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)

Wireless/ Wired X-Ray Flat Panel Detectors

K-Number: K243734 · 2025-04-18

ApplicantAllengers Medical Systems Limited
Decision Date2025-04-18
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Wireless/ Wired X-Ray Flat Panel Detectors is the device name listed in this FDA 510(k) record. The listed applicant is Allengers Medical Systems Limited. It received FDA 510(k) clearance on 2025-04-18 under 510(k) number K243734. 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 Wireless/ Wired X-Ray Flat Panel Detectors?

Wireless/ Wired X-Ray Flat Panel Detectors is a medical device that received FDA 510(k) clearance on 2025-04-18. The listed applicant is Allengers Medical Systems Limited. The 510(k) number is K243734.

When did Wireless/ Wired X-Ray Flat Panel Detectors receive FDA 510(k) clearance?

Wireless/ Wired X-Ray Flat Panel Detectors received FDA 510(k) clearance on 2025-04-18, under 510(k) number K243734.

Who is the listed applicant for Wireless/ Wired X-Ray Flat Panel Detectors?

The FDA 510(k) record lists Allengers Medical Systems Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Wireless/ Wired X-Ray Flat Panel Detectors?

The FDA product code for Wireless/ Wired X-Ray Flat Panel Detectors 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 Allengers Medical Systems Limited 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.

K253296Digital C-ARM with 3DK223009Wireless/Wired X-Ray Flat Panel DetectorsK223060DigiX FDXK220311Cardiovascular Angiography SystemK200218Digiscan FDXK192541DigiX FDX

View all 8 devices →

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.

↑