Decision Date2019-09-25
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
3D Visualization System is the device name listed in this FDA 510(k) record. The listed applicant is Scivita Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-09-25 under 510(k) number K183675. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the 3D Visualization System?
3D Visualization System is a medical device that received FDA 510(k) clearance on 2019-09-25. The listed applicant is Scivita Medical Technology Co., Ltd.. The 510(k) number is K183675.
When did 3D Visualization System receive FDA 510(k) clearance?
3D Visualization System received FDA 510(k) clearance on 2019-09-25, under 510(k) number K183675.
Who is the listed applicant for 3D Visualization System?
The FDA 510(k) record lists Scivita Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for 3D Visualization System?
The FDA product code for 3D Visualization System is GCJ.
Other records listing Scivita Medical Technology Co., Ltd. as applicant
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.