Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L) (K241554)
Description
Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L) by Telefield Medical Imaging (Shenzhen) Limited, an FDA 510(k) cleared radiology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241554
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. Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L) (K241554) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K201967 | SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Pa... | CHISON Medical Technologies Co., Ltd. | 2021 |
| K182845 | minisono | Alpinion Medical Systems Co., Ltd. | 2018 |
| K150204 | DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound Systems | Shenzhen Mindray Bio-Medical Electr... | 2015 |
Trace the full predicate network for K241554
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.