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FDA 510(k), K221552, EFAI ChestSuite XR Pneumothorax Assessment System
FDA 510(k), K221552, EFAI ChestSuite XR Pneumothorax Assessment System
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510(K) Number: K221552
Device Name: EFAI ChestSuite XR Pneumothorax Assessment System
Manufacturer: Joseph Chang
Device Classification Name: Radiological Computer-Assisted Prioritization Software For Lesions
Regulation Number: QFM
Classification Product Code: KXA
Date Received: 05/31/2022
Decision Date: 11/08/2022
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
Device Name: EFAI ChestSuite XR Pneumothorax Assessment System
Manufacturer: Joseph Chang
Device Classification Name: Radiological Computer-Assisted Prioritization Software For Lesions
Regulation Number: QFM
Classification Product Code: KXA
Date Received: 05/31/2022
Decision Date: 11/08/2022
Decision: Substantially Equivalent (SESE)
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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