging | Coded | ||||||||||
| Pulse | Other | ||||||||||
| ** | |||||||||||
| Ophthalmic | |||||||||||
| Fetal / Obstetrics | |||||||||||
| Abdominal1 | E | E | E | E | E | E | E | E | E | E | E |
| Pediatric | E | E | E | E | E | E | E | E | E | E | |
| Small OrganPl | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | E | E | E | E | E | E | E | E | E | E | |
| Cardiac3 | E | E | E | E | E | E | E | E | E | E | |
| Peripheral Vascular | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | |||||||||||
| Other14 | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperative5 | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic | |||||||||||
| N - new indication: P - previously cleared by FDA: E = added under Appendix E |
Notes. { } | Abdominal includes renal. GYN/Pelvic
{2] Small organ includes breast. testes, and thyroid.
(3) Cardiac is Adult and Pedialiic
[4] Other use includes Urology/Prossate
(4) Carlin LES Visions Orders abdominal, theracic (cardiac), and vascular (PV).
[1] Combined modes are B/M, B/Color M, B/PWD or CWD, B/ColoriPWD or CWD, B/PoweriPWD.
(**) Other mode is 4D / Reallime 3D
IPLE ASE DO NOT MRITE BELOW THIS LINE - CONTINUE ON PARTINER PAGE IE MEEDEDI Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription User (Per 2) CFR 801.109)
Michael O'Dell for David 6. Brown
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
s10K K101874
13
Image /page/13/Picture/0 description: The image shows a black and white logo. The logo is circular and contains a stylized monogram of the letters 'GE'. The monogram is composed of curved lines and swirls, creating an abstract design. The logo is surrounded by a thin, slightly jagged border.
Diagnostic Ultrasound Indications for Use Form
GE LOGIQ P6 with 6Tc Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as tollows:
| Clinical Application | Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Anatomy/Region of | |||||||||||
| Interest | B | M | PW | ||||||||
| Doppler | CW | ||||||||||
| Doppler | Color | ||||||||||
| Doppler | Color M | ||||||||||
| Doppler | Power | ||||||||||
| Doppler | Combined | ||||||||||
| Modes' | Harmonic | ||||||||||
| Imaging | Coded | ||||||||||
| Pulse | Other** | ||||||||||
| Ophthalmic | |||||||||||
| Fetal / Obstetrics | |||||||||||
| Abdominal(1) | |||||||||||
| Pediatric | |||||||||||
| Small Organ(2) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| 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 | P | P | P | P | P | P | P | P | P | P | |
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperative(5) | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic | |||||||||||
| N = new indication; P = previously cleared by FDA(LOGIQ E9 K092271); E = added under Appendix E | |||||||||||
| Notes: (1) Abdominal includes renal, GYN/Pelvic |
[2] Small organ includes breast, testes, and thyroid
[3] Cardiacus Adult and Pediatric
[4] Other use includes Urology/Pros1ate
(1) Other ass morbead Grology: (1994).
(5) 'atraoperative includes abdominal, thorace (cardiac), and vascular (PV).
[1] Combined modes are BrM. B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
[™] Other mode is 4D / Reallime 3D
IPLE ASSE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANQTHER PAGE IE NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription User (Per 21 CFR 801.100)
25
Michal D. O'K. & David G. Brown
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Division of Hadiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
Diagnostic Device Evaluation and Safety
810K K101874
14
Image /page/14/Picture/0 description: The image shows a logo of the General Electric (GE) company. The logo consists of the letters 'GE' intertwined within a circular border. The logo is in black and white and has a slightly distressed or vintage appearance.
Diagnostic Ultrasound Indications for Use Form
GE LOGIO 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 | |||||||||||
| Interest | B | M | PW | ||||||||
| Doppler | CW | ||||||||||
| Doppler | Color | ||||||||||
| Doppler | Color M | ||||||||||
| Doppler | Power | ||||||||||
| Doppler | Combined | ||||||||||
| Modes | Harmonic | ||||||||||
| Imaging | Coded | ||||||||||
| Pulse | Other ** | ||||||||||
| Ophthalmic | |||||||||||
| Fetal / Obstetrics | |||||||||||
| Abdominal1 | P | P | P | P | P | P | P | P | P | [6] | |
| Pediatric | P | P | P | P | P | P | P | P | P | [6] | |
| Small Organ2 | P | P | P | P | P | P | P | P | P | [6] | |
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac3 | |||||||||||
| Peripheral Vascular | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | |||||||||||
| Other4 | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperative5 | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic | |||||||||||
| N = new indication; P = previously cleared by FDA(LOGIQ E9 K092271); 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 Undingy(Prostatio
[5] intracperative includes abdominal, theracic (cardiac), and vascular (PV)
(6) Elaslography Imaging
[0] Llastography Iniaging
[1] Combined modes are B/M. B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
Division of Radiological Devices Office of In Vitro Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
{""} Other mode is 4D / Reatlime 3D
(FLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CORH, Office of Device Evaluation (ODE)
Preseription User (Per 21 CFR 801.109)
510K
ટ્રેક
Mull D.H. for David 6. Brown
(Division Sign-Off)
15
Image /page/15/Picture/0 description: The image shows a black and white logo. The logo is circular and contains the letters 'GE' intertwined in the center. The letters are stylized and appear to be hand-drawn. The logo is likely for General Electric.
Diagnostic Ultrasound Indications for Use Form
GE LOGIO P6 with BE9CS Transducer
Inlended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as Iollows:
| Clinical Application | Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Anatomy Region of | |||||||||||
| Interest | B | M | PW | ||||||||
| Doppler | CW | ||||||||||
| Doppler | Color | ||||||||||
| Doppler | Color M | ||||||||||
| Doppler | Power | ||||||||||
| Doppler | Combined | ||||||||||
| Modes* | Harmonic | ||||||||||
| Imaging | Coded | ||||||||||
| Pulse | Other | ||||||||||
| ** | |||||||||||
| Ophthalmic | |||||||||||
| Fetal / Obstetrics | |||||||||||
| Abdominal[1] | E | E | E | E | E | E | E | E | |||
| Pediatric | E | E | E | E | E | E | E | E | |||
| Small Organ | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Peripheral Vascular | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | |||||||||||
| Other | E | E | E | E | E | E | E | E | |||
| Exam Type Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | E | E | E | E | E | E | E | E | |||
| Transvaginal | E | E | E | E | E | E | E | E | |||
| Transuretheral | |||||||||||
| Intraoperative | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic | |||||||||||
| N new indication; P = previously cleared by FDA(minor modification to BE9C): E = added under Appendix E | |||||||||||
| Notes: [1] Abdominal includes renal, GYN/Pelvic |
[2] Small organ includes breast, testes, and thyroid.
13] Cardiac is Adult and Pediainc.
|4| Other use includes Uncludes Unology/Prostate
15| Intracterative includes abdominal, thuracic (cardiac), and vascular (PV)
16] Elastography Intaging
[0] Lastcgraphy miaging
[1] Combined modes are B/M, B/Color M, B/PWO or CWD, B/Color/PWD or CWD, B/Power/PWD
[™] Other mode is 4D / Realtime 30
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription User (Per 21 CFR 801.109)
.27
Michael D. O'Dell Con. David B. Brown
(Division Sign-Off)
Division of Radiological Devices Office of In Ditision of Hadlological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
610K. K101874