Who is the manufacturer of LOGIQ E10?

GE Healthcare filed the 510(k) submission for LOGIQ E10 (K173555).

What is the FDA product code for LOGIQ E10?

IYN. It is classified under 21 CFR 892.1550 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for LOGIQ E10?

510(k) clearance (submission type: Traditional).

What are the predicate devices for LOGIQ E10?

LOGIQ E9 Diagnostic Ultrasound System (K163077).

Who can help prepare an FDA 510(k) submission like LOGIQ E10?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

LOGIQ E10

K173555 · GE Healthcare · IYN · Dec 20, 2017 · Radiology

Device Facts

Record ID	K173555
Device Name	LOGIQ E10
Applicant	GE Healthcare
Product Code	IYN · Radiology
Decision Date	Dec 20, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1550
Device Class	Class 2
Attributes	Pediatric

Intended 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).

Device Story

The LOGIQ E10 is a mobile, general-purpose diagnostic ultrasound system. It acquires, processes, and displays ultrasound signals to produce diagnostic images and perform fluid flow analysis. The system consists of a console with a keyboard, specialized controls, a 12-inch LCD touch screen, and a color widescreen monitor. It is operated by qualified physicians in clinical settings. The device transforms acoustic inputs from various transducers into real-time 2D, 3D, and 4D images, supporting modes such as B-mode, M-mode, PW/CW/Color/Power Doppler, and elastography. The output is displayed for the clinician to review, measure, and report, aiding in diagnostic decision-making across multiple anatomical regions. The system benefits patients by providing non-invasive, real-time diagnostic imaging for a wide range of clinical applications.

Clinical Evidence

No clinical studies were required to support substantial equivalence. The device was evaluated through non-clinical bench testing, including acoustic output, biocompatibility, cleaning/disinfection effectiveness, and thermal, electrical, electromagnetic, and mechanical safety testing in accordance with recognized standards (e.g., AAMI/ANSI ES60601-1, IEC60601-2-37, NEMA UD 2).

Technological Characteristics

Mobile console ultrasound system with digital acquisition and processing. Supports B, M, PW/CW/Color/Power Doppler, combined modes, harmonic imaging, and coded pulse. Features include 3D/4D imaging, elastography, and volume navigation. Complies with AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, and ISO10993-1. Connectivity via DICOM (NEMA PS 3.1-3.20).

Indications for Use

Indicated for ultrasound evaluation of fetal, abdominal, pediatric, small organ (breast, testes, thyroid), neonatal/adult cephalic, cardiac (adult/pediatric), peripheral vascular, musculoskeletal (conventional/superficial), urological (including prostate), transrectal, transvaginal, transesophageal, and intraoperative (vascular) applications. Intended for use by qualified physicians.

Regulatory Classification

Identification

An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

LOGIQ E9 Diagnostic Ultrasound System (K163077)

Reference Devices

LOGIQ S8 Diagnostic Ultrasound System (K170445)
Voluson E6/E8/E10 Diagnostic Ultrasound System (K172342)

Related Devices

K123564 — LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM · GE Healthcare · Dec 18, 2012
K200158 — LOGIQ E10 · GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · Apr 17, 2020
K200119 — LOGIQ E10s · GE Medical Systems Ultrasound and Primary Care Diagnostics · Apr 1, 2020
K110943 — LOGIQ E9 · GE Healthcare · Jul 22, 2011
K142160 — LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM · GE Healthcare · Oct 10, 2014

Submission Summary (Full Text)

{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}------------------------------------------------ Image /page/2/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 font in the center. The circle is surrounded by a decorative border with swirling patterns. The logo is simple and recognizable, and it is associated with a well-known company. 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}------------------------------------------------ Image /page/4/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 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 Ultraso…