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FDA 510(k), K221320, Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX; Scanning Laser Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EX
FDA 510(k), K221320, Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX; Scanning Laser Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EX
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510(K) Number: K221320
Device Name: Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX; Scanning Laser Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EX
Manufacturer: Tsutomu Sunada
Device Classification Name: Tomography, Optical Coherence
Regulation Number: OBO
Classification Product Code: 05/06/2022
Date Received: 03/30/2023
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ophthalmic
Device Name: Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX; Scanning Laser Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EX
Manufacturer: Tsutomu Sunada
Device Classification Name: Tomography, Optical Coherence
Regulation Number: OBO
Classification Product Code: 05/06/2022
Date Received: 03/30/2023
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ophthalmic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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