Cleared Traditional

K182639 - MOBILETT Elara Max

K182639 is an FDA 510(k) clearance for MOBILETT Elara Max, manufactured by Siemens Medi Cal Solutions, Inc.. The device is a Class 2 Radiology device with 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

FDA 510(k) Submission Details - K182639

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.

IZL Device Classification - Class 2, Special Controls

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 169
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