SyncVision System
FDA 510(k) K172574 · Volcano Corporation
510(k) numberK172574
Submission
- Device name
- SyncVision System
- Applicant
- Volcano Corporation
San Diego, CA, US - Received
- August 28, 2017
- Decision date
- October 5, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was SyncVision System cleared by the FDA?
SyncVision System (K172574) received a 510(k) decision of Substantially Equivalent on October 5, 2017, 38 days after the submission was received.
What is the product code of K172574?
The FDA product code is OWB – Interventional Fluoroscopic X-Ray System, a Class II (moderate risk) device regulated under 21 CFR 892.1650.