.decimal p.d
FDA 510(k) K151369 · .Decimal, LLC
510(k) numberK151369
Submission
- Device name
- .decimal p.d
- Applicant
- .Decimal, LLC
Sanford, FL, US - Received
- May 21, 2015
- Decision date
- August 7, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code MUJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260750 | Virtual Cone (1.0)MUJ · Traditional | Varian Medical Systems, Inc. | 07/08/2026SE |
| K253050 | RadOncAIMUJ · Traditional | Informai | 06/18/2026SE |
| K260207 | Multimodality Simulation Workspace (MM Sim) (v1.0.0)MUJ · Traditional | Philips Medical Systems Nederland B.V. | 05/27/2026SE |
| K252784 | eXaSkin PlusMUJ · Traditional | Anatomical Geometry S.L. | 05/22/2026SE |
| K253078 | ART.1-USMUJ · Traditional | Seetreat Pty, Ltd. | 05/14/2026SE |
| K252304 | syngo.via RT Image Suite VC10MUJ · Traditional | Varian Medical Systems, Inc. | 03/18/2026SE |
| K260308 | TrueFit BolusMUJ · Special | Adaptiiv Medical Technologies, Inc. | 02/19/2026SE |
| K252002 | Monaco RTP System (6.3)MUJ · Traditional | Elekta Solutions AB | 02/19/2026SE |
| K253091 | ART-Plan+ (v3.1.0)MUJ · Traditional | Therapanacea Sas | 12/23/2025SE |
| K252109 | RayStation (2024A SP3)MUJ · Traditional | RaySearch Laboratories AB (PUBL) | 12/22/2025SE |
More from RaySearch Laboratories AB (PUBL)
| 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 |
| 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 |
| K091911 | Bolus CompensatorIXI · Special | 07/21/2009SE |
| K083672 | P.D SoftwareMUJ · Traditional | 04/13/2009SE |
| K071078 | .Decimal Range CompensatorIXI · Traditional | 05/22/2007SE |
Questions and answers
When was .decimal p.d cleared by the FDA?
.decimal p.d (K151369) received a 510(k) decision of Substantially Equivalent on August 7, 2015, 78 days after the submission was received.
What is the product code of K151369?
The FDA product code is MUJ – System, Planning, Radiation Therapy Treatment, a Class II (moderate risk) device regulated under 21 CFR 892.5050.