CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System
FDA 510(k) K171755 · Omega Medical Imaging, LLC
510(k) numberK171755
Submission
- Device name
- CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System
- Applicant
- Omega Medical Imaging, LLC
Sanford, FL, US - Received
- June 13, 2017
- Decision date
- February 9, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System cleared by the FDA?
CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System (K171755) received a 510(k) decision of Substantially Equivalent on February 9, 2018, 241 days after the submission was received.
What is the product code of K171755?
The FDA product code is OWB – Interventional Fluoroscopic X-Ray System, a Class II (moderate risk) device regulated under 21 CFR 892.1650.