Class Class II
MIM – Additional Tracers (K223800)
Description
MIM – Additional Tracers by Mim Software, Inc., an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223800
Clearance Date2023-01-17
Clearance TypeSpecial
Product CodeLLZ
Regulation Number892.2050
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223800
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. MIM – Additional Tracers (K223800) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K190379 | MIM on Linux | Mim Software, Inc. | 2019 |
| K060816 | MIM 4.0 (NEURO | Mimvista Corp. | 2006 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K233620 | MIM - Centiloid Scaling | Mim Software, Inc. | 2024 |
Trace the full predicate network for K223800
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.