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FDA 510(k)

PerkinElmer, XRpad2 3025 HWC-M Flat Panel Detector

K-Number: K161942 · 2016-09-01

ApplicantPerkinelmer, Inc.
Decision Date2016-09-01
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PerkinElmer, XRpad2 3025 HWC-M Flat Panel Detector is the device name listed in this FDA 510(k) record. The listed applicant is Perkinelmer, Inc.. It received FDA 510(k) clearance on 2016-09-01 under 510(k) number K161942. 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 PerkinElmer, XRpad2 3025 HWC-M Flat Panel Detector?

PerkinElmer, XRpad2 3025 HWC-M Flat Panel Detector is a medical device that received FDA 510(k) clearance on 2016-09-01. The listed applicant is Perkinelmer, Inc.. The 510(k) number is K161942.

When did PerkinElmer, XRpad2 3025 HWC-M Flat Panel Detector receive FDA 510(k) clearance?

PerkinElmer, XRpad2 3025 HWC-M Flat Panel Detector received FDA 510(k) clearance on 2016-09-01, under 510(k) number K161942.

Who is the listed applicant for PerkinElmer, XRpad2 3025 HWC-M Flat Panel Detector?

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

What is the FDA product code for PerkinElmer, XRpad2 3025 HWC-M Flat Panel Detector?

The FDA product code for PerkinElmer, XRpad2 3025 HWC-M Flat Panel 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 Perkinelmer, 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.

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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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