(31 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on ultrasound-based technology and viscoelastic properties, with no mention of AI/ML algorithms for analysis or interpretation.
No.
The device is an in vitro diagnostic device intended for evaluating the viscoelastic properties of whole blood to assess coagulation, not for directly treating a medical condition.
Yes
The text explicitly states multiple times that the Quantra System is "intended for in vitro diagnostic use" and is an "in vitro diagnostic device." It also mentions "Results obtained with the Quantra System should not be the sole basis for patient diagnosis," further confirming its role in diagnosis.
No
The device description explicitly states the system consists of a Quantra Hemostasis Analyzer (instrument), single-use disposable cartridges, and quality controls, indicating hardware components are integral to the device's function.
Yes, the provided text explicitly states that the Quantra® System is an IVD (In Vitro Diagnostic).
Here are the key phrases from the text that confirm this:
- "The Quantra® System is intended for in vitro diagnostic use." (from the Intended Use section)
- "The Quantra System is an in vitro diagnostic device..." (from the Device Description section)
N/A
Intended Use / Indications for Use
The Quantra® System is composed of the Quantra Hemostasis Analyzer, QPlus Cartridge, QStat Cartridge, and Quantra Quality Controls Level 1 and 2. The Quantra System is intended for in vitro diagnostic use.
The Quantra Hemostasis Analyzer uses Sonic Estimation of Elasticity via Resonance (SEER) Sonorheometry, an ultrasound-based technology, to measure the shear modulus of whole blood during coagulation. The system is intended to be used by trained professionals at the point-of-care and in clinical laboratories to evaluate the viscoelastic properties of whole blood.
The QPlus Cartridge is a multi-channel cartridge that provides sem-quantitative indications of the coagulation state of a 3.2% citrated venous or arterial whole blood sample. The QPlus Cartridge includes tests to assess coagulation characteristics via the intrinsic pathway, via the extrinsic pathway, and includes tests with a heparin neutralizer. The QPlus Cartridge is indicated for use in cardiovascular or major orthopedic surgeries before, and following the procedure.
The QStat Cartridge is a multi-channel cartridge that provides semi-quantitative indications of the coagulation and clot lysis state of a 3.2% citrated venous whole blood sample. The QStat Cartridge includes tests to assess coagulation characteristics via the intrinsic pathway, via the extrinsic pathway, and includes a test with tranexamic acid to evaluate clot lysis characteristics. The QStat Cartridge is indicated for use in trauma and liver transplantation procedures.
The Quantra System is indicated for the evaluation of blood coagulation in perioperative patients age 18 years and older to assess possible hypocoagulable and hypercoagulable conditions. Results obtained with the Quantra System should not be the sole basis for patient diagnosis.
Product codes
OFR
Device Description
The Quantra System is an in vitro diagnostic device designed to assess a patient's coagulation system by measuring the viscoelastic properties of a blood sample during clot formation and lysis in trauma, surgical and intensive care settings. The system consists of the Quantra Hemostasis Analyzer (instrument), single-use disposable cartridges, (OPlus and OStat cartridges) and Quantra Quality Controls (external Quality Control materials).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound-based technology
Anatomical Site
Not Found
Indicated Patient Age Range
18 years and older
Intended User / Care Setting
trained professionals at the point-of-care and in clinical laboratories
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 864.5430 Coagulation system for the measurement of whole blood viscoelastic properties in perioperative patients.
(a)
Identification. A coagulation system for the measurement of whole blood viscoelastic properties in perioperative patients is an in vitro diagnostic device used to evaluate blood coagulation, fibrinolysis, or both, in perioperative patients, as an aid in the assessment of coagulopathies when used in conjunction with clinical signs and symptoms and other clinical and laboratory findings.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Design verification and validation must include detailed documentation of, and results from, the following:
(i) A study assessing precision using protocols determined to be acceptable by FDA, to cover the measurement range for each reported parameter (test output). Testing must include native specimens with coagulation profiles representative of the intended use population. In order to cover the measuring range, testing may include a limited number of contrived specimens, not to exceed 10 to 20 percent, or as otherwise deemed appropriate by FDA. The contrived specimens must be prepared to resemble clinical specimens. This testing must evaluate repeatability and reproducibility and provide assessments of within-run, within-day, between-run, between-day, between-reagent lot, between-instrument, between-site, and between-operator precision, as applicable to the system;
(ii) Studies that demonstrate the performance of each parameter (test output) throughout the claimed measurement range, to include linearity studies or dose-response studies, as applicable to the parameter (test output);
(iii) Potential interferent study that includes evaluation of hemolyzed and lipemic samples as potential interferents; exogenous and endogenous interferents associated with each patient population intended for use with the device, and which might be expected to affect assay performance, must be evaluated; and potential interferents that are specific for, or related to, the technology or methodology of the device. Evaluation of all potential interferents must be performed using a protocol determined to be acceptable to the FDA (
e.g., an FDA-recognized standard) and include both normal and abnormal specimens covering coagulation profiles representative of the intended use population;(iv) A study that evaluates specimen stability under the intended conditions for specimen collection, handling, and storage, using samples that cover the coagulation profiles representative of the intended use population, and using protocols determined to be acceptable by FDA;
(v) A multisite clinical study, determined to be acceptable by FDA, demonstrating performance, relative to clinically relevant and clinically validated laboratory test(s) for each parameter (test output). Further, the study must meet all of the following criteria:
(A) The study must be performed in the intended use population and include representation from all patient populations for whom the device is intended to be used. Potential endogenous and exogenous interferents for each target patient population must be evaluated or known prior to the study;
(B) The study must be conducted at a minimum of three external sites representative of the intended use setting by the intended operators;
(C) Test samples must be collected at time intervals relevant to the device's use in the intended use population;
(D) Clinical specimens, which cover coagulation profiles representative of the intended use population, must be evaluated at each of the three clinical sites in the study;
(E) Analysis of the concordance of clinical interpretation of patient coagulation status made from individual test parameter (test output) results as compared to clinical interpretation of coagulation status from a clinically relevant laboratory test or tests (
e.g., a comparative viscoelastic device or standard laboratory tests) must be conducted; and(F) Expected (reference) values for each parameter (test output) must be demonstrated by testing a statistically appropriate number of samples from apparently healthy normal individuals;
(vi) For a device with a user interface that has information that needs to be interpreted by the user in correctly using the device to achieve the intended test results or a device that does not provide a final output that is a comprehensive interpretation of all parameter (test output) results, a study evaluating the ability of device users to correctly interpret results;
(vii) For any device indicated to guide blood product use, a clinical outcome study determined to be acceptable by FDA that specifically validates the device's indicated use in guiding blood product use; and
(viii) For any device indicated to guide use of medication, a clinical outcome study determined to be acceptable by FDA that specifically validates the device's indicated use in guiding use of medication.
(2) The labeling required under § 809.10(b) of this chapter must include the following:
(i) A summary of results from the study required by paragraph (b)(1)(i) of this section, including repeatability, reproducibility, and assessments of within-run, within-day, between-run, between-day, between-reagent lot, between-instrument, between-site, and between-operator precision, as applicable to the system.
(ii) The claimed measurement range of each parameter (test output), as supported by demonstrated performance of the parameter (test output) throughout the claimed measurement range, including studies required by paragraphs (b)(1)(i) through (iii) and (v) of this section, and, if applicable, paragraphs (b)(1)(vii) and (viii) of this section.
(iii) Identification of known interferents, including all endogenous, exogenous, technology-specific, and patient population-specific interferents, specific to each parameter (test output). The information must include the concentration(s) or level(s) at which interference was found to occur and the concentration range or levels at which interference was not found to occur.
(iv) Information regarding the multisite clinical study required by paragraph (b)(1)(v) of this section, including:
(A) Each patient population evaluated;
(B) Each intended use setting and the operators;
(C) A summary of the results, including the concordance analysis to clinically relevant laboratory test(s); and
(D) Demonstrated expected (reference) values for each parameter (test output).
(3) The labeling required under § 809.10 of this chapter must include the following:
(i) A limiting statement that the result(s) from the device is(are) not intended to be used as the sole basis for a patient diagnosis.
(ii) Unless appropriate clinical outcome studies are done in accordance with paragraph (b)(1)(vii) of this section that specifically validate an indication for the device's use in guiding blood product use, a limiting statement that the device has not been evaluated to guide blood product use.
(iii) Unless appropriate clinical outcome studies are done in accordance with paragraph (b)(1)(viii) of this section that specifically validate an indication for the device's use in guiding use of medication, a limiting statement that the device has not been evaluated to guide use of medication.
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March 24, 2023
HemoSonics, LLC Debbie Winegar Vice-President, Clinical Affairs 4020 Stirrup Creek Drive. Suite 105 Durham, North Carolina 27703
Re: K230461
Trade/Device Name: Quantra Hemostasis Analyzer Regulation Number: 21 CFR 864.5430 Regulation Name: Coagulation system for the measurement of whole blood viscoelastic properties in perioperative patients Regulatory Class: Class II Product Code: OFR Dated: February 21, 2023 Received: February 21, 2023
Dear Debbie Winegar:
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. 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 located 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.
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
1
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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/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,
Min Wu)-
Min Wu, Ph.D. Branch Chief Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K230461
Device Name Quantra Hemostasis Analyzer
Indications for Use (Describe)
The Quantra® System is composed of the Quantra Hemostasis Analyzer, OPlus Cartridge, and Quantra Quality Controls Level 1 and 2. The Quantra System is intended for in vitro diagnostic use.
The Quantra Hemostasis Analyzer uses Sonic Estimation of Elasticity via Resonance (SEER) Sonorheometry, an ultrasound-based technology, to measure the shear modulus of whole blood during coagulation. The system is intended to be used by trained professionals at the point-of-care and in clinical laboratories to evaluate the viscoelastic properties of whole blood.
The QPlus Cartridge is a multi-channel cartridge that provides sem-quantitative indications of the coagulation state of a 3.2% citrated venous or arterial whole blood sample. The QPlus Cartridge includes tests to assess coagulation characteristics via the intrinsic pathway, via the extrinsic pathway, and includes tests with a heparin neutralizer. The QPlus Cartridge is indicated for use in cardiovascular or major orthopedic surgeries before, and following the procedure.
The QStat Cartridge is a multi-channel cartridge that provides semi-quantitative indications of the coagulation and clot lysis state of a 3.2% citrated venous whole blood sample. The QStat Cartridge includes tests to assess coagulation characteristics via the intrinsic pathway, via the extrinsic pathway, and includes a test with tranexamic acid to evaluate clot lysis characteristics. The QStat Cartridge is indicated for use in trauma and liver transplantation procedures.
The Quantra System is indicated for the evaluation of blood coagulation in perioperative patients age 18 years and older to assess possible hypocoagulable and hypercoagulable conditions. Results obtained with the Quantra System should not be the sole basis for patient diagnosis.
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) |
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Image /page/3/Picture/0 description: The image shows the logo for Hemosonics. The logo consists of a red blood drop with sound waves emanating from the bottom left. To the right of the blood drop is the word "HEMOSONICS" in black, sans-serif font.
SECTION 5: 510(K) SUMMARY
A. APPLICANT INFORMATION
| Submission Date: | February 21, 2023 |
|---|---|
| Submitter Information: | HemoSonics, LLC |
| 4020 Stirrup Creek Drive, Suite 105 | |
| Durham, NC 27703 | |
| Phone: 919-244-6990 | |
| Contact Person: | Deborah Winegar, PhD |
| Email: dwinegar@hemosonics.com | |
| Phone 919-244-6990 |
B. PROPRIETARY AND ESTABLISHED NAMES
Quantra® System
C. REGULATORY INFORMATION
| Trade/Device Name: | Quantra System |
|---|---|
| Regulation Number: | 21 CFR 864.5430 |
| Regulation Name: | Coagulation system for the measurement of whole blood |
| viscoelastic properties in perioperative patients | |
| Regulatory Classification: | Class II |
| Product Code: | QFR |
D. PURPOSE OF SUBMISSION
To implement a new operating system (Microsoft Windows 10 IoT Enterprise LTSC 2019) in the Quantra Hemostasis Analyzer. This change does not affect the device's intended use nor alter the device's fundamental scientific technology.
E. MEASURAND
The combination of clot time and clot stiffness parameters measured from the four channels of the cartridge provides information about the functional role of coagulation factors, fibrinogen, and platelets in the sample.
F. TYPE OF TEST
The Quantra System is an in vitro diagnostic device designed to assess a patient's coagulation system by measuring the viscoelastic properties of a blood sample during clot formation and
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Image /page/4/Picture/0 description: The image contains the logo for Hemosonics. The logo consists of a red blood drop with sound waves emanating from the bottom left. To the right of the blood drop is the word "HEMOSONICS" in a sans-serif font.
lysis in trauma, surgical and intensive care settings. The system consists of the Quantra Hemostasis Analyzer (instrument), single-use disposable cartridges, (OPlus and OStat cartridges) and Quantra Quality Controls (external Quality Control materials).
G. INTENDED USE/INDICATIONS FOR USE
The intended use/indications for use have not been modified from the intended use/indication for use cleared in K213917 and K223433.
The Quantra® System is composed of the Quantra Hemostasis Analyzer, QPlus Cartridge, QStat Cartridge, and Quantra Quality Controls Level 1 and 2. The Quantra System is intended for in vitro diagnostic use.
The Quantra Hemostasis Analyzer uses Sonic Estimation of Elasticity via Resonance (SEER) Sonorheometry, an ultrasound-based technology, to measure the shear modulus of whole blood during coagulation. The QPlus Cartridge is a multi-channel cartridge that provides semiquantitative indications of the coagulation state of a 3.2% citrated venous or arterial whole blood sample. The QPlus Cartridge includes tests to assess coagulation characteristics via the intrinsic pathway, via the extrinsic pathway, and includes tests with a heparin neutralizer. The OStat Cartridge is a multi-channel cartridge that provides semi-quantitative indications of the coagulation and clot lysis state of a 3.2% citrated venous whole blood sample. The QStat Cartridge includes tests to assess coagulation characteristics via the intrinsic pathway, via the extrinsic pathway, and includes a test with tranexamic acid to evaluate clot lysis characteristics.
The system is intended to be used by trained professionals at the point-of-care and in clinical laboratories to evaluate the viscoelastic properties of whole blood.
The Quantra System is indicated for the evaluation of blood coagulation in perioperative patients age 18 years and older to assess possible hypocoagulable and hypercoagulable conditions. The QPlus Cartridge is indicated for use in cardiovascular or major orthopedic surgeries before, during, and following the procedure. The QStat Cartridge is indicated for use in trauma and liver transplantation procedures.
Results obtained with the Quantra System should not be the sole basis for patient diagnosis.
H. DEVICE MODIFICATION DESCRIPTION
The Quantra System was previously cleared under K213917 and K223433. HemoSonics is submitting this Special 510(k) to implement a new operating system (W10IoT) in the Quantra Hemostasis Analyzer.
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Image /page/5/Picture/0 description: The image shows the logo for Hemosonics. The logo consists of a red blood drop with sound waves emanating from it on the left, and the word "HEMOSONICS" in black text on the right. The text is in a sans-serif font.
SUBSTANTIAL EQUIVALENCE INFORMATION
Predicate Device Name: Quantra System
K223433, K213917 Predicate 510(k) Number:
Comparison with the Predicate:
Table 5-1 provides an overall comparison of the modified Quantra System with the previously cleared Quantra System.
Table 5-1: Comparison between Quantra System (K223433, K213917) and Modified Quantra System
| Modified Device | Predicate Device | |
|---|---|---|
| Quantra System | ||
| (Subject of Special 510(k)) | Quantra System | |
| (K223433, K213917) | ||
| Similarities | ||
| Manufacturer | Same as predicate device | HemoSonics, LLC |
| Trade Name | Same as predicate device | Quantra Hemostasis Analyzer |
| Common Name | Same as predicate device | Whole Blood Hemostasis System |
| Classification Name | Same as predicate device | Coagulation system for the measurement of whole blood |
| viscoelastic properties in perioperative patients. | ||
| Regulation Number | Same as predicate device | 21 CFR 864.5430 |
| Product Code | Same as predicate device | QFR (K213917, K223433) |
| Device Class | Same as predicate device | II |
| Indications for Use | Same as predicate device | The Quantra® System is composed of the Quantra Hemostasis |
| Analyzer, QPlus Cartridge, QStat Cartridge, and Quantra Quality | ||
| Controls Level 1 and 2. The Quantra System is intended for in vitro | ||
| diagnostic use. |
The Quantra Hemostasis Analyzer uses Sonic Estimation of
Elasticity via Resonance (SEER) Sonorheometry, an ultrasound-
based technology, to measure the shear modulus of whole blood
during coagulation. The system is intended to be used by trained
professionals at the point-of-care and in clinical laboratories to
evaluate the viscoelastic properties of whole blood.
The QPlus Cartridge is a multi-channel cartridge that provides
semi-quantitative indications of the coagulation state of a 3.2%
citrated venous or arterial whole blood sample. The QPlus
Cartridge includes tests to assess coagulation characteristics via the
intrinsic pathway, via the extrinsic pathway, and includes tests with
a heparin neutralizer. The QPlus Cartridge is indicated for use in
cardiovascular or major orthopedic surgeries before, during, and
following the procedure.
The QStat Cartridge is a multi-channel cartridge that provides semi-
quantitative indications of the coagulation and clot lysis state of a
3.2% citrated venous whole blood sample. The QStat Cartridge
includes tests to assess coagulation characteristics via the intrinsic
pathway, via the extrinsic pathway, and includes a test with |
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Image /page/6/Picture/0 description: The image shows the logo for Hemosonics. The logo consists of a red blood drop with sound waves emanating from it on the left, and the word "HEMOSONICS" in black capital letters on the right. Below the logo is the word "mille" in a smaller font.
Quantra® QPlus® System Special 510(k)
Device Modification to K213917, K223433
| | Modified Device
Quantra System
(Subject of Special 510(k)) | Predicate Device
Quantra System
(K223433, K213917) |
|-----------------------------------------|------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | tranexamic acid to evaluate clot lysis characteristics. The QStat
Cartridge is indicated for use in trauma and liver transplantation
procedures. |
| | | The QStat Cartridge is a multi-channel cartridge that provides semi-
quantitative indications of the coagulation and clot lysis state of a
3.2% citrated venous whole blood sample. The QStat Cartridge
includes tests to assess coagulation characteristics via the intrinsic
pathway, via the extrinsic pathway, and includes a test with
tranexamic acid to evaluate clot lysis characteristics. The QStat
Cartridge is indicated for use in trauma and liver transplantation
procedures. |
| | | The Quantra System is indicated for the evaluation of blood
coagulation in perioperative patients age 18 years and older to
assess possible hypocoagulable and hypercoagulable conditions.
Results obtained with the Quantra System should not be the sole
basis for patient diagnosis. |
| Intended Use | Same as predicate device | Same as indications for use |
| Disposables | Same as predicate device | QPlus Cartridge (multichannel cartridge)
QStat Cartridge (multichannel cartridge)
Quantra Quality Controls (Level 1 and Level 2) |
| | | Quantra Hemostasis Analyzer
HS-002 |
| Analyzer Hardware | Same as predicate device | |
| | | Differences |
| Quantra Hemostasis
Analyzer Software | v2.2.16 | v2.0.36.1 (K213917)
v2.1.37 (K223433) |
| Embedded
Windows Operating
System | Microsoft Windows 10 IoT
Enterprise LTSC 2019 | Windows Embedded Standard 8 |