OTIS Optical Coherence Tomography SYstem
FDA 510(k) clearance K190404 · decided 2019-03-26
Clearance details
- K-number
- K190404
- Device name
- OTIS Optical Coherence Tomography SYstem
- Applicant
- Perimeter Medical Imaging, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-02-19
- Decision date
- 2019-03-26
- Days to decision
- 35 days
- Clearance type
- Traditional
- Product code
- NQQ
- Device class
- 2
- Regulation number
- 892.1560
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Toronto, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.