Bolus Compensator
FDA 510(k) K091911 · .Decimal, Inc.
510(k) numberK091911
Submission
- Device name
- Bolus Compensator
- Applicant
- .Decimal, Inc.
Sanford, FL, US - Received
- June 25, 2009
- Decision date
- July 21, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code IXI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253025 | Ricoh 3D for Healthcare BolusIXI · Traditional | Ricoh 3D For Healthcare, LLC | 04/06/2026SE |
| K222639 | VHA Radiotherapy BolusIXI · Traditional | Vha Dean | 11/04/2022SE |
| K214093 | VSP BolusIXI · Traditional | 3D Systems | 03/30/2022SE |
| K132236 | .Decimal Proton ApertureIXI · Traditional | .Decimal, Inc. | 10/16/2013SE |
| K131150 | Cura CompensatorIXI · Traditional | Cura Medical Technologies, LLC | 07/30/2013SE |
| K123893 | Cura CollimatorIXI · Traditional | Cura Medical Technologies, LLC | 03/04/2013SE |
| K123015 | .Decimal Photon BlockIXI · Traditional | .Decimal, Inc. | 11/21/2012SE |
| K111676 | ApexIXI · Traditional | Elekta Limited | 09/30/2011SE |
| K111759 | .Decimal Electron ApertureIXI · Traditional | .Decimal, Inc. | 09/09/2011SE |
| K091403 | MOD1T Compensators for Radiation Beam TherapyIXI · Traditional | Oncology Tech, LLC | 07/29/2009SE |
More from Oncology Tech, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K211511 | decimal BolusMUJ · Traditional | 07/01/2021SE |
| K192554 | decimal3DMUJ · Traditional | 12/13/2019SE |
| K173940 | Astroid Planning AppMUJ · Traditional | 05/15/2018SE |
| K151369 | .decimal p.dMUJ · Traditional | 08/07/2015SE |
| K150547 | .decimal Astroid Dosimetry AppMUJ · Traditional | 05/15/2015SE |
| K132236 | .Decimal Proton ApertureIXI · Traditional | 10/16/2013SE |
| K123015 | .Decimal Photon BlockIXI · Traditional | 11/21/2012SE |
| K111759 | .Decimal Electron ApertureIXI · Traditional | 09/09/2011SE |
| K083672 | P.D SoftwareMUJ · Traditional | 04/13/2009SE |
| K071078 | .Decimal Range CompensatorIXI · Traditional | 05/22/2007SE |
Questions and answers
When was Bolus Compensator cleared by the FDA?
Bolus Compensator (K091911) received a 510(k) decision of Substantially Equivalent on July 21, 2009, 26 days after the submission was received.
What is the product code of K091911?
The FDA product code is IXI – Block, Beam-Shaping, Radiation Therapy, a Class II (moderate risk) device regulated under 21 CFR 892.5710.