Cleared Traditional

K051753 - ACCU-SOURCE

K051753 is the FDA 510(k) clearance for ACCU-SOURCE by Oncology Systems, Inc.. It is a Class 2 Radiology device (product code JAQ) cleared through the Traditional 510(k) pathway after a 273-day FDA review.

K051753 · Oncology Systems, Inc. · Radiology device
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Mar 2006
Decision
273d
Days
Class 2
Risk

K051753 is an FDA 510(k) clearance for the ACCU-SOURCE. Classified as System, Applicator, Radionuclide, Remote-controlled (product code JAQ), Class II - Special Controls.

Submitted by Oncology Systems, Inc. (Champaign, US). The FDA issued a Cleared decision on March 29, 2006 after a review of 273 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5700 - 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 Oncology Systems, Inc. devices

Submission Details

510(k) Number K051753 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2005
Decision Date March 29, 2006
Days to Decision 273 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
166d slower than avg
Panel avg: 107d · This submission: 273d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JAQ System, Applicator, Radionuclide, Remote-controlled
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5700
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 - JAQ System, Applicator, Radionuclide, Remote-controlled

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