Cleared Special

K091911 - BOLUS COMPENSATOR

K091911 is an FDA 510(k) clearance for BOLUS COMPENSATOR, manufactured by .Decimal, Inc.. The device is a Class 2 Radiology device with product code IXI cleared through the Special 510(k) pathway after a 26-day FDA review.

K091911 · .Decimal, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2009
Decision
26d
Days
Class 2
Risk

K091911 is an FDA 510(k) clearance for the BOLUS COMPENSATOR. Classified as Block, Beam-shaping, Radiation Therapy (product code IXI), Class II - Special Controls.

Submitted by .Decimal, Inc. (Sanford, US). The FDA issued a Cleared decision on July 21, 2009 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5710 - 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.

FDA 510(k) Submission Details - K091911

510(k) Number K091911 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2009
Decision Date July 21, 2009
Days to Decision 26 days
Submission Type Special
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
81d faster than avg
Panel avg: 107d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

IXI Device Classification - Class 2, Special Controls

Product Code IXI Block, Beam-shaping, Radiation Therapy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5710
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 - IXI Block, Beam-shaping, Radiation Therapy

All 42
Devices cleared under the same product code (IXI) and FDA review panel - the closest regulatory comparables to K091911.
APEX
K111676 · Elekta Limited · Sep 2011
.DECIMAL ELECTRON APERTURE
K111759 · .Decimal, Inc. · Sep 2011
MOD1T COMPENSATORS FOR RADIATION BEAM THERAPY
K091403 · Oncology Tech, LLC · Jul 2009
AXXENT FLEXISHIELD MINI
K090417 · Xoft, Inc. · Jun 2009
.DECIMAL RANGE COMPENSATOR
K071078 · .Decimal, Inc. · May 2007
.DECIMAL APERTURE
K071077 · .Decimal, Inc. · May 2007