Cleared Traditional

K182317 - AMADEO M-DR mini

K182317 is the FDA 510(k) clearance for AMADEO M-DR mini by Oehm Und Rehbein GmbH. It is a Class 2 Radiology device (product code IZL) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K182317 · Oehm Und Rehbein GmbH · Radiology device
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Sep 2018
Decision
28d
Days
Class 2
Risk

K182317 is an FDA 510(k) clearance for the AMADEO M-DR mini, AMADEO M-AX mini. Classified as System, X-ray, Mobile (product code IZL), Class II - Special Controls.

Submitted by Oehm Und Rehbein GmbH (Rostock, DE). The FDA issued a Cleared decision on September 24, 2018 after a review of 28 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Oehm Und Rehbein GmbH devices

Submission Details

510(k) Number K182317 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2018
Decision Date September 24, 2018
Days to Decision 28 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
79d faster than avg
Panel avg: 107d · This submission: 28d
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 Consultant

Kamm & Associates
Daniel Kamm

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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