TRINITY— 510(k) K160357
Substantially EquivalentKoelis
FDA 510(k) clearance K160357 for TRINITY, Substantially Equivalent on 2016-05-02. Applicant: Koelis. Device class: 2.
Clearance details
- Applicant
- Koelis
- Product code
- 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
- La Tronche, FR
Recent devices under product code IYN
view all- K261313 — Vivid Explorer/Vivid Advanced/Vivid Focus
- K254027 — Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90 CV/Marvo 90 Pro/Marvo 90 Exp/Marvo 90 Elite/Marvo Expert/Marvo 85/Marvo 85 Pro/Marvo 85 Exp/Marvo 85 Elite/Marvo Senior/Marvo 75 Elite/Marvo 75i/Fenix 95/Fenix 95 Elite/Fenix 90/Fenix 90 Elite/Fenix Expert/Fenix 85/Fenix 85 Elite/Fenix Senior/Fenix 75 Elite/Fenix 75i/Endo 80/Endo 90)
- K261668 — Venue Go
- K262311 — Alturion Series Diagnostic Ultrasound System
- K261288 — Handheld Ultrasound Scanner
More clearances from Koelis
view all- K180970 — Disposable guides KDNG00
- K171040 — Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range
- K170521 — TRINITY/3D PROSTATE SUITE
- K141334 — REUSABLE GUIDE
- K131448 — 3D PROSTATE SUITE 3DTRUS PROSTATE MAPPING, MRI/3DTRUS FUSION OPTION, SECOND LOOK 3DTRUS FUSION OPTION
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.