# K212523: VFSS Pro Mobile Digital Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Imagexray, LLC
- Decided: Nov 5, 2021 after 86 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K973598 (1997). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 10 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211191: Virtual C DRF Digital Imaging System, Portavision Medical, LLC (2021) Summary page 4.

## Most influential descendants
- K242731: MasteRad MiniX Mobile Digital Imaging System (Mini-X) (2025), 0 descendants of its own

## Indications for use
The VFSS Pro Mobile system is intended for use by a qualified/trained medical professionals, who have full understanding of the safety information and emergency procedures as well of capabilities and function of the device. The device provides fluoroscopic imaging and is used for guidance and visualization during diagnostic radiographic, surgery, and interventional procedures. The device is to be used in healthcare facilities both inside and outside of hospital, in a variety of procedures of the skull, spinal column, chest, abdomen, extremities, and at the discretion of the medical professional the device may be used for other imaging applications on all patients except neonates (birth to one month) within the limits of the device. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. The system is not intended for mammography applications

Source page: https://510kreport.com/device/K212523
Methodology: https://510kreport.com/methodology