TrueFit Bolus— 510(k) K260308

Name: FDA 510(k) clearance K260308
Creator: U.S. Food and Drug Administration
Published: 2026-02-19

Substantially Equivalent

Adaptiiv Medical Technologies, Inc.

FDA 510(k) clearance K260308 for TrueFit Bolus, Substantially Equivalent on 2026-02-19. Applicant: Adaptiiv Medical Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Adaptiiv Medical Technologies, Inc.
Product code: Code MUJ
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2026-01-30
Decision date: 2026-02-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Halifax, CA

Download summary PDF View on FDA.gov ↗

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More clearances from Adaptiiv Medical Technologies, Inc.

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K243057 — TrueFit Bolus; TrueFlex Bolus2024-10-23
K241318 — Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA)2024-08-30

Data sourced from openFDA. This site is unofficial and independent of the FDA.