Cleared Special

K090279 - SEDECAL

K090279 is an FDA 510(k) clearance for SEDECAL, 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.

K090279 · Sedecal., Sa. · Radiology device
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Mar 2009
Decision
35d
Days
Class 2
Risk

K090279 is an FDA 510(k) clearance for the SEDECAL, MILLENNIUM PLUS. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Sedecal., Sa. (Deerfield, US). The FDA issued a Cleared decision on March 11, 2009 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 - K090279

510(k) Number K090279 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2009
Decision Date March 11, 2009
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.

Regulatory Peers - KPR System, X-ray, Stationary

All 189
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K090279.
DX-D 300
K103050 · Agfa Healthcare N.V. · Oct 2010
DIGITAL X-RAY IMAGING SYSTEM, MODEL DRC-1000
K092830 · VATECH Co., Ltd. · Jul 2010
DRX-EVOLUTION, MODEL VX3733-SYS
K091889 · Carestream Health, Inc. · Jul 2009
SEDECAL X-PLUS LP PLUS DIGITAL DIAGNOSTIC X-RAY SYSTEMS
K090238 · Sedecal., Sa. · Feb 2009
DRAD30003/RADREX-I
K083503 · Toshiba America Medical Systems, In.C · Feb 2009
YSIO
K081722 · Siemens Medical Solutions USA, Inc. · Aug 2008