Cleared Traditional

K060187 - TOPSLANE DMLC

K060187 is an FDA 510(k) clearance for TOPSLANE DMLC, manufactured by Topslane International, LLC. The device is a Class 2 Radiology device with product code IXI cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K060187 · Topslane International, LLC · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
184d
Days
Class 2
Risk

K060187 is an FDA 510(k) clearance for the TOPSLANE DMLC. Classified as Block, Beam-shaping, Radiation Therapy (product code IXI), Class II - Special Controls.

Submitted by Topslane International, LLC (Clearwater, US). The FDA issued a Cleared decision on July 27, 2006 after a review of 184 days - an extended review 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: 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.

FDA 510(k) Submission Details - K060187

510(k) Number K060187 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2006
Decision Date July 27, 2006
Days to Decision 184 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
77d slower than avg
Panel avg: 107d · This submission: 184d
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 48
Devices cleared under the same product code (IXI) and FDA review panel - the closest regulatory comparables to K060187.
.DECIMAL RANGE COMPENSATOR
K071078 · .Decimal, Inc. · May 2007
.DECIMAL APERTURE
K071077 · .Decimal, Inc. · May 2007
MOD1 COMPENSATORS FOR RADIATION BEAM THERAPY
K062781 · Symtium Corporation · Nov 2006
INNOCURE IMRT FILTER (COMPENSATORS)
K052383 · Innocure, LLC · Mar 2006
.DECIMAL TISSUE COMPENSATOR/INTENSITY MODULATOR
K040804 · Southeastern Radiation Products, Inc. · Apr 2004
MODIFICATION TO ACCULEAF
K040553 · Direx Systems Corp. · Apr 2004
K060187 · TOPSLANE DMLC
Download PDF FDA Summary Topslane Internationa…