Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SkyPlate Detector for Philips Radiography/Fluoroscopy Systems

K-Number: K171461 · 2017-07-07

ApplicantPhilips Medical Systems Dmc GmbH
Decision Date2017-07-07
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SkyPlate Detector for Philips Radiography/Fluoroscopy Systems is a medical device manufactured by Philips Medical Systems Dmc GmbH. It received FDA 510(k) clearance on 2017-07-07 under approval number K171461. 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 SkyPlate Detector for Philips Radiography/Fluoroscopy Systems?

SkyPlate Detector for Philips Radiography/Fluoroscopy Systems is a medical device that received FDA 510(k) clearance on 2017-07-07. It is manufactured by Philips Medical Systems Dmc GmbH. The 510(k) number is K171461.

When was SkyPlate Detector for Philips Radiography/Fluoroscopy Systems approved by the FDA?

SkyPlate Detector for Philips Radiography/Fluoroscopy Systems received FDA 510(k) clearance on 2017-07-07, under approval number K171461.

What company makes SkyPlate Detector for Philips Radiography/Fluoroscopy Systems?

SkyPlate Detector for Philips Radiography/Fluoroscopy Systems is manufactured by Philips Medical Systems Dmc GmbH.

What is the FDA product code for SkyPlate Detector for Philips Radiography/Fluoroscopy Systems?

The FDA product code for SkyPlate Detector for Philips Radiography/Fluoroscopy Systems is MQB.

Other Devices by Philips Medical Systems Dmc GmbH

K170113pixium 4343RCE K163210Philips CombiDiagnost R90 K173433ProxiDiagnost N90 K182973DigitalDiagnost C90 K203087CombiDiagnost R90 K202564DigitalDiagnost C90

View all 14 devices →

Related Devices (Code: MQB)

K162555EVS 4343, EVS 4343GDRTECH Corporation K162344INNOLUX RICInnolux Corporation K161730Wireless Digital Flat Panel DetectorIray Technology (Shanghai) , Ltd. K162552EVS 3643, EVS 3643GDRTECH Corporation K163019CareView 750Cw/750C X-ray Flat Panel DetectorsCareray Digital Medical System Co., Ltd. K160143ClearVision ExamVue Flat Panel DetectorJpi Healthcare, Inc.

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.

↑