Class Class II
GF85 (models GF85-3P, GF85-SP) (K242478)
Description
GF85 (models GF85-3P, GF85-SP) by Samsung Electronics Co., Ltd., an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242478
Clearance Date2024-09-19
Clearance TypeTraditional
Product CodeKPR
Regulation Number892.1680
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242478
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. GF85 (models GF85-3P, GF85-SP) (K242478) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K222353 | GM85 | Samsung Electronics Co., Ltd. | 2022 |
| K181629 | GC85A | Samsung Electronics Co., Ltd. | 2018 |
Trace the full predicate network for K242478
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.