Cleared Special

K120629 - FDR GO FLEX (FDA 510(k) Clearance)

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

K120629 · Fujifilm Medical System U.S.A., Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2012
Decision
180d
Days
Class 2
Risk

K120629 is an FDA 510(k) clearance for the FDR GO FLEX. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Fujifilm Medical System U.S.A., Inc. (Stamford, US). The FDA issued a Cleared decision on August 28, 2012 after a review of 180 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Fujifilm Medical System U.S.A., Inc. devices

Submission Details

510(k) Number K120629 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2012
Decision Date August 28, 2012
Days to Decision 180 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
73d slower than avg
Panel avg: 107d · This submission: 180d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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

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