Class Class II
MetaLite DX Digital Pathology Software (K240303)
Description
MetaLite DX Digital Pathology Software by Jellox Biotech, Inc., an FDA 510(k) cleared pathology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK240303
Clearance Date2024-10-28
Clearance TypeTraditional
Product CodeQKQ
Regulation Number864.3700
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240303
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. MetaLite DX Digital Pathology Software (K240303) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K203845 | Philips IntelliSite Pathology Solution | Philips Medical Systems Nederland B.V. | 2021 |
Trace the full predicate network for K240303
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.