(144 days)
No
The summary describes a digital X-ray detector and associated workstation for image display and adjustment. It mentions electronic image adjustment by the user but does not mention any automated analysis, interpretation, or processing that would typically involve AI/ML. There is no mention of AI, DNN, or ML in the text, nor are there descriptions of training or test sets which are common for AI/ML devices.
No
The device is described as a diagnostic imaging system (Digital X-Ray System) used for capturing images of human anatomy, not for treating any medical condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for use in general radiographic images of human anatomy" and is "intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures." This clearly indicates its use in diagnosing medical conditions.
No
The device description explicitly states it is a "flat-panel type digital X-ray detector" and uses a "Detector Panel" to capture images, indicating it includes significant hardware components beyond just software.
No, 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 KrystalRad 560 (FLAATZ 560) is a digital X-ray system. It captures images of the human anatomy using X-rays, which is an in vivo (within the living body) imaging modality.
- Intended Use: The intended use clearly states it's for "general radiographic images of human anatomy," not for analyzing biological specimens.
The device description and intended use are consistent with a medical imaging device used for diagnostic purposes, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The KrystalRad 560 (FLAATZ 560) 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 generalpurpose diagnostic procedures (excluding fluoroscopic, angiographic, and mammographic applications).
Product codes (comma separated list FDA assigned to the subject device)
MQB, KPR
Device Description
The KrystalRad 560 (FLAATZ 560) 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 560 (FLAATZ 560) device differs from traditional X-ray systems in that, instead of exposing a film and chemically processing it to create a hard copy image, 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.
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
Yes
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 / 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)
Electrical, mechanical safety and performance testing according to standard EN/IEC 60601-1, EN/IEC 60601-1-1, EN/IEC 60601-1-3, EN/IEC 60601-2-7, EN/IEC 60601-2-28 and EN/IEC 60601-2-32 was performed, and EMC testing was conducted in accordance with standard EN/IEC 60601-2-22 was test results were satisfactory. In accordance with standard EN/IEC 60601-1-2(2001).
The results of all testing demonstrate that the KrystalRad 560 (FLAATZ 560) 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): 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.
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.
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
510(k) Summary K102284 This 510k summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
- 3 2010
| Initial Importer/Distributor | MedicaTechUSA | |
|---|---|---|
| Address: | 50 Maxwell | |
| Irvine, CA 92618 | JAN | |
| Phone number: | (800) 817-5030 | |
| Fax number: | (949) 679-2882 | |
| Manufacturer | DRTECH CORP. | |
| 333-1, Sangdeawon 1-Dong | ||
| Jungwon-gu | ||
| Seongnam-shi, Gyeonggi-do 462-807 | ||
| Republic of Korea. | ||
| Phone number: | +82 31 730-6800 | |
| Fax number: | +82 31 730-6869 | |
| Contact Person | George Makar | |
| Email: | george@medicatechusa.com | |
| Phone: | (800) 817-5030 | |
| Cell: | (949) 929-5910 | |
| Fax: | (949) 679-2882 | |
| Device Name and Classification | ||
| Trade name/Product Name: | KrystalRad 560 (FLAATZ 560) 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
Substantial Equivalence claimed to:
DRTech FLAATZ 750 (K080064)
Device Description
The KrystalRad 560 (FLAATZ 560) 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 560 (FLAATZ 560) device differs from traditional X-ray systems in that, instead of exposing a film and chemically processing it to create a hard copy image, 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. .1
15.2010
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
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 560 (FLAATZ 560) 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 generalpurpose diagnostic procedures (excluding fluoroscopic, angiographic, and mammographic applications).
Substantial Equivalence
The KrystalRad 560 (FLAATZ 560) is substantially equivalent to the commercially available DRTech FLAATZ 750 system cleared on January 23, 2010 via 510k K080064. X-ray generation used with the KrystalRad 560 (FLAATZ 560) is identical to the DRTech 750. The KrystalRad 560 (FLAATZ 560) utilizes OmniVision Software while the DRTech FLAATZ 750 system utilizes the proprietary ECOM Omni Vue software to control the system and manage digital images collected
| 510(k) Number | DRTech Corporation
(K080064) | KrystalRad 560 (FLAATZ 560) | |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|------------------------------|
| 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
FDA cleared via 510k K101315 | |
| Design | Panel Shape | Square | Rectangle |
| | Detector Size | 42.9 x 42.9 (cm) | 35x43 cm |
| | Dimensions
(W x L x H) | 482 x 482 x 35 (mm) | 383 X 460 X15mm |
| | Pixel Pitch | 168 (um) | 139 um |
| | Image Size | 3072 x 3072 (pixels) | 3072 x 2560 pixel |
| | Selenium
Thickness | 500 (μm) | 500 (μm) |
| | Weight
(Detector) | 6.2 (kg) | 3.8kg |
| Materials | | Amorphous Selenium
(a-Se) Detector | Amorphous Selenium
(a-Se) |
| Performance | DQE | 48.5% @ 0.5lp/mm | 52.5% @ .5lp/mm |
| | MTF | 78% @ 3.5lp/mm | 77% @ 3.5lp/mm |
| | Resolution | 3.6lp/mm | 3.5lp/mm |
2
| 510(k) Number | DRTech Corporation
(K080064). | KrystalRad 560 (FLAATZ 560) |
|---------------------------------|---------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
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