Class Class II
Clarius Prostate AI (K243853)
Description
Clarius Prostate AI by Clarius Mobile Health Corp., an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243853
Clearance Date2025-04-16
Clearance TypeTraditional
Product CodeQIH
Regulation Number892.2050
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243853
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. Clarius Prostate AI (K243853) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K232257 | Clarius Bladder AI | Clarius Mobile Health Corp. | 2023 |
| K193283 | AI-Rad Companion Prostate MR | Siemens Medical Solutions USA, Inc. | 2020 |
Trace the full predicate network for K243853
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.