Who is the manufacturer of LOGIQ Totus?

GE Medical Systems Ultrasound and Primary Care Diagnostics filed the 510(k) submission for LOGIQ Totus (K232381).

What is the FDA product code for LOGIQ Totus?

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 Totus?

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

Does LOGIQ Totus use AI or machine learning?

Yes. LOGIQ Totus (K232381) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

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

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 Totus 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 Totus

Q: What are the predicate devices for LOGIQ Totus?

LOGIQ E10s, LOGIQ Fortis (K211524).

K232381 · GE Medical Systems Ultrasound and Primary Care Diagnostics · IYN · Dec 7, 2023 · Radiology

Device Facts

Record ID	K232381
Device Name	LOGIQ Totus
Applicant	GE Medical Systems Ultrasound and Primary Care Diagnostics
Product Code	IYN · Radiology
Decision Date	Dec 7, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1550
Device Class	Class 2
Attributes	AI/ML, Pediatric

AI Performance

Output	Algorithm	Acceptance	Observed	Dev DS	Dev Readers	Test DS	Test Readers
Auto Preset Selection	—	success rate >= 80%	>= 80%	330+ images from 50+ patients	>1 (sonographer/clinician)	—	—
Auto Abdominal Color Assistant	—	success rate >= 80%	>= 80%	280+ images from 40 patients	>1 (sonographer/clinician)	—	—

Indications for Use

The LOGIQ Totus is a general-purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. LOGIQ Totus clinical applications include: 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. 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, Contrast Enhanced Imaging and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/PWD. The system is intended to be used in Hospital or Clinical environments such as Intensive Care Unit(ICU, CVICU, CCU), Neonatal Intensive Care Unit(NICU), Pediatric Intensive Care Unit(PICU), Emergency Room, Operating Room, Outpatient Surgery Clinic, Radiology, Medical Office (Nurse Practitioner), Observational Units, Cath Lab, Clinic, Physician's Office, Labor/Deliver Unit and Oncology.

Device Story

Mobile diagnostic ultrasound console; provides digital acquisition, processing, and display of ultrasound images. Inputs: ultrasound signals from various probes. Processing: digital signal processing, AI-assisted preset selection, and abdominal color assistance. Outputs: real-time images, measurements, and analysis on 23.8-inch HDU display and 14-inch touch screen. Used in hospitals/clinics by sonographers/physicians. Assists clinicians in diagnostic imaging and fluid flow analysis; supports clinical decision-making through automated view suggestions and measurement tools.

Clinical Evidence

No clinical studies required. Substantial equivalence supported by non-clinical bench testing, including acoustic output, biocompatibility, electrical/mechanical safety, and software verification/validation. AI algorithm performance validated using datasets (50+ patients for Auto Preset; 40 patients for Auto Abdominal Color) with success rates ≥80%.

Technological Characteristics

Mobile console (490mm x 835mm x 1415-1815mm); 23.8-inch HDU display; 14-inch touch screen. Modalities: B, M, Doppler (PW/CW/Color/Power), 3D/4D, Elastography, Contrast. Connectivity: DICOM. Biocompatible patient-contact materials. Standards: ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, ISO 14971, IEC 62359.

Indications for Use

Indicated for ultrasound imaging, measurement, and analysis of human body and fluid in patients requiring diagnostic ultrasound. Applications include fetal/obstetrics, abdominal, pediatric, small organ, neonatal/adult cephalic, cardiac, vascular, musculoskeletal, and urology. Used by qualified healthcare professionals in clinical/hospital settings.

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 E10s, LOGIQ Fortis (K211524)

Reference Devices

Vscan Air (K202035)
Vivid E80/Vivid E90/Vivid E95 R4 (K200743)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 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 and Human Services seal on the left and the FDA acronym and name on the right. The FDA acronym is in a blue box, and the full name is in blue text. December 7, 2023 GE Medical Systems Ultrasound and Primary Care Diagnostics % Bryan Behn Regulatory Affairs Director GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC 9900 Innovation Drive WAUWATOSA WI 53226 Re: K232381 Trade/Device Name: LOGIO Totus Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX, QIH Dated: November 16, 2023 Received: November 16, 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}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K232381 Device Name LOGIQ Totus #### Indications for Use (Describe) The LOGIQ Totus is a general-purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. LOGIO Totus clinical applications include: 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); Transvaginal. Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppier, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, Shear Wave Elastography, Attenuation Imaging, Contrast, Enhanced Imaging and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/PWD. The system is intended to be used in Hospital or Clinical environments such as Intensive Care Unit(ICU, CVICU, CCU), Neonatal Intensive Care Unit(NICU), Pediatric Intensive Care Unit(PICU), Emergency Room, Operating Room, Outpatient Surgery Clinic, Radiology, Medical Office(Nurse Practitioner), Observational Units, Cath Lab, Clinic, Physician's Office, Labor/Deliver Unit and Oncology. Type of Use (Select one or both, as applicable) X 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 Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the GE HealthCare logo. The logo consists of a circular symbol with a stylized "GE" inside, followed by the text "GE HealthCare". The logo and text are both in a purple color. GE Healthcare 510(k) Premarket Notification Submission ### 510(k) Summary # K232381 | In accordance with 21 CFR 807.92 the following summary of information is provided: | | |------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Date: | Dec 5, 2023 | | Submitter: | GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC. 9900 Innovation Dr Wauwatosa, WI 53226 | | Manufacturer: | GE Ultrasound Korea, Ltd. 9, Sunhwan-ro 214 beon-gil, Jungwon-gu, Seongnam- si, Gyeonggi-do 13204, Republic of Korea | | Primary Contact Person: | Bryan Behn Regulatory Affairs Director GE Healthcare T:(262)-247-5502 | | Alternate Contact Person: | Chae-Rin, Song Regulatory Affairs Leader GE Healthcare GE Ultrasound Korea, Ltd. T: +82-31-740-6310 | | Device: | LOGIQ Totus | | Common/Usual Name: | Diagnostic Ultrasound System | | Classification Names: | Class II | | Product Code: | IYN(primary), IYO, ITX, QIH (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, 21CFR 892.2050 | | Primary Predicate Device: | K211524 LOGIQ E10s, LOGIQ Fortis Diagnostic Ultrasound System | | Reference Predicate Device(s): | K202035 Vscan Air K200743 Vivid E80/Vivid E90/Vivid E95 R4 | | Device Description: | The LOGIQ Totus is full featured, Track 3 device, primarily intended for general purpose diagnostic ultrasound system which consists of a mobile console approximately 490mm wide(monitor width: 545mm), 835mm deep and 1415~1815mm high that provides digital acquisition, processing and display capability. | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for GE HealthCare. The logo consists of a circular emblem on the left and the text "GE HealthCare" on the right. The emblem is purple and features a stylized "GE" monogram. The text "GE HealthCare" is also purple and is written in a sans-serif font. Indications for Use: specialized controls. 14-inch LCD touch screen and color 23.8-inch LCD & HDU image display. The LOGIQ Totus is a general-purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. LOGIQ Totus clinical applications include: 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. 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, Contrast Enhanced Imaging and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/PWD. The system is intended to be used in Hospital or Clinical environments such as Intensive Care Unit(ICU, CVICU, CCU), Neonatal Intensive Care Unit(NICU), Pediatric Intensive Care Unit(PICU), Emergency Room, Operating Room, Outpatient Surgery Clinic, Radiology, Medical Office (Nurse Practitioner), Observational Units, Cath Lab, Clinic, Physician's Office, Labor/Deliver Unit and Oncology. The user interface includes a computer keyboard, | Technology: | The LOGIQ Totus employs the same fundamental scientific technology as its predicate devices. | |----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Determination of Substantial Equivalence: | The proposed LOGIQ Totus systems is substantially equivalent to the predicate LOGIQ E10s and LOGIQ Fortis(K211524) with regards to intended use, imaging capabilities, technological characteristics, imaging modes, hardware, and safety effectiveness. The system is all intended for diagnostic ultrasound imaging and fluid flow analysis. The Proposed LOGIQ Totus and the predicate LOGIQ E10s and LOGIQ Fortis(K211524) have the same | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for GE HealthCare. The logo consists of a circular emblem with a stylized "GE" monogram in purple. To the right of the emblem, the words "GE HealthCare" are written in a simple, sans-serif font, also in purple. clinical intended use except Transesophageal and Intraoperative(Abdominal, Vascular). LOGIQ Totus doesn't include both clinical applications. The proposed LOGIQ Totus and the predicate LOGIQ E10s and LOGIQ Fortis(K211524) have the same imaging modes. The proposed LOGIQ Totus are manufactured with materials which have been evaluated and found to be safe for the intended use of the device. The proposed LOGIQ Totus have acoustic power levels which are below the applicable FDA limits. The proposed LOGIQ Totus and the predicate LOGIQ E10s and LOGIQ Fortis(K211524) have similar capability in terms of performing measurements, capturing digital images, reviewing and reporting studies. The proposed LOGIQ Totus have been designed in compliance with approved electrical and physical safety standards. The following is an overview of the differences between the proposed LOGIO Totus and the predicate LOGIQ E10s, LOGIQ Fortis(K211524). #### Probes: The probes supported in prosed LOGIQ Totus and the predicate LOGIQ E10s, LOGIQ Fortis(K211524) are identical except; - Addition - -9S-D (migrated from Vivid E80/E90/E95 R4 K200743) - -12S-D (migrated from Vivid E80/E90/E95 R4 K200743) #### Software: The software features supported in proposed LOGIQ Totus and the predicate LOGIQ E10s, LOGIQ Fortis(K211524) are similar except: - Auto Preset Selection - Auto Abdominal Color Assistant ● {6}------------------------------------------------ Image /page/6/Picture/0 description: The image contains the logo for GE HealthCare. The logo consists of a circular emblem on the left and the text "GE HealthCare" on the right. The emblem is a stylized version of the letters "GE" inside of a circle. The text is in a simple, sans-serif font. - Vscan Air CL Support . - VITA on demand ● - Auto EF/AFI Enhancement ### Compatible device: Addition of Vscan Air CL, WiFi SUB for Vscan Air CL and Wireless Charger ## AI Testing Summary: ### - Auto preset selection: | Summary test statics 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 patient's images were collected from: 50+ patients • The number of samples, if different from above, and the relationship between the two: 330+ images | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Information about clinical subgroups and confounders present in the dataset | • Gender: Male & Female • Age: Reproductive age, specific age not collected. • Ethnicity/Country; USA(57%) and Australia(43%) | | Information about equipment and protocols used to collect images | Mix of data from across 4 different probe models with LOGIQ Totus console. The data collection protocol was standardized across all data | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for GE HealthCare. The logo consists of a purple circular emblem with a stylized "GE" monogram inside. To the right of the emblem, the words "GE HealthCare" are written in a simple, sans-serif font, also in purple. The logo is clean and modern, reflecting the company's focus on technology and healthcare. | | collection sites. | |-----------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Information about how the reference standard was derived from the dataset(i.e. the "truthing" process) | For the testing process, the results are generated by the AI software and the same are verified as Pass or Fail by a certified sonographer/clinician. The results are then aggregated to yield an accuracy metric for the AI algorithm. | | 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. | ## - Auto Abdominal Color Assistant: | 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: 40 patients. • The number of samples, if different from above, and the relationship between the two: 280+ images | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Information about clinical subgroups and confounders present in the dataset | • Gender: Male & Female • Age: Reproductive age, specific age not collected. • Ethnicity/country: USA(35%) and Australia(65%) | | Information about equipment and protocols used to | Mix of data from across 4 different probe models with LOGIQ Totus console. The | {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for GE HealthCare. The logo consists of a circular emblem with a stylized "GE" inside, followed by the text "GE HealthCare" in a sans-serif font. The color of the logo is a shade of purple. GE Healthcare 510(k) Premarket Notification Submission | collect images | 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) | For the testing process, the results are generated by the AI software and the same are verified a Pass or Fail by a certified sonographer / clinician. The results are then aggregated to yield an accuracy metric for the AI algorithm. | | 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 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 to applicable medical device safety standards. The LOGIQ Totus and its applications comply with voluntary standards: - . ANSI AAMI ES60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 2005/(R)2012 And A1:2012, C1:2009/(R)2012 & A2:2010/(R)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, Edition 4.1, 2020 - IEC 60601-2-37, Medical Electrical Equipment ● – Part 2-37: Particular Requirements for the {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for GE HealthCare. The logo consists of the GE monogram in a circle on the left, followed by the words "GE HealthCare" in a sans-serif font. The color of the logo is purple. The logo is simple and modern, and it is easily recognizable. Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment, Edition 2.1, 2015 - ISO 10993-1, Biological Evaluation of Medical . Devices-Part 1: Evaluation and Testing Within A Risk Management Process, Fifth edition, 2018 - . ISO 14971, Medical devices - Application of risk management to medical device, 2019 - IEC 62359, Ultrasonics Field characterization ● - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields, Edition 2.1, 2017 - . 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, LOGIQ Totus, did not require clinical studies to support substantial equivalence. - GE Healthcare considers the LOGIQ Totus to be as Conclusion: safe, as effective, and performance is substantially equivalent to the predicate device(s).

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