(170 days)
Not Found
No
The description focuses on the hardware components and basic image acquisition/correction, with no mention of AI/ML terms or functionalities.
No
The device is used for generating radiographic images for diagnosis, not for treating or preventing disease.
Yes
The device is described as being used for "general-purpose diagnostic procedures" and its performance studies mention the quality of "diagnostic images."
No
The device description explicitly lists multiple hardware components (Detector Panel, Control Box, Switch Box, Interconnecting Cables) in addition to the API (software).
No, the FLAATZ 760 is not an IVD (In Vitro Diagnostic) device.
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. This testing is done outside the body (in vitro).
- FLAATZ 760 Function: The FLAATZ 760 is a radiographic image acquisition device. It generates images of human anatomy by capturing X-rays that pass through the body. This is an in vivo process (within the living body).
- Intended Use: The intended use clearly states it's for "generating radiographic images of human anatomy" and "replace radiographic film/screen systems in all general-purpose diagnostic procedures." This describes an imaging device, not a device that analyzes biological specimens.
Therefore, based on the provided information, the FLAATZ 760 falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The FLAATZ 760 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 (comma separated list FDA assigned to the subject device)
KPR
Device Description
The FLAATZ 760 is a radiographic image acquisition device. It is a fully integrated image capture and routing system under human operator control. This system may be usable by a technician in a typical radiology environment.
The FLAATZ 760 system includes a Detector Panel, 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)
Performance test (MTF, DQE, Line Resolution) were done for FLAATZ 760 and the result concludes FLAATZ 760 can display similar images as FLAATZ 750.
Various parts of FLAATZ 760 images were shown to 5 experts and clinical study concludes FLAATZ 760 diagnostic images of equivalent quality as FLAATZ 750.
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.
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
NOV 3 0 2011
510(k) Summary
| 1. Submitter | DRTECH Corporation
333-1 Sangdaewon1-Dong, Seongnam City
Gyeonggi-do, Korea [462-807]
http://drtech.co.kr |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| 2. Contact Person
cwshin@drtech.co.kr | Choul-Woo Shin
Vice President
- 82-31-730-6823 |
| 3. Date Prepared | March 31, 2011 |
| 4. Device Name | FLAATZ 760 |
| 5. Reason for Submission | New Device |
| 6. Classification | 21 CFR §892.1650 |
| 7. Product Code | KPR |
| 8. Predicate Device | FLAATZ 750
DRTECH Corp. South Korea
510(k) No.: K080064 |
9. Device Description
The FLAATZ 760 is a radiographic image acquisition device. It is a fully integrated image capture and routing system under human operator control. This system may be usable by a technician in a typical radiology environment.
The FLAATZ 760 system includes a Detector Panel, 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
10. Intended Use
The FLAATZ 760 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).
-
- Substantial Equivalence
The FLAATZ 760 is substantially equivalent to the FLAATZ 750 cleared on Jan 28 2008 via 510k K080064.
- Substantial Equivalence
| FLAATZ 760 | FLAATZ 750 | ||
|---|---|---|---|
| 510(k) Number | Pending | K080064 | |
| Indication for Use | The FLAATZ 760 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) | The FLAATZ 750 system | ||
| generates digital X-ray images | |||
| that can be used for general X- | |||
| ray system. The FLAATZ 750 | |||
| system can interface to | |||
| traditional X-ray generator and | |||
| get digital X-ray image. The | |||
| FLAATZ 750 is intended to be | |||
| used in same clinical application | |||
| as traditional film-screen based | |||
| general radiography system. | |||
| Panel Shape | Square Panel | Square Panel | |
| Detector Size | 43 x 43 (cm) | 43 x 43 (cm) | |
| Dimensions (W/L/H) | 460 x 460 x 15 (mm) | 482 x 482 x 35 (mm) | |
| Design | Pixel Pitch | 168 x 168 (µm) | 168 x 168 (μm) |
| Image Size | 2,560 x 2,560 (pixels) | 2,560 x 2,560 (pixels) | |
| Weight (Detector) | 4.6 (kg) | 6.2 (kg) | |
| Fill Factor | 83% | 83% | |
| Materials | Amorphous Selenium | ||
| (a-Se) Detector | Amorphous Selenium | ||
| (a-Se) Detector | |||
| DQE | 45.1% @ 0.5lp/mm | 40% @ 0.5 lp/mm | |
| MTF | 78% @ 3lp/mm | 77.7% @ 3lp/mm | |
| Resolution | 3.0 lp/mm | 3.0 lp/mm | |
| Performance | Ghosting |