Cleared Traditional

K071077 - .DECIMAL APERTURE

K071077 is an FDA 510(k) clearance for .DECIMAL APERTURE, manufactured by .Decimal, Inc.. The device is a Class 2 Radiology device with product code IXI cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K071077 · .Decimal, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
31d
Days
Class 2
Risk

K071077 is an FDA 510(k) clearance for the .DECIMAL APERTURE. 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 May 18, 2007 after a review of 31 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K071077

510(k) Number K071077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2007
Decision Date May 18, 2007
Days to Decision 31 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
76d faster than avg
Panel avg: 107d · This submission: 31d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K071077.
BOLUS COMPENSATOR
K091911 · .Decimal, Inc. · Jul 2009
AXXENT FLEXISHIELD MINI
K090417 · Xoft, Inc. · Jun 2009
.DECIMAL RANGE COMPENSATOR
K071078 · .Decimal, Inc. · May 2007
MOD1 COMPENSATORS FOR RADIATION BEAM THERAPY
K062781 · Symtium Corporation · Nov 2006
TOPSLANE DMLC
K060187 · Topslane International, LLC · Jul 2006
INNOCURE IMRT FILTER (COMPENSATORS)
K052383 · Innocure, LLC · Mar 2006