decimal Bolus
510(k) K211511
decimal Bolus is a Class II device made by .Decimal, LLC, cleared under FDA 510(k) K211511 on 1 Jul 2021, 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 | NumberK211511 | Date1 Jul 2021 | StatusActive |
Official records
- FDA 510(k) database K211511
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- Withdrawn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 K211511
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 Bolus (FlexiBol) | N/A | 00851147007137 | — | On the market |
Similar devices
Other devices filed under FDA product code MUJ (System, Planning, Radiation Therapy Treatment).
- PROTON VISION 7.0 by Varian Medical Systems, Inc.
- CADPLAN PLUS: 3D TREATMENT PLANNING SYSTEM by Varian Assoc., Inc.
- DCM 2.0 by Mds Nordion, Inc.
- RayStation 6.1.1 by RaySearch Laboratories AB (PUBL)
- RADVISION by Acoustic Medsystems, Inc.
- ONCENTRA-VISIR by Nucletron Corp.
- TOMOTHERAPY TREATMENT SYSTEM by Tomotherapy Incorporated
- SMART SEGMENTATION KNOWLEDGE BASED CONTOURING by Varian Medical Systems, Inc.
- MODIFICATION TO HI-ART TREATMENT SYSTEM by Tomotherapy Incorporated
- syngo.via RT Image Suite by SIEMENS MEDICAL SOLUTIONS USA, INC.