Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR
FDA 510(k) clearance K241496 · decided 2024-08-20
Clearance details
- K-number
- K241496
- Device name
- Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR
- Applicant
- Canon Medical Systems Corporation
- Decision
- Substantially Equivalent
- Date received
- 2024-05-28
- Decision date
- 2024-08-20
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- LNH
- Device class
- 2
- Regulation number
- 892.1000
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Otawara-Shi, JP
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.