Yes
The document explicitly mentions "AI Testing Summary" and lists features like "Auto preset selection" and "Auto Abdominal Color Assistant" which are described as being generated by "AI software".
No.
The device is described as a "general-purpose diagnostic ultrasound system" intended for "ultrasound imaging, measurement, display and analysis," which indicates it is used for diagnosis, not therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states, "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."
No
The device description explicitly states it is a "full featured, Track 3 device, primarily intended for general purpose diagnostic ultrasound system which consists of a mobile console approximately 490mm wide...". This indicates the device includes significant hardware components beyond just software.
Based on the provided information, the LOGIQ Totus is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: In Vitro Diagnostic devices are used to examine specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- LOGIQ Totus Function: The LOGIQ Totus is a diagnostic ultrasound system. It uses sound waves to create images of internal body structures. It does not analyze biological specimens.
- Intended Use: The intended use clearly states it's for "ultrasound imaging, measurement, display and analysis of the human body and fluid." This is in vivo (within the living body) imaging, not in vitro (in glass or outside the body) analysis of specimens.
- Device Description: The description focuses on the physical console, user interface, and imaging capabilities, not on handling or analyzing biological samples.
- Clinical Applications: The listed clinical applications are all based on imaging internal anatomy.
Therefore, the LOGIQ Totus falls under the category of medical imaging devices, not In Vitro Diagnostic devices.
No
The input text does not include any explicit statement that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / 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); 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.
Product codes
IYN, IYO, ITX, QIH
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.
The user interface includes a computer keyboard, specialized controls. 14-inch LCD touch screen and color 23.8-inch LCD & HDU image display.
Mentions image processing
digital acquisition, processing and display capability.
Mentions AI, DNN, or ML
AI Testing Summary:
- Auto preset selection
- Auto Abdominal Color Assistant
Input Imaging Modality
Ultrasound
Anatomical Site
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.
Indicated Patient Age Range
Adult and Pediatric; Neonatal; Reproductive age
Intended User / Care Setting
qualified and trained healthcare professionals
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.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Auto preset selection:
- Sample size: 50+ patients, 330+ images
- Data source: USA(57%) and Australia(43%). Mix of data from across 4 different probe models with LOGIQ Totus console.
- Annotation protocol: 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.
- Independence: 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:
- Sample size: 40 patients, 280+ images
- Data source: USA(35%) and Australia(65%). Mix of data from across 4 different probe models with LOGIQ Totus console.
- Annotation protocol: 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.
- Independence: 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 Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Auto preset selection:
- Study type: Performance testing
- Sample size: 50+ patients, 330+ images
- Key results: 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.
Auto Abdominal Color Assistant:
- Study type: Performance testing
- Sample size: 40 patients, 280+ images
- Key results: The overall model success rate of the Aorta, Kidney, Liver, GB and Pancreas view suggestion is expected to be 80% or higher.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Auto preset selection: Overall model success rate expected to be 80% or higher.
Auto Abdominal Color Assistant: Overall model success rate expected to be 80% or higher.
Predicate Device(s)
K211524 LOGIQ E10s, LOGIQ Fortis Diagnostic Ultrasound System
Reference Device(s)
K202035 Vscan Air, K200743 Vivid E80/Vivid E90/Vivid E95 R4
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
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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)
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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. |
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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 |
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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 ●
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- 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 |
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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 |
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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
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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).