Aura 10 PET/CT
FDA 510(k) clearance K231420 · decided 2023-08-10
Clearance details
- K-number
- K231420
- Device name
- Aura 10 PET/CT
- Applicant
- Xeos Medical
- Decision
- Substantially Equivalent
- Date received
- 2023-05-16
- Decision date
- 2023-08-10
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- QXL
- Device class
- 2
- Regulation number
- 892.1200
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Gent, BE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.