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FDA 510(k)

TrueFit Bolus

K-Number: K260308 · 2026-02-19

ApplicantAdaptiiv Medical Technologies, Inc.
Decision Date2026-02-19
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TrueFit Bolus is the device name listed in this FDA 510(k) record. The listed applicant is Adaptiiv Medical Technologies, Inc.. It received FDA 510(k) clearance on 2026-02-19 under 510(k) number K260308. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TrueFit Bolus?

TrueFit Bolus is a medical device that received FDA 510(k) clearance on 2026-02-19. The listed applicant is Adaptiiv Medical Technologies, Inc.. The 510(k) number is K260308.

When did TrueFit Bolus receive FDA 510(k) clearance?

TrueFit Bolus received FDA 510(k) clearance on 2026-02-19, under 510(k) number K260308.

Who is the listed applicant for TrueFit Bolus?

The FDA 510(k) record lists Adaptiiv Medical Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TrueFit Bolus?

The FDA product code for TrueFit Bolus is MUJ.

Other records listing Adaptiiv Medical Technologies, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243057TrueFit Bolus; TrueFlex BolusK241318Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA)

Related Devices (Code: MUJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260750Virtual Cone (1.0)Varian Medical Systems, Inc.K253050RadOncAIInformaiK260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V.K252784eXaSkin PlusAnatomical Geometry S.L.K253078ART.1-USSeetreat Pty, Ltd.K252304syngo.via RT Image Suite VC10Varian Medical Systems, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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