(275 days)
No
The device description and performance studies focus on the optical and digital imaging components, with no mention of AI or ML for image processing or analysis.
No
The device is an imaging device (digital x-ray imager) used for diagnostic purposes, not for treating or preventing disease.
No
This device is an X-ray imager, which is used for image acquisition to aid in diagnosis, but it does not perform diagnostic functions itself. It converts X-ray energy into visible light to produce a digital image.
No
The device description explicitly details hardware components like a fluorescent screen, mirror, and CCD camera, indicating it is a hardware-based digital x-ray imager, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The Xplorer 1000 is a digital x-ray imager. It works by converting x-ray energy into a digital image of the internal structures of the human body. It does not analyze biological specimens.
- Intended Use: The intended use is for "general human radiography imaging," which is a form of medical imaging performed directly on the patient, not on a sample taken from the patient.
- Device Description: The description clearly outlines the process of capturing an image from incident x-rays on the body, not from a biological sample.
Therefore, the Xplorer 1000 falls under the category of medical imaging devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The Xplorer 1000 is a digital x-ray imager intended as a replacement for x-ray film for general human radiography.
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.
Product codes
90 MQB
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
general human radiography
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
In an image quality study, 20 human subjects were x-rayed both conventionally and with the Xplorer 1000. A range of anatomy was covered representative of general radiography. The results were examined by a panel of 3 radiologists and found equivalent to film.
Summary of Performance Studies
Non-clinical testing: The Xplorer 1000 uses a fluorescent screen of the type used in film / screen radiography to convert x-rays to light. This light is then captured by a high resolution CCD sensor. To verify the spatial resolution and determine its equivalence to film, tests were performed using line pair resolution targets and radiological phantoms. Resolution was found to exceed the standards set by the American College of Radiologists and, qualitatively, imaging of bone detail, particularly trabeculae, was found equivalent by radiologists.
Clinical testing: In an image quality study, 20 human subjects were x-rayed both conventionally and with the Xplorer 1000. A range of anatomy was covered representative of general radiography. The results were examined by a panel of 3 radiologists and found equivalent to film.
Key Metrics
Not Found
Predicate Device(s)
K974863, 21 CFR 892.1840
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
N - 2 200
DRAFT
CONFIDENTIAL
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2.1 Summary for Public Disclosure
Submitter Robin Winsor Director - Regulatory Affairs # 151, 2340 Pegasus Way NE Calgary, Alberta T2E 8M5 Canada Tel: (403) 251 9939 Fax: (403) 251 1771 E-mail: rwinsor@xrayimaging.com
Date summary was prepared
August 24, 1999
Name(s) of the device
| Trade name | Xplorer 1000 Digital X-ray Imager |
|---|---|
| Common name | Digital X-ray Imager |
Classification name Solid State X-ray Imager
Identification of predicate device(s)
Equivalency is based on the IMIX DIGITAL THORAX SYSTEM (K974863) and conventional radiographic film (21 CFR 892.1840).
Description of the device
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.
Intended Use
The Xplorer 1000 is a digital x-ray imager intended as a replacement for x-ray film for general human radiography.
June 1, 2000 IMAGING DYNAMICS CORPORATION Xplorer 1000 Digital X-ray Image
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Comparison of device characteristics to predicate
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| Feature | Xplorer 1000 | IMIX | Film / Screen |
|---|---|---|---|
| 510(k)/Regulation | Pending | K974863 | 892.1840 |
| Intended Use | General Human Radiography | ||
| Fluorescent screen | |||
| to convert x-rays to | |||
| light | Yes | Yes | Yes |
| Mirror to separate | |||
| x-rays from light | Yes | Yes | No |
| Lens to focus light | Yes | Yes | No |
| CCD to capture | |||
| image | Yes | Yes | No |
| Spatial Resolution | |||
| (microns) at 100% | |||
| MTF | 127 | 200 |