TRINITY
FDA 510(k) clearance K160357 · decided 2016-05-02
Clearance details
- K-number
- K160357
- Device name
- TRINITY
- Applicant
- Koelis
- Decision
- Substantially Equivalent
- Date received
- 2016-02-08
- Decision date
- 2016-05-02
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- IYN
- Device class
- 2
- Regulation number
- 892.1550
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- La Tronche, FR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.