Cleared Traditional

K151207 - Proton Immobilization Solution (FDA 510(k) Clearance)

K151207 · Orfit Industries NV · Radiology device
Jul 2015
Decision
83d
Days
Class 2
Risk

K151207 is an FDA 510(k) clearance for the Proton Immobilization Solution. This device is classified as a Accelerator, Linear, Medical (Class II - Special Controls, product code IYE).

Submitted by Orfit Industries NV (Wijnegem, BE). The FDA issued a Cleared decision on July 28, 2015, 83 days after receiving the submission on May 6, 2015.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K151207 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2015
Decision Date July 28, 2015
Days to Decision 83 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

Product Code IYE - Accelerator, Linear, Medical
Device Class Class II - Special Controls
CFR Regulation 21 CFR 892.5050