Who is the manufacturer of LOGIQ E10?

GE Medical Systems Ultrasound and Primary Care Diagnostics filed the 510(k) submission for LOGIQ E10 (K231966).

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).

Does LOGIQ E10 use AI or machine learning?

Yes. LOGIQ E10 (K231966) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

What are the predicate devices for LOGIQ E10?

LOGIQ E10 Diagnostic Ultrasound System (K211488); LOGIQ E10s and FORTIS R3 Diagnostic Ultrasound System (K211524).

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.

Can an AI/ML device like LOGIQ E10 get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

LOGIQ E10

K231966 · GE Medical Systems Ultrasound and Primary Care Diagnostics · IYN · Nov 7, 2023 · Radiology

Device Facts

Record ID	K231966
Device Name	LOGIQ E10
Applicant	GE Medical Systems Ultrasound and Primary Care Diagnostics
Product Code	IYN · Radiology
Decision Date	Nov 7, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1550
Device Class	Class 2
Attributes	AI/ML, Pediatric

Intended Use

LOGIQ E10 is intended for use by a qualified physician for ultrasound evaluation of Fetal / Obstetrics; Abdominal (including Renal, Gynecology/Pelvic); Pediatric; Small Organ (Breast, Testes, Thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (Adult and Pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including Prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (Abdominal and Vascular). Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, Shear Wave Elastography, Attenuation Imaging and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/PWD. The LOGIQ E10 is intended to be used in a hospital or medical clinic.

Device Story

LOGIQ E10 is a mobile diagnostic ultrasound console; provides digital acquisition, processing, and display of ultrasound images. Inputs: ultrasound signals from various probes. Processing: system performs B-mode, Doppler, 3D/4D, and elastography imaging; includes AI-assisted tools for automated measurements and view suggestions. Outputs: real-time images and measurements on a 23.8-inch LED LCD monitor and 12-inch touch screen. Used by physicians in hospitals/clinics for diagnostic evaluation. AI features (Auto Renal Measure, Auto Color/Preset Assistants) aid clinicians by suggesting views or automating measurements, potentially increasing workflow efficiency and consistency. Healthcare providers use outputs to inform clinical decisions regarding patient anatomy and pathology.

Clinical Evidence

No clinical studies required. Bench testing only. Performance of AI features (Auto Renal Measure, Auto Abdominal/Preset Assistants) validated using prospective datasets of 30-110+ patients. Metrics: Auto Renal Measure accuracy 92.94%-96.45% (longitudinal/transverse); Auto Abdominal/Preset view suggestion success rates ≥80%. Ground truth established by certified sonographers/clinicians and arbitrated by a nephrologist.

Technological Characteristics

Mobile console (585mm x 991mm x 1300mm). 23.8-inch LED LCD monitor, 12-inch touch screen. Supports various probes (e.g., L4-20t-D, P8D). Complies with AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, ISO 14971. Connectivity: DICOM. Software includes AI-based automated measurement and view suggestion tools.

Indications for Use

Indicated for ultrasound evaluation of fetal/obstetrics, abdominal, pediatric, small organ, neonatal/adult cephalic, cardiac, peripheral vascular, musculoskeletal, and urological applications in hospital or clinic settings 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 E10 Diagnostic Ultrasound System (K211488)
LOGIQ E10s and FORTIS R3 Diagnostic Ultrasound System (K211524)

Reference Devices

Vivid E80/ Vivid E90/ Vivid E95 R3 Diagnostic Ultrasound System (K181685)
Vivid E80/ Vivid E90/ Vivid E95 R4 Diagnostic Ultrasound System (K200743)
Vscan Air Ultrasound Transducer (K202035)
L4-20t-D Ultrasound Transducer, Venue Go Diagnostic Ultrasound System (K202233)
P8D Ultrasound Transducer, LOGIQ S8 Diagnostic Ultrasound System (K170445)

Related Devices

K251985 — LOGIQ E10 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Oct 29, 2025
K251963 — LOGIQ E10s · GE Medical Systems Ultrasound and Primary Care Diagnostics · Oct 29, 2025
K253370 — LOGIQ Totus · GE Medical Systems Ultrasound and Primary Care Diagnostics · Jan 8, 2026
K232381 — LOGIQ Totus · GE Medical Systems Ultrasound and Primary Care Diagnostics · Dec 7, 2023
K173555 — LOGIQ E10 · GE Healthcare · Dec 20, 2017

Submission Summary (Full Text)

{0}------------------------------------------------ November 7, 2023 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square. GE Medical Systems Ultrasound and Primary care Diagnostics, LLC % Bryan Behn Regulatory Affairs Director 9900 Innovation Drive WAUWATOSA WI 53226 Re: K231966 Trade/Device Name: LOGIQ E10 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: October 5, 2023 Received: October 6, 2023 Dear Bryan 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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). {1}------------------------------------------------ Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Yanna S. Kang -S Yanna Kang, Ph.D. Assistant Director Mammography and Ultrasound Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health {2}------------------------------------------------ Image /page/2/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 circular frame. The frame is adorned with wave-like elements, giving the logo a dynamic and recognizable appearance. The color of the logo is a light blue. | DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration | Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. | |-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------| |-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------| **Indications for Use** | 510(k) Number (if known) | K231966 | |--------------------------|-----------| | Device Name | LOGIQ E10 | Indications for Use (Describe) LOGIQ E10 is intended for use by a qualified physician for ultrasound evaluation of Fetal / Obstetrics; Abdominal (including Renal, Gynecology/Pelvic); Pediatric; Small Organ (Breast, Testes, Thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (Adult and Pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including Prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (Abdominal and Vascular). Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, Shear Wave Elastography, Attenuation Imaging and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/PWD. The LOGIQ E10 is intended to be used in a hospital or medical clinic. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------| | <label><input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> | 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." {3}------------------------------------------------ K231966 GE Healthcare 510(k) Premarket Notification Submission ### 510(k) Summary In accordance with 21 CFR 807.92 the following summary of information is provided: October 4, 2023 Date: Submitter: GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC 9900 Innovation Dr Wauwatosa, WI 53226 Manufacturer: GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC 9900 Innovation Dr Wauwatosa, WI 53226 Primary Contact Person: Bryan Behn Regulatory Affairs Director GE Healthcare E: bryan.behn@ge.com T: (262) 247-5502 Elizabeth Wentworth Alternate Contact Person: Regulatory Affairs Leader GE Healthcare LOGIO E10 Device: Trade Name: Common/Usual Name: LOGIQ E10 Classification Names: Class II Product Code: IYN (primary), IYO, ITX (secondary) 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: K211488 LOGIQ E10 Diagnostic Ultrasound System K211524 LOGIQ E10s and FORTIS R3 Diagnostic Ultrasound System Reference Device(s): K181685 Vivid E80/ Vivid E90/ Vivid E95 R3 Diagnostic Ultrasound System K200743 Vivid E80/ Vivid E90/ Vivid E95 R4 Diagnostic Ultrasound System K202035 Vscan Air Ultrasound Transducer K202233 L4-20t-D Ultrasound Transducer, Venue Go Diagnostic Ultrasound System K170445 P8D Ultrasound Transducer , LOGIQ S8 Diagnostic Ultrasound System Device Description: The LOGIO E10 is a full featured, track 3, general purpose diagnostic ultrasound system which consists of a mobile console approximately 585 {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. Three curved lines emanate from the circle, creating a sense of motion or energy around the letters. mm wide (keyboard), 991 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 highresolution color touch screen and 23.8-inch High Contrast LED LCD monitor. LOGIQ E10 is intended for use by a qualified physician for ultrasound Indications for Use: evaluation of Fetal / Obstetrics; Abdominal (including Renal, Gynecology/Pelvic); Pediatric; Small Organ (Breast, Testes, Thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (Adult and Pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including -------------------------------------------------------------------------------------------------------------------------------------------------------------------Prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (Abdominal and Vascular). > Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, Shear Wave Elastography, Attenuation Imaging and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/PWD. The LOGIQ E10 is intended to be used in a hospital or medical clinic. > The LOGIO E10 employs the same fundamental scientific technology as its predicate device(s). ## Technology: Determination of Comparison to Predicates Substantial Equivalence: The proposed LOGIQ E10 is substantially equivalent to the predicate devices. The following is an overview of the differences between the proposed LOGIO E10 and the predicate LOGIO E10 (K211488). The systems are all intended for diagnostic ultrasound imaging and fluid flow analysis. · The LOGIQ E10 and predicate LOGIQ E10 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 LOGIO E10 and predicate LOGIO E10 systems have similar capability in terms of performing measurements, capturing digital images, reviewing and reporting studies. · The LOGIO E10 and predicate LOGIO E10 systems have been designed in compliance with approved electrical and physical safety standards. Probes: The probes supported in proposed LOGIQ E10, and predicate {5}------------------------------------------------ Image /page/5/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 frame. The frame has decorative swirls or flourishes around the perimeter, giving it a classic and recognizable appearance. The logo is presented in a blue color. ## GE Healthcare 510(k) Premarket Notification Submission ## LOGIQ E10 are identical except: - Addition of new probes: . - L4-20t-D probe with button control (L4-20t-D probe is . substantial equivalent to L4-20t-RS probe cleared on the Venue Go K202233). - P8D probe (migrated from LOGIQ S8 K170445). ● ### Software: - The software features supported in proposed LOGIQ E10 ● and the predicate LOGIQ E10 are identical except: - Addition of new software features: - Auto Preset Assistant - Auto Color Assistant - Auto Renal Measure Assistant - APP Launchpad - Raw Data Streaming/Network Streaming - Auto EF2.0 / AFI 2.0 - Vscan Air CL Support - CEUS LI-RADS check-sheet ● ### Hardware: - The hardware in proposed LOGIQ E10 LOGIQ and the ● predicate LOGIQ E10s (K211524) are identical. Compatible devices: - Addition of Vscan Air CL, wifi USB for Vscan Air CL and Wireless charger. #### Appearance: - Minor updates on device front cover. Addition of U-light. {6}------------------------------------------------ Image /page/6/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 frame. The frame is made up of swirling, wave-like elements. The logo is colored in a shade of blue. ## AI Testing Summary ## Auto Renal Measure Assistant : Al Summary of Testing | Summary test statistics or other test results including acceptance criteria or other information supporting the appropriateness of the characterized performance | For Longitudinal model the accuracy of measurement is expected to be higher than 80% and for the Transverse model it is expected to be higher than 70% | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Information about clinical subgroups and confounders present in the dataset | The number of individual patients' images were collected from: 30 Patients. | | | The number of samples is 60 with 30 Longitudinal views and 30 Transverse view | | | Gender: Male & Female | | | Age: range 26-81 yrs old | | | Ethnicity/Country; USA (58%) and Japan (42%) | | Information about equipment and protocols used to collect images | The datasetused for final verification was collected prospectively on 30 demographically diverse patients at 2 sites: Japan and the USA exclusively with the system under consideration GE Logiq Fortis after the Auto Renal Measure Assistant function was developed using C1-6-D probe in Abdomen application; | | Information about how the reference standard was derived from the dataset (i.e. the "truthing" process) | The Validation set of 30 patient ( 60 images ) were loaded onto the LOGIQ validation system. | | | 2 Readers (certified sonographer/Clinician) to ground truth the measurements: Length on the Longitudinal views and the Height and Width Measurements on the Transverse views. | | | Board Certified Nephrologist arbitrated the ground truth between the above two readers to establish the reference standard for the dataset | | | Summary of Results: The Longitudinal model for length measurements has average accuracy of 96.45 with 95% CI of ± 1.26% and average absolute error of 0.35cm at 95% CI of ±0.12 cm. The Transverse model for width measurements has average accuracy of 92.94% with 95% CI of ± 3.02% and average absolute error of 0.38cm at 95% CI of ±0.14 cm. The Transverse model for width measurements has average accuracy of 93.13% with 95% CI of ± 3.63% and average | | | absolute error of 0.37cm at 95% CI of ±0.14 cm. | | | | | Description of how independence of test data from training data was ensured | The verification data was acquired independently during validation process after the development of the model as described above. | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the General Electric (GE) logo, which consists of the letters 'GE' in a stylized script, enclosed within a circular frame. The logo is colored in a bright blue hue. The circular frame has decorative swirls or flourishes around it, adding a touch of elegance to the design. The logo is simple, yet recognizable. ## Auto Abdominal Color Assistant : Al Summary of Testing | Summary test statistics or other test results including acceptance criteria or other information supporting the appropriateness of the characterized performance | The overall model success rate of the Aorta, Kidney, Liver, GB, and Pancreas view suggestion is expected to be 80% or higher. The number of individual patients' images were collected from: 50+ patients The number of samples, if different from above, and the relationship between the two: 1100+ images | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Information about clinical subgroups and confounders present in the dataset | Gender: Male & Female Age: Wide range, but specific age not collected Ethnicity/Country; USA (77%) and Australia (23%) | | Information about equipment and protocols used to collect images | Mix of data from across three different probe models and two different Console variants. The data collection protocol was standardized across all data collection sites. | | Information about how the reference standard was derived from the dataset (i.e. the "truthing" process) | Before the process of data annotation, all information displayed on the device is removed and performed on information extracted purely from Ultrasound B-mode images. Readers (certified sonographer/Clinician) to ground truth the "anatomy" visible in static B-Mode image. (Before running AI) Ran AI and created confusion matrix of ground truth vs AI predictions. Calculated the accuracies of the algorithm against each class. | | Description of how independence of test data from training data was ensured | The exams used for test/training validation purpose are separated from the ones used during training process and there is no overlap between the two. | | Summary test statistics or other test results including acceptance criteria or other information supporting the appropriateness of the characterized performance | • The overall model success rate of the Abdomen, Air, Breast, Carotid, Leg, MSK, Scrotal, Thyroid and Carotid/Thyroid (Mixed) view suggestion is expected to be 80% or higher. | | | • The number of individual patients' images were collected from: 110+ patients • The number of samples, if different from above, and the relationship between the two: 2600+ images | | Information about clinical subgroups and confounders present in the dataset | • Gender: Male & Female • Age: Wide range, but specific age not collected • Ethnicity/Country; USA (41.2%) , Austria (3.8%), Australia (1.1%), Japan (41.3%), Italy (0.7%) and Greece (12%). | | Information about equipment and protocols used to collect images | Mix of data from across five different probe models and three different Console variants. The data collection protocol was standardized across all data collection sites. | | Information about how the reference standard was derived from the dataset (i.e. the "truthing" process) | • Before the process of data annotation, all information displayed on the device is removed and performed on information extracted purely from Ultrasound B-mode images. | | | • Readers (certified sonographer/Clinician) to ground truth the "anatomy" visible in static B- Mode image. (Before running AI) • Ran AI and created confusion matrix of ground truth vs AI predictions. • Calculated the accuracies of the algorithm against each class. | | Description of how independence of test data from training data was ensured | The exams used for test/training validation purpose are separated from the ones used during training process and there is no overlap between the two. | {8}------------------------------------------------ Image /page/8/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. There are swirling designs around the letters, giving the logo a classic and recognizable look. The blue color is consistent throughout the logo. #### Auto Preset Assistant : Al Summary of Testing ## 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 {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 blue circle. There are also four white teardrop shapes surrounding the circle, positioned at the cardinal directions. applications comply with voluntary standards: - AAMI/ANSI ES60601-1, Medical Electrical Equipment Part 1: ● General Requirements for Safety, 2005/(R)2012 And A1:2012 - . IEC 60601-1-2 Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance -Collateral Standard: Electromagnetic Disturbance - Requirements and Tests, 2014 - . IEC 60601-2-37, Medical Electrical Equipment - Part 2-37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment, 2015 - ISO 10993-1, Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing Within A Risk Management Process, 2018 - ISO 14971, Application of risk management to medical devices, 2012 - NEMA PS 3.1 3.20, Digital Imaging and Communications in ● Medicine (DICOM) Set. (Radiology) 2016 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) - Performance testing (Verification) ● - Safety testing (Verification) ● Transducer materials and other patient contact materials are biocompatible. Summary of Clinical Tests: The subject of this premarket submission, LOGIO E10, did not require clinical studies to support substantial equivalence. Conclusion: GE Healthcare considers the LOGIQ E10 to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).