(275 days)
Intended for use in general human radiography imaging similar to the optically coupled CCD based device cleared under 510(k) number K974863. Not to be used for mammography.
The Xplorer 1000 is an optical based digital x-ray imager. It works by converting incident x-ray energy to visible light by use of fluorescent screen. The visible light is deflected by a mirror to a high resolution CCD camera that produces a digital image. The device trigger mechanism ensures that image is captured when the x-ray beam is turned on. The device does not require any connection to the x-ray generator.
Here's a breakdown of the acceptance criteria and study as described in the provided documents for the Xplorer 1000 Digital X-ray Imager:
Acceptance Criteria and Reported Device Performance
The core acceptance criterion for the Xplorer 1000 was to demonstrate equivalence to its predicate devices: the IMIX DIGITAL THORAX SYSTEM (K974863) and conventional radiographic film (21 CFR 892.1840). This equivalence was assessed in terms of intended use and radiographic performance.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category/Measure | Acceptance Criteria (Implicit for Predicate Equivalence) | Reported Xplorer 1000 Performance |
|---|---|---|
| Intended Use | General human radiography (same as predicates) | General human radiography |
| Radiographic Performance | ||
| Spatial Resolution (microns at 100% MTF) | At least 200 microns (IMIX) or |
§ 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.