(175 days)
No
The summary describes standard digital X-ray image acquisition, processing, and management software. There is no mention of AI, ML, or related concepts like algorithms for automated analysis, detection, or prediction. The image processing mentioned appears to be for enhancement, not AI-driven analysis.
No.
The device is a digital X-ray image processing system used for acquiring images, managing data, and image processing, not for treatment or therapy.
No
The RADMAX Digital Imaging Software acquires, processes, stores, and manages X-ray images. It does not provide an interpretation or diagnosis of the images. The text states, "The Users must be qualified to create and diagnose radiological image data," implying that the diagnosis is made by the user, not the device.
Yes
The device is described as "RADMAX Digital Imaging Software" and explicitly states that the X-ray generator and digital detector are not part of the device. Its functions are software-based, including image acquisition control, storage, management, and processing.
Based on the provided information, the RADMAX Digital Imaging Software 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 (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- RADMAX Function: The RADMAX software is designed to acquire, process, store, and manage digital X-ray images. X-ray imaging is an in vivo (within the living body) diagnostic method, not an in vitro method.
- Intended Use: The intended use clearly states it's for use with a digital X-ray image processing system for acquiring and processing images. There is no mention of analyzing biological specimens.
Therefore, the RADMAX Digital Imaging Software falls under the category of medical imaging software used for in vivo diagnostic purposes, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The RADMAX Digital Imaging Software, used together with a digital X-ray image processing system designed for acquiring images and processing acquired images. The main features of the software are controlling and interfacing the detector, acquiring images after X-ray, storing acquired images, managing data, and image processing. The RADMAX Digital Imaging Software, is not intended for the acquisition of mammographic image data.
The X-ray generator is not part of the RADMAX Digital Imaging Software, device.
If the X-ray generator does not allow interfacing with external software the RADMAX Digital Imaging Software device cannot be interfaced with X-ray Generator.
However, when using third-party generator, use the AED function to acquire the image by sensing the X-ray photon. When using the DRGEM Corporation, generator (models GXR, GXR-U), the RADMAX Digital Imaging Software can only select or change values of X-ray exposure parameters (kVP, mAs or kVP, mA or density).
Product codes
LLZ
Device Description
The RADMAX Digital Imaging Software from DRGEM Corporation, is a digital Xray image processing system designed for acquiring images and processing acquired images. The software can be used together with a digital X-ray detector and or an X-Ray generator. The main features of the software are controlling and interfacing the detector, acquiring images after X-ray, storing acquired images, managing data, and image processing.
The X-ray generator or digital detector is not part of the RADMAX Digital lmaging Software, device. The RADMAX Digital Imaging Software does not control exposure or electrical charge and X-ray calibration. If the X-ray generator does not allow interfacing with external software like the RADMAX Digital Imaging Software device, then the software cannot be interfaced with X-ray Generator. The RADMAX Digital Imaging Software can only select or change values of X-ray exposure parameters (KVp. mA second or kVp. mAs) according to the defined value determined by each X-ray company.
The RADMAX Digital Imaging Software, is not intended for the acquisition of mammographic image data and is meant to be used by qualified medical personnel only. The Users must be qualified to create and diagnose radiological image data.
The main functions of the RADMAX Imaging Software are as follows:
- . Acquisition and storage of digital X-ray images from a digital X-ray Detector.
- Input Study information (patient information, exam information). .
- . Management of stored (archived) images.
- Image processing for enhancement of archived images. ●
- Review of stored images. ●
- Editing of images. ●
- DICOM conformance (e.g. DICOM Storage, DICOM Work list, DICOM Print, etc.) ●
- For a DR system (X-ray machine and generator and Digital X-rav detector, etc.) or a need to interface with installed X-ray system, the:
- Ability to configure X-ray exposure condition (kVp, mA, Sec etc) for various body parts and positions.
- -Communication between the Generator Console and the RADMAX device.
The X-ray generator control function depends on the X-ray Generator company. The X-ray generator is not part of the RADMAX Digital Imaging Software device since the RADMAX device can only interface and control the Generator by the algorithm provided by the X-ray Company. The RADMAX device can only select or change values of X-ray exposure parameters (kVp, mA second or kVp; mAs) according to the defined value determined by each X-ray company.
The RADMAX Digital Imaging Software, device does not control exposure or electrical charge and or calibration of the X-ray equipment. If the X-ray generator does not allow interfacing with an external software like the RADMAX Imaging Software, then RADMAX, cannot be interfaced with the X-rav Generator.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
digital X-ray
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified medical personnel, Radiologists, Clinicians and or referring Physicians
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)
Nonclinical Testing:
The complete system configuration has been assessed and tested at the factory and has passed all predetermined in-house testing criteria. The Validation Test Plan was designed to evaluate all input functions, output functions, and actions performed by the RADMAX Digital Imaging Software and followed the process documented in the System Validation Test Plan.
Nonclinical testing results are provided in the 510(k). Validation testing indicated that as required by the risk analysis, designated individuals performed all verification and validation activities and that the results demonstrated that the predetermined acceptance criteria were met.
Nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as 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
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 8, 2019
DRGEM Corporation % Mr. Carl Alletto Consultant OTech Inc. 8317 Belew Drive MCKINNEY TX 75071
Re: K182537
Trade/Device Name: RADMAX Digital Imaging Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: January 11, 2019 Received: January 29, 2019
Dear Mr. Alletto:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Hsl. 2. Nils
Thalia Mills, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182537
Device Name RADMAX Digital Imaging Software
Indications for Use (Describe)
The RADMAX Digital Imaging Software, used together with a digital X-ray image processing system designed for acquiring images and processing acquired images. The main features of the software are controlling and interfacing the detector, acquiring images after X-ray, storing acquired images, managing data, and image processing. The RADMAX Digital Imaging Software, is not intended for the acquisition of mammographic image data.
The X-ray generator is not part of the RADMAX Digital Imaging Software, device.
If the X-ray generator does not allow interfacing with external software the RADMAX Digital Imaging Software device cannot be interfaced with X-ray Generator.
However, when using third-party generator, use the AED function to acquire the image by sensing the X-ray photon. When using the DRGEM Corporation, generator (models GXR, GXR-U), the RADMAX Digital Imaging Software can only select or change values of X-ray exposure parameters (kVP, mAs or kVP, mA or density).
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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This 510(k) Summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR Part 807.87(h):
Date Prepared:
January 9, 2019
Submitter's Information: 21 CFR 807.92(a)(1)
Mr. Ki-Nam YANG Director | QM representative DRGEM Corporation 7F E-B/D Gwangmyeong Techno-Park 60, Haan-ro, Gwangmyeong-si, Gyeonggi-do, 14322 Korea Email: radcheck@drgem.co.kr
Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2)
Product Name: RADMAX Digital Imaging Software Common Name: Picture, archive and communications system Classification Name: System, Image Processing, Radiological Product Code: LLZ
Predicate Device: 21 CFR 807. 92(a)(3)
The RADMAX Digital Imaging Software is substantially equivalent to K123650:
| Device Classification Name | System, Image Processing, Radiological |
|---|---|
| 510(K) Number | K123650 |
| Device Name | ARIX RAD ACQUISITION CONSOLE |
| Applicant | COMPANIA MEXICANA DE RADIOLOGIA CGR, |
| S.A. DE C.V. | |
| Regulation Number | 892.2050 |
| Classification Product Code | LLZ |
| Decision Date | 02/20/2013 |
| Decision | Substantially Equivalent (SESE) |
| Requlation Medical Specialty | Radiology |
| Summary | Summary |
| Type | Traditional |
Device Description: 21 CFR 807 92(a)(4)
The RADMAX Digital Imaging Software from DRGEM Corporation, is a digital Xray image processing system designed for acquiring images and processing acquired images. The software can be used together with a digital X-ray detector and or an X-Ray generator. The main features of the software are controlling and interfacing the detector, acquiring images after X-ray, storing acquired images, managing data, and image processing.
The X-ray generator or digital detector is not part of the RADMAX Digital lmaging Software, device. The RADMAX Digital Imaging Software does not control exposure or electrical charge and X-ray calibration. If the X-ray generator does not allow interfacing with external software like the RADMAX Digital Imaging Software device, then the software cannot be interfaced with X-ray
4
Generator. The RADMAX Digital Imaging Software can only select or change values of X-ray exposure parameters (KVp. mA second or kVp. mAs) according to the defined value determined by each X-ray company.
The RADMAX Digital Imaging Software, is not intended for the acquisition of mammographic image data.
The RADMAX Digital Imaging Software device is not intended for the acquisition of mammographic image data and is meant to be used by qualified medical personnel only. The Users must be qualified to create and diagnose radiological image data.
The main functions of the RADMAX Imaging Software are as follows:
- . Acquisition and storage of digital X-ray images from a digital X-ray Detector.
- Input Study information (patient information, exam information). .
- . Management of stored (archived) images.
- Image processing for enhancement of archived images. ●
- Review of stored images. ●
- Editing of images. ●
- DICOM conformance (e.g. DICOM Storage, DICOM Work list, DICOM Print, etc.) ●
- For a DR system (X-ray machine and generator and Digital X-rav detector, etc.) or a need to interface with installed X-ray system, the:
- Ability to configure X-ray exposure condition (kVp, mA, Sec etc) for various body parts and positions.
- -Communication between the Generator Console and the RADMAX device.
The X-ray generator control function depends on the X-ray Generator company. The X-ray generator is not part of the RADMAX Digital Imaging Software device since the RADMAX device can only interface and control the Generator by the algorithm provided by the X-ray Company. The RADMAX device can only select or change values of X-ray exposure parameters (kVp, mA second or kVp; mAs) according to the defined value determined by each X-ray company.
The RADMAX Digital Imaging Software, device does not control exposure or electrical charge and or calibration of the X-ray equipment. If the X-ray generator does not allow interfacing with an external software like the RADMAX Imaging Software, then RADMAX, cannot be interfaced with the X-rav Generator.
Indications for Use: 21 CFR 807 92(a)(5)
The RADMAX Digital Imaging Software, used together with a digital X-ray detector is a digital X-ray image processing system designed for acquiring images and processing acquired images. The main features of the software are controlling and interfacing the detector, acquiring images after X-ray, storing acquired images, managing data, and image processing. The RADMAX Digital Imaging Software, is not intended for the acquisition of mammographic image data.
The X-ray generator is not part of the RADMAX Digital Imaging Software, device.
If the X-ray generator does not allow interfacing with external software the RADMAX Digital Imaging Software device cannot be interfaced with X-ray Generator.
However, when using third-party generator, use the AED function to acquire the image by sensing the X-ray photon. When using the DRGEM Corporation, generator (models GXR, GXR-C, GXR-U), the RADMAX Digital Imaging Software can only select or change values of X-ray exposure parameters (kVP, mA, Time, or kVP, mAs or kVP, mA or density).
5
Technological Characteristics: 21 CFR 807 92(a)(6)
RADMAX Digital Imaging Software, is a software device that handles digital medical images. The device does not contact the patient, nor does it control any life sustaining devices. Diagnosis is not performed by the software but by Radiologists, Clinicians and or referring Physicians. A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed.
The subject device does not raise any new potential safety risks and is equivalent in performance to the existing legally marketed devices. Both systems have been developed to replace traditional film handling in radiology. The 2 devices are substantially equivalent in the areas of design, architecture, general function, application, and intended use.
The following table compares the predicate device and the new device. Any differences between the predicate and the new device has no impact on safety or efficacy of the new device and does not raise any new potential or increased safety risks and is equivalent in performance to existing legally marketed devices.
| Item | Functionality | Subject Device: RADMAX
Digital Imaging Software | Predicate K123650
ARIX RAD Acquisition
Console | If different, Impact on Safety and or
Efficacy |
|------|--------------------------------|--------------------------------------------------------------------------------------|------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Computer &
Operating System | Microsoft Windows 10
(minimum) | Microsoft Windows
XP/Windows 7
(minimum) | Yes, there is a difference. Differences are
in the processor speeds, Windows
operating system, amount of RAM
memory, monitors, and hard drive space
requirements. These differences are due
to the state of computer technology that
was available at the time the predicate
device was developed. There is "No
impact on safety or efficacy" and there are
no new potential or increased safety risks. |
| 2 | Intended use | Acquiring, viewing, editing
and storing radiographs and
related patient images | Same | No difference |
| 3 | Intended user | radiologist | radiologist | No difference |
| 4 | Network | 10/100/100 Ethernet | Same | No difference |
| 5 | Monitor | Two color display adaptors
1920x1080 | 19-inch monitor using
1280x1024 | Yes, there is a difference. See item 1
above. |
| 6 | User interaction/input | Mouse, keyboard, touch
monitor | Same | No difference |
| 7 | Multi-user | Available, but at a time, only
one user can use it | Same | No difference |
| 8 | Import / export
images | Yes | Yes | No difference |
| 9 | Acquisition devices | Digital X-Ray detectors | Digital X-Ray
detectors | No difference |
| 10 | Imaging interfaces | Detector dependent | Detector dependent | Yes, there is a difference. Subject device
uses Flat panel detectors cleared by FDA:
K171138, & K172951 |
| 11 | Image organization | Yes. Patient ID, Name,
study instance UID | Same | No difference |
| 12 | Image search
available | Yes | Yes | No difference |
| 13 | Image storage | Yes | Yes | No difference |
| 14 | Database software | MySQL | MySQL | No difference |
| 15 | Image viewing | Yes | Yes | No difference |
| 16 | Image measurement | Yes | Yes | No difference |
| 17 | Image annotation | Yes | Yes | No difference |
| 18 | Image operations | Yes | Yes | No difference |
| 19 | Security | Yes (Priority by user) | Same | No difference |
| 20 | DICOM 3.0
compatibility | Yes | Yes | No difference |
| 21 | Generator Control | Yes | Yes | No difference |
| 22 | Generator Control
Protocol | Generator dependent | Generator dependent | No difference |
6
| Item | Functionality | Subject Device: RADMAX
Digital Imaging Software | Predicate K123650
ARIX RAD Acquisition
Console | If different, Impact on Safety and or
Efficacy |
|------|-------------------------------------------------------|----------------------------------------------------|------------------------------------------------------|---------------------------------------------------|
| 23 | RAW Image data
processing | Yes | Yes | No difference |
| 24 | Post image data
processing | Yes | Yes | No difference |
| 25 | RIS code manager | Yes | Yes | No difference |
| 26 | Worklist | Yes | Yes | No difference |
| 27 | Patient size/Laterality | Yes | Yes | No difference |
| 28 | Display radiographic
technique, kV, mA,
ms, mAs | Yes | Yes | No difference |
| 29 | Thumbnail viewing | Yes | Yes | No difference |
| 30 | Login | Yes | Yes | No difference |
| 31 | New patient manual
register | Yes | Yes | No difference |
| 32 | X-Ray generator
window | Yes | Yes | No differences |
| 33 | Bucky selection | Yes | Yes | No difference |
| 34 | Body part | Yes | Yes | No difference |
| 35 | Generator status
display | Yes | Yes | No difference |
| 36 | Image reset | Yes | Yes | No difference |
| 37 | panning | Yes | Yes | No difference |
| 38 | Magnify glass | Yes | Yes | No difference |
| 39 | Fit image | Yes | Yes | No difference |
| 40 | Image Stitching | Yes | Yes | No difference |
| 41 | Series/Image list | Yes | Yes | No difference |
Nonclinical Testing:
The complete system configuration has been assessed and tested at the factory and has passed all predetermined in-house testing criteria. The Validation Test Plan was designed to evaluate all input functions, output functions, and actions performed by the RADMAX Digital Imaging Software and followed the process documented in the System Validation Test Plan.
Nonclinical testing results are provided in the 510(k). Validation testing indicated that as required by the risk analysis, designated individuals performed all verification and validation activities and that the results demonstrated that the predetermined acceptance criteria were met.
Conclusion: 21 CFR 807 92(b)(1)
The 510(k) Pre-Market Notification for the RADMAX Digital Imaging Software, device contains adequate information, data, and nonclinical test results to enable FDA - CDRH to determine substantial equivalence to the predicate device.
The subject device will be manufactured in accordance with the voluntary standards listed in the voluntary standard survey. The new device and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application, and intended use does not raise any new potential safety risks and is equivalent in performance to existing legally marketed devices.
Nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as the predicate device.
Therefore, RADMAX Digital Imaging Software, is substantially equivalent to the predicate device.