(33 days)
No
The document does not mention AI, ML, or any related terms, and the description focuses on standard ultrasound system components and capabilities.
No.
The device is described as a "diagnostic ultrasound system" intended for "ultrasound evaluation," which means it is used for diagnosis rather than treatment.
Yes
Explanation: The Device Description explicitly states: "The LOGIQ E10 is a full featured, general purpose diagnostic ultrasound system".
No
The device description clearly states it is a "full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 585 mm wide (keyboard), 900 mm deep and 1300 mm high". This indicates a physical hardware component, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is a "diagnostic ultrasound system." Ultrasound is an imaging modality that uses sound waves to create images of internal body structures. It does not involve testing samples taken from the body.
- Intended Use: The intended use describes various anatomical sites and patient populations for ultrasound evaluation. This is consistent with the use of an imaging device, not an IVD.
Therefore, the LOGIQ E10 is a diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transvaginal; Transesophageal and Intraoperative (vascular).
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal / Obstetrics; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac; Peripheral Vascular; Musculo-skeletal Conventional; Musculo-skeletal Superficial; Other (Urology/Prostate); Transesophageal; Transrectal; Transvaginal; Intraoperative.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
The LOGIQ E10 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 585 mm wide (keyboard), 900 mm deep and 1300 mm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 12-inch LCD touch screen and color widescreen monitor.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transvaginal; Transesophageal and Intraoperative (vascular).
Indicated Patient Age Range
Fetal, Neonatal, Pediatric, Adult
Intended User / Care Setting
Qualified physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The subject of this premarket submission, LOGIQ E10, did not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K163077 LOGIQ E9 Diagnostic Ultrasound System
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K170445 LOGIQ S8 Diagnostic Ultrasound System, K172342 Voluson E6/E8/E10 Diagnostic Ultrasound System
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
December 20, 2017
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
GE Healthcare % Mr. Bryan Behn RA Director 9900 Innovation Drive WAUWATOSA WI 53226
Re: K173555
Trade/Device Name: LOGIO E10 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: November 15, 2017 Received: November 17, 2017
Dear Mr. Behn:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.
1
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone
(1-800-638-2041 or 301-796-7100).
Sincerely,
Robert Ochs
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
| Form Approved: OMB No. | 0910-0120 |
|---|---|
| Expiration Date: | 06/30/2020 |
| See PRA Statement below. |
| 510(k) Number (if known) | K173555 |
|---|---|
| Device Name |
Device Name LOGIO E10
Indications for Use (Describe)
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transvaginal; Transesophageal and Intraoperative (vascular).
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (7/17)
Page 1 of 1
3
Image /page/3/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The letters are enclosed within a circular border, and the entire logo is presented in a blue color.
GE Healthcare 510(k) Premarket Notification Submission
Indications for Use Forms
The following forms represent indications with clinical applications and exam types along with the modes of operation for the LOGIQ E10 system and for all of its probe/mode combinations. Combinations identified by "P" for probes represent those previously cleared with another GE Ultrasound system. "N" is new in this submission.
The subject modification does not alter the previously cleared system level indications and clinical applications.
4
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Diagnostic Ultrasound Indications for Use Form LOGIQ E10 Ultrasound Systems
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | |||||||||||
| Anatomy/Region of Interest | B | M | PW | ||||||||
| Doppler | CW | ||||||||||
| Doppler | Color | ||||||||||
| Doppler | Color M | ||||||||||
| Doppler | Power | ||||||||||
| Doppler | Combined | ||||||||||
| Modes* | Harmonic | ||||||||||
| Imaging | Coded | ||||||||||
| Pulse | Other | ||||||||||
| [Notes] | |||||||||||
| Ophthalmic | |||||||||||
| Fetal / Obstetrics[7] | N | N | N | N | N | N | N | N | N | N | 3,5,6,9 |
| Abdominal[1] | N | N | N | N | N | N | N | N | N | N | 3,5,6,9,10 |
| Pediatric | N | N | N | N | N | N | N | N | N | N | 3,5,6,9,10 |
| Small Organ[2] | N | N | N | N | N | N | N | N | N | N | 3,5,6,9,10 |
| Neonatal Cephalic | N | N | N | N | N | N | N | N | N | N | 3,5,9 |
| Adult Cephalic | N | N | N | N | N | N | N | N | N | N | 3,5,9 |
| Cardiac | N | N | N | N | N | N | N | N | N | N | |
| Peripheral Vascular | N | N | N | N | N | N | N | N | N | N | 3,5,6,9 |
| Musculo-skeletal Conventional | N | N | N | N | N | N | N | N | N | N | 3,5,6,9,10 |
| Musculo-skeletal Superficial | N | N | N | N | N | N | N | N | N | N | 3,5,6,9,10 |
| Other[4] | N | N | N | N | N | N | N | N | N | N | 3,5,6,9,10 |
| Exam Type, Means of Access | |||||||||||
| Transesophageal | N | N | N | N | N | N | N | N | N | N | |
| Transrectal | N | N | N | N | N | N | N | N | N | N | 3,5,6,9 |
| Transvaginal | N | N | N | N | N | N | N | N | N | N | 3,5,6,7,9 |
| Transuretheral | |||||||||||
| Intraoperative[8] | N | N | N | N | N | N | N | N | N | N | 3,5,6,9 |
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic |
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] Elastography Imaging - Elasticity
[4] Other use includes Urology/Prostate
[5] 3D/4D Imaging mode
[6] Needle guidance imaging
[7] Includes infertility monitoring of follicle development, GYN
[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)
[9] Volume navigation
[10] Shear wave elastography
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
5
Image /page/5/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 colored in a light blue hue.
Diagnostic Ultrasound Indications for Use Form LOGIQ E10 with L2-9-D/L2-9VN-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | |||||||||||
| Anatomy/Region of Interest | B | M | PW | ||||||||
| Doppler | CW | ||||||||||
| Doppler | Color | ||||||||||
| Doppler | Color M | ||||||||||
| Doppler | Power | ||||||||||
| Doppler | Combined | ||||||||||
| Modes* | Harmonic | ||||||||||
| Imaging | Coded | ||||||||||
| Pulse | Other | ||||||||||
| [Notes) | |||||||||||
| Ophthalmic | |||||||||||
| Fetal / Obstetrics[7] | N | N | N | N | N | N | N | N | 3,5,6,9 | ||
| Abdominal[1] | N | N | N | N | N | N | N | N | 3,5,6,9,10 | ||
| Pediatric | N | N | N | N | N | N | N | N | 3,5,6,9,10 | ||
| Small Organ [2] | N | N | N | N | N | N | N | N | 3,5,6,9,10 | ||
| Neonatal Cephalic | N | N | N | N | N | N | N | N | |||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Peripheral Vascular | N | N | N | N | N | N | N | N | 3,5,6,9 | ||
| Musculo-skeletal Conventional | N | N | N | N | N | N | N | N | 3,5,6,9,10 | ||
| Musculo-skeletal Superficial | N | N | N | N | N | N | N | N | 3,5,6,9,10 | ||
| Other[4] | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal[8] | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperative[8] | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
[1] Abdominal includes Renal, GYN/Pelvic. Notes:
[2] Small organ includes breast, testes and thyroid
[3] Elastography Imaging - Elasticity.
[4] Other use includes Urology/Prostate
[5] 3D/4D Imaging mode
[6] Needle guidance imaging
[7] Includes infertility monitoring of follicle development, GYN
[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)
[9] Volume navigation
[10] Shear wave elastography
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
6
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 logo is enclosed within a circular border, and the entire design is presented in a blue color.
Diagnostic Ultrasound Indications for Use Form LOGIQ E10 with ML6-15-D 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 | Code | ||||||||||
| d | |||||||||||
| Pulse | Other | ||||||||||
| [Notes) | |||||||||||
| Ophthalmic | |||||||||||
| Fetal / Obstetrics[7] | |||||||||||
| Abdominal[1] | |||||||||||
| Pediatric | P | P | P | P | P | P | P | P | 3,5,6,9 | ||
| Small Organ[2] | P | P | P | P | P | P | P | P | 3,5,6,9 | ||
| Neonatal Cephalic | P | P | P | P | P | P | P | P | 9 | ||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | P | 3,5,6,9 | ||
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P | 3,5,6,9 | ||
| Musculo-skeletal Superficial | P | P | P | P | P | P | P | P | 3,5,6,9 | ||
| Other[4] | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal[8] | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperative[8] | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA (K163077)
Notes: [1] Abdominal includes Renal, GYN/Pelvic.
[2] Small organ includes breast, testes and thyroid
[3] Elastography Imaging - Elasticity.
[4] Other use includes Urology/Prostate
[5] 3D/4D Imaging mode
[6] Needle guidance imaging
[7] Includes infertility monitoring of follicle development, GYN
[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)
[9] Volume navigation
[10] Shear wave elastography
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
7
Image /page/7/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined in a stylized script, enclosed within a circular frame. The logo is colored in a light blue hue, with the letters and the frame sharing the same color.
Diagnostic Ultrasound Indications for Use Form LOGIQ E10 with ML4-16-D/ML4-16VN-D 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 | Code | ||||||||||
| d | |||||||||||
| Pulse | Other | ||||||||||
| (Notes) | |||||||||||
| Ophthalmic | |||||||||||
| Fetal / Obstetrics[7] | |||||||||||
| Abdominal[1] | |||||||||||
| Pediatric | N | N | N | N | N | N | N | N | 3,5,6,9,10 | ||
| Small Organ[2] | N | N | N | N | N | N | N | N | 3,5,6,9,10 | ||
| Neonatal Cephalic | N | N | N | N | N | N | N | N | 9 | ||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Peripheral Vascular | N | N | N | N | N | N | N | N | 3,5,6,9 | ||
| Musculo-skeletal Conventional | N | N | N | N | N | N | N | N | 3,5,6,9,10 | ||
| Musculo-skeletal Superficial | N | N | N | N | N | N | N | N | 3,5,6,9,10 | ||
| Other[4] | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal[8] | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperative[8] | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [1] Abdominal includes Renal, GYN/Pelvic.
[2] Small organ includes breast, testes and thyroid
[3] Elastography Imaging - Elasticity.
[4] Other use includes Urology/Prostate
[5] 3D/4D Imaging mode
[6] Needle guidance imaging
[7] Includes infertility monitoring of follicle development, GYN
[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)
[9] Volume navigation
[10] Shear wave elastography
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
8
Image /page/8/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The letters are enclosed within a circular border, giving the logo a classic and recognizable appearance. The color of the logo is a light blue.
Diagnostic Ultrasound Indications for Use Form LOGIQ E10 with M5Sc-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | |||||||||||
| Anatomy/Region of Interest | B | M | PW | ||||||||
| Doppler | CW | ||||||||||
| Doppler | Color | ||||||||||
| Doppler | Color M | ||||||||||
| Doppler | Power | ||||||||||
| Doppler | Combined | ||||||||||
| Modes* | Harmonic | ||||||||||
| Imaging | Coded | ||||||||||
| Pulse | Other | ||||||||||
| [Notes] | |||||||||||
| Ophthalmic | |||||||||||
| Fetal / Obstetrics[7] | |||||||||||
| Abdominal[1] | P | P | P | P | P | P | P | P | P | P | 5,6 |
| Pediatric | |||||||||||
| Small Organ[2] | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | P | P | P | P | P | P | P | P | P | P | 5 |
| Cardiac | P | P | P | P | P | P | P | P | P | P | |
| Peripheral Vascular | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other[4] | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal[8] | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperative[8] | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA (K170445)
Notes: [1] Abdominal includes Renal, GYN/Pelvic.
[2] Small organ includes breast, testes and thyroid
[3] Elastography Imaging - Elasticity.
[4] Other use includes Urology/Prostate
[5] 3D/4D Imaging mode
[6] Needle guidance imaging
[7] Includes infertility monitoring of follicle development, GYN
[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)
[9] Volume navigation
[10] Shear wave elastography
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
9
Image /page/9/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a circular border. The color of the logo is a light blue.
Diagnostic Ultrasound Indications for Use Form LOGIQ E10 with IC5-9-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | |||||||||||
| Anatomy/Region of Interest | B | M | PW Doppler | CW Doppler | Color Doppler | Color M Doppler | Power Doppler | Combined | |||
| Modes* | Harmonic | ||||||||||
| Imaging | Coded | ||||||||||
| Pulse | Other | ||||||||||
| [Notes] | |||||||||||
| Ophthalmic | |||||||||||
| Fetal / Obstetrics[7] | P | P | P | P | P | P | P | P | 3,5,6,9 | ||
| Abdominal[1] | P | P | P | P | P | P | P | P | 3,5,6,9 | ||
| Pediatric | |||||||||||
| Small Organ[2] | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Peripheral Vascular | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other[4] | P | P | P | P | P | P | P | P | 3,5,6,9 | ||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal[8] | P | P | P | P | P | P | P | P | 3,5,6,9 | ||
| Transvaginal | P | P | P | P | P | P | P | P | 3,5,6,7,9 | ||
| Transuretheral | |||||||||||
| Intraoperative[8] | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA (K163077)
[1] Abdominal includes Renal, GYN/Pelvic. Notes:
[2] Small organ includes breast, testes and thyroid
[3] Elastography Imaging - Elasticity.
[4] Other use includes Urology/Prostate
[5] 3D/4D Imaging mode
[6] Needle guidance imaging
[7] Includes infertility monitoring of follicle development, GYN
[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)
[9] Volume navigation
[10] Shear wave elastography
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
10
Image /page/10/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a blue circle. The circle has a white border with decorative swirls, giving it a classic and recognizable appearance.
Diagnostic Ultrasound Indications for Use Form LOGIQ E10 with L8-18i-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | ||||||||||||
| Anatomy/Region of Interest | B | M | PW | |||||||||
| Doppler | CW | |||||||||||
| Doppler | Color | |||||||||||
| Doppler | Color M | |||||||||||
| Doppler | Power | |||||||||||
| Doppler | Combined | |||||||||||
| Modes* | Harmonic | |||||||||||
| Imaging | Coded | |||||||||||
| Pulse | Other | |||||||||||
| [Notes) | ||||||||||||
| Ophthalmic | ||||||||||||
| Fetal / Obstetrics[7] | ||||||||||||
| Abdominal[1] | ||||||||||||
| Pediatric | P | P | P | P | P | P | P | P | 5,6,9 | |||
| Small Organ[2] | P | P | P | P | P | P | P | P | 5,6,9 | |||
| Neonatal Cephalic | P | P | P | P | P | P | P | P | 5,9 | |||
| Adult Cephalic | ||||||||||||
| Cardiac | ||||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | P | 5,6,9 | |||
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P | 5,6,9 | |||
| Musculo-skeletal Superficial | P | P | P | P | P | P | P | P | 5,6,9 | |||
| Other[4] | ||||||||||||
| Exam Type, Means of Access | ||||||||||||
| Transesophageal | ||||||||||||
| Transrectal[8] | ||||||||||||
| Transvaginal | ||||||||||||
| Transuretheral | ||||||||||||
| Intraoperative[8] | P | P | P | P | P | P | P | P | 5,6,9 | |||
| Intraoperative Neurological | ||||||||||||
| Intravascular | ||||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA (K163077)
Notes: [1] Abdominal includes Renal, GYN/Pelvic.
[2] Small organ includes breast, testes and thyroid
[3] Elastography Imaging - Elasticity.
[4] Other use includes Urology/Prostate
[5] 3D/4D Imaging mode
[6] Needle guidance imaging
[7] Includes infertility monitoring of follicle development, GYN
[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)
[9] Volume navigation
[10] Shear wave elastography
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
11
Image /page/11/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized script inside. The letters are also blue, and they are surrounded by a decorative swirl pattern. The logo is simple and recognizable, and it is often used to represent the company.
Diagnostic Ultrasound Indications for Use Form LOGIQ E10 with P2D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | ||||||||||||
| Anatomy/Region of Interest | B | M | PW | |||||||||
| Doppler | CW | |||||||||||
| Doppler | Color | |||||||||||
| Doppler | Color M | |||||||||||
| Doppler | Power | |||||||||||
| Doppler | Combined | |||||||||||
| Modes* | Harmonic | |||||||||||
| Imaging | Coded | |||||||||||
| Pulse | Other | |||||||||||
| [Notes] | ||||||||||||
| Ophthalmic | ||||||||||||
| Fetal / Obstetrics[7] | ||||||||||||
| Abdominal[1] | ||||||||||||
| Pediatric | ||||||||||||
| Small Organ[2] | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | P | |||||||||||
| Cardiac | P | |||||||||||
| Peripheral Vascular | P | |||||||||||
| Musculo-skeletal Conventional | ||||||||||||
| Musculo-skeletal Superficial | ||||||||||||
| Other[4] | ||||||||||||
| Exam Type, Means of Access | ||||||||||||
| Transesophageal | ||||||||||||
| Transrectal[8] | ||||||||||||
| Transvaginal | ||||||||||||
| Transuretheral | ||||||||||||
| Intraoperative[8] | ||||||||||||
| Intraoperative Neurological | ||||||||||||
| Intravascular | ||||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA (K163077)
Notes: [1] Abdominal includes Renal, GYN/Pelvic.
[2] Small organ includes breast, testes and thyroid
[3] Elastography Imaging - Elasticity.
[4] Other use includes Urology/Prostate
[5] 3D/4D Imaging mode
[6] Needle guidance imaging
[7] Includes infertility monitoring of follicle development, GYN
[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)
[9] Volume navigation
[10] Shear wave elastography
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
12
Image /page/12/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized script inside. The letters are also blue, and they are surrounded by a decorative swirl pattern. The logo is simple and recognizable, and it is often used to represent the company.
Diagnostic Ultrasound Indications for Use Form LOGIQ E10 with C2-9-D/C2-9VN-D 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 [Notes] | |
| Ophthalmic | ||||||||||||
| Fetal/Obstetrics[7] | P | P | P | P | P | P | P | P | P | P | 3,5,6,9 | |
| Abdominal[1] | P | P | P | P | P | P | P | P | P | P | 3,5,6,9 | |
| Pediatric | P | P | P | P | P | P | P | P | P | P | 3,5,6,9 | |
| Small Organ[2] | ||||||||||||
| Neonatal Cephalic | P | P | P | P | P | P | P | P | 3,5,9 | |||
| Adult Cephalic | ||||||||||||
| Cardiac Adult | ||||||||||||
| Cardiac Pediatric | ||||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | P | 3,5,6,9 | |||
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P | 3,5,6,9 | |||
| Musculo-skeletal Superficial | P | P | P | P | P | P | P | P | 3,5,6,9 | |||
| Other [4] | ||||||||||||
| Exam Type, Means of Access | ||||||||||||
| Transesophageal | ||||||||||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Transurethral | ||||||||||||
| Intraoperative[8] | ||||||||||||
| Intraoperative Neurological | ||||||||||||
| Intravascular | ||||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA (K163077)
[1] Abdominal includes Renal, GYN/Pelvic. Notes:
[2] Small organ includes breast, testes and thyroid
[3] Elastography Imaging - Elasticity.
[4] Other use includes Urology/Prostate
[5] 3D/4D Imaging mode
[6] Needle guidance imaging
[7] Includes infertility monitoring of follicle development, GYN
[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)
[9] Volume navigation
[10] Shear wave elastography
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
System provides real-time 3D and 4D acquisition when used with special 4D probes
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
13
Image /page/13/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The letters are enclosed within a circular border that has decorative swirls or flourishes around the perimeter. The logo is presented in a blue color.
Diagnostic Ultrasound Indications for Use Form LOGIQ E10 with RAB6-D Transducer
Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | ||||||||||||
| Anatomy/Region of Interest | B | M | PW | |||||||||
| Doppler | CW | |||||||||||
| Doppler | Color | |||||||||||
| Doppler | Color M | |||||||||||
| Doppler | Power | |||||||||||
| Doppler | Combined | |||||||||||
| Modes* | Harmonic | |||||||||||
| Imaging | Coded | |||||||||||
| Pulse | Other | |||||||||||
| [Notes] | ||||||||||||
| Ophthalmic | ||||||||||||
| Fetal/Obstetrics[7] | P | P | P | P | P | P | P | P | 5,6 | |||
| Abdominal[1] | P | P | P | P | P | P | P | P | 5,6 | |||
| Pediatric | P | P | P | P | P | P | P | P | 5,6 | |||
| Small Organ[2] | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Cardiac Adult | ||||||||||||
| Cardiac Pediatric | ||||||||||||
| Peripheral Vascular | ||||||||||||
| Musculo-skeletal Conventional | ||||||||||||
| Musculo-skeletal Superficial | ||||||||||||
| Other[4] | ||||||||||||
| Exam Type, Means of Access | ||||||||||||
| Transesophageal | ||||||||||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Transurethral | ||||||||||||
| Intraoperative[8] | ||||||||||||
| Intraoperative Neurological | ||||||||||||
| Intravascular | ||||||||||||
| Laparoscopic |
N = new indication; P* = previously cleared by FDA (K163077)
[1] Abdominal includes Renal, GYN/Pelvic. Notes:
[2] Small organ includes breast, testes and thyroid
[3] Elastography Imaging - Elasticity.
[4] Other use includes Urology/Prostate
[5] 3D/4D Imaging mode
[6] Needle guidance imaging
[7] Includes infertility monitoring of follicle development, GYN
[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)
[9] Volume navigation
[10] Shear wave elastography
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
System provides real-time 3D and 4D acquisition when used with special 4D probes
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
14
Image /page/14/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a circular border. The color of the logo is a light blue.
Diagnostic Ultrasound Indications for Use Form LOGIQ E10 with RIC5-9-D 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[7] | P | P | P | P | P | P | P | P | P | P | 5,6 | |
| Abdominal[1] | P | P | P | P | P | P | P | P | P | P | 5,6 | |
| Pediatric | ||||||||||||
| Small Organ[2] | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Cardiac Adult | ||||||||||||
| Cardiac Pediatric | ||||||||||||
| Peripheral Vascular | ||||||||||||
| Musculo-skeletal Conventional | ||||||||||||
| Musculo-skeletal Superficial | ||||||||||||
| Other [4] | P | P | P | P | P | P | P | P | P | P | 5,6 | |
| Exam Type, Means of Access | ||||||||||||
| Transesophageal | ||||||||||||
| Transrectal | P | P | P | P | P | P | P | P | P | P | 5,6 | |
| Transvaginal | P | P | P | P | P | P | P | P | P | P | 5,6 | |
| Transurethral | ||||||||||||
| Intraoperative[8] | ||||||||||||
| Intraoperative Neurological | ||||||||||||
| Intravascular | ||||||||||||
| Laparoscopic |
N = new indication; P* = previously cleared by FDA (K163077)
[1] Abdominal includes Renal, GYN/Pelvic. Notes:
[2] Small organ includes breast, testes and thyroid
[3] Elastography Imaging - Elasticity.
[4] Other use includes Urology/Prostate
[5] 3D/4D Imaging mode
[6] Needle guidance imaging
[7] Includes infertility monitoring of follicle development, GYN
[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)
[9] Volume navigation
[10] Shear wave elastography
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
System provides real-time 3D and 4D acquisition when used with special 4D probes
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
15
Image /page/15/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The letters are enclosed within a circular border that has decorative swirls or flourishes around the perimeter. The logo is presented in a blue color.
Diagnostic Ultrasound Indications for Use Form LOGIQ E10 with 6Tc-RS Transducer
Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PW | 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[7] | |||||||||||
| Abdominal[1] | |||||||||||
| Pediatric | |||||||||||
| Small Organ[2] | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac Adult | P | P | P | P | P | P | P | P | P | P | |
| Cardiac Pediatric | |||||||||||
| 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 | |||||||||||
| Transurethral | |||||||||||
| Intraoperative[8] | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA (K170445)
[1] Abdominal includes Renal, GYN/Pelvic. Notes:
[2] Small organ includes breast, testes and thyroid
[3] Elastography Imaging - Elasticity.
[4] Other use includes Urology/Prostate
[5] 3D/4D Imaging mode
[6] Needle guidance imaging
[7] Includes infertility monitoring of follicle development, GYN
[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)
[9] Volume navigation
[10] Shear wave elastography
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
System provides real-time 3D and 4D acquisition when used with special 4D probes
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
16
Image /page/16/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined in a stylized, cursive font. The letters are enclosed within a circular border, and the entire logo is presented in a blue color.
Diagnostic Ultrasound Indications for Use Form LOGIQ E10 with C1-6-D/C1-6VN-D Transducer
Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | ||||||||||||
| Anatomy/Region of Interest | B | M | PW | |||||||||
| Doppler | CW | |||||||||||
| Doppler | Color | |||||||||||
| Doppler | Color M | |||||||||||
| Doppler | Power | |||||||||||
| Doppler | Combined | |||||||||||
| Modes* | Harmonic | |||||||||||
| Imaging | Coded | |||||||||||
| Pulse® | Other | |||||||||||
| [Notes] | ||||||||||||
| Ophthalmic | ||||||||||||
| Fetal/Obstetrics[7] | P | P | P | P | P | P | P | P | 3,5,6,9 | |||
| Abdominal[1] | P | P | P | P | P | P | P | P | 3,5,6,9,10 | |||
| Pediatric | P | P | P | P | P | P | P | P | 3,5,6,9,10 | |||
| Small Organ[2] | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Cardiac Adult | ||||||||||||
| Cardiac Pediatric | ||||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | P | 3,5,6,9 | |||
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P | 3,5,6,9 | |||
| Musculo-skeletal Superficial | P | P | P | P | P | P | P | P | 3,5,6,9 | |||
| Other [4] | P | P | P | P | P | P | P | P | 3,5,6,9 | |||
| Exam Type, Means of Access | ||||||||||||
| Transesophageal | ||||||||||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Transurethral | ||||||||||||
| Intraoperative[8] | ||||||||||||
| Intraoperative Neurological | ||||||||||||
| Intravascular | ||||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA (K163077)
[1] Abdominal includes Renal, GYN/Pelvic. Notes:
[2] Small organ includes breast, testes and thyroid
[3] Elastography Imaging - Elasticity.
[4] Other use includes Urology/Prostate
[5] 3D/4D Imaging mode
[6] Needle guidance imaging
[7] Includes infertility monitoring of follicle development, GYN
[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)
[9] Volume navigation
[10] Shear wave elastography
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
System provides real-time 3D and 4D acquisition when used with special 4D probes
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
17
Image /page/17/Picture/0 description: The image shows the 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, and the entire logo is presented in a blue color.
Diagnostic Ultrasound Indications for Use Form LOGIQ E10 with C2-7-D/C2-7VN-D Transducer
Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | ||||||||||||
| Anatomy/Region of Interest | B | M | PW | |||||||||
| Doppler | CW | |||||||||||
| Doppler | Color | |||||||||||
| Doppler | Color M | |||||||||||
| Doppler | Power | |||||||||||
| Doppler | Combined | |||||||||||
| Modes* | Harmonic | |||||||||||
| Imaging | Coded | |||||||||||
| Pulse* | Other | |||||||||||
| [Notes] | ||||||||||||
| Ophthalmic | ||||||||||||
| Fetal/Obstetrics[7] | ||||||||||||
| Abdominal[1] | P | P | P | P | P | P | P | P | 5,6,9 | |||
| Pediatric | P | P | P | P | P | P | P | P | 5,6,9 | |||
| Small Organ[2] | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Cardiac Adult | ||||||||||||
| Cardiac Pediatric | ||||||||||||
| Peripheral Vascular | ||||||||||||
| Musculo-skeletal Conventional | ||||||||||||
| Musculo-skeletal Superficial | ||||||||||||
| Other[4] | ||||||||||||
| Exam Type, Means of Access | ||||||||||||
| Transesophageal | ||||||||||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Transurethral | ||||||||||||
| Intraoperative[8] | ||||||||||||
| Intraoperative Neurological | ||||||||||||
| Intravascular | ||||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA (K163077)
[1] Abdominal includes Renal, GYN/Pelvic. Notes:
[2] Small organ includes breast, testes and thyroid
[3] Elastography Imaging - Elasticity.
[4] Other use includes Urology/Prostate
[5] 3D/4D Imaging mode
[6] Needle guidance imaging
[7] Includes infertility monitoring of follicle development, GYN
[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)
[9] Volume navigation
[10] Shear wave elastography
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
System provides real-time 3D and 4D acquisition when used with special 4D probes
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
18
Image /page/18/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized script, enclosed within a blue circle. The letters are white, creating a contrast against the blue background.
Diagnostic Ultrasound Indications for Use Form LOGIQ E10 with C3-10-D Transducer
Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PW | |||||||||
| Doppler | CW | |||||||||||
| Doppler | Color | |||||||||||
| Doppler | Color M | |||||||||||
| Doppler | Power | |||||||||||
| Doppler | Combined | |||||||||||
| Modes* | Harmonic | |||||||||||
| Imaging | Coded | |||||||||||
| Pulse® | Other | |||||||||||
| [Notes] | ||||||||||||
| Anatomy/Region of Interest | ||||||||||||
| Ophthalmic | ||||||||||||
| Fetal/Obstetrics[7] | ||||||||||||
| Abdominal[1] | ||||||||||||
| Pediatric | P | P | P | P | P | P | P | P | 5,6,9 | |||
| Small Organ[2] | P | P | P | P | P | P | P | P | 5,6,9 | |||
| Neonatal Cephalic | P | P | P | P | P | P | P | P | 5,9 | |||
| Adult Cephalic | ||||||||||||
| Cardiac Adult | P | P | P | P | P | P | P | P | 5,6,9 | |||
| Cardiac Pediatric | P | P | P | P | P | P | P | P | 5,6,9 | |||
| Peripheral Vascular | P | P | P | P | P | P | P | P | 5,6,9 | |||
| Musculo-skeletal Conventional | ||||||||||||
| Musculo-skeletal Superficial | ||||||||||||
| Other [4] | ||||||||||||
| Exam Type, Means of Access | ||||||||||||
| Transesophageal | ||||||||||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Transurethral | ||||||||||||
| Intraoperative[8] | ||||||||||||
| Intraoperative Neurological | ||||||||||||
| Intravascular | ||||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA (K163077)
[1] Abdominal includes Renal, GYN/Pelvic. Notes:
[2] Small organ includes breast, testes and thyroid
[3] Elastography Imaging - Elasticity.
[4] Other use includes Urology/Prostate
[5] 3D/4D Imaging mode
[6] Needle guidance imaging
[7] Includes infertility monitoring of follicle development, GYN
[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)
[9] Volume navigation
[10] Shear wave elastography
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
System provides real-time 3D and 4D acquisition when used with special 4D probes
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
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Image /page/19/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized script, enclosed within a circular frame. The frame has decorative flourishes resembling water droplets or stylized leaves. The logo is colored in a light blue hue.
510(k) Summary
| In accordance with 21 CFR 807.92 the following summary of information is provided: | |
|---|---|
| Date: | November 15, 2017 |
| Submitter: | GE Healthcare |
| 9900 Innovation Dr | |
| Wauwatosa, WI 53226 | |
| Manufacturer: | GE Medical Systems Ultrasound and Primary Care Diagnostics, |
| LLC. | |
| 9900 Innovation Drive | |
| Wauwatosa, WI 53226 USA | |
| Primary Contact Person: | Bryan Behn |
| Regulatory Affairs Director | |
| GE Healthcare | |
| T:(414)721-4214 | |
| F:(414)918-8275 | |
| Alternate Contact Person: | |
| Device: | |
| Trade Name: | LOGIQ E10 |
| Common/Usual Name: | LOGIQ E10 |
| Additional Marketing | |
| Names: | LOGIQ E10 Pro, LOGIQ E11, LOGIQ E20 |
| Classification Names: | |
| Product Code: | Class II |
| Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-IYN | |
| Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO | |
| Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX | |
| Primary Predicate Device: | K163077 LOGIQ E9 Diagnostic Ultrasound System |
| Reference Predicate | |
| Device(s): | K170445 LOGIQ S8 Diagnostic Ultrasound System |
| K172342 Voluson E6/E8/E10 Diagnostic Ultrasound System | |
| Device Description: | |
| Intended Use: | The LOGIQ E10 is a full featured, general purpose diagnostic |
| ultrasound system which consists of a mobile console | |
| approximately 585 mm wide (keyboard), 900 mm deep and 1300 | |
| mm high that provides digital acquisition, processing and display | |
| capability. The user interface includes a computer keyboard, | |
| specialized controls, 12-inch LCD touch screen and color | |
| widescreen monitor. | |
| The device is intended for use by a qualified physician for | |
| Technology: | The LOGIQ E10 employs the same fundamental scientific |
| technology as its predicate device(s). | |
| ultrasound evaluation of Fetal/Obstetrics; Abdominal; Pediatric; | |
| Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult | |
| Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; | |
| Musculo-skeletal Conventional and Superficial; Urology | |
| (including prostate); Transrectal; Transvaginal; Transesophageal | |
| and Intraoperative (vascular). | |
| Determination of | |
| Substantial Equivalence: | Comparison to Predicates |
| The proposed LOGIQ E10 is a new platform substantially | |
| equivalent to the predicate devices. The following is an overview of the differences between the proposed LOGIQ E10 and the predicate LOGIQ E9 (K163077). The systems are all intended for diagnostic ultrasound imaging and fluid flow analysis. The LOGIQ E10 and predicate LOGIQ E9 systems have | |
| the same clinical intended use. The LOGIQ E10 and predicate LOGIQ E9 systems have | |
| the same imaging modes The systems are manufactured with materials which have | |
| been evaluated and found to be safe for the intended use | |
| of the device. The systems have acoustic power levels which are below | |
| the applicable FDA limits. The LOGIQ E10 and predicate LOGIQ E9 systems have | |
| similar capability in terms of performing measurements, | |
| capturing digital images, reviewing and reporting studies. The LOGIQ E10 and predicate systems have been | |
| designed in compliance with approved electrical and | |
| physical safety standards. The following probe and feature has been migrated from | |
| the LOGIQ S8 (K170445): M5Sc-D probe and power | |
| assistant. The following features have been migrated from the | |
| VOLUSON E Series (K172342) STIC, Elastography | |
| Analysis and Omniview with VCI. The new probes L2-9-D, L2-9VN-D, ML4-16-D, ML4- | |
| 16VN-D are incremental technology improvements to | |
| predicate probes 9L-D and ML6-15-D on the predicate | |
| LOGIQ E9 (K163077) |
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Image /page/20/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined within a blue circular frame. The frame has decorative swirls around the perimeter, giving it a classic and recognizable appearance. The logo is simple, yet distinctive, representing the brand identity of General Electric.
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Image /page/21/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized script, enclosed within a circular border. The border has a swirling design, giving it a dynamic and fluid appearance. The logo is presented in a blue color scheme.
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 E10 and its applications comply with voluntary standards:
- AAMI/ANSI ES60601-1, Medical Electrical Equipment -Part 1: General Requirements for Safety, 2005/(R)2012 And A1:2012
- IEC60601-1-2 Medical Electrical Equipment Part 1-2: ● General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility Requirements and Tests, 2007
- IEC60601-2-37, Medical Electrical Equipment Part 2-● 37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment, 2007
- ISO10993-1, Biological Evaluation of Medical Devices-. Part 1: Evaluation and Testing- Third Edition, 2009
- . NEMA UD 2, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment:2004
- ISO14971, Application of risk management to medical devices: Second edition 2007
- NEMA PS 3.1 - 3.20 (2011), Digital Imaging and Communications in Medicine (DICOM) Set. (Radiology)
The following quality assurance measures are applied to the development of the system:
- Risk Analysis ●
- Requirements Reviews ●
- Design Reviews ●
- Testing on unit level (Module verification) ●
- Integration testing (System verification) ●
- Final Acceptance Testing (Validation) ●
- Performance testing (Verification) ●
- Safety testing (Verification) .
Transducer materials and other patient contact materials are biocompatible.
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Image /page/22/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a blue circle. The circle is surrounded by what appear to be stylized water droplets or swirls, also in blue. The logo is simple, recognizable, and represents the company's brand identity.
Summary of Clinical Tests:
The subject of this premarket submission, LOGIQ E10, did not require clinical studies to support substantial equivalence.
GE Healthcare considers the LOGIQ E10 to be as safe, as Conclusion: effective, and performance is substantially equivalent to the predicate device(s).