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)

Yushan X-Ray Flat Panel Detector with DROC

K-Number: K201528 · 2020-10-11

ApplicantInnocare Optoelectronics Corp.
Decision Date2020-10-11
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Yushan X-Ray Flat Panel Detector with DROC is the device name listed in this FDA 510(k) record. The listed applicant is Innocare Optoelectronics Corp.. It received FDA 510(k) clearance on 2020-10-11 under 510(k) number K201528. 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 Yushan X-Ray Flat Panel Detector with DROC?

Yushan X-Ray Flat Panel Detector with DROC is a medical device that received FDA 510(k) clearance on 2020-10-11. The listed applicant is Innocare Optoelectronics Corp.. The 510(k) number is K201528.

When did Yushan X-Ray Flat Panel Detector with DROC receive FDA 510(k) clearance?

Yushan X-Ray Flat Panel Detector with DROC received FDA 510(k) clearance on 2020-10-11, under 510(k) number K201528.

Who is the listed applicant for Yushan X-Ray Flat Panel Detector with DROC?

The FDA 510(k) record lists Innocare Optoelectronics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Yushan X-Ray Flat Panel Detector with DROC?

The FDA product code for Yushan X-Ray Flat Panel Detector with DROC 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 Innocare Optoelectronics Corp. 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.

K250211Yushan X-Ray Flat Panel DetectorK243171Yushan X-Ray Flat Panel DetectorK220510Yushan X-Ray Flat Panel Detector with DROCK210988Yushan X-Ray Flat Panel Detector with DROCK191939Yushan X-Ray Flat Panel Detector

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.

↑