MODEL 6150 (MYLAB70) AND MODEL 6100 (MYLAB90)— 510(k) K081386
Substantially EquivalentEsaote, S.p.A.
FDA 510(k) clearance K081386 for MODEL 6150 (MYLAB70) AND MODEL 6100 (MYLAB90), Substantially Equivalent on 2008-09-25. 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
- Carmel, 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 K081386
K-number listed on FDA's recall record- Z-1137-2018 — MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; PA023E Probe 7.5/10
- Z-1138-2018 — MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; Probes: BL433, C 18, CA541, EC1123, EC123, IH 618, IOT332, IOT342, L 415, LA332E, LA435, LA523, LA533, SI2C41, SL2325, TRT33
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K081386.
Data sourced from openFDA. This site is unofficial and independent of the FDA.