ES-Series— 510(k) K260589
Substantially EquivalentE-Scopics
FDA 510(k) clearance K260589 for ES-Series, Substantially Equivalent on 2026-04-29. Applicant: E-Scopics. Device class: 2.
Summary
E-Scopics' ES-Series is filed under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic). The name is generic, and the record doesn't describe the product beyond it and that code name.
Class II, 21 CFR 892.1550. Radiology is both the classification panel and the review panel, and it came in as a Special 510(k).
E-Scopics filed from Aix-En-Provence, France. The decision came 68 calendar days after FDA received it (February 20 to April 29, 2026).
Clearance details
- Applicant
- E-Scopics
- 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
- Special
- Location
- Aix-En-Provence, FR
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
More clearances from E-Scopics
view allAdverse 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.