6440 MyLabX90
FDA 510(k) clearance K230179 · decided 2023-11-29
Clearance details
- K-number
- K230179
- Device name
- 6440 MyLabX90
- Applicant
- Esaote, S.p.A.
- Decision
- Substantially Equivalent
- Date received
- 2023-01-23
- Decision date
- 2023-11-29
- Days to decision
- 310 days
- Clearance type
- Traditional
- Product code
- IYN
- Device class
- 2
- Regulation number
- 892.1550
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Genoa, IT
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038 recall (Z-1490-2026) | ESAOTE S.P.A. | 2026-03-03 |