X-ray Flat Panel Detectors/CareView 3600RF
K-Number: K202995 · 2021-02-19
Decision Date2021-02-19
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
X-ray Flat Panel Detectors/CareView 3600RF is a medical device manufactured by Careray Digital Medical System Co., Ltd.. It received FDA 510(k) clearance on 2021-02-19 under approval number K202995. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the X-ray Flat Panel Detectors/CareView 3600RF?
X-ray Flat Panel Detectors/CareView 3600RF is a medical device that received FDA 510(k) clearance on 2021-02-19. It is manufactured by Careray Digital Medical System Co., Ltd.. The 510(k) number is K202995.
When was X-ray Flat Panel Detectors/CareView 3600RF approved by the FDA?
X-ray Flat Panel Detectors/CareView 3600RF received FDA 510(k) clearance on 2021-02-19, under approval number K202995.
What company makes X-ray Flat Panel Detectors/CareView 3600RF?
X-ray Flat Panel Detectors/CareView 3600RF is manufactured by Careray Digital Medical System Co., Ltd..
What is the FDA product code for X-ray Flat Panel Detectors/CareView 3600RF?
The FDA product code for X-ray Flat Panel Detectors/CareView 3600RF is MQB.
Other Devices by Careray Digital Medical System Co., Ltd.
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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.