Cleared Special

K062335 - SEDECAL X PLUS LP PLUS

K062335 is an FDA 510(k) clearance for SEDECAL X PLUS LP PLUS, manufactured by Sedecal., Sa.. The device is a Class 2 Radiology device with product code KPR cleared through the Special 510(k) pathway after a 35-day FDA review.

K062335 · Sedecal., Sa. · Radiology device
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Sep 2006
Decision
35d
Days
Class 2
Risk

K062335 is an FDA 510(k) clearance for the SEDECAL X PLUS LP PLUS. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Sedecal., Sa. (Deer Field, US). The FDA issued a Cleared decision on September 14, 2006 after a review of 35 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 Sedecal., Sa. devices

FDA 510(k) Submission Details - K062335

510(k) Number K062335 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2006
Decision Date September 14, 2006
Days to Decision 35 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
72d faster than avg
Panel avg: 107d · This submission: 35d
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.

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