(70 days)
The software displays medical images and data. It also includes functions for image review, image manipulation, basic measurements and 3D visualization.
Viewer is a software for viewing DICOM data, such as native slices generated with medical imaging devices, axial, coronal and sagittal reconstructions, and data specific volume rendered views (e.g., skin, vessels, bone). Viewer supports basic manipulation such as windowing, reconstructions or alignment and it provides basic measurement functionality for distances and angles. Viewer is not intended for diagnosis nor for treatment planning.
The Subject Device (Viewer) for which we are seeking clearance consists of the following software modules.
- Viewer 5.4.2 (General Viewing)
- Universal Atlas Performer 6.0
- Universal Atlas Transfer Performer 6.0
Universal Atlas Performer
Software for analyzing and processing medical image data with Universal Atlas to create different output results for further use by Brainlab applications
Universal Atlas Transfer Performer
Software that provides medical image data auto-segmentation information to Brainlab applications
When installed on a server, Viewer can be used on mobile devices like tablets. No specific application or user interface is provided for mobile devices. In mixed reality, the data and the views are selected and opened via desktop PC. The views are then "cloned" into the virtual image space of connected mixed reality glasses. Multiple users in the same room can connect to the Viewer session and view/review the data (such as already saved surgical plans) on their mixed reality glasses.
The provided document describes the FDA 510(k) clearance for Brainlab AG's Viewer device. However, it explicitly states, "Viewer is not intended for diagnosis nor for treatment planning." This means the device primarily focuses on image display, manipulation, and basic measurements rather than making diagnostic or clinical decisions.
As such, the performance data presented is related to technical functionality and accuracy of measurements rather than diagnostic accuracy against a ground truth for a medical condition. Therefore, many of the requested sections regarding diagnostic performance, ground truth, experts, and comparative effectiveness studies are not applicable in the context of this specific regulatory submission.
Here's a breakdown of the requested information based on the provided document:
Acceptance Criteria and Reported Device Performance
Given the nature of the device (medical image management and processing system, not for diagnosis), the acceptance criteria and performance reported are largely functional and technical.
| Acceptance Criteria Category | Specific Criteria/Test Description | Reported Device Performance/Outcome |
|---|---|---|
| Software Functionality | Successful implementation of product specifications, incremental testing for different release candidates, testing of risk control measures, compatibility testing, cybersecurity tests. (General V&V) | Passed: Documentation indicating successful completion of these tests was provided, as recommended by FDA guidance. (Enhanced level) |
| Ambient Light Test | Determine Magic Leap 2 display quality for sufficient visualization in a variety of ambient lighting conditions. | Passed: The display quality was determined to be sufficient. (Specific results not detailed beyond "sufficient visualization") |
| Hospital Environment Tests | Test compatibility of the Subject Device with various hardware platforms and compatible software. | Passed: Compatibility was confirmed. (Specific platforms/software not detailed) |
| Display Quality Tests | Measure and compare optical transmittance, luminance non-uniformity, and Michelson contrast of the head-mounted display (Magic Leap 2) to ensure seamless integration of real and virtual content, and maintenance of high visibility and image quality. Tests were conducted with and without segmented dimming. | Passed: The tests ensured seamless integration, high visibility, and image quality. (Specific numerical results not detailed, but the outcome implies they met internal quality standards). |
| Measurement Accuracy Test | Inexperienced test persons (3) able to place distance measurements using a Mixed Reality user interface (Magic Leap controller) with a maximal deviation of less than one millimeter in each axis compared to mouse and touch on desktop as input methods. | Passed: The test concluded that the specified accuracy was achieved, meaning the maximal deviation was less than one millimeter. |
Study Details
-
Sample size used for the test set and the data provenance:
- Measurement Accuracy Test: 3 inexperienced test persons. No information on the number of measurements or specific datasets used.
- Other Tests (Ambient Light, Hospital Environment, Display Quality): The sample sizes for these bench tests are not explicitly stated in terms of patient data or specific items tested, but represent functional validation of the system and its components.
- Data Provenance: Not applicable for the described functional and accuracy tests. The device deals with DICOM data, but the specific source of that data for these tests is not mentioned as the tests focus on the device's capabilities rather than clinical diagnostic performance on a dataset.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Measurement Accuracy Test: No experts were explicitly mentioned for establishing "ground truth" for the measurement accuracy test. The comparison was between different input methods (Magic Leap controller vs. mouse/touch). The "ground truth" for these measurements would likely be the known distances within the virtual environment or the established accuracy of the mouse/touch methods themselves, assumed to be accurate. The "inexperienced test persons (3)" were the subjects performing the measurements, not experts establishing ground truth.
- Other Tests: Not applicable, as these were functional and technical performance tests not involving clinical ground truth.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. The tests described are bench tests and functional validations, not clinical studies requiring adjudication of findings.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC comparative effectiveness study was done or is applicable. This device is cleared as a "Medical Image Management And Processing System" and explicitly states it is "not intended for diagnosis nor for treatment planning." Therefore, there is no AI assistance for human readers in a diagnostic context described, and no effect size would be reported.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable in the conventional sense of a diagnostic algorithm. The device's core function is to display and manipulate images with some basic automated measurements. The measurement accuracy test (3D measurement placement) involves human interaction with the device.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the Measurement Accuracy Test, the ground truth appears to be based on the established accuracy of desktop input methods (mouse and touch) for placing measurements, and the expectation of how accurately the mixed reality controller should perform relative to those. It is not an expert consensus on a clinical condition, pathology, or outcomes data.
- For other tests (Ambient Light, Hospital Environment, Display Quality), the "ground truth" refers to engineering specifications and visual quality standards.
-
The sample size for the training set:
- Not applicable. This document describes a software update and clearance for an image viewing and manipulation device, not an AI/ML algorithm that requires a "training set" for diagnostic or predictive tasks.
-
How the ground truth for the training set was established:
- Not applicable, as there was no training set mentioned.
FDA 510(k) Clearance Letter - K252476
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.00
October 16, 2025
Brainlab AG
Sadwini Suresh
QM Consultant
Olof-Palme-Str. 9
Munich, 81829
Germany
Re: K252476
Trade/Device Name: Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout
Regulation Number: 21 CFR 892.2050
Regulation Name: Medical Image Management And Processing System
Regulatory Class: Class II
Product Code: LLZ
Dated: September 24, 2025
Received: September 24, 2025
Dear Sadwini Suresh:
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 (the 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.
October 16, 2025
Brainlab AG
Sadwini Suresh
QM Consultant
Olof-Palme-Str. 9
Munich, 81829
Germany
Re: K252476
Trade/Device Name: Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout
Regulation Number: 21 CFR 892.2050
Regulation Name: Medical Image Management And Processing System
Regulatory Class: Class II
Product Code: LLZ
Dated: September 24, 2025
Received: September 24, 2025
Dear Sadwini Suresh:
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 (the 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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K252476 - Sadwini Suresh Page 2
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 (QS) 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 (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-reporting-combination-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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
Page 3
K252476 - Sadwini Suresh Page 3
assistance/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,
Jessica Lamb, Ph.D.
Assistant Director
Imaging Software Team
DHT8B: Division of Radiological Imaging Devices and Electronic Products
OHT8: Office of Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
Indications for Use
Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. K252476
Please provide the device trade name(s).
Viewer (5.4);
Elements Viewer;
Mixed Reality Viewer;
Smart Layout;
Elements Viewer Smart Layout
Please provide your Indications for Use below.
The software displays medical images and data. It also includes functions for image review, image manipulation, basic measurements and 3D visualization.
Please select the types of uses (select one or both, as applicable).
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
Viewer Page 6 of 27
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510(k) Summary
OCTOBER 13, 2025
General Information
| Manufacturer | Brainlab AG; Olof-Palme-Str.9, 81829, Munich, Germany |
|---|---|
| Establishment Registration | 8043933 |
| Trade Name | Viewer 5.4; Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout |
| Classification Name | System, Image Processing, Radiological |
| Product Code | LLZ |
| Regulation Number | 892.2050 |
| Regulatory Class | II |
| Panel | Radiology |
| Predicate Device(s) | Viewer 5.4; K232759 |
Contact Information
| Primary Contact | Alternate Contact |
|---|---|
| Sadwini SureshQM Consultant – Regulatory AffairsPhone: +49 89 99 15 68 0Email: regulatory.affairs@brainlab.com | Chiara CunicoPhone: +49 89 99 15 68 0Fax: +49 89 99 15 68 5033Email: chiara.cunico@brainlab.com |
1. Indications for Use
The software displays medical images and data. It also includes functions for image review, image manipulation, basic measurements and 3D visualization.
2. Device Description
Viewer is a software for viewing DICOM data, such as native slices generated with medical imaging devices, axial, coronal and sagittal reconstructions, and data specific volume rendered views (e.g., skin, vessels, bone). Viewer supports basic manipulation such as windowing, reconstructions or alignment and it provides basic measurement functionality for distances and angles. Viewer is not intended for diagnosis nor for treatment planning.
The Subject Device (Viewer) for which we are seeking clearance consists of the following software modules.
- Viewer 5.4.2 (General Viewing)
- Universal Atlas Performer 6.0
- Universal Atlas Transfer Performer 6.0
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Page 2 of 5
Universal Atlas Performer: Software for analyzing and processing medical image data with Universal Atlas to create different output results for further use by Brainlab applications
Universal Atlas Transfer Performer: Software that provides medical image data auto-segmentation information to Brainlab applications
When installed on a server, Viewer can be used on mobile devices like tablets. No specific application or user interface is provided for mobile devices. In mixed reality, the data and the views are selected and opened via desktop PC. The views are then "cloned" into the virtual image space of connected mixed reality glasses. Multiple users in the same room can connect to the Viewer session and view/review the data (such as already saved surgical plans) on their mixed reality glasses.
3. Substantial Equivalence
For the Substantial Equivalence determination, comparison of the Subject Device features with the following predicate device(s) was carried out:
Viewer 5.4; K232759
There are no major changes between the subject device and the predicate.
| Feature | Predicate Device | Subject Device |
|---|---|---|
| Indications for use | The software displays medical images and data. It also includes functions for image review, image manipulation, basic measurements and 3D visualization. | The software displays medical images and data. It also includes functions for image review, image manipulation, basic measurements and 3D visualization. The device itself does not have clinical indications. |
| Computer hardware requirements | - Graphics: DirectX 11 compatible with 512 MB graphics memory- Display resolution: 1280x1024- Processor: 4 physical cores- RAM: 4GB, 8GB for 3D Stereo- With a mouse or touchscreen as pointing device | - Graphics: DirectX 11 compatible with 512 MB graphics memory- Display resolution: 1280x1024- Processor: 4 physical cores- RAM: 4GB, 8GB for 3D Stereo- With a mouse or touchscreen as pointing device |
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| Feature | Predicate Device | Subject Device |
|---|---|---|
| Mixed Reality Glasses | Magic Leap 2 IT version | Magic Leap 2 medtech and IT version |
| Operating System | Windows Server 2012, 2016, 2019min Windows 10MacOS | Windows Server 2012, 2016, 2019min Windows 10MacOS |
| Buzz Virtual Viewer Remote Control | The views streamed to Buzz Virtual from Viewer, can be interacted through mobile devices with a special layout. This remote control layout consists of predefined essentials tools:• Scroll• Switch• Pan• Rotate• Zoom• Scroll• Windowing• reset | The views streamed to Buzz Virtual from Viewer, can be interacted through mobile devices with a special layout. This remote control layout consists of predefined essentials tools:• Scroll• Switch• Pan• Rotate• Zoom• Scroll• Windowing• reset |
| Mixed Reality Segmented Dimming | The background of the 2D area Mixed Reality scene is displayed in real black (instead of dark transparent) in Mixed Reality, depending on distance between user and 2D area. | The background of the 2D area Mixed Reality scene is displayed in real black (instead of dark transparent) in Mixed Reality, depending on distance between user and 2D area. |
| Distance Display | Distance measurements can be set and displayed on 2D Slices on desktop viewer and also on 3D mixed reality views. Moreover, 3D distance measurements can be displayed over multiple 2D views. | Distance measurements can be set and displayed on 2D Slices on desktop viewer and also on 3D mixed reality views. Moreover, 3D distance measurements can be displayed over multiple 2D views. |
| Origin Data Management (component) | Origin Data Management 3.1 and 3.2 versions compatible to Viewer 5.4.0 include Universal Atlas and UA Transfer | Origin Data Management 3.1 and 3.2 compatible to Image Viewer 5.4.2 include the medical device components Universal Atlas and |
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| Feature | Predicate Device | Subject Device |
|---|---|---|
| Performers 6.0.0 as components. Additionally, they include the medical device component DICOM Proxy 5.0.0 and 5.1.0, respectively. | UA Transfer 6.0.1. Additionally, Origin Data Management 3.1 and 3.2 include the updated medical device component DICOM Proxy 5.1.1. In DICOM Proxy 5.1.1, bugs related to patient data merges were fixed. |
4. Performance Data
a. Software Verification and Validation Testing
Software verification and validation testing has been conducted and documentation is provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Device Software Functions". These include successful implementation of product specifications, incremental testing for different release candidates, testing of risk control measures, compatibility testing or cybersecurity tests. The documentation submitted is for enhanced level.
b. Bench Tests
The following performance bench tests were carried out:
Ambient Light Test: To determine the Magic Leap 2 display quality for sufficient visualization in a variety of ambient lighting conditions
Hospital Environment Tests: To test compatibility of the Subject Device with various hardware platforms and compatible software's.
c. Display Quality Tests
Tests were carried out to measure and compare the optical transmittance, and luminance non-uniformity and Michelson contrast of the head mounted display to ensure seamless integration of real and virtual content, and maintenance of high visibility and image quality. The tests were carried out with and without segmented dimming.
d. Measurement accuracy test
Additionally, tests were performed to evaluate the accuracy of 3D measurement placement using a Mixed Reality user interface, specifically Magic Leap controller in relation to mouse and touch on desktop as input methods. The accuracy of each input method was compared. The accuracy of each input method was compared. The test was concluded to be passed when inexperienced test persons (3) were able
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to place distance measurements with an maximal deviation of less than one millimeter in each axis compared to the other tested input methods.
5. Conclusion
The comparison of the Subject Device with the predicate device shows that the Viewer 5.4 has similar functionality, intended use and technological characteristics as the predicate devices. Based on the comparison to the predicate and the performance testing conducted, the Subject Device is considered substantially equivalent to the predicate device.
§ 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).