Class Class II
Deep Learning Image Reconstruction (K230807)
Description
Deep Learning Image Reconstruction by Ge Healthcare Japan Corporation, an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK230807
Clearance Date2023-04-20
Clearance TypeSpecial
Product CodeJAK
Regulation Number892.1750
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230807
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. Deep Learning Image Reconstruction (K230807) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K213999 | Deep Learning Image Reconstruction | Ge Medical Systems, LLC | 2022 |
| K213938 | Revolution Ascend | Ge Healthcare Japan Corporation | 2022 |
| K120833 | DISCOVERY CT750 HD | Ge Medical Systems, LLC | 2012 |
Trace the full predicate network for K230807
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.