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FDA 510(k)

IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector)

K-Number: K241346 · 2024-11-07

ApplicantAspen Imaging Healthcare, Inc.
Decision Date2024-11-07
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector) is a medical device manufactured by Aspen Imaging Healthcare, Inc.. It received FDA 510(k) clearance on 2024-11-07 under approval number K241346. 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 IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector)?

IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector) is a medical device that received FDA 510(k) clearance on 2024-11-07. It is manufactured by Aspen Imaging Healthcare, Inc.. The 510(k) number is K241346.

When was IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector) approved by the FDA?

IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector) received FDA 510(k) clearance on 2024-11-07, under approval number K241346.

What company makes IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector)?

IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector) is manufactured by Aspen Imaging Healthcare, Inc..

What is the FDA product code for IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector)?

The FDA product code for IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector) is MQB.

Other Devices by Aspen Imaging Healthcare, Inc.

K241425AspenView

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.

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