Cleared Special

K140683 - 0180 INTUITION

K140683 is an FDA 510(k) clearance for 0180 INTUITION, manufactured by Arcoma AB. The device is a Class 2 Radiology device with product code KPR cleared through the Special 510(k) pathway after a 77-day FDA review.

K140683 · Arcoma AB · Radiology device
Download Printable Device Report (PDF)
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Jun 2014
Decision
77d
Days
Class 2
Risk

K140683 is an FDA 510(k) clearance for the 0180 INTUITION, 0072 PRECISION. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Arcoma AB (Naples, US). The FDA issued a Cleared decision on June 3, 2014 after a review of 77 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. 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Arcoma AB devices

FDA 510(k) Submission Details - K140683

510(k) Number K140683 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2014
Decision Date June 03, 2014
Days to Decision 77 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
30d faster than avg
Panel avg: 107d · This submission: 77d
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 206
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