TrueFit Bolus
FDA 510(k) K260308 · Adaptiiv Medical Technologies, Inc.
510(k) numberK260308
Submission
- Device name
- TrueFit Bolus
- Applicant
- Adaptiiv Medical Technologies, Inc.
Halifax, CA - Received
- January 30, 2026
- Decision date
- February 19, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code MUJ
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|---|---|---|---|
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| 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 |
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| K252304 | syngo.via RT Image Suite VC10MUJ · Traditional | Varian Medical Systems, Inc. | 03/18/2026SE |
| 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 |
| K252863 | ClearCalc Model RADCA V2.6MUJ · Traditional | Radformation, Inc. | 12/19/2025SE |
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Questions and answers
When was TrueFit Bolus cleared by the FDA?
TrueFit Bolus (K260308) received a 510(k) decision of Substantially Equivalent on February 19, 2026, 20 days after the submission was received.
What is the product code of K260308?
The FDA product code is MUJ – System, Planning, Radiation Therapy Treatment, a Class II (moderate risk) device regulated under 21 CFR 892.5050.