Cleared Special

K101686 - FDR IMAGE STITCHING OPTION

K101686 is an FDA 510(k) clearance for FDR IMAGE STITCHING OPTION, manufactured by Fujifilm Medical System U.S.A., Inc.. The device is a Class 2 Radiology device with product code KPR cleared through the Special 510(k) pathway after a 135-day FDA review.

K101686 · 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
Oct 2010
Decision
135d
Days
Class 2
Risk

K101686 is an FDA 510(k) clearance for the FDR IMAGE STITCHING OPTION. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Fujifilm Medical System U.S.A., Inc. (Stamford, US). The FDA issued a Cleared decision on October 29, 2010 after a review of 135 days - within the typical 510(k) review window.

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 - K101686

510(k) Number K101686 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2010
Decision Date October 29, 2010
Days to Decision 135 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
28d slower than avg
Panel avg: 107d · This submission: 135d
Pathway characteristics
Modification to existing cleared device.

KPR Device Classification - Class 2, Special Controls

Product Code KPR System, X-ray, Stationary
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 - KPR System, X-ray, Stationary

All 357
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K101686.
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K101686 · FDR IMAGE STITCHING OPTION
Download PDF FDA Summary Fujifilm Medical Syst…