---
AI Summary: "\\- Conducted a cybersecurity gap assessment for OXOS Medical\\'s MC2\
  \ Portal Portable X-ray System.  \n- Drafted essential cybersecurity documents and\
  \ updated company procedures.  \n- Ensured compliance with FDA cybersecurity guidelines.\
  \  \n- Achieved FDA Clearance through collaboration and multiple reviews with the\
  \ FDA."
Anonymous: false
Assignee: []
Last Edited Time: '2025-11-09T21:59:00+00:00'
client_logo:
- 18dbd5b7-a754-80f5-81ca-fda60faf58d3
client_name: OXOS Medical, Inc
date: '2025-11-09'
featured: false
medical_panel: null
name: OXOS Cybersecurity Remediation
services:
- 1c8bd5b7-a754-80a8-a972-d8ecb02ce167
summary: ''
tags:
- 510k
- SIMD
- Cybersecurity
testimonials: []
---

## The Problem

OXOS Medical is the manufacturer of ultraportable X-ray imaging systems for point-of-need radiographic diagnostic imaging. They're an established manufacturer with previous experience submitting and clearing devices with the FDA. For their latest device, the MC2 Portal Portable X-ray System, they needed help quickly putting together cybersecurity documentation for an upcoming 510(k).

## Highlights

- The OXOS MC2 device successfully achieved FDA Clearance, supported by cybersecurity guidance from Innolitics through multiple rounds of correspondence with the FDA.
- Innolitics worked quickly to identify and address cybersecurity requirements in the OXOS MC2, allowing for submission within the target timeline.

## What We Did

- Performed an initial cybersecurity gap assessment, identifying all the areas that needed to be addressed before submission. These included specific documents, security controls and updates to current procedures.
- Met with OXOS every week until the submission to address cybersecurity gaps.
- Drafted several new cybersecurity documents.
- Guided updates to company procedures to comply with FDA cybersecurity guidelines.
- Helped draft new software requirements to comply with FDA cybersecurity guidelines.
- Provided support for FDA Additional information Request and Interactive Reviews.