MYLABGAMMA— 510(k) K142077
Substantially EquivalentEsaote, S.p.A.
FDA 510(k) clearance K142077 for MYLABGAMMA, Substantially Equivalent on 2014-09-12. Applicant: Esaote, S.p.A.. Device class: 2.
Clearance details
- Applicant
- Esaote, S.p.A.
- 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
- Indianpolis, IN, US
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 Esaote, S.p.A.
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 K142077
K-number listed on FDA's recall record- Z-0204-2019 — MyLab Alpha, Model 7400
- Z-0205-2019 — MyLab Gamma, Model 7410
- Z-0206-2019 — MyLab Seven, Model 6400
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K142077.
Data sourced from openFDA. This site is unofficial and independent of the FDA.