Cleared Traditional

K213568 - DRX-Rise Mobile X-ray System

K213568 is the FDA 510(k) clearance for DRX-Rise Mobile X-ray System by Carestream Health. It is a Class 2 Radiology device (product code IZL) cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K213568 · Carestream Health · Radiology device
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Mar 2022
Decision
134d
Days
Class 2
Risk

K213568 is an FDA 510(k) clearance for the DRX-Rise Mobile X-ray System. Classified as System, X-ray, Mobile (product code IZL), Class II - Special Controls.

Submitted by Carestream Health (Rochester, US). The FDA issued a Cleared decision on March 23, 2022 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1720 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Carestream Health devices

Submission Details

510(k) Number K213568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2021
Decision Date March 23, 2022
Days to Decision 134 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 107d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IZL System, X-ray, Mobile
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1720
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - IZL System, X-ray, Mobile

All 116
Devices cleared under the same product code (IZL) and FDA review panel - the closest regulatory comparables to K213568.
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