Cleared Traditional

K012490 - ORION DIGITAL IMAGING SYSTEM

K012490 is an FDA 510(k) clearance for ORION DIGITAL IMAGING SYSTEM, manufactured by Infimed, Inc.. The device is a Class 2 Radiology device with product code OWB cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K012490 · Infimed, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2002
Decision
193d
Days
Class 2
Risk

K012490 is an FDA 510(k) clearance for the ORION DIGITAL IMAGING SYSTEM. Classified as Interventional Fluoroscopic X-ray System (product code OWB), Class II - Special Controls.

Submitted by Infimed, Inc. (Liverpool, US). The FDA issued a Cleared decision on February 12, 2002 after a review of 193 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1650 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Infimed, Inc. devices

FDA 510(k) Submission Details - K012490

510(k) Number K012490 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2001
Decision Date February 12, 2002
Days to Decision 193 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
86d slower than avg
Panel avg: 107d · This submission: 193d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OWB Device Classification - Class 2, Special Controls

Product Code OWB Interventional Fluoroscopic X-ray System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
Definition Interventional Fluoroscopy
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 - OWB Interventional Fluoroscopic X-ray System

All 254
Devices cleared under the same product code (OWB) and FDA review panel - the closest regulatory comparables to K012490.
INNOVA 2000 AND INNOVA 2000S (MOBILE VERSION)
K024200 · Ge Medical Systems, Inc. · Jan 2003
INNOVA 4100
K023178 · Ge Medical Systems, Inc. · Nov 2002
INNOVA AND INNOVA 2000 S
K022322 · Ge Medical Systems, Inc. · Oct 2002
DIGITAL RADIOGRAPHY SYSTEM, MODEL DFP-8000D
K013608 · Toshiba America Medical Systems, In.C · Nov 2001
ZIEHM VISION
K011292 · Ziehm International, Inc. · Jun 2001
U04
K010942 · Siemens Medical Solutions USA, Inc. · Apr 2001