G-scan Brio
FDA 510(k) clearance K142421 · decided 2015-04-09
Clearance details
- K-number
- K142421
- Device name
- G-scan Brio
- Applicant
- Esaote, S.p.A.
- Decision
- Substantially Equivalent
- Date received
- 2014-08-28
- Decision date
- 2015-04-09
- Days to decision
- 224 days
- Clearance type
- Traditional
- Product code
- LNH
- Device class
- 2
- Regulation number
- 892.1000
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Genova, IT
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Magnetic Resonance System G-scan Brio (Part Number /Model No.101002000) recall (Z-2124-2016) | Esaote S.p.A. | 2016-07-05 |