(14 days)
This device is indicated as a general radiography device. It is capable of providing digital images of the head, neck, spine, chest abdomen and limbs by converting x-rays to digital images. Excluded indications include mammography, fluoroscopy and angiography studies.
The RADREX-I is a general purpose x-ray system that employs Solid State Imager(s), SSXI, which converts x-rays directly into electrical signals which can ofter annager(s), processing be displayed on LCD monitors or printed to a medical grade image printer. The system console is a PC based device that allows for worklist management, image storage, image processing, image exporting and image printing. The system may be equipped with a table and/or vertical wall unit. is configurable with up to two x-ray tubes, and has an optional auto stitching function.
The provided text is a 510(k) Pre-market Notification for the Toshiba DRAD-3000E, RADREX-i. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain information about acceptance criteria, a specific study designed to prove the device meets acceptance criteria, reported device performance figures, sample sizes for test or training sets, data provenance, the number or qualifications of experts, adjudication methods, multi-reader multi-case studies, standalone performance, or how ground truth was established.
The document focuses on demonstrating that the DRAD-3000E, RADREX-i is substantially equivalent to existing devices, primarily K073165 (another Toshiba DRAD-3000E, RADREX-i submission) and Philips Medical Systems Bucky Vision (Digital Diagnost) K982795. This type of submission relies on the fact that if a new device has the same intended use and similar technological characteristics to a legally marketed predicate device, it can be cleared without extensive new clinical trials demonstrating performance against specific acceptance criteria.
Therefore, it is not possible to fill in the requested table or answer the specific questions based on the provided text. The information requested, particularly regarding performance metrics, study design, and ground truth establishment, is typically found in detailed performance studies or clinical trials, which are not part of this 510(k) summary.
Summary of what CAN be extracted from the document:
- Device Name: DRAD-3000E, RADREX-i
- Intended Use: General radiography device, capable of providing digital images of the head, neck, spine, chest, abdomen, and limbs by converting x-rays to digital images. Excluded indications include mammography, fluoroscopy, and angiography studies.
- Predicate Devices: Toshiba DRAD-3000E, RADREX-i [K073165] and Philips Medical Systems Bucky Vision (Digital Diagnost) [K982795].
- Reason for Submission: Modification to an existing device.
- Type of device: Solid State X-ray Imager (Flat Panel/Digital Imager).
- Regulatory Class: II (under 21 CFR 892.1650).
- Compliance: Designed and manufactured under Quality System Regulations (21 CFR § 820), Federal Diagnostic Equipment Standard (21 CFR § 1020), and in conformance with applicable parts of IEC 60601-1, IEC 60601-2-32, and IEC 60601-2-28.
In conclusion, the provided 510(k) submission establishes substantial equivalence but does not include the detailed performance study information requested.
§ 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.