# K253899: 3D-Anywhere

- Pathway: 510(k) (Traditional)
- Applicant: Provect.AI
- Decided: Jul 9, 2026 after 216 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K003266 (2000). 8 ancestors in all.
No later device cites it as a predicate yet.
1 of 9 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081672: C-Insight, Mazor Surgical Technologies, Ltd. (2008) Summary page 5.

## 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.

Source page: https://510kreport.com/device/K253899
Methodology: https://510kreport.com/methodology