Cleared Special

MOBILETTE XP AND MOBILETT XPHYBRID (K033238) - FDA 510(k) Clearance

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K033238 · Siemens Medical Systems, Inc. · Radiology device
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Optimized for regulatory review, auditing and printing
Nov 2003
Decision
39d
Days
Class 2
Risk

K033238 is an FDA 510(k) clearance for the MOBILETTE XP AND MOBILETT XPHYBRID. Classified as System, X-ray, Mobile (product code IZL), Class II - Special Controls.

Submitted by Siemens Medical Systems, Inc. (Mavern, US). The FDA issued a Cleared decision on November 14, 2003 after a review of 39 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1720 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Siemens Medical Systems, Inc. devices

Submission Details

510(k) Number K033238 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 2003
Decision Date November 14, 2003
Days to Decision 39 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 107d · This submission: 39d
Pathway characteristics
Modification to existing cleared device.

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 93
Devices cleared under the same product code (IZL) and FDA review panel - the closest regulatory comparables to K033238.
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