(60 days)
No
The summary does not mention AI, ML, or related terms, and the device description focuses on standard digital x-ray technology and image processing.
No
The device is described as an x-ray detector system used for acquiring digital x-ray images, which is a diagnostic tool, not a therapeutic one. It does not provide treatment or therapy.
Yes
The device aids in diagnosis by generating X-ray images, which are then used by radiologists to identify health issues.
No
The device description explicitly states it consists of "a line of 3 different models of solid state x-ray detectors" in addition to the software. These detectors are hardware components.
Based on the provided information, the ExamVue Apex flat panel x-ray detector system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- ExamVue Apex Function: The ExamVue Apex system is an X-ray detector that captures digital images of the anatomy of a patient. It works by converting X-rays that pass through the body into electronic signals to create an image.
- No Specimen Analysis: The device does not analyze any biological specimens taken from the body. It directly images the internal structures of the body using radiation.
Therefore, the ExamVue Apex system falls under the category of medical imaging devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The ExamVue Apex flat panel x-ray detector system is indicated for use in general radiology including podiatry, orthopedic, and other specialties, and in mobile x-ray systems. The Exam Vue Apex flat panel x-ray detector system is not indicated for use in mammography.
Product codes
MQB
Device Description
The ExamVue Apex flat panel x-ray detector system consists of a line of 3 different models of solid state x-ray detectors, of differing size and characteristics, combined with a single controlling software designed for use by radiologists and radiology technicians for the acquisition of digital x-ray images. The ExamVue Apex flat panel x-ray detector system captures digital images of anatomy through the conversion of x-rays to electronic signals, eliminating the need for film or chemical processing to create a hard copy image. ExamVue Apex flat panel x-ray detector system incorporates the ExamVue Duo software, which performs the processing, presentation and storage of the image in DICOM format. All models of the ExamVue Apex flat panel x-ray detector system use a Si TFTD for the collection of light generated by a CsI scintillator, for the purpose of creating a digital x-ray image.
The three available models are:
EVA 14W, with a 14x17in (35x43cm) wireless cassette sized panel
EVA 17W, with a 17x17in (43x43cm) wireless cassette sized panel
EVA 10W, with a 10x12 (24x30cm) wireless cassette sized panel
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
radiologists and radiology technicians
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)
- Electrical Safety, Electromagnetic Compatability and Performance: The ExamVue Apex Digital X-ray Detectors comply with voluntary standards for electrical safety, electromagnetic compatibility and product design.
- Additional bench testing: performed detailing the direct comparison of functions between the ExamVue Apex and predicate device. These testing demonstrated that the product performs with similar or greater imaging characteristics (Resolution, Sensitivity, Dynamic range in image acquisition, That the software performs the same required basic functions as the predicate device).
- Software Validation: The ExamVue Apex Digital X-ray Detectors contain software of a MODERATE level of concern. The software was designed and developed according to a software development process in compliance with IEC 62304 and tested to show that it performs all the functions of the software in the predicate device.
- Cybersecurity: Cybersecurity documentation and procedures have been provided according to the FDA Guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions."
- Clinical Testing: Clinical data was provided with the submission to demonstrate equivalence with the predicate device. This data includes images of all the relevant ROI. The images were evaluated by an ABR certified radiologist who evaluated the image quality to be of equivalent or better to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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 logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
February 24, 2025
JPI Healthcare Co, Ltd % William Little Senior Product Manager JPI Healthcare Solutions, Inc 3555 Veterans Memorial Highway Unit D RONKONKOMA NY 11779
Re: K244010
Trade/Device Name: ExamVue Apex Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: Class II Product Code: MQB Dated: October 2, 2024 Received: December 26, 2024
Dear William Little:
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 (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.
1
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).
Your device is also subject to, among other requirements, the Quality System (OS) 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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 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.
2
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,
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-ray Systems Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K244010
Device Name ExamVue Apex
Indications for Use (Describe)
The ExamVue Apex flat panel x-ray detector system is indicated for use in general radiology including podiatry, orthopedic, and other specialties, and in mobile x-ray systems. The Exam Vue Apex flat panel x-ray detector system is not indicated for use in mammography.
| 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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4
510(k) Summary
ExamVue Apex Digital X-ray Detector
K244010
-
- Company and Correspondant Making the Submission:
Name: JPI Healthcare Co., LTD Address: 608-ho, 28, Digital-ro 33-gil, Guro-gu, 08377 Seoul, Korea Telephone: +82-2-2108 - 2580 Fax: +82-2-2108-1180 Contact: Lee Jang Won Website: http://www.jpi.co.kr/
- Company and Correspondant Making the Submission:
-
- Identification of Device
Classification Name: Stationary x-ray system Common Name: Digital X-ray Acquisition System Trade/Proprietary Name: ExamVue Apex
- Identification of Device
-
- Predicate Device
Manufacturer: JPI Healthcare, Inc Device: ClearVision ExamVue Flat Panel Detector 510(k) Number: K160143 Classification Name: Stationary x-ray system Common Name: Digital X-ray System Regulatory Number:21 CFR 892.1680 Regulatory Class: II Product Code: 90 MQB
- Predicate Device
-
- Product Classification Names and Citations
Regulatory Number:21 CFR 892.1680 Regulatory Class: II 90 MQB Product Code:
- Product Classification Names and Citations
5
Description: 5.
The ExamVue Apex flat panel x-ray detector system consists of a line of 3 different models of solid state x-ray detectors, of differing size and characteristics, combined with a single controlling software designed for use by radiologists and radiology technicians for the acquisition of digital x-ray images. The ExamVue Apex flat panel x-ray detector system captures digital images of anatomy through the conversion of x-rays to electronic signals, eliminating the need for film or chemical processing to create a hard copy image. ExamVue Apex flat panel x-ray detector system incorporates the ExamVue Duo software, which performs the processing, presentation and storage of the image in DICOM format. All models of the ExamVue Apex flat panel x-ray detector system use a Si TFTD for the collection of light generated by a CsI scintillator, for the purpose of creating a digital x-ray image.
The three available models are:
EVA 14W, with a 14x17in (35x43cm) wireless cassette sized panel EVA 17W, with a 17x17in (43x43cm) wireless cassette sized panel EVA 10W, with a 10x12 (24x30cm) wireless cassette sized panel
6. Indication for use
The ExamVue Apex flat panel x-ray detector system is indicated for use in general radiology, specialist radiology including podiatry, orthopedic, and other specialties, and in mobile x-ray systems. The ExamVue Apex flat panel x-ray detector system is not indicated for use in mammography.
7. Comparison with Predicate Device:
JPI Healthcare Co., Ltd, believes that the ExamVue Apex is substantially equivalent to the ClearVision ExamVue Flat Panel Detector registered by JPI Healthcare Co. Ltd.
The ExamVue Apex and the predicate device both
-Are a combination of a digital x-ray detector with an image acquisition software -Include digital x-ray detectors that are built upon the same fundamental technology (Amorphous Silicon collectors and Cesium lodide scintillator) to turn incoming x-rays into a digital image.
-Provide a user interface for the registration, acquisition, and evaluation of x-ray studies.
-Perform the functions of image transfer, image acquisition, image processing, and maintaining a patient database.
-Use the DICOM 3.0 standard for medical imaging
-Are intended for installation on Windows operating systems for use in a medical environment.
-Interface with and process images from multiple models of hardware.
6
ExamVue Apex and the predicate device share the same essential functions of image acquisition, transfer, and processing. The detector hardware differs in resolution and the substrate material for the electronics. The software on the ExamVue Apex is ExamVue Duo, previously registered with 510(k) number K213057 for use with flat panel detectors. The software represents a moderate level of concern, which is addressed in the software validation and verification and bench testing provided with the submission. The software performs the same functions as the software for the predicate device with some additional features, including expanded tool sets to simplify measurement and image viewing and management tools, that do not impact the core functions of the device. We believe these differences do not represent a substantial difference between the two devices, as the indications for use, core technologies, and user interface presents the same essential data and supports similar workflow as the predicate device.
8. Non-Clinical Test Summary
- a) Electrical Safety, Electromagnetic Compatability and Performance The ExamVue Apex Digital X-ray Detectors comply with voluntary standards for electrical safety, electromagnetic compatibility and product design. Safety and quality testing and documentation have been performed and provided following IEC standards.
| Standards No | Standards Title | Version | Publication
Year |
|----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|---------------------|
| ISO 10993 | Biological Evaluation of
Medical Devices | 2018 | 2018 |
| IEC 60529 | Degrees of protection
provided by enclosures (IP
Code) | IEC
60529:1989+
AMD1:1999+
AMD2:2013
CSV | 2019 |
| IEC 62304 | Medical device software -
Software life cycle
processes | IEC 62304
Ed. 1.1 | 2015 |
| IEC 62366 | Medical devices - Part 1:
Application of usability
engineering to medical
devices | IEC 62366-1
Ed. 1.1
b:2020 | 2020 |
| IEC 60068-2-27 | Environmental testing - Part
2-27: Tests - Test Ea and
guidance: Shock | IEC
60068-2-27
Ed. 4.0
b:2008▷ | 2008 |
| IEC 60601-1-2 | Medical electrical
equipment - Part 1-2:
General requirements for
basic safety and essential
performance - Collateral
Standard: Electromagnetic
disturbances -
Requirements and tests | IEC
60601-1-2 Ed.
4.1 en:2020 | 2020 |
| IEC 60601-1-3 | Medical electrical
equipment - Part 1-3:
General requirements for
basic safety and essential
performance - Collateral
Standard: Radiation
protection in diagnostic
| IEC
60601-1-3:20
08+AMD1:20
13+AMD2:20
21 CSV | 2021 |
| IEC 60601-1-6 | Medical electrical
equipment - Part 1-6:
General requirements for
basic safety and essential
performance - Collateral
standard: Usability | IEC
60601-1-6:20
10+AMD1:20
13+AMD2:20
20 CSV | 2020 |
| IEC 60601-1-8 | mendment 2 - Medical
electrical equipment - Part
1-8: General requirements
for basic safety and
essential performance -
Collateral Standard:
General requirements,
tests and guidance for
alarm systems in medical
electrical equipment and
medical electrical systems | IEC
60601-1-8:20
06/AMD2:202
0 | 2020 |
| IEC 60601-2-54 | Medical electrical
equipment - Part 2-54:
Particular requirements for | IEC
60601-2-54:2
022 | 2022 |
| | the basic safety and
essential performance of
X-ray equipment for
radiography and
radioscopy | | |
| IEC 61000-3-2 | Electromagnetic
compatibility (EMC) - Part
3-2: Limits - Limits for
harmonic current emissions
(equipment input current
≤16 A per phase) | IEC
61000-3-2:20
18 | 2018 |
| IEC 61000-3-3 | Electromagnetic
compatibility (EMC) - Part
3-3: Limits - Limitation of
voltage changes, voltage
fluctuations and flicker in
public low-voltage supply
systems, for equipment
with rated current ≤16 A
per phase and not subject
to conditional connection | IEC
61000-3-3:20
13+AMD1:20
17+AMD2:20
21 CSV | 2017 |
| 61000-4-2 | Electromagnetic
compatibility (EMC) - Part
4-2: Testing and
measurement techniques -
Electrostatic discharge
immunity test | IEC
61000-4-2:20
08 | 2008 |
| IEC 61000-4-3 | Electromagnetic
compatibility (EMC) - Part
4-3 : Testing and
measurement techniques -
Radiated, radio-frequency,
electromagnetic field
immunity test | IEC
61000-4-3:20
20 | 2020 |
| IEC 61000-4-4 | Electromagnetic
compatibility (EMC) - Part
4-4: Testing and
measurement techniques -
Electrical fast
transient/burst immunity | IEC
61000-4-4:20
12 | 2012 |
| | test | | |
| IEC 61000-4-5 | Electromagnetic
compatibility (EMC) - Part
4-5: Testing and
measurement techniques -
Surge immunity test | IEC
61000-4-5:20
14 | 2014 |
| IEC 61000-4-6 | Electromagnetic
compatibility (EMC) - Part
4-6: Testing and
measurement techniques -
Immunity to conducted
disturbances, induced by
radio-frequency fields | IEC
61000-4-6:20
23 | 2023 |
| IEC 61000-4-8 | Electromagnetic
compatibility (EMC) - Part
4-8: Testing and
measurement techniques -
Power frequency magnetic
field immunity test | IEC
61000-4-8:20
09 | 2009 |
| IEC 61000-4-11 | Electromagnetic
compatibility (EMC) - Part
4-11: Testing and
measurement techniques -
Voltage dips, short
interruptions and voltage
variations immunity tests
for equipment with input
current up to 16 A per
phase | IEC
61000-4-11:2
020 | 2020 |
| IEC 61000-4-39 | Electromagnetic
compatibility (EMC) - Part
4-39: Testing and
measurement techniques -
Radiated fields in close
proximity - Immunity test | IEC
61000-4-39:2
017 | 2017 |
| IEC 60950-1 | Information technology
equipment - Safety - Part 1:
General requirements | IEC 60950-1
Ed. 2.2
b:2013 | 2013 |
| | CONSOLIDATED EDITION | | |
| IEC 62133-2 | Secondary cells and
batteries containing
alkaline or other non-acid
electrolytes - Safety
requirements for portable
sealed secondary cells,
and for batteries made from
them, for use in portable
applications - Part 2:
Lithium systems | IEC
62133-2:2017 | 2017 |
| IEC 62304 | Medical device software -
Software life cycle
processes | IEC 62304
Ed. 1.1
b:2015 | 2015 |
| IEC 62366-1 | Medical devices - Part 1:
Application of usability
engineering to medical
devices | IEC 62366-1
Ed. 1.1
b:2020 | 2020 |
7
2/24/2025 510(k) Summary K244010
8
9
10
- b) Additional bench testing was performed detailing the direct comparison of functions between the ExamVue Apex and predicate device. These testing demonstrated that the product performs with similar or greater imaging characteristics
- i) Resolution
- ii) Sensitivity
- iii) Dynamic range in image acquisition
- iv) That the software performs the same required basic functions as the predicate device.
- c) Software Validation
The ExamVue Apex Digital X-ray Detectors contain software of a MODERATE level of concern. The software was designed and developed according to a software development process in compliance with IEC 62304 and tested to show that it performs all the functions of the software in the predicate device. Software development and testing documentation has been provided in accordance with the FDA guidance "The Content of Premarket Submissions for Software Contained in Medical Devices."
- d) Cybersecurity
11
Cybersecurity documentation and procedures have been provided according to the FDA Guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions."
- e) Clinical Testing
Clinical data was provided with the submission to demonstrate equivalence with the predicate device. This data includes images of all the relevant ROI. The images were evaluated by an ABR certified radiologist who evaluated the image quality to be of equivalent or better to the predicate device.
In conclusion, the clinical testing indicate adequate imaging performance of the ExamVue Apex Digital X-ray Detectors.
-
- Conclusions:
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification JPI Healthcare Co., Ltd. concludes that the ExamVue Apex is safe and effective and substantially equivalent to predicate devices as described herein.
- Conclusions:
A detailed comparison supporting this conclusion can be found in Exhibit 1, Substantial Equivalence Chart.
EXHIBIT 1
SUBSTANTIAL EQUIVALENCE CHART
| Device Name | ExamVue Apex | ClearVision ExamVue FPD |
|---|---|---|
| Hardware Manufacturer | Thales | Toshiba |
| Software Manufacturer | JPI Healthcare Co, Ltd | JPI Healthcare Co, Ltd |
| FDA 510(k) | K244010 | K160143 |
| Models | EVA 10W/ EVA 14W/ EVA | |
| 17W | 1417T / 1417W / 1717 | |
| Intended Use | The ExamVue Apex flat | |
| panel x-ray detector system | ||
| is indicated for use in | ||
| general radiology, specialist | ||
| radiology including podiatry, | ||
| orthopedic, and other | ||
| specialties, and in mobile | The ClearVision ExamVue | |
| Flat Panel detector is | ||
| indicated for use in general | ||
| radiology, specialist | ||
| radiology including podiatry, | ||
| orthopedic, and other | ||
| specialties. and in mobile | ||
| x-ray systems. | ||
| The ExamVue Apex flat | ||
| panel x-ray detector system | ||
| is not indicated for use in | ||
| mammography. | x-ray systems. The | |
| ClearVision ExamVue Flat | ||
| Panel detector is not | ||
| indicated for use in | ||
| mammography. | ||
| Configuration | This submission is for a | |
| digital panel and software. It | ||
| is intended for use with | ||
| unconnected or software | ||
| integrated x-ray generators | ||
| and associated equipment. | This submission is for the | |
| digital panel and software | ||
| only, no generator or stand | ||
| provided. | ||
| Detector Type | Amorphous Silicon | Amorphous Silicon |
| Pixel Pitch (um) | 99 | 143 / 140 / 143 |
| A/D Conversion (bits) | 16 | 16 / 14 / 14 |
| Active Area | 222x285mm | |
| 345x425mm | ||
| 423x423mm | 14x17 inch | |
| 14x17 inch | ||
| 16.9x17.3 inch | ||
| Dimensions (mm) | 267.5(W) x 327.5(D) x | |
| 15(H) | ||
| 383.5(W) x 459.5(D) x | ||
| 15(H) | ||
| 459.5(W) x 459.5(D) x | ||
| 15(H) | 384(W) x 460(D) x 15(H) | |
| 384(W) x 460(D) x 15(H) | ||
| 512(W) x 495(D) x 43(H) | ||
| Weight (kg) | 1.6 / 2.6 / 3 | 3 / 3 / 9 |
| DQE @ 0 lp/mm | 73 % @ 6 μGy / 70 % @ 2 | |
| μGy | 57% / 60% / 58% | |
| MTF @ 1 lp/mm | 68% | 63% / 68% / 65% |
| DICOM Functionality | Yes | Yes |
| Scintillator | CsI | CsI |
| Interface | Wifi (802.11ac/ax) or cable | Gigabit Ethernet or Wireless |
| Automatic Exposure | ||
| Detection | Thales Full-Field AED | Yes |
| Generator Exposure | ||
| Trigger or Sensor | Optional | Yes |
| Power Source | AC Line | AC Line |
| Acquisition and Control | ||
| Software | ExamVue Duo (K213057) | ExamVueDR (K142930) |
12
Summary
- The software used in ExamVue Apex is the direct successor of the ExamVueDR software used in the predicate device, including similar image acquisition,
13
processing, and other features. Both softwares are independently registered with 510(k) submissions.
- -The new features for general medicine, chiropractic and podiatry applications in ExamVue Apex are additional features not included in the predicate device. However, they are similar to the image management and measurement functions already incorporated in the software for the predicate device and are included in the previously registered 510(k) for the included software.
- In Conclusion, the intended use and environment of the device is the same as the predicate devices, with only minor differences in features that are not integral to the function of the device. The differences do not introduce a fundamentally new scientific technology.
The intended use and environment of the device is the same as the predicate devices, with only minor differences in features that are not integral to the function of the device. For this reason, we believe it is substantially equivalent to the predicate devices.