3D-Anywhere
Device Facts
| Record ID | K253899 |
|---|---|
| Device Name | 3D-Anywhere |
| Applicant | Provect.AI |
| Product Code | LLZ · Radiology |
| Decision Date | Jul 9, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.2050 |
| Device Class | Class 2 |
| Attributes | Software as a Medical Device |
Indications for Use
The 3D-Anywhere software provides processing and conversion of 2D fluoroscopic projections from standard C-Arms into volumetric 3D image. The 3D-Anywhere software provides processing and conversion of 2D fluoroscopic projections from standard C-Arms into volumetric 3D image. It is intended to be used whenever the clinician and/or patient benefits from generated 3D imaging of high contrast anatomical structures, such as bony anatomy, particularly for orthopedic applications. It is not intended to replace diagnostic imaging modalities (e.g., C-arm, CT or MRI) and is not indicated for procedures involving low contrast tissue or liquid materials.
Device Story
3D-Anywhere software processes 2D fluoroscopic projections from standard C-Arms into volumetric 3D images; intended for hospital/operating room use by clinicians. System utilizes a rigid rectangular jig placed externally in a sterile bag near the anatomy for pose estimation; connects to C-Arm via video output and runs on an IEC 60601-1 compliant PC workstation with touch screen. Output is a 3D volumetric representation exported in DICOM format for reference during procedures or viewing in third-party software. Benefits include CT-like visualization of bony anatomy to assist orthopedic decision-making without replacing diagnostic imaging modalities.
Clinical Evidence
No clinical data. Bench testing included phantom testing, simulated datasets from reference CT images, and cadaveric acquisitions. Evaluated geometric accuracy, spatial resolution, image noise, and bone contrast. Results met predefined acceptance criteria for CT-like visualization.
Technological Characteristics
PC-based workstation (ONYX Healthcare ACCEL-VM1000) with Magewell Pro Capture AIO card. Uses a rigid rectangular jig for pose estimation. Connectivity via standard video input/output and DICOM export. Standards: IEC 60601-1, IEC 60601-1-2, IEC 62304, ISO/IEC/IEEE 29148:2018. Software validation and cybersecurity controls implemented.
Indications for Use
Indicated for adult patients undergoing orthopedic procedures requiring 3D visualization of high-contrast anatomical structures (e.g., bone). Not indicated for low-contrast tissue or liquid materials.
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
- Mazor Surgical Technologies, Ltd, C-InSight System (K081672)
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
July 9, 2026
Provect.AI
% Paul Dryden
Consultant
ProMedic Consulting, LLC
131 Bay Point Dr. NE
St. Petersburg, Florida 33704
Re: K253899
Trade/Device Name: 3D-Anywhere
Regulation Number: 21 CFR 892.2050
Regulation Name: Medical Image Management And Processing System
Regulatory Class: Class II
Product Code: LLZ
Dated: June 9, 2026
Received: June 9, 2026
Dear Paul Dryden:
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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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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 Management System Regulation (QMSR) (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-
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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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
# Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known)
K253899
Device Name
3D-Anywhere
Indications for Use (Describe)
The 3D-Anywhere software provides processing and conversion of 2D fluoroscopic projections from standard C-Arms into volumetric 3D image.
The 3D-Anywhere software provides processing and conversion of 2D fluoroscopic projections from standard C-Arms into volumetric 3D image.
It is intended to be used whenever the clinician and/or patient benefits from generated 3D imaging of high contrast anatomical structures, such as bony anatomy, particularly for orthopedic applications.
It is not intended to replace diagnostic imaging modalities (e.g., C-arm, CT or MRI) and is not indicated for procedures involving low contrast tissue or liquid materials.
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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K253899
# 510(k) Summary
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| Date Prepared: | 9-Jun-26 |
| --- | --- |
| Sponsor: | Provect.AI 115 Lancewood Pl. Los Gatos, CA 95032 Tel: 469-850-2282 |
| Sponsor Contact: | Dorian Averbuch - CEO |
| Submission Correspondent: | Paul Dryden ProMedic Consulting, LLC |
| Proprietary or Trade Name: | 3D-Anywhere |
| Classification Name: | Medical image management and processing system |
| Product Code: | QIH |
| CFR | 892.2050 |
| Predicate Device: | K081672, Mazor Surgical Technologies, Ltd, C-InSight System |
| Classification Name: | Medical image management and processing system |
| Product Code: | LLZ |
| CFR | 892.2050 |
# Device Description
The 3D-Anywhere software provides processing and conversion of 2D fluoroscopic projections from standard C-Arms into volumetric 3D image.
3D Anywhere is software that runs on an IEC 60601-1 compliant computer with a built-in touch screen display. The system connects to a customer-provided medical-grade monitor and to a C-Arm via standard video output for integration. The computer is from ONYX Healthcare model ACCEL-VM1000 with a Magewell Pro Capture AIO video capture card.
The system supports exporting reconstructed 3D volumes in standard DICOM format, ensuring compatibility with PACS systems and third-party imaging software.
# Indications for Use:
The 3D-Anywhere software provides processing and conversion of 2D fluoroscopic projections from standard C-Arms into volumetric 3D image.
The 3D-Anywhere software provides processing and conversion of 2D fluoroscopic projections from standard C-Arms into volumetric 3D image.
It is intended to be used whenever the clinician and/or patient benefits from generated 3D imaging of high contrast anatomical structures, such as bony anatomy, particularly for orthopedic applications.
It is not intended to replace diagnostic imaging modalities (e.g., C-arm, CT or MRI) and is not indicated for procedures involving low contrast tissue or liquid materials.
# Patient Population:
Adults
# Environments of use:
It is intended for use in hospital/institutional settings.
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K253899
510(k) Summary
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Table of Comparison of Subject vs. Predicate
| | Proposed Device 3D-Anywhere | Predicate Mazor C-Insight System | Comparison |
| --- | --- | --- | --- |
| K# | K253899 | K081672 | |
| Product Code | QIH | LLZ | Added due to AI enabled utility |
| CFR | 892.2050 | 892.2050 | |
| Indications for Use | The 3D-Anywhere software provides processing and conversion of 2D fluoroscopic projections from standard C-Arms into volumetric 3D image. The 3D-Anywhere software provides processing and conversion of 2D fluoroscopic projections from standard C-Arms into volumetric 3D image. It is intended to be used whenever the clinician and/or patient benefits from generated 3D imaging of high contrast anatomical structures, such as bony anatomy, particularly for orthopedic applications. It is not intended to replace diagnostic imaging modalities (e.g., C-arm, CT or MRI) and is not indicated for procedures involving low contrast tissue or liquid materials. | The C-InSight software provides processing and conversion of 2D fluoroscopic projections from standard C-Arms into volumetric 3D image. It is intended to be used whenever the clinician and/or patient benefits from generated 3D imaging of high contrast objects particularly for orthopedic applications. | Similar |
| Target Population | Orthopedic patients | Orthopedic patients | |
| Environment of Use | Hospital setting (operating room) | Hospital setting (operating room) | |
| Orthopedic procedures | Yes Orthopedic procedures | Yes Not specified | Similar |
| Fundamental scientific technology | Converts 2D fluoroscopy images into a 3D volume. | Converts 2D fluoroscopy images into a 3D volume. | Similar |
| Software based on a PC | Yes | Yes | Similar |
| Accessory | Jig with targets (markers) used for registration – non-sterile placed in a sterile pouch for use | Belt with targets (markers) in single-use sterile sheath. | Similar |
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K253899
# 510(k) Summary
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| | Proposed Device 3D-Anywhere | Predicate Mazor C-Insight System | Comparison |
| --- | --- | --- | --- |
| Equipment Compatibility | Each C-Arm model is qualified during installation | Not listed | Similar |
| Imaging Modalities | Fluoro based imaging | CT and Fluoro based imaging | Similar |
| Computer specifications | PC Workstation | PC Workstation | Similar |
| Standards | IEC 60601-1 IEC 60601-1-2 IEC 62304 (replaced IEC 60601-1-4) ISO/IEC/IEEE 29148:2018 Human Factors Cybersecurity Image Quality testing Software Validations | IEC 60601-1 IEC 60601-1-2 IEC 60601-1-4 & FDA Guidelines Image Quality testing Software Validation | Similar |
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K253899
510(k) Summary
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## Difference Between Subject and Predicate
The subject device (Provect.AI 3D-Anywhere System) and the predicate device (Mazor C-Insight System, cleared under K081672) share a similar intended use, product code (LLZ), device classification (21 CFR 892.2050 – Radiological Image Processing System), and fundamental operational principle of generating a volumetric 3D dataset from 2D fluoroscopic projections acquired intraoperatively. Both devices process sequences of fluoroscopy images obtained from standard mobile C-Arm systems to produce a 3D volumetric representation of high-contrast anatomical structures.
Both devices only provide 3D imaging from 2D X-Ray, so there is no planning, registration and navigation. Doctor may use the generated images as a reference during a procedure or store in a DICOM format and upload into any other software reading DICOM, such as 3rd party DICOM viewer or 3rd party navigation software
Any differences are limited to system configuration, accessory design, and implementation details. These differences do **not** alter the intended use, mode of operation, or raise new questions of safety or effectiveness.
Key differences include:
| Feature | Subject Device – Provect.AI 3D-Anywhere | Predicate – Mazor C-Insight (K081672) | Comment |
| --- | --- | --- | --- |
| **Reference Object for Pose Estimation** | Rigid rectangular jig placed externally in a sterile bag and secured adjacent to the anatomical region of interest. | Sterile belt-style reference marker positioned around the anatomy of interest. | Same fundamental function (image-based pose estimation). Form factor change does not alter imaging principle or user interaction steps. |
| **Disposable Components** | No disposable components; the jig is reusable and sterile-barrier protected. | Includes a single-use sterile sheath and belt accessory. | Eliminates special disposable use without affecting safety or workflow. No new materials contact the patient. |
| **Algorithmic Implementation** | Tomographic reconstruction using geometric estimation based on Rectangular Jig coordinate system | Tomographic reconstruction using geometric estimation based on belt coordinate system. | Same scientific principle. Differences are implementation-level and validated through performance testing. |
| **Hardware Platform** | Runs on a modern workstation-based PC. | Runs on a workstation-based PC. | Same. Improved performance only; does not change feature set, architecture category, or user workflow. |
## Non-clinical Testing
Non-clinical testing was performed to verify and validate the 3D-Anywhere system against its design requirements and intended use. The testing included software verification, hardware verification,
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510(k) Summary
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cybersecurity testing, penetration testing, imaging performance testing, workflow validation, and physician image-review validation.
Software testing included static analysis, code review, unit and integration testing, system-level workflow testing, regression testing, stress testing, and exploratory testing. Hardware testing verified the integrated computing platform, image capture hardware, fluoroscopic jig, display interfaces, and related system components.
Imaging performance was evaluated using a combination of phantom testing, simulated datasets generated from reference CT images, and cadaveric acquisitions obtained under representative imaging conditions. The evaluated performance characteristics included geometric accuracy, spatial resolution, image noise, bone contrast and visibility, and robustness to acquisition and patient-size variability. Testing included assessment of reconstructed 3D volume accuracy, isotropic resolution in multiple anatomical planes, noise behavior using volumetric noise analysis, and bone-to-background contrast across phantom, simulated, and cadaveric datasets. The imaging performance results met the predefined acceptance criteria and supported the ability of the system to generate CT-like 3D images suitable for the intended orthopedic use environment.
Cybersecurity testing verified implementation of access control, authentication, integrity protection, data protection, malware protection, vulnerability management, network isolation, and event logging. Penetration testing was also performed to assess the system within the defined cybersecurity test scope. The results confirmed that cybersecurity controls were implemented as intended, and any identified findings were resolved or assessed as acceptable residual risk.
Workflow validation confirmed that intended users could complete representative setup, acquisition, reconstruction, and image-review workflows using the 3D-Anywhere system. Physician image-review validation confirmed that the reconstructed 3D images provided CT-like visualization suitable for the intended orthopedic use environment.
The results of non-clinical testing support that the 3D-Anywhere system meets its specified performance, safety, workflow, and cybersecurity requirements and is suitable for its intended use.
### Clinical Testing
Not performed
### Substantial Equivalence Discussion
As discussed above, the differences between the subject device and predicate do not raise different risk concerns compared to the predicate.
### Substantial Equivalence Conclusion
The sponsor has demonstrated through testing and comparison that the subject device is substantially equivalent to the predicate.
