Class Class II
Vivid S60N, Vivid S70N (K223832)
Description
Vivid S60N, Vivid S70N by Ge Medical System Ultrasound and Primary Care Diagnostics, an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223832
Clearance Date2023-02-16
Clearance TypeTraditional
Product CodeIYN
Regulation Number892.1550
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223832
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. Vivid S60N, Vivid S70N (K223832) cites 3 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K223733 | CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.4 | Biosense Webster, Inc. | 2023 |
| K223766 | NUVISION™ NAV Ultrasound Catheter | Biosense Webster, Inc. | 2023 |
| K220619 | Vivid S60N, Vivid S70N | GE Medical Systems Ultrasound and P... | 2022 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K251169 | Vivid Pioneer | GE Medical Systems Ultrasound and P... | 2025 |
Trace the full predicate network for K223832
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.