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FDA 510(k)

PEDRA-17F Digital Flat Panel X-ray Detector

K-Number: K180989 · 2018-06-13

ApplicantRadisen, Inc.
Decision Date2018-06-13
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PEDRA-17F Digital Flat Panel X-ray Detector is a medical device manufactured by Radisen, Inc.. It received FDA 510(k) clearance on 2018-06-13 under approval number K180989. 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 PEDRA-17F Digital Flat Panel X-ray Detector?

PEDRA-17F Digital Flat Panel X-ray Detector is a medical device that received FDA 510(k) clearance on 2018-06-13. It is manufactured by Radisen, Inc.. The 510(k) number is K180989.

When was PEDRA-17F Digital Flat Panel X-ray Detector approved by the FDA?

PEDRA-17F Digital Flat Panel X-ray Detector received FDA 510(k) clearance on 2018-06-13, under approval number K180989.

What company makes PEDRA-17F Digital Flat Panel X-ray Detector?

PEDRA-17F Digital Flat Panel X-ray Detector is manufactured by Radisen, Inc..

What is the FDA product code for PEDRA-17F Digital Flat Panel X-ray Detector?

The FDA product code for PEDRA-17F Digital Flat Panel X-ray Detector is MQB.

Related Devices (Code: MQB)

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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.

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