Bolus Compensator

510(k) Number

K091911 ↗

FDA product code

IXI

FDA applicant

.Decimal, Inc.

Device class

Class II

Regulation

21 CFR Part 892.5710

Advisory committee

Radiology

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code IXI (Block, Beam-Shaping, Radiation Therapy).

• SIEMENS MULTILEAF COLLIMATOR by SIEMENS MEDICAL SOLUTIONS USA, INC.
• INNOCURE IMRT FILTER (COMPENSATORS) by Innocure, LLC
• MOTORIZED MICRO MULTILEAF COLLIMATOR by Stryker Leibinger
• DG 200/300 DIGITAL ANGIOGRAPHIC SYSTEM by Thomson-Cgr Medical Corp.
• AXXENT FLEXISHIELD MINI by Xoft, Inc.
• VHA Radiotherapy Bolus by Vha Dean
• SATURNE MULTILEAF COLLIMATOR by General Electric Co.
• MULTILEAF INTENSITY MODULATING COLLIMATOR by Nomos Corp.
• VARIAN MULTILEAF COLLIMATOR by Varian Assoc., Inc.
• MOD1 COMPENSATORS FOR RADIATION BEAM THERAPY by Symtium Corporation

• .decimal Electron Bolus 1.0

  Class II

  FDA 510(k) K091911 Active Cleared 21 Jul 2009 GUDID on market

• decimal Bolus (FlexiBol)

  Class II

  FDA 510(k) K211511 Active Cleared 1 Jul 2021 GUDID on market

• .decimal Proton Range Compensator 2.8

  Class II

  FDA 510(k) K071078 Active Cleared 22 May 2007 GUDID on market

• .decimal Electron Aperture 1.0

  Class II

  FDA 510(k) K111759 Active Cleared 9 Sep 2011 GUDID on market

See all devices from .Decimal, LLC →