VisionX 3.0

K213326 · Durr Dental SE · LLZ · Nov 2, 2021 · Radiology

Device Facts

• Record ID: K213326
• Device Name: VisionX 3.0
• Applicant: Durr Dental SE
• Product Code: LLZ · Radiology
• Decision Date: Nov 2, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: AI/ML, Software as a Medical Device

Intended 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 optimisation of the display of 2D and 3D images for improved diagnosis - Acquisition, storage, management, display, analysis, editing and supporting diagnosis of digital/digitised 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.

Device Story

VisionX 3.0 is a medical imaging software system for dental clinics; operated by authorized healthcare professionals on standard PC-compatible hardware. It ingests data from optical video cameras, image plate scanners, extraoral X-ray devices, intraoral scanners, and TWAIN-compatible sources. The software provides tools for acquisition, storage, management, display, analysis, and editing of 2D/3D images. New features include AI-driven automatic nerve canal calculation, automatic image plate quality checks, improved 3D panoramic display, and automatic image rotation. Output is displayed on diagnostic monitors for clinical review, supporting diagnosis and treatment planning. The system facilitates data forwarding to third-party software via VisionX Connect. Benefits include improved diagnostic workflow efficiency and image quality optimization through automated processing.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, software verification, and validation conducted in accordance with IEC 62304 and FDA guidance for software of moderate level of concern.

Technological Characteristics

Medical imaging software; runs on 64-bit Windows OS (8.1, 10, Server 2016/2019). Hardware requirements: Intel Core i3, >=4GB RAM (8GB for nerve canal detection), NVIDIA GeForce GPU. DICOM compliant. Features AI-based algorithms for image processing, nerve canal tracing, and quality checks. Cybersecurity controls implemented per FDA guidance.

Indications for Use

Indicated for authorized dental healthcare professionals to view, diagnose, acquire, store, manage, edit, and analyze 2D and 3D dental images and videos. Not for mammography.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• VisionX 2.4 (K192743)

Reference Devices

• SensorX (K203116)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows 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 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.

November 2, 2021

Dürr Dental SE % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct NAPLES FL 34114

Re: K213326

Trade/Device Name: VisionX 3.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: October 1, 2021 Received: October 5, 2021

Dear Mr. 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] 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

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## Indications for Use

510(k) Number (if known)

### K213326

Device Name VisionX 3.0

### 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 optimisation of the display of 2D and 3D images for improved diagnosis
- Acquisition, storage, management, display, analysis, editing and supporting diagnosis of digital/digitised 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)

| <span style="font-size: 100%;">✖</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|--------------------------------------------------------------------------------------|
| <span style="font-size: 100%;">❍</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

| Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary, DÜRR DENTAL SE, Device Name: VisionX 3.0 K213326

This 510(k) is being submitted in accordance with the requirements of 21 CFR §807.92.

#### 1. Submitter

| Submitter: | DÜRR DENTAL SE<br>Höpfigheimer Str. 17<br>74321 Bietigheim-Bissingen, Germany<br>Phone: + 49 (0) 7142 70 5-0<br>Fax: + 49 (0) 7142 705-500<br>E-Mail: [e-mail] | Establishment Registration Name in FURLS: | Duerr DENTAL SE |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|-----------------|
| Establishment Registration<br>Number: | 3015509619 | | |
| Contact Person: | Mr. Oliver Lange<br>Director of Quality Management<br>DÜRR DENTAL SE<br>Höpfigheimer Str. 17<br>74321 Bietigheim-Bissingen, Germany<br>Phone: + 49 (0) 7142 70 5-190<br>Email: [e-mail] | | |
| U.S. Agent & Contact: | Mr. Joseph Latkowski<br>Director of Quality and Regulatory<br>Air Techniques, Inc.<br>1295 Walt Whitman Road<br>Melville, NY 11747, USA<br>U.S. Phone: [phone]<br>E-Mail: [e-mail] | | |

## Date summary prepared: Thursday, September 30, 2021

#### 2. Device:

| Trade /Proprietary Name: | VisionX 3.0 |
|-------------------------------|-------------------------------------------------|
| Device: | Medical Imaging Software |
| Regulation Description: | Medical image management and processing system. |
| Regulation Medical Specialty: | Radiology |
| Review Panel | Radiology |
| Product Code | LLZ |
| Regulation Number | 892.2050 |
| Device Class | 2 |

#### 3. Predicate Device:

| Legally Marketed Predicate Device Information: | |
|------------------------------------------------|----------------|
| 510(k) Number: | K192743 |
| Manufacturer: | DÜRR DENTAL SE |
| Trade /Proprietary Name | VisionX 2.4 |

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| Device: | Medical Imaging Software |
|-------------------------------|-------------------------------------------------|
| Regulation Description: | Medical image management and processing system. |
| Regulation Medical Specialty: | Radiology |
| Review Panel | Radiology |
| Product Code | LLZ |
| Regulation Number | 892.2050 |
| Device Class | 2 |

#### 4. Device Description:

VisionX 3.0 imaging software is an image management system that allows dentists to acquire, display, edit, view, store, print, and distribute medical images. VisionX 3.0 software runs on user provided PCcompatible computers and utilize previously cleared digital image capture devices for image acquisition.

#### 5. 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, 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.

#### 6. Comparison of technological characteristics with the predicate device

VisionX 3.0 represents these enhancements as compared to our predicate:

- -Automatic nerve canal calculation
- Automatic imaging plate quality check ।
- -Improved 3D panoramic display
- -VisionX Connect
- Automatic image rotation -
- -User management

A detailed comparison table is provided on the next page.

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| | VisionX 2.4 K192743 | VisionX 3.0 | Evaluation |
|-----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Manufacturer | DÜRR DENTAL SE | DÜRR DENTAL SE | Identical |
| Clinical: | Indications for use | The software is intended for the viewing<br>and diagnosis of image data in relation<br>to dental issues. Its proper use is<br>documented in the operating<br>instructions of the corresponding<br>image-generating systems. Image-<br>generating systems that can be used<br>with the software include optical video<br>cameras, digital X-ray cameras, image<br>plate scanners, extraoral X-ray devices,<br>intraoral scanners and TWAIN<br>compatible image sources.<br><br>The software must only be used by<br>authorized healthcare professionals in<br>dental areas for the following tasks:<br>- Filter optimization of the display of<br>2D and 3D images for improved<br>diagnosis<br>- Acquisition, storage, management,<br>display, analysis, editing and<br>supporting diagnosis of<br>digital/digitized 2D and 3D images<br>and videos<br>- Forwarding of images and<br>additional data to external software<br>(third-party software)<br><br>The software is not intended for<br>mammography use. | Identical |
| Specifications: | | | |
| Functions | - Imaging application including a<br>viewer and job interface<br>- Viewer<br>- Test module<br>- Implant visualization<br>- 3D imaging module<br>- Layouts (structured displays)<br>- DICOM-Workflow (RIS & PACS) | - Imaging application including a<br>viewer and job interface<br>- Image viewer<br>- Inspect test module<br>- Implant visualization<br>- 3D imaging module<br>- Layouts (structured displays)<br>- DICOM-Workflow (RIS & PACS &<br>Print)<br>- User management<br>- Automatic rotation (AI)<br>- Automatic nerve canal tracing (AI)<br>- In-line automatic image plate<br>quality checks (AI)<br>- Improved panoramic curve<br>detection (AI)<br>- VistaSoft/VisionX Connect to<br>integrate Dürr Dental and Air<br>Techniques devices into 3rd party<br>software | New functions<br>were added |
| Patient | Yes | Yes | Identical |
| | VisionX 2.4 K192743 | VisionX 3.0 | Evaluation |
| Manufacturer | DÜRR DENTAL SE | DÜRR DENTAL SE | Identical |
| Image Management | Yes | Yes | Identical |
| Acquisition sources<br>X-ray (i.e. Phosphor<br>Plate, Digital<br>Panoramic) | Yes | Yes | Identical |
| Laser<br>Fluorescence<br>Caries Detection Aid | Yes | Yes | |
| Display images | Yes | Yes | |
| Safe/Store images | Yes | Yes | |
| Produce reports | Yes | Yes | |
| Enhance images | | | |
| Brightness | Yes | Yes | |
| Contrast | Yes | Yes | |
| 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<br>compatible<br>computers | Yes | Yes | Identical |
| Computer operating<br>systems | Microsoft Windows 7<br>Microsoft Windows 8.1<br>Microsoft Windows 10<br>Microsoft Windows Server 2016<br>Microsoft Windows Server 2019 | 64-bit operating system:<br>Microsoft Windows 8.1 (not Windows RT)<br>Microsoft Windows 10 (Pro or higher)<br>Microsoft Windows Server 2016<br>Microsoft Windows Server 2019 | Identical<br>(except of<br>Windows 7,<br>which is no<br>longer<br>supported by<br>Microsoft) |
| Supportive devices | - ScanX<br>- ProVecta S-Pan<br>- ProVecta 3D<br>- CamX | - ScanX<br>- ProVecta S-Pan<br>- ProVecta 3D<br>- CamX<br>- SensorX | Added Device:<br>SensorX<br>(K203116) |
| System requirements: | | | |
| CPU | $\ge$ Intel Core i3 | $\ge$ Intel Core i3 | Identical |
| RAM | $\ge$ 4 GB | $\ge$ 4 GB<br>For automatic nerve canal detection: $\ge$ 8 GB | Similar |
| Drive | DVD ROM | USB, DVD-ROM or download | Similar |
| Hard disk | Workstation (without database) $\ge$ 50 GB<br>The database memory requirements<br>depend on the number of images taken<br>at the surgery in question. (Camera<br>image: approx. 1 MB, X-ray image:<br>approx. 2 MB – 10 MB, CBCT: 200 – 300<br>MB) | Workstation (without database) $\ge$ 50 GB<br>The database memory requirements<br>depend on the number of images taken<br>at the surgery in question. (Camera<br>image: approx. 1 MB, X-ray image:<br>approx. 2 MB - 10 MB, CBCT: 200 - 300<br>MB) | Identical |
| Data backup | Daily data back-up | Daily data back-up | Identical |
| | VisionX 2.4 K192743 | VisionX 3.0 | Evaluation |
| Manufacturer | DÜRR DENTAL SE | DÜRR DENTAL SE | Identical |
| Diagnostic Monitor | In accordance with DIN 6868-157, room<br>category 5 or 6 (depending on the<br>requirements) | In accordance with DIN 6868-157, room<br>category 5 or 6 (depending on the<br>requirements) | Identical |
| Resolution / graphics | Resolution ≥ 1280 x 1024<br>Depth of color 32-bit, 16.7 million colors<br>Recommended for 3D X-ray images:<br>NVIDIA GeForce 750 2 GB | Resolution ≥ 1280 x 1024<br>Depth of color 32-bit, 16.7 million colors<br>For display of 3-D X-ray images:<br>NVIDIA GeForce ≥ 1 GB<br>For automatic nerve canal tracing:<br>NVIDIA GeForce ≥ 4 GB | Similar |

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#### 7. Non-Clinical Data and Performance Testing

VisionX 3.0 was developed in compliance with the harmonized standard of IEC 62304 for medical device software life cycle requirements.

Software testing, effectiveness, and functionality were successfully conducted and verified between VisionX 3.0 and image capture devices. Software was documented using the FDA guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" using a moderate level of concern. Cybersecurity was addressed according to the FDA guidance document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff." VisionX 3.0 is DICOM compliant.

Risk Analysis based design development and design reviews were conducted. Full functional software cross check testing was performed.

- 8. Clinical Data: Not required for a finding of substantial equivalence.
#### 9. 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, DURR DENTAL SE concludes that the VisionX 3.0 Imaging Software is substantially equivalent to the predicate device as described herein.

The device modifications to VisionX 3.0 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 3.0 can be found substantially equivalent to the predicate device as cleared in K192743.