MIRAGE, RELEASE 5.5
FDA 510(k) clearance K043441 · decided 2005-01-13
Clearance details
- K-number
- K043441
- Device name
- MIRAGE, RELEASE 5.5
- Applicant
- Segami Corporation
- Decision
- Substantially Equivalent
- Date received
- 2004-12-14
- Decision date
- 2005-01-13
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- KPS
- Device class
- 2
- Regulation number
- 892.1200
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Columbia, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.