Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)— 510(k) K241554
Substantially EquivalentTelefield Medical Imaging (Shenzhen) Limited
FDA 510(k) clearance K241554 for Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L), Substantially Equivalent on 2024-10-24. Applicant: Telefield Medical Imaging (Shenzhen) Limited. Device class: 2.
Clearance details
- Applicant
- Telefield Medical Imaging (Shenzhen) Limited
- Product code
- Product code IYN
- Device class
- Class 2
- Regulation
- 21 CFR 892.1550
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
Recent devices under product code IYN
view all- K261617 — Diagnostic Ultrasound System (11+ models)
- K263150 — V10 Diagnostic Ultrasound System +10 more
- K261933 — Voluson Expert 18; Voluson Expert 20; Voluson Expert 22
- K262548 — EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
- K263182 — EVO X30 Diagnostic Ultrasound System +8 more
Adverse events under product code IYN
product code IYN- Death
- 25
- Injury
- 163
- Malfunction
- 1,538
- Other
- 4
- Total
- 1,730
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.