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FDA 510(k), K172574, SyncVision System
FDA 510(k), K172574, SyncVision System
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510(K) Number: K172574
Device Name: SyncVision System
Manufacturer: Volcano Corporation
Device Classification Name: Interventional Fluoroscopic X-Ray System
Regulation Number: 892.1650
Classification Product Code: OWB
Date Received: 08/28/2017
Decision Date: 10/05/2017
Regulation Medical Specialty: Radiology
Device Name: SyncVision System
Manufacturer: Volcano Corporation
Device Classification Name: Interventional Fluoroscopic X-Ray System
Regulation Number: 892.1650
Classification Product Code: OWB
Date Received: 08/28/2017
Decision Date: 10/05/2017
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
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