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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 the device name listed in this FDA 510(k) record. The listed applicant is Radisen, Inc.. It received FDA 510(k) clearance on 2018-06-13 under 510(k) 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. The listed applicant is Radisen, Inc.. The 510(k) number is K180989.

When did PEDRA-17F Digital Flat Panel X-ray Detector receive FDA 510(k) clearance?

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

Who is the listed applicant for PEDRA-17F Digital Flat Panel X-ray Detector?

The FDA 510(k) record lists Radisen, Inc. as the applicant. This does not by itself establish the device manufacturer.

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 Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07092553Evaluation of C-arm PCD-CBCT for Image-Guided InterventionsNOT_YET_RECRUITING

Other records listing Radisen, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K213520AXIR-CXK221144PEDRA-1417MC, PEDRA-1417MG, PEDRA-1417FC, PEDRA-1417FG

Related Devices (Code: MQB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K2538000909FCE, 0909FCE-HSRayence Co., Ltd.K260820VIVIX-S 4386W (FXRD-4386WA)Vieworks Co., Ltd.K252996Universal 1417PIKonica Minolta Healthcare Americas, Inc.K252911Lux HD 2530 detector (Lux HD 2530)Iray Imaging Technology (Haining) LimitedK250211Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp.K250665SKR 3000Konica Minolta, 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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