Cleared Special

K091145 - FLEXIPLAN 3D AND 3D+

K091145 is an FDA 510(k) clearance for FLEXIPLAN 3D AND 3D+, manufactured by Isodose Control B.V.. The device is a Class 2 Radiology device with product code MUJ cleared through the Special 510(k) pathway after a 37-day FDA review.

K091145 · Isodose Control B.V. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2009
Decision
37d
Days
Class 2
Risk

K091145 is an FDA 510(k) clearance for the FLEXIPLAN 3D AND 3D+. Classified as System, Planning, Radiation Therapy Treatment (product code MUJ), Class II - Special Controls.

Submitted by Isodose Control B.V. (Ede, NL). The FDA issued a Cleared decision on May 27, 2009 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Isodose Control B.V. devices

FDA 510(k) Submission Details - K091145

510(k) Number K091145 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2009
Decision Date May 27, 2009
Days to Decision 37 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 107d · This submission: 37d
Pathway characteristics
Modification to existing cleared device.

MUJ Device Classification - Class 2, Special Controls

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 167
Devices cleared under the same product code (MUJ) and FDA review panel - the closest regulatory comparables to K091145.
LEKSELL GAMMAPLAN
K090972 · Elekta Instrument AB · Jul 2009
MONACO RTP SYSTEM, VMAT OPTION
K091179 · Computerized Medical Systems, Inc. · Jul 2009
MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEM
K091492 · Varian Medical Systems, Inc. · Jun 2009
PINNACLE3 SMARTARC
K090808 · Philips Medical Systems, Inc. · Apr 2009
ONCENTRA RT VIEWER 1.0
K082642 · Nucletron Corporation · Nov 2008
MODEIFICATION TO IPLAN RT DOSE
K080888 · Brainlab AG · Jun 2008