(119 days)
Not Found
No
The description focuses on the hardware components and basic image acquisition/correction functions, with no mention of AI, ML, or advanced image processing beyond defect correction.
No
The device is used for generating radiographic images, falling under diagnostic imaging, not therapeutic treatment.
Yes
The "Intended Use / Indications for Use" section states that the device is intended for "general-purpose diagnostic procedures."
No
The device description explicitly lists multiple hardware components including a Detector Panel, Case, Grid, Control Box, Switch Box, and Interconnecting Cables, in addition to the API (software).
Based on the provided information, the FLAATZ 560 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is "generating radiographic images of human anatomy." This is a diagnostic imaging device, not a device used to examine specimens (like blood, urine, or tissue) outside the body.
- Device Description: The description details a system for capturing X-ray images, including a detector panel, control box, and related components. This aligns with an imaging system, not an IVD.
- Input Imaging Modality: The input is X-ray, which is an imaging modality used on the patient's body, not on in vitro samples.
- Anatomical Site: The device is used for "General Radiography," which refers to imaging the human body.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The FLAATZ 560's function is to create images of the internal structure of the body using X-rays.
N/A
Intended Use / Indications for Use
The FLAATZ 560 is indicated for use in generating 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
Device Description
The FLAATZ 560 is a radiographic image acquisition device. It is a fully integrated image capture and routing system under human operator control. TThis system may be usable by a technician in a typical radiology environment.
The FLAATZ 560 system includes a Detector Panel, Case, Grid, Control Box, Switch Box, Interconnecting Cables, and API. The Detector Panel is a direct conversion device in the form of a rectangular plate in which the input x-ray photons are absorbed in an a-Se layer. The Control Box functions as a buffer between the Detector Panel and Operating PC while also supplying power to the Detector Panel. The Switch Box transfers signals between the Control Box and X-ray Generator and also indicates the status of the panel using LED lights. Finally, the API contains functions for image data capture and correction of defects on the image data.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
General Radiography
Indicated Patient Age Range
Not Found
Intended User / Care Setting
technician in a typical radiology environment
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)
Non-clinical test report: Performance test (MTF, DQE, Line Resolution) were done for FLAATZ 560 and the result concludes FLAATZ 560 can display similar images as KRYSTALRAD 560 (FLAATZ 560).
Clinical test report: Various parts of FLAATZ 560 images were shown to 5 experts and clinical study concludes FLAATZ 560 diagnostic images of equivalent quality as KRYSTALRAD 560 (FLAATZ 560)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
| 1. Submitter | DRTECH Corporation
333-1 Sangdaewon1-Dong, Seongnam City
Gyeonggi-do, Korea [462-807]
www.drtech.co.kr |
|--------------------------|-----------------------------------------------------------------------------------------------------------------|
| 2. Contact Person | Choul-Woo Shin
Vice President
cwshin@drtech.co.kr
- 82-31-788-7653 |
| 3. Date Prepared | March 25, 2011 |
| 4. Device Name | FLAATZ 560 |
| 5. Reason for Submission | New Device |
| 6. Classification | 21 CFR §892.1650 |
| 7. Product Code | MQB |
| 8. Predicate Device | KRYSTALRAD 560 (FLAATZ 560) SYSTEM
Medicatech USA,
510(k) No.: K102284 |
9. Device Description
The FLAATZ 560 is a radiographic image acquisition device. It is a fully integrated image capture and routing system under human operator control. TThis system may be usable by a technician in a typical radiology environment.
The FLAATZ 560 system includes a Detector Panel, Case, Grid, Control Box, Switch Box, Interconnecting Cables, and API. The Detector Panel is a direct conversion device in the form of a rectangular plate in which the input x-ray photons are absorbed in an a-Se layer. The Control Box functions as a buffer between the Detector Panel and Operating PC while also supplying power to the Detector Panel. The Switch Box transfers signals between the Control Box and X-ray Generator and also indicates the status of the panel using LED lights. Finally, the API contains functions for image data capture and correction of defects on the image data.
1
- K 111 583
-
- Intended Use
The FLAATZ 560 is indicated for use in generating 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).
11. Substantial Equivalence
The FLAATZ 560 is substantially equivalent to the KRYSTALRAD 560 (FLAATZ 560) cleared on Jan 3, 2011 via 510k K102284.
Those two systems include same detector, FLAATZ 560, so technological characteristics are equivalent.
| | FLAATZ 560 | KRYSTALRAD 560
(FLAATZ 560) SYSTEM | |
|------------------------------|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| 510(k) Number | | Pending | K102284 |
| Indication for Use | | The FLAATZ 560 is indicated
for use in general radiographic
images of human anatomy too.
It is the upgraded model of
previous FLAATZ
500(K091747), also intended to
replace radiographic film/screen
systems in all general-purpose
diagnostic procedures | Same as predicate |
| | Panel Shape | Rectangular Panel | Rectangular Panel |
| | Detector Size | 353 x 424 (mm) | 353 x 424 (mm) |
| Design | Dimensions
(W x L x H) | 383 x 460 x 15 (mm) | 383 x 460 x 15 (mm) |
| | Pixel Pitch | 139 x 139 (μm) | 139 x 139 (μm) |
| | Image Size | 2,560 x 3,072 (pixels) | 2,560 x 3,072 (pixels) |
| | Se Thickness | 500 (μm) | 500 (μm) |
| | Weight (Detector) | 3.0(kg) | 3.0 (kg) |
| Materials | | Amorphous Selenium
(a-Se) Detector | Amorphous Selenium
(a-Se) Detector |
| | DQE | 49.3% @ 0.5lp/mm | 48.5% @ 0.5 lp/mm |
| Performance | MTF | 78% @3lp/mm | 78% @3lp/mm |
| | Resolution | 3.6 lp/mm | 3.6 lp/mm |
| | Ghosting |