(144 days)
Not Found
No
The summary describes a standard digital X-ray system with image capture, display, storage, and basic electronic adjustment capabilities. There is no mention of AI, ML, or advanced image processing techniques that would typically indicate the use of such technologies. The performance studies focus on standard radiographic metrics and safety testing.
No.
The device is indicated for diagnostic procedures (capturing radiographic images) and does not provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures." This indicates its role in diagnosing medical conditions based on the images it produces.
No
The device description explicitly mentions a "Detector Panel" which is a hardware component used to capture the image in electronic form. The summary also details electrical and mechanical safety testing, further indicating the presence of hardware.
Based on the provided information, the KrystalRAD (ATAL8) Digital X-Ray System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body. The KrystalRAD system is used to capture images of the human anatomy directly, without the need for samples like blood, urine, or tissue.
- The intended use and device description clearly state it's for general radiographic images of human anatomy. This involves external imaging using X-rays, not analysis of biological samples.
Therefore, the KrystalRAD (ATAL8) is a medical imaging device, specifically a digital X-ray system, and not an IVD.
N/A
Intended Use / Indications for Use
The KrystalRAD (ATAL8) Digital X-Ray System is indicated for use in general radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures (excluding fluoroscopic, angiographic, and mammographic applications).
Product codes
MQB, KPR
Device Description
The KrystalRAD (ATAL8) System is a flat-panel type digital X-ray detector that captures projection radiographic images in digital format within seconds, eliminating the need for an entire X-ray film or an image plate as an image capture medium. The KrystalRAD (ATAL8) device differs from traditional Xray systems in that, instead of exposing a film and chemically processing it to create a hard convenial 71 a device called a Detector Panel is used to capture the image in electronic form.
Once the system captures a radiographic image and subsequently displaying and storing an image, radiologists or physicians can adjust the image electronically to optimize the view of the desired anatomy at a work station.
The system enables a user to duplicate images without having to take additional exposures so that the user can easily transmit a duplicate to the second physician who needs the duplicate image through the network. 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 11 : 33m .
Hardcopy images can also be made from digital printers, optimizing for the user's preference. The system can have DICOM-compliant output to ensure compatibility with existing imaging network infrastructure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
human anatomy, General Radiography
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Radiologists or physicians
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)
Bench testing and electrical safety further substantiate equivalence to the predicate.
Electrical, mechanical safety and performance testing according to standard EN/IEC 60601-1, EN/IEC 60601-1-1, EN/EC 60601-1-3, EN/IEC 60601-2-7, EN/IEC 60601-2-28 and EN/IEC 60601-2-23 was performed, and EMC testing was conducted in accordance with standard EN/IEC 60601-12202 All test results were satisfactory. The results of all testing demonstrate that the KrystalRAD (ATAL8) does not raise any new significant issues of safety, effectiveness or performance of the device when compare to the existing predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
DRTech FLAATZ 750 (K080064)
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
510(k) Summary K102285
This 510k summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
| Initial Importer/Distributor | MedicaTechUSA |
|---|---|
| Address: | 50 Maxwell |
| Irvine, CA 92618 | |
| Phone number: | (800) 817-5030 |
| Fax number: | (949) 679-2882 |
| JAN - 3 | |
| Contact Person | George Makar |
| Email: | george@medicatechusa.com |
| Phone: | (800) 817-5030 |
| Cell: | (949) 929-5910 |
| Fax: | (949) 679-2882 |
| Manufacturer | Atlaim |
| 1018/19 Sicox Tower Sangdaewon | |
| Seongnam Gyeonggi | |
| 462-120, Republic of Korea | |
| Tel #: +82 70 7997 2900 | |
| Fax #: +82 31 749 0777 | |
| Device Name and Classification | |
| Trade name/Product Name: | KrystalRAD (ATAL8) System |
| Classification name: | Stationary X-ray System |
| Common name: | General purpose diagnostic X-ray System |
| Classification Panel: | Radiology |
| Product Code: | MQB |
| Regulation Number: | 892.1680 |
| Date Prepared | December 15, 2010 |
| Substantial Equivalence claimed to: | DRTech FLAATZ 750 (K080064) |
Device Description
The KrystalRAD (ATAL8) System is a flat-panel type digital X-ray detector that captures projection radiographic images in digital format within seconds, eliminating the need for an entire X-ray film or an image plate as an image capture medium. The KrystalRAD (ATAL8) device differs from traditional Xray systems in that, instead of exposing a film and chemically processing it to create a hard convenial 71 a device called a Detector Panel is used to capture the image in electronic form.
Once the system captures a radiographic image and subsequently displaying and storing an image, radiologists or physicians can adjust the image electronically to optimize the view of the desired anatomy at a work station.
The system enables a user to duplicate images without having to take additional exposures so that the user can easily transmit a duplicate to the second physician who needs the duplicate image through the network. 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 11 : 33m .
1 | 图标
2010
1
Hardcopy images can also be made from digital printers, optimizing for the user's preference. The system can have DICOM-compliant output to ensure compatibility with existing imaging network infrastructure.
Indications for Use
The KrystalRAD (ATAL8) Digital X-Ray System is indicated for use in general radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures (excluding fluoroscopic, angiographic, and mammographic applications).
Substantial Equivalence
The KrystalRAD (ATAL 8) is substantially equivalent to the commercially available DRTech FLAATZ 750 system cleared on January 23, 2010 via 510k K080064. Bench testing and electrical safety further substantiate equivalence to the predicate. The KrystalRAD (ATAL 8) utilizes OmniVision Software while the DRTech FLAATZ 750 system utilizes the proprietary ECOM OmniVue software to control the system and manage digital images collected.
| 510(k) Number | | DRTech Corporation
(K080064) | KrystalRAD (ATAL8) |
|---------------|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|
| | Indication for Use | The FLAATZ 750 is indicated for
use in general radiographic images
of human anatomy. It is intended
to replace radiographic film/screen
systems in all general-purpose
diagnostic procedures (excluding
fluoroscopic, angiographic, and
mammographic applications). | Same as predicate. |
| | User Interface | Software Driven
Touch Panel LCD +
remote control unit +
remote console | Same as predicate. |
| | Software | ECOM OmniVue | OmniVision |
| Design | Panel Shape | Square | Square Panel |
| | Detector Size | 42.9 x 42.9 (cm) | 43 x 43 cm |
| | Dimensions
(W x L x H) | 482 x 482 x 35 (mm) | 500 X 500 X 40mm |
| | Pixel Pitch | 168 (um) | 143 um |
| | Image Size | 3072 x 3072 (pixels) | 3072 x 3072 pixel |
| | Selenium Thickness | 500 (µm) | no selenium |
| | Weight (Detector) | 6.2 (kg) | 12.7 kg |
| Materials | | Amorphous Selenium
(a-Se) Detector | Amorphous Silicon (a-Si) |
| Performance | DQE | 48.5% @ 0.5 lp/mm | 68%@ .5 lp/mm |
+ 1 . 1411 Substantial Equivalence Table
Image /page/1/Picture/7 description: The image is a black and white image that appears to be a low-resolution photograph of a natural scene. The image is grainy and lacks sharp details. There are many small black dots scattered throughout the image, which could be due to noise or artifacts from the image processing.
2
| 510(k) Number | DRTech Corporation
(K080064) | | KrystalRAD (ATAL8) |
|------------------------------|-------------------------------------------------------------------------------------------------------------|----------------------|---------------------------------------------------------------------------------------------------------|
| | MTF | 78% @ 3.5 lp/mm | 525 @ 3.5 lp/mm |
| | Resolution | 3.6 lp/mm | 3.5 lp/mm |
| | Ghosting |