Cleared Traditional

K121838 - LIEBEL-FLARSHEIM DIRECT DIGITAL IMAGING SYSTEM

K121838 is an FDA 510(k) clearance for LIEBEL-FLARSHEIM DIRECT DIGITAL IMAGING..., manufactured by Liebel-Flarsheim. The device is a Class 2 Radiology device with product code MQB cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K121838 · Liebel-Flarsheim · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2012
Decision
19d
Days
Class 2
Risk

K121838 is an FDA 510(k) clearance for the LIEBEL-FLARSHEIM DIRECT DIGITAL IMAGING SYSTEM. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Liebel-Flarsheim (Cincinnati, US). The FDA issued a Cleared decision on July 11, 2012 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - 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.

FDA 510(k) Submission Details - K121838

510(k) Number K121838 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2012
Decision Date July 11, 2012
Days to Decision 19 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 107d · This submission: 19d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

MQB Device Classification - Class 2, Special Controls

Product Code MQB Solid State X-ray Imager (flat Panel/digital Imager)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
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

Regulatory Technology Services, LLC
MARK JOB

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.

Regulatory Peers - MQB Solid State X-ray Imager (flat Panel/digital Imager)

All 423
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K121838.
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K121132 · Humanray Co,Ltd · May 2012
K121838 · LIEBEL-FLARSHEIM DIRECT DIGITAL IMAGING SYSTEM
Download PDF FDA Summary Liebel-Flarsheim