(186 days)
Not Found
No
The description focuses on the hardware components and basic image capture/correction, with no mention of AI/ML terms or functionalities.
No
The device is described as an image acquisition device used for generating radiographic images for diagnostic purposes, not for treating or alleviating a medical condition.
Yes
The device is described as being used for "general-purpose diagnostic procedures" in its intended use, indicating its role in diagnosis.
No
The device description explicitly lists hardware components such as a Detector Panel, Control Box, Switch Box, and interconnecting Cables, indicating it is not a software-only device.
No, based on the provided information, the FLAATZ 750E is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- FLAATZ 750E Function: The FLAATZ 750E is described as a device for generating radiographic images of human anatomy. It directly captures X-ray photons that pass through the body to create an image. This is an in vivo process (occurring within the living body), not an in vitro process (occurring outside the living body).
- Intended Use: The intended use clearly states "generating radiographic images of human anatomy," which aligns with diagnostic imaging, not laboratory testing of specimens.
- Device Description: The description focuses on the components involved in capturing X-ray images (Detector Panel, Control Box, etc.) and processing that image data. There is no mention of handling or analyzing biological specimens.
Therefore, the FLAATZ 750E falls under the category of a medical imaging device, specifically for radiography, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The FLAATZ 750E 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, MQB
Device Description
The FLAATZ 750E is a radlographic image ecquisition 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 750E 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 square 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 Delector 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
human anatomy
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)
The FLAATZ 750E has been evaluated as per FDA's "Guldance for the Submission of 510(k)s for Solld State X-ray Imaging Devices" and has shown good performance, substantially equivalent to the predicate device.
The FLAATZ 750E has also met applicable Electro Magnetic Compatibility (EMC) requirements.
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
MAR - 4 2011
510(k) Summary
| 1. Submitter | DRTECH Corporation
333-1 Sangdaewon1-Dong, Seongnam City
Gyeonggi-do, Korea (462-807)
www.drtech.co.kr |
|--------------------------|-----------------------------------------------------------------------------------------------------------------|
| 2. Contact Person | Beom-Jin Moon
Vice President
bimoon@drtech.co.kr
- 82-31-788-7653 |
| 3. Date Prepared | June 25, 2010 |
| 4. Device Name | FLAATZ 750E |
| 5. Reason for Submission | New Device |
| 6. Classification | 21 CFR §892.1650 |
| 7. Product Code | KPR |
| 8. Predicate Device | FLAATZ 750
DRTECH Corporation
510(k) No.: K080064 |
9. Device Description
The FLAATZ 750E is a radlographic image ecquisition 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 750E 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 square 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 Delector 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.
DRTECH
.
CONFIDENTIAL
Premarket Notification: FLAATZ 750
નિર
1
10. Intended Use
The FLAATZ 750E 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, anglographic, and mammographic applications).
11. Functional and Safety Testing
The FLAATZ 750E has been evaluated as per FDA's "Guldance for the Submission of 510(k)s for Solld State X-ray Imaging Devices" and has shown good performance, substantially equivalent to the predicate device.
The FLAATZ 750E has also met applicable Electro Magnetic Compatibility (EMC) requirements.
-
- Conclusion
The FLAATZ 750E is substantially equivalent to the Predicate Device in design and performance.
- Conclusion
DRTECH
CONFIDENTIAL
Premarket Notification: FLAATZ 750
2
Image /page/2/Picture/0 description: The image shows the logo of the Department of Health & Human Services. The logo consists of a stylized graphic of human figures in blue, along with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in blue font. The text is positioned to the right of the graphic.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
DRTECH Corporation % Mr. Charlie Mack Principal Engineer IRC 77325 Joyce Way ECHO OR 97826
Re: K102474
Trade/Device Name: FLAATZ 750E Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: February 18, 2011 Received: February 25, 2011
AUG 2 3 2013
Dear Mr. Mack:
This letter corrects our substantially equivalent letter of March 4, 2011.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition. FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Parts 801 and 809): medical device reporting (reporting of
3
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Janine M. Morri Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known):
Device Name: FLAATZ 750E
Indications for Use:
The FLAATZ 750E is indicated for use in generating 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).
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Bewine Evaluation (ODE) CCVI
Mary Scott
Division of Radio Offica of in Vitro Diagno
510K K102474
DRTECH
Confidential
Premarket Notification: FLAATZ: 750E