CareView 1500P X-ray Flat Panel Detectors
K-Number: K162178 · 2016-09-01
Decision Date2016-09-01
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
CareView 1500P X-ray Flat Panel Detectors is a medical device manufactured by Careray Digital Medical System Co., Ltd.. It received FDA 510(k) clearance on 2016-09-01 under approval number K162178. 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 CareView 1500P X-ray Flat Panel Detectors?
CareView 1500P X-ray Flat Panel Detectors is a medical device that received FDA 510(k) clearance on 2016-09-01. It is manufactured by Careray Digital Medical System Co., Ltd.. The 510(k) number is K162178.
When was CareView 1500P X-ray Flat Panel Detectors approved by the FDA?
CareView 1500P X-ray Flat Panel Detectors received FDA 510(k) clearance on 2016-09-01, under approval number K162178.
What company makes CareView 1500P X-ray Flat Panel Detectors?
CareView 1500P X-ray Flat Panel Detectors is manufactured by Careray Digital Medical System Co., Ltd..
What is the FDA product code for CareView 1500P X-ray Flat Panel Detectors?
The FDA product code for CareView 1500P X-ray Flat Panel Detectors 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.