Cleared Traditional

K012546 - OPTIMA URS UNIVERSAL RADIOGRAPHIC SYSTEM

K012546 is an FDA 510(k) clearance for OPTIMA URS UNIVERSAL RADIOGRAPHIC SYSTEM, manufactured by Sedecal USA, Inc.. The device is a Class 2 Radiology device with product code KPR cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K012546 · Sedecal USA, Inc. · Radiology device
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Nov 2001
Decision
87d
Days
Class 2
Risk

K012546 is an FDA 510(k) clearance for the OPTIMA URS UNIVERSAL RADIOGRAPHIC SYSTEM. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Sedecal USA, Inc. (Deer Field, US). The FDA issued a Cleared decision on November 2, 2001 after a review of 87 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sedecal USA, Inc. devices

FDA 510(k) Submission Details - K012546

510(k) Number K012546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2001
Decision Date November 02, 2001
Days to Decision 87 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 107d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 237
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K012546.
AN5150 AND AN7150 DIGITAL RADIOLOGY SYSTEMS
K033345 · Analogic Corp. · Nov 2003
PHILIPS EASYDIAGNOST ELEVA
K031535 · Philips Medical Systems North America Co. · Jun 2003
AXIOM ARISTOS FX (MULTI PURPOSE RADIOGRAPHY SYSTEM)
K013826 · Siemens Medical Systems, Inc. · Feb 2002
DUAL ENERGY AND TISSUE EQUALIZATION SOFTWARE OPTION
K013481 · GE Medical Systems · Nov 2001
OLDELFT THORASCAN MODEL NUMBER 180T
K012165 · Nucletron Corp. · Sep 2001
REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM
K012389 · Ge Medical Systems, Inc. · Aug 2001