G-SCAN-MODEL 9800020000, E-SCAN MODEL 9800010000 AND E-SCAN XQ-MODELS-9800010011/9800010005,9800010009/9800010004
FDA 510(k) clearance K060956 · decided 2006-05-04
Clearance details
- K-number
- K060956
- Device name
- G-SCAN-MODEL 9800020000, E-SCAN MODEL 9800010000 AND E-SCAN XQ-MODELS-9800010011/9800010005,9800010009/9800010004
- Applicant
- Esaote, S.p.A.
- Decision
- Substantially Equivalent
- Date received
- 2006-04-07
- Decision date
- 2006-05-04
- Days to decision
- 27 days
- Clearance type
- Special
- Product code
- LNH
- Device class
- 2
- Regulation number
- 892.1000
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Carmel, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.