.decimal p.d
510(k) K151369
.decimal p.d is a Class II device made by .Decimal, LLC, cleared under FDA 510(k) K151369 on 7 Aug 2015, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK151369 | Date7 Aug 2015 | StatusActive |
Official records
- FDA 510(k) database K151369
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MUJ
- Device class
- Class II
- Regulation
- 21 CFR Part 892.5050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K151369
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.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| .decimal P.D 5.1 | 5.1 | 00851147007069 | — | On the market |
Similar devices
Other devices filed under FDA product code MUJ (System, Planning, Radiation Therapy Treatment).
- syngo VSim by SIEMENS MEDICAL SOLUTIONS USA, INC.
- Leksell GammaPlan by Elekta Instrument AB
- Radiation Planning Assistant by University of Texas, MD Anderson Cancer Center
- Monaco Rtp System by Computerized Medical Systems, Inc.
- Monaco Rtp System, Vmat Option by Computerized Medical Systems, Inc.
- XPLAN 2.1 by Radionics, Inc.
- 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