Cleared Special

URS LP DIGITAL, MILLENNIUM, RADPRO (K042876) - FDA 510(k) Clearance

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K042876 · Sedecal., Sa. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2004
Decision
31d
Days
Class 2
Risk

K042876 is an FDA 510(k) clearance for the URS LP DIGITAL, MILLENNIUM, RADPRO. 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 November 18, 2004 after a review of 31 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

Submission Details

510(k) Number K042876 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2004
Decision Date November 18, 2004
Days to Decision 31 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
76d faster than avg
Panel avg: 107d · This submission: 31d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 116
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K042876.
REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS
K051967 · Ge Healthcare · Aug 2005
KODAK DIRECTVIEW DR 7500 SYSTEM, MODEL 8791345
K051258 · Eastman Kodak Company · Jun 2005
MODIFICATION TO: REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH IMAGE PASTING AND AUTOPOSITIONING
K050704 · General Electric Co. · Apr 2005
DUAL ENERGY AND TISSUE EQUALIZATION SOFTWARE OPTION
K013481 · GE Medical Systems · Nov 2001
MULTIX COMPACT K AND MULTIX L RADIOGRAPHIC X-RAY SYSTEMS
K001201 · Siemens Medical Solutions USA, Inc. · Jun 2000
REVOLUTION TX/I DIGITAL RADIOGRAPHIC TABLE SYSTEM
K992066 · GE Medical Systems · Aug 1999