# K191503: MobileRay Pulse SE Digital Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Portavision Medical, LLC
- Decided: Sep 4, 2019 after 90 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: 4 generations back to K973598 (1997). 6 ancestors in all.
7 later devices descend from it; 2 cite it directly.
1 of 14 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160279: ANYVIEW-500R Fluoroscopic Mobile X-Ray System, Ecotron Co., Ltd. (2016) Summary page 4.

## Most influential descendants
- K211191: Virtual C DRF Digital Imaging System (2021), 5 descendants of its own
- K241567: MC2 Portable X-ray System (2024), 1 descendant of its own
- K212523: VFSS Pro Mobile Digital Imaging System (2021), 1 descendant of its own
- K212557: Virtual C DRF-NEO Digital Imaging System (2021), 1 descendant of its own
- K210469: Insight Agile DRF (2021), 1 descendant of its own

## Indications for use
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 radiographic, multi-radiographic and 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. The device may be used for other imaging applications on all patients except pediatrics 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. (RX Only)

Source page: https://510kreport.com/device/K191503
Methodology: https://510kreport.com/methodology