Class Class II
Digital Color Doppler Ultrasound System (P60 Series) (K241949)
Description
Digital Color Doppler Ultrasound System (P60 Series) by Sonoscape Medical Corp., an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241949
Clearance Date2025-01-17
Clearance TypeTraditional
Product CodeIYN
Regulation Number892.1550
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241949
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. Digital Color Doppler Ultrasound System (P60 Series) (K241949) cites 3 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K222596 | S90 Exp Series Digital Color Doppler Ultrasound System | Sonoscape Medical Corp. | 2023 |
| K221140 | P20 Elite Series Digital Color Doppler Ultrasound System | Sonoscape Medical Corp. | 2022 |
| K171000 | P60 Series Digital Color Doppler Ultrasound System | Sonoscape Medical Corp. | 2017 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K254027 | Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95... | Sonoscape Medical Corp. | 2026 |
Trace the full predicate network for K241949
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.