.decimal Astroid Dosimetry App

510(k) Number

K150547 ↗

FDA product code

MUJ

FDA applicant

.Decimal, Inc.

Device class

Class II

Regulation

21 CFR Part 892.5050

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 MUJ (System, Planning, Radiation Therapy Treatment).

• RayStation 11B by RaySearch Laboratories AB (PUBL)
• Multimodality Simulation Workspace (MM Sim)1.0 728349 by Philips Medical Systems Nederland B.V.
• MRI Planner 3.0 M7104RT by GE Medical Systems, L.L.C.
• RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review by Brainlab AG
• syngo.via RT Image Suite by SIEMENS MEDICAL SOLUTIONS USA, INC.
• Simuplan Treatment Planning System, Model V. 7.5 by Simuplan S.L.
• RayCare 2.3 by RaySearch Laboratories AB (PUBL)
• CYBERNIFE STEREOTACTIC RADIOSURGERY SYSTEM by Accuray, Inc.
• RADIONICS XKNIFE HDRT SYSTEM by Integra Radionics, Inc.
• Virtual Cone (1.0) by Varian Medical Systems, Inc.

• .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 →