Cleared Traditional

K182639 - MOBILETT Elara Max

K182639 is the FDA 510(k) clearance for MOBILETT Elara Max by Siemens Medi Cal Solutions, Inc.. It is a Class 2 Radiology device (product code IZL) cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K182639 · Siemens Medi Cal Solutions, Inc. · Radiology device
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Mar 2019
Decision
172d
Days
Class 2
Risk

K182639 is an FDA 510(k) clearance for the MOBILETT Elara Max. Classified as System, X-ray, Mobile (product code IZL), Class II - Special Controls.

Submitted by Siemens Medi Cal Solutions, Inc. (Malvern, US). The FDA issued a Cleared decision on March 15, 2019 after a review of 172 days - an extended review cycle.

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 Siemens Medi Cal Solutions, Inc. devices

Submission Details

510(k) Number K182639 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2018
Decision Date March 15, 2019
Days to Decision 172 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
65d slower than avg
Panel avg: 107d · This submission: 172d
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
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