(13 days)
Not Found
No
The description focuses on hardware components and basic image processing (defect correction) without mentioning AI/ML algorithms or training/testing data.
No
The device is used for generating radiographic images for diagnostic purposes, not for treating or preventing disease.
Yes
The "Intended Use / Indications for Use" section states that the device is "intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures." This explicitly indicates its use for diagnostic purposes.
No
The device description explicitly lists hardware components such as a Detector Panel, Control Box, Switch Box, and Interconnecting Cables, in addition to the API (software).
Based on the provided information, the FLAATZ 750 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is clearly stated as "generating radiographic images of human anatomy." This is an in vivo (within the living body) imaging procedure, not an in vitro (outside the living body) diagnostic test.
- Device Description: The description details a system for acquiring radiographic images using X-rays. This aligns with medical imaging, not laboratory testing of biological samples.
- Input Imaging Modality: The input modality is "radiographic," which is a form of medical imaging.
- Anatomical Site: The device is used on "human anatomy," indicating direct interaction with the patient's body.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment. The FLAATZ 750 does not perform this function.
N/A
Intended Use / Indications for Use
The FLAATZ 750 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)
MQB
Device Description
The FLAATZ 750 is a radiographic image acquisition device. It is a fully integrated image capture and rouling system under human operator control. This system may be useble by a technician in a typical radiology environment
The FLAATZ 750 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 buffen believe a the Detector Panel and Operating PC while also supplying power to the Detector Panell 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
radiographic
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 750 has been evaluated as per FDA's "Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices" and has shown good performance, substantially equivalent to the predicate device.
The FLAATZ 750 has also met applicable ElectroMagnetic 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.
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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
bjmoon@drtech.co.kr
- 82-31-730-6804 |
| 3. Date Prepared | December 5, 2007 |
| 4. Device Name | FLAATZ 750 |
| 5. Reason for Submission | New Device |
| 6. Classification | 21 CFR §892.1650 |
| 7. Product Code | MQB |
| 8. Predicate Device | Saturn 9000
New Medical Co., LTD.
510(k) No.: K063710 |
9. Device Description
The FLAATZ 750 is a radiographic image acquisition device. It is a fully integrated image capture and rouling system under human operator control. This system may be useble by a technician in a typical radiology environment
The FLAATZ 750 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 buffen believe a the Detector Panel and Operating PC while also supplying power to the Detector Panell 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.
CONFIDENTIAL
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10. Intended Use
The FLAATZ 750 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. Functional and Safety Testing
The FLAATZ 750 has been evaluated as per FDA's "Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices" and has shown good performance, substantially equivalent to the predicate device.
The FLAATZ 750 has also met applicable ElectroMagnetic Compatibility (EMC) requirements.
12. Conclusion
The FLAATZ 750 is substantially equivalent to the Predicate Device in design and performance.
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Image /page/2/Picture/0 description: The image shows the Department of Health & Human Services USA logo. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird-like figure. The symbol is composed of several curved lines and shapes, creating a stylized representation of a bird in flight.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
DRTECH Corporation % Mr. Ned Devine Senior Staff Engineer/Program Reviewer Underwriters Laboratories. Inc. 333 Pfingsten Road NORTHBROOK IL 60062
AUG 2 3 2013
Re: K080064
Trade/Device Name: FLAATZ 750 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: December 20, 2007 Received: January 10, 2008
Dear Mr. Devine:
This letter corrects our substantially equivalent letter of January 23, 2008.
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becamined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use surve in the encreations of 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, devices mat have boon require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, and 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 that I Drims made a actives and regulations administered by other Federal agencies. You must or any I cacial statutes and regarations, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of
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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 11 you dostro openio an 100 co 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 I va may other valle guits guiners, 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
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): Ko80064
Device Name: FLAATZ 750
Indications for Use:
The FLAATZ 750 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 × (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 Device Evaluation (ODE)
Lust Het Witz
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
DRTECH
CONFIDENTIAL
Premarket Notification000063
. ••
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