.decimal Photon Compensator 1.0

• FDA 510(k) K040804 decided 28 Apr 2004 Active
• FDA GUDID UDI-DI 00851147007052 listed 24 Sep 2016 Listed

1. 28 Apr 2004 Cleared FDA 510(k) K040804
2. 24 Sep 2016 Listed FDA GUDID 00851147007052

Trade name

.decimal Photon Compensator

Generic name

Radiation therapy beam block material

Model / reference

1.0

Primary DI / UDI-DI

00851147007052

510(k) Number

K040804 ↗

FDA product code

IXI

GMDN term

Radiation therapy beam block material

Device class

Class II

Regulation number

892.5710

GUDID distribution status

In Commercial Distribution

Category: Radiation therapy beam block material

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

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• Autimo 2.5-D and Autimo 3-D by C.L. Mcintosh & Assoc., Inc.
• Aktina Medical Physics Corporation Photon Beam Blocking System by Aktina Medical Physics Corp.
• Enhanced Compensating Filter by Computerized Medical Systems, Inc.
• Decimal Tissue Compensator/Intensity Modulator by Southeastern Radiation Products, Inc.

• .decimal Electron Bolus 1.0

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

• decimal Bolus (FlexiBol)

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  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 →