(31 days)
No
The document describes standard image processing and management features, with no mention of AI, ML, or related concepts.
No
The software is intended for viewing and diagnosis of image data, not for direct therapeutic intervention or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The software is intended for the viewing and diagnosis of image data in relation to dental issues" and lists "supporting diagnosis of digital/digitized 2D and 3D images and videos" as one of its tasks.
No
The device description explicitly states that "new hardware was integrated: Support of the ScanX Touch / Duo Touch (K191623)". While the software is a standalone component, its functionality is tied to and includes support for specific hardware, making it not purely software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device's intended use: The software is intended for the viewing and diagnosis of image data related to dental issues. It processes images generated by various imaging modalities (X-ray, cameras, scanners).
- Lack of biological specimen analysis: The description does not mention the analysis of any biological specimens. The software operates on digital images, not biological samples.
Therefore, while this is a medical device used for diagnosis, it falls under the category of medical imaging software rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The software is intended for the viewing and diagnosis of image data in relation to dental issues. Its proper use is documented in the operating instructions of the corresponding image-generating systems. Image-generating systems that can be used with the software include optical video cameras, image plate scamers, extraoral X-ray devices, intraoral scanners and TWAIN compatible image sources. The software must only be used by authorized healthcare professionals in dental areas for the following tasks:
-
Filter optimization of the display of 2D and 3D images for improved diagnosis
-
Acquisition, storage, management, display, analysis, editing and supporting diagnosis of digital/digitized 2D and 3D images and videos
-
Forwarding of images and additional data to external software (third-party software)
The software is not intended for mammography use.
Product codes
LLZ
Device Description
VisionX 2.4 imaging software is an image management system that allows dentists to acquire, display, edit, view, store, print, and distribute medical images. VisionX 2.4 software runs on user provided PC-compatible computers and utilizes previously cleared digital image capture devices for image acquisition. This software was cleared in K181432 as part of the x-Ray system ProVecta 3D Prime. With this submission VisionX will be established as standalone software. Additionally, new hardware was integrated: Support of the ScanX Touch / Duo Touch (K191623)
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
optical video cameras, digital X-ray cameras, image plate scanners, extraoral X-ray devices, intraoral scanners and TWAIN compatible image sources.
Anatomical Site
dental areas
Indicated Patient Age Range
Not Found
Intended User / Care Setting
authorized healthcare professionals in dental areas
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)
Software testing, effectiveness, and functionality were successfully conducted and verified between VisionX 2.4 and image capture devices. Full functional software cross check testing was performed.
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized image of a human figure, and the text on the right is in blue. The words "U.S. FOOD & DRUG" are in a larger font than the word "ADMINISTRATION".
October 31, 2019
Durr Dental SE % Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct Naples, FLORIDA 34114
Re: K192743
Trade/Device Name: VisionX 2.4 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: September 26, 2019 Received: September 30, 2019
Dear Mr. Daniel Kamm:
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); 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,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K192743
Device Name VisionX 2.4
Indications for Use (Describe)
The software is intended for the viewing and diagnosis of image data in relation to dental issues. Its proper use is documented in the operating instructions of the corresponding image-generating systems. Image-generating systems that can be used with the software include optical video cameras, image plate scamers, extraoral X-ray devices, intraoral scanners and TWAIN compatible image sources. The software must only be used by authorized healthcare professionals in dental areas for the following tasks:
-
Filter optimization of the display of 2D and 3D images for improved diagnosis
-
Acquisition, storage, management, display, analysis, editing and supporting diagnosis of digital/digitized 2D and 3D images and videos
-
Forwarding of images and additional data to external software (third-party software)
The software is not intended for mammography use.
| 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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3
510(k) Summary, DÜRR DENTAL SE,
Device Name: VisionX 2.4
K192743
This 510(k) is being submitted in accordance with the requirements of 21 CFR §807.92.
1. Date Summary Prepared:
September 19, 2019
2. Submitter's Identification:
DÜRR DENTAL SE (Registered as DUERR DENTAL SE) Höpfigheimer Str. 17 74321 Bietigheim-Bissingen Deutschland/Germany Phone: + 49 (0) 7142 70 5-0 Fax: + 49 (0) 7142 705-500 E-Mail info@duerr.de Internet: www.duerrdental.com
Responsible Individual Contact/Prepared by: Oliver Lange, Director of Quality Management DÜRR DENTAL SE Höpfigheimer Str. 17 74321 Bietigheim-Bissingen Deutschland/Germany Phone: 49-7142-705-190 Email: oliver.lange@duerrdental.com
Mr. Joseph Latkowski Director of Quality and Regulatory Air Techniques, Inc. 1295 Walt Whitman Road Melville, NY 11747, USA U.S. Phone: 516-214-5574 E-Mail: Joseph.Latkowski@airtechniques.com
3. Device:
Trade /Proprietary Name: VisionX 2.4 Device: Medical Imaging Software Regulation Description: Picture archiving and communications system. Regulation Medical Specialty: Radiology Review Panel Radiology Product Code LLZ 892.2050 Regulation Number Device Class 2
4
4. Predicate Device:
Legally Marketed Predicate Device Information:
| 510(k) Number: | K190629 |
|---|---|
| Manufacturer: | DÜRR DENTAL SE |
| Trade /Proprietary Name | DBSWIN and VistaEasy Imaging Software |
| Device: | Medical Imaging Software |
| Regulation Description: | Picture archiving and communications system. |
| Regulation Medical Specialty: | Radiology |
| Review Panel | Radiology |
| Product Code | LLZ |
| Regulation Number | 892.2050 |
| Device Class | 2 |
5. Device Description:
VisionX 2.4 imaging software is an image management system that allows dentists to acquire, display, edit, view, store, print, and distribute medical images. VisionX 2.4 software runs on user provided PC-compatible computers and utilizes previously cleared digital image capture devices for image acquisition. This software was cleared in K181432 as part of the x-Ray system ProVecta 3D Prime. With this submission VisionX will be established as standalone software. Additionally, new hardware was integrated: Support of the ScanX Touch / Duo Touch (K191623)
6. Indications for Use
The software is intended for the viewing and diagnosis of image data in relation to dental issues. Its proper use is documented in the operating instructions of the corresponding imagegenerating systems. Image-generating systems that can be used with the software include optical video cameras, digital X-ray cameras, image plate scanners, extraoral X-ray devices, intraoral scanners and TWAIN compatible image sources.
The software must only be used by authorized healthcare professionals in dental areas for the following tasks:
-
Filter optimization of the display of 2D and 3D images for improved diagnosis
-
Acquisition, storage, management, display, analysis, editing and supporting diagnosis of digital/digitized 2D and 3D images and videos
-
Forwarding of images and additional data to external software (third-party software) The software is not intended for mammography use.
7. Summary of the technological characteristics of the device compared to the predicate device:
5
Comparison of the Technological Characteristics
| Descriptive
| Information: | Predicate Device: | Subject Device: |
|---|---|---|
| DBSWIN and VistaEasy Imaging Software | VisionX 2.4 | |
| K190629 | ||
| Indications for | ||
| Use | DBSWIN and VistaEasy imaging software | |
| are intended for use by qualified dental | ||
| professionals for windows-based | ||
| diagnostics. The software is a diagnostic | ||
| aide for licensed radiologists, dentists | ||
| and clinicians, who perform the actual | ||
| diagnosis based on their training, | ||
| qualification, and clinical experience. | ||
| DBSWIN and VistaEasy are clinical | ||
| software applications that receive | ||
| images and data from various imaging | ||
| sources (i.e., radiography devices and | ||
| digital video capture devices) that are | ||
| manufactured and distributed by DÜRR | ||
| Dental and Air Techniques. It is intended | ||
| to acquire, display, edit (i.e., resize, | ||
| adjust contrast, etc.) and distribute | ||
| images using standard PC hardware. In | ||
| addition, DBSWIN enables the | ||
| acquisition of still images from 3rd party | ||
| TWAIN compliant imaging devices (e.g., | ||
| generic image devices such as scanners) | ||
| and the storage and printing of clinical | ||
| exam data, while VistaEasy distributes | ||
| the acquired | ||
| images to 3rd party TWAIN compliant | ||
| PACS systems for storage and printing. |
DBSWIN and VistaEasy software are not
intended for mammography use. | The software is intended for the
viewing and diagnosis of image data in
relation to dental issues. Its proper use
is documented in the operating
instructions of the corresponding
image-generating systems. Image-
generating systems that can be used
with the software include optical video
cameras, digital X-ray cameras, image
plate scanners, extraoral X-ray devices,
intraoral scanners and TWAIN
compatible image sources.
The software must only be used by
authorized healthcare professionals in
dental areas for the following tasks:
- Filter optimization of the display of
2D and 3D images for improved
diagnosis - Acquisition, storage, management,
display, analysis, editing and
supporting diagnosis of
digital/digitized 2D and 3D images
and videos - Forwarding of images and
additional data to external
software (third-party software)
The software is not intended for
mammography use. |
| Patient
Management | Yes | Yes |
| Image
Management | Yes | Yes |
| X-ray
(i.e., Phosphor
Plate, Digital
Panoramic) | Yes | Yes |
| Laser
Fluorescence
Caries
Detection Aid | Yes | Yes |
| Video | Yes | No |
| Photos | Yes | Yes |
| Documents | Yes | No |
| Import | Yes | Yes |
| Display Images | Yes | Yes |
| Save/Store Images | Yes | Yes |
| Produce Reports | Yes | Yes |
| Print/Export Images | Yes | Yes |
| Brightness | Yes | Yes |
| Contrast | Yes | Yes |
| Colorize | Yes | No |
| Crop | Yes | Yes |
| Rotate | Yes | Yes |
| Zoom In/Out | Yes | Yes |
| Invert | Yes | Yes |
| Sharpen | Yes | Yes |
| Measure | Yes | Yes |
| Annotate | Yes | Yes |
| Run on standard PC compatible computers | Yes | Yes |
| Operating Systems | Microsoft Windows 7, 32-bit (from Home to Premium)
Microsoft Windows 7, 64-bit (from Home to Premium)
Microsoft Windows 8.1, 64-bit
Microsoft Windows 10, 64-bit
Microsoft Windows Server 2012
Microsoft Windows Server 2016 | Microsoft Windows 7, 64-bit
Microsoft Windows 8.1, 64-bit
Microsoft Windows 10, 64-bit
Microsoft Windows Server 2016
Microsoft Windows Server 2019
Same but since Windows 7 is no longer supported by Microsoft we no longer recommend using this OS.. |
| Supported Devices | Supported Device Families:
• ScanX
• ProVecta S-Pan
• CamX | Supported Device Families:
• ScanX
• ProVecta S-Pan
• CamX
Added Device Family:
• ProVecta 3D |
6
7
8. Discussion of Similarities and Differences:
VisionX 2.4 represents these enhancements as compared to our predicate:
- VisionX as standalone software. Currently the VisionX is cleared as part of the System of ● ProVecta 3D prime only.
- . 3D functionality: 3D images and videos for acquisition, storage, management, display, analysis, editing and supporting diagnosis of digital/digitized.
- Integration of the device family ProVecta 3D (x-ray system, cleared in K181432).
- Integration of new variants of image plate scanner of the "ScanX" device family.
- . Integration of a new interface for an intraoral scanner.
9. Non-Clinical Data and Performance Testing
VisionX 2.4 was developed in compliance with the harmonized standard of IEC 62304 for medical device software life cycle requirements. We consulted this FDA guidance document during the software development: Guidance for Industry and FDA Staff- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. Software testing, effectiveness, and functionality were successfully conducted and verified between VisionX 2.4 and image capture devices. VisionX 2.4 is DICOM compliant. Risk Analysis based design development and design reviews were conducted. Full functional software cross check testing was performed.
Labeling and internal procedures have been updated to assure compliance with the FDA Guidance: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices-Guidance for Industry and Food and Drug Administration Staff Document. In addition, we performed what we call a "Clinical Evaluation." This was an extensive detailed review of literature data, data from practical tests in dental practices, and safety data. It concluded that the software is suitable for an effective, efficient and safe dental use for the indications mentioned.
-
- Clinical Data: Not required for a finding of substantial equivalence.
11. Conclusion:
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the similarity to the predicate device in terms of technology, performance and indications for use, DÜRR DENTAL SE concludes that the VisionX 2.4 Imaging Software is substantially equivalent to the predicate device as described herein. The device modifications to VisionX 2.4 do not alter the fundamental scientific technology of the predicate device and summary level information is adequate to assess the modifications. The verification testing demonstrates that the device continues to meet its performance specifications and the results of the testing did not raise new issues of safety or effectiveness. Therefore, the modified VisionX 2,4 can be found substantially equivalent to the predicate device as cleared in K190629.