Cleared Special

K120629 - FDR GO FLEX

K120629 is an FDA 510(k) clearance for FDR GO FLEX, manufactured by Fujifilm Medical System U.S.A., Inc.. The device is a Class 2 Radiology device with product code MQB cleared through the Special 510(k) pathway after a 180-day FDA review.

K120629 · Fujifilm Medical System U.S.A., Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K120629

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d slower than avg
Panel avg: 107d · This submission: 180d
Pathway characteristics
Modification to existing cleared device.

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 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 K120629.
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K121095 · Agfa Healthcare N.V. · Aug 2012
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K122182 · Rayence Co., Ltd. · Aug 2012
CR 10-X DIGITIZER
K121948 · Agfa Healthcare N.V. · Jul 2012
K120629 · FDR GO FLEX
Download PDF FDA Summary Fujifilm Medical Syst…