FDA 510(k), K161756, SyncVision System
FDA 510(k), K161756, SyncVision System
510(K) Number: K161756
Device Name: SyncVision System
Manufacturer: Elaine Alan
Device Classification Name: Interventional Fluoroscopic X-Ray System
Regulation Number: OWB
Classification Product Code: KXA
Date Received: 06/27/2016
Decision Date: 09/05/2016
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
276 pages (839 of 1,115 original pages are fully redacted)
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