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The BSD4343R Digital Flat Panel X-ray Detector (Model: BT-DA24-IA) is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic system in all general-purpose diagnostic procedures. It is not to be used for mammography.

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This document is a 510(k) clearance letter from the FDA for a digital flat panel X-ray detector. It is not a study proving the device meets acceptance criteria for an AI/ML medical device. Therefore, I cannot extract the information required to populate the fields you specified.

The provided text discusses:

• Device: BSD4343R Digital Flat Panel X-ray Detector
• Manufacturer: Bontech Inc.
• Regulatory Classification: Class II, Product Code MOB, Regulation Number 21 CFR 892.1680 (Stationary x-ray system)
• Approval Date: June 21, 2017
• Indications for Use: Digital imaging solution for general radiographic systems for human anatomy, intended to replace film or screen-based systems in general-purpose diagnostic procedures (not for mammography).

The letter confirms substantial equivalence to a predicate device, meaning it's cleared because it's as safe and effective as a device already on the market, not because it's an AI/ML device that has met specific performance criteria through a clinical study.

Therefore, I cannot provide the requested information for acceptance criteria and study details because this document does not contain that information, nor does it describe an AI/ML device or its performance study.

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