Brainomix 360 e-CTP
FDA 510(k) clearance K223555 · decided 2023-06-01
Clearance details
- K-number
- K223555
- Device name
- Brainomix 360 e-CTP
- Applicant
- Brainomix Limited
- Decision
- Substantially Equivalent
- Date received
- 2022-11-28
- Decision date
- 2023-06-01
- Days to decision
- 185 days
- Clearance type
- Traditional
- Product code
- LLZ
- Device class
- 2
- Regulation number
- 892.2050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Oxford, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.