Cleared Special

K042876 - URS LP DIGITAL

K042876 is an FDA 510(k) clearance for URS LP DIGITAL, 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 31-day FDA review.

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

FDA 510(k) Submission Details - K042876

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 107d · This submission: 31d
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 K042876.
MODIFICATION TO: REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH IMAGE PASTING AND AUTOPOSITIONING
K050704 · General Electric Co. · Apr 2005
MULTIDIAGNOST ELEVA
K050151 · Philips Medical Systems North America, Inc. · Feb 2005
SYNERAD OMNI, DIGITAL X-RAY SYSTEM, MODEL AN6250
K043025 · Analogic Corp. · Nov 2004
SYNERAD MULTI DIGITAL X-RAY SYSTEM, MODEL AN6150
K040995 · Analogic Corp. · May 2004
AN5150 AND AN7150 DIGITAL RADIOLOGY SYSTEMS
K033345 · Analogic Corp. · Nov 2003
PHILIPS EASYDIAGNOST ELEVA
K031535 · Philips Medical Systems North America Co. · Jun 2003