FDA applicant
Sonoscape Medical Corp.
FDA records 26 decisions for Sonoscape Medical Corp. (Shenzhen, CN) from 2015 to 2026: 26 510(k) clearances. Most are in product codes IYN (System, Imaging, Pulsed Doppler, Ultrasonic) and NWB (Endoscope, Accessories, Narrow Band Spectrum). Since 2016 its 510(k)s took a median of 106 days from receipt to decision, against 83 for FDA’s reviews in the same codes and years. Its devices cite 26 predicates, 20 of them its own earlier devices. 2 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Sonoscape Medical Corp.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2015.
Planning a device like Sonoscape Medical Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Sonoscape”
FDA records each applicant name separately; these may or may not be the same firm.