Cleared Abbreviated

FLEXIPLAN BRACHYTHERAPY TREATMENT PLANNING SYSTEM (K081112) - FDA 510(k) Clearance

Class II Radiology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K081112 · Isodose Control B.V. · Radiology device
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Optimized for regulatory review, auditing and printing
Jul 2008
Decision
102d
Days
Class 2
Risk

K081112 is an FDA 510(k) clearance for the FLEXIPLAN BRACHYTHERAPY TREATMENT PLANNING SYSTEM. Classified as System, Planning, Radiation Therapy Treatment (product code MUJ), Class II - Special Controls.

Submitted by Isodose Control B.V. (Veenendaal, NL). The FDA issued a Cleared decision on July 29, 2008 after a review of 102 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Isodose Control B.V. devices

Submission Details

510(k) Number K081112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2008
Decision Date July 29, 2008
Days to Decision 102 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 107d · This submission: 102d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code MUJ System, Planning, Radiation Therapy Treatment
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 - MUJ System, Planning, Radiation Therapy Treatment

All 106
Devices cleared under the same product code (MUJ) and FDA review panel - the closest regulatory comparables to K081112.
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K091492 · Varian Medical Systems, Inc. · Jun 2009
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K073020 · Varian Medical Systems, Inc. · Dec 2007
MODIFICATION TO: ECLIPSE TREATMENT PLANNING SYSTEM
K071760 · Varian Medical Systems, Inc. · Nov 2007
MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEM
K071873 · Varian Medical Systems, Inc. · Aug 2007