(253 days)
Not Found
No
The summary mentions "Digital image processing (optimized gray scale)" but does not mention AI, ML, or any related terms, nor does it describe any AI/ML-specific training or testing data.
No
This device is for digital radiography, which is an imaging modality used for diagnosis, not therapy.
Yes
The device is used for general radiographic examinations, which are performed to diagnose medical conditions by imaging internal body structures.
No
The device description explicitly states it includes a "digital bucky" which incorporates a "selenium-based flat panel detector," indicating the presence of hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Quix Digital Radiography Upgrade is an imaging device that captures X-ray images of the inside of the body. It does not analyze biological specimens.
- Intended Use: The intended use clearly states it's for "general radiographic examinations and applications," which involves taking images of the body, not analyzing samples.
- Device Description: The description focuses on the hardware (flat panel detector, console) and its function in capturing and displaying X-ray images.
Therefore, the Quix Digital Radiography Upgrade falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Quix Digital Radiography Upgrade is based on a solid state imaging device and is intended for use in general radiographic examinations and applications wherever conventional film-screen systems may be used, excluding mammography, fluoroscopy, and angiography.
Product codes (comma separated list FDA assigned to the subject device)
MQB
Device Description
The Quix Digital Radiography Upgrade enables a conventional film-screen X-ray system to perform digital radiography exams by replacing the film-screen and the film-screen bucky with a digital bucky and operator console. The digital bucky incorporates a selenium-based flat panel detector with 16" x 17" imaging area. Images are displayed in approximately 10 seconds after exposure over a wide range of dose settings. The operator console provides local image storage and communicates with other network devices using DICOM 3.0 protocols.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Solid State X-ray Imaging Device
Anatomical Site
General radiography
Indicated Patient Age Range
General population
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
exempt from 510(k), K993861, K992794
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
JUN - 7 2006
Section 10 Administrative Requirements
510(k) Summary of Safety and Effectiveness
- Submitter :
EDGE MEDICAL DEVICES Ltd. 25 Hatasia St. P.O. Box 2126 Raanana 43654 lsrael Contact: Vered Scharf vscharf@edge-medical.com Eli Shalev eshalev@edge-medical.com 972-9-7413675 September, 2005
-
- Device Name:
| Classification Name: | Solid State X-ray Imaging Device |
|---|---|
| Common/Usual Name | Flat Panel Digital Imager |
| Proprietary Name | Quix Digital Radiography Upgrade |
-
- Equivalent Devices:
| Proprietary
Name: | AGFA CP-B 200
screen / AGFA CP-BU
New film | Fuji CR 5501D | Infimed Stingray DR
System |
|--------------------------|--------------------------------------------------|--------------------------------|-------------------------------|
| 510(k) Numbers: | exempt from 510(k) | K993861 | K992794 |
| Common Name: | Analog Screen-Film
system | Computed Radiography
System | Digital Radiography
System |
| Regulatory Class: | Class I (screen and film) | Class II | Class II |
| Classification
Panel: | Radiology | Radiology | Radiology |
| Product Code: | 892.1960 (screen)
892.1840 (film) | 901XW 892.1900 | 90MQB 892.1650 |
4. Device Description:
The Quix Digital Radiography Upgrade enables a conventional film-screen X-ray system to perform digital radiography exams by replacing the film-screen and the film-screen bucky with a digital bucky and operator console. The digital bucky incorporates a selenium-based flat panel detector with 16" x 17" imaging area. Images are displayed in approximately 10 seconds after exposure over a wide range September, 2005 510(k) Premarket Notification Submission
1
of dose settings. The operator console provides local image storage and communicates with other network devices using DICOM 3.0 protocols.
- క్. Statement of Intended Use:
The Quix Digital Radiography Upgrade is based on a solid state imaging device and is intended for use in general radiographic examinations and applications wherever conventional film-screen systems may be used, excluding mammography, fluoroscopy, and angiography.
Comparison to substantially equivalent devices: റ.
AGFA CP-B 200 screen / AGFA CP-BU New film Fuji Computed Radiography System K893861 Infimed Stingray Digital Radiography System K992774
The following chart depicts the comparison characteristics.
| Item | Current Device | Predicate Device | Predicate Device | Predicate Device |
|---|---|---|---|---|
| Device | Quix DR Upgrade | AGFA CP-B 200 screen / AGFA CP-BU New film | Fuji CR System | Infimed Stingray DR Upgrade |
| 510(k) Number | exempt from 510(k) | K993861 | K992794 | |
| Intended Use | Provide diagnostic images for general radiographic use | Same | Same | Same |
| Anatomical Sites | General radiography | Same | Same | Same |
| Target Population | General population | Same | Same | Same |
| Design | Digital acquisition, electronic processing | Analog acquisition, chemical processing | Digital acquisition, electronic processing | Digital acquisition, electronic processing |
| X-ray Converter | Amorphous selenium, converts X-rays to latent charge image | Fluorescent screen, converts X-rays to light | Photostimulable phosphor imaging plate converts X-rays to stable exited states of the material | Cesium lodide scintillator, converts X-rays to light |
| Image Readout | Plasma DR Readout Technology – line scanner sweeps across sensor surface to readout latent charge image. | Silver halide film | Mechanical scanner sweeps Laser across phosphor surface to readout latent stored image. | Photodiode and TFT amorphous silicon active matrix array convert light to electrical charge which is readout electronically. |
| Moving line scanner | Yes | No | Yes | No |
| Performance | Digital image processing (optimized gray scale) | Chemical processing (fixed gray scale) | Digital image processing (optimized gray scale) | Digital image processing (optimized gray scale) |
| Imaging area | 16" x 17" | 14" x 17" | 14" x 17" | 17" x 17" |
| Monolithic sensor | Yes | Yes | Yes | No (tiled subarrays) |
| Pixel array size | 2540 x 2700 | N/A | 2140 x 2140 | 2981 x 3021 (from 510(k)) |
| 3000 x 3000 (current "chart smart") |
September, 2005
510(k) Premarket Notification Submission
2
| Item | Current Device | Predicate Device | Predicate Device | Predicate Device |
|---|---|---|---|---|
| Device | Quix DR Upgrade | AGFA CP-B 200 screen/ AGFA CP-BU New film | Fuji CR System | Intimed Stingray DR Upgrade |
| Pixel size | $160 \mu m$ | $ |