HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System (K230084)
Description
HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System by Samsung Medison Co., Ltd., an FDA 510(k) cleared radiology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230084
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. HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System (K230084) cites 1 predicate device and is itself cited by 2 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K220043 | HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic U... | Samsung Medison Co., Ltd. | 2022 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K242444 | HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic U... | Samsung Medison Co., Ltd. | 2024 |
| K241971 | HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2024 |
Trace the full predicate network for K230084
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.