Class Class II
TrueFit Bolus; TrueFlex Bolus (K243057)
Description
TrueFit Bolus; TrueFlex Bolus by Adaptiiv Medical Technologies, Inc., an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243057
Clearance Date2024-10-23
Clearance TypeSpecial
Product CodeMUJ
Regulation Number892.5050
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243057
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. TrueFit Bolus; TrueFlex Bolus (K243057) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K213438 | 3D Bolus Software Application, 3D Brachy Software Applicati... | Adaptiiv | 2022 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K260308 | TrueFit Bolus | Adaptiiv Medical Technologies, Inc. | 2026 |
Trace the full predicate network for K243057
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.