ARIETTA 70/ARIETTA S70/ARIETTA V70 DIAGNOSTIC ULTRASOUND SCANNER— 510(k) K134016
Substantially EquivalentHitachi Aloka Medical,Ltd. (Hitachi Aloka Medical
FDA 510(k) clearance K134016 for ARIETTA 70/ARIETTA S70/ARIETTA V70 DIAGNOSTIC ULTRASOUND SCANNER, Substantially Equivalent on 2014-03-28. Applicant: Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical. Device class: 2.
Clearance details
- Applicant
- Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical
- 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
- Wallingford, CT, US
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 Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical
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 →
Recalls naming K134016
K-number listed on FDA's recall record- Z-1341-2020 — UST-2265-2 Probe, Part Number: UST-2265-2 - Product Usage: The UST-2265-2 probe is intended to be used for diagnostic ultrasound imaging or fluid flow analysis of the human body as Continuous-wave Doppler (CWD) for Cardiac Adult, Cardiac Pediatric, and Peripheral Vessel.
- Z-2090-2017 — Arietta 70 Ultrasound System Intended for use by trained personnel (doctor, sonographer. etc.) for the diagnostic Ultrasound evaluation.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K134016.
Data sourced from openFDA. This site is unofficial and independent of the FDA.