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

FDA 510(k)

CSX-30 Flat Panel Detector

K-Number: K162909 · 2017-01-27

ApplicantCanon, Inc. – Medical Equipment Group
Decision Date2017-01-27
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CSX-30 Flat Panel Detector is the device name listed in this FDA 510(k) record. The listed applicant is Canon, Inc. – Medical Equipment Group. It received FDA 510(k) clearance on 2017-01-27 under 510(k) number K162909. 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 CSX-30 Flat Panel Detector?

CSX-30 Flat Panel Detector is a medical device that received FDA 510(k) clearance on 2017-01-27. The listed applicant is Canon, Inc. – Medical Equipment Group. The 510(k) number is K162909.

When did CSX-30 Flat Panel Detector receive FDA 510(k) clearance?

CSX-30 Flat Panel Detector received FDA 510(k) clearance on 2017-01-27, under 510(k) number K162909.

Who is the listed applicant for CSX-30 Flat Panel Detector?

The FDA 510(k) record lists Canon, Inc. – Medical Equipment Group as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CSX-30 Flat Panel Detector?

The FDA product code for CSX-30 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 Canon, Inc. – Medical Equipment Group 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.

K173689Ophthalmic Software Platform RX

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.

↑