HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound System (K241971)
Description
HERA Z20, R20, HERA Z30, R30 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 K241971
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 Z20, R20, HERA Z30, R30 Diagnostic Ultrasound System (K241971) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K241302 | SonoSync | Samsung Medison Co., Ltd. | 2024 |
| K240631 | V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound Sy... | Samsung Medison Co., Ltd. | 2024 |
| K231965 | Voluson Expert 22, Voluson Expert 20, Voluson Expert 18 | GE Medical Systems Ultrasound and P... | 2023 |
| K230084 | HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic U... | Samsung Medison Co., Ltd. | 2023 |
Trace the full predicate network for K241971
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.