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FDA 510(k), K222476, OmegaAI Image Viewer
FDA 510(k), K222476, OmegaAI Image Viewer
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510(K) Number: K222476
Device Name: OmegaAI Image Viewer
Manufacturer: RamSoft Inc.
Device Classification Name: System, Image Processing, Radiological
Regulation Number: 892.2050
Classification Product Code: LLZ
Date Received: 08/16/2022
Decision Date: 11/17/2022
Regulation Medical Specialty: Radiology
Device Name: OmegaAI Image Viewer
Manufacturer: RamSoft Inc.
Device Classification Name: System, Image Processing, Radiological
Regulation Number: 892.2050
Classification Product Code: LLZ
Date Received: 08/16/2022
Decision Date: 11/17/2022
Regulation Medical Specialty: Radiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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