Cleared Traditional

K011763 - OMNIDOS

K011763 is an FDA 510(k) clearance for OMNIDOS, manufactured by Scanditronix Medical AB. The device is a Class 2 Radiology device with product code IYE cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K011763 · Scanditronix Medical AB · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2001
Decision
90d
Days
Class 2
Risk

K011763 is an FDA 510(k) clearance for the OMNIDOS. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Scanditronix Medical AB (Uppsala S-754 50, SE). The FDA issued a Cleared decision on September 5, 2001 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - 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.

FDA 510(k) Submission Details - K011763

510(k) Number K011763 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2001
Decision Date September 05, 2001
Days to Decision 90 days
Submission Type Traditional
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
17d faster than avg
Panel avg: 107d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYE Device Classification - Class 2, Special Controls

Product Code IYE Accelerator, Linear, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
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 - IYE Accelerator, Linear, Medical

All 723
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K011763.
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INTRA OPERATIVE RADIATION THERAPY
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MODIFICATION TO: VIEWGT ELECTRONIC PORTAL IMAGING DEVICE (EPID)
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CYBERKNIFE SYSTEM
K011024 · Accuray, Inc. · Aug 2001
EXAC TRAC 2.0 (NOVALIS BODY MODULE)
K003285 · Brainlab AG · Jul 2001
K011763 · OMNIDOS
Download PDF FDA Summary Scanditronix Medical …