(30 days)
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.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.