(164 days)
Not Found
No
The summary describes a standard digital radiography system focused on image acquisition and basic correction, with no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is described as a radiographic image acquisition device used for generating diagnostic images, not for treating or preventing disease.
Yes
The device is described as generating "radiographic images" and is intended to replace systems in "general-purpose diagnostic procedures," with clinical studies focused on "diagnostic equivalency" and producing "diagnostic images." This indicates its role in the diagnostic process.
No
The device description explicitly lists multiple hardware components including a Detector Panel, Case, Grid, Power Box, Switch Box, and Interconnecting Cables, in addition to the API (software).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to generate radiographic images of human anatomy. This is an in vivo (within the living body) diagnostic imaging procedure, not an in vitro (outside the living body) diagnostic test.
- Device Description: The device is a radiographic image acquisition system that captures X-ray images. This aligns with in vivo imaging.
- Input Imaging Modality: The input is X-ray, which is used for in vivo imaging.
- Anatomical Site: The device is used on human anatomy, which is consistent with in vivo imaging.
IVD devices are typically used to examine specimens (like blood, urine, or tissue) outside of the body to diagnose diseases or conditions. This device directly interacts with the patient's body to produce images.
N/A
Intended Use / Indications for Use
The FLAATZ 600 Series (FLAATZ 600/601) 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 600 Series (FLAATZ 600/601) 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 600 Series (FLAATZ 600/601) system includes a Detector Panel, Case, Grid, Power 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 Power 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 Power 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)
Non-Clinical Testing: The performance of Detector can be evaluated by DQE and MTF according to IEC 62220-1:2003 Standard.DQE & MTF have been tested by acquiring the X-ray image with designated devices. Moreover, FLAATZ 600 Series is in accordance with Safety, EMC and DICOM standards (IEC 606001-1:2005, IEC 60601-1- 2:2007 and NEMA PS 3.1-3.20:2011) The test results conclude that FLAATZ 600 Series (FLAATZ 600/601) is substantially equivalent compared to the predicate device (FLAATZ 560)
Clinical Testing: Clinical study is to investigate the diagnostic equivalency of detector panels with. the same a-Se technology and same pixel sizes. We've tested for eight body parts (Chest, Shoulder, L-Spine L, L-Spine_AP, Hand, Forearm, Foot and Knee) compared to the predicate device. The result of tests, FLAATZ 600 Series (FLAATZ 600/601) produces diagnostic images of equivalent quality as the predicate device (FLAATZ 560)
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
K132842
Page 1 of 3
510(k) Summary
FEB 2 1 2014
| | 1. Submitter | DRTECH Corporation
Suite No. 2, 3 Floor, 29, Dunchon-daero541beon-gil,
Jungwon-gu, Seongnam-si, Gyeonggi-do, Republic of Korea
Post code: 462-807
www.drtech.co.kr |
|--|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 2. Contact Person | Name: Choul-Woo Shin
Position: Vice President
E-mail: cwshin@drtech.co.kr
Telephone: + 82-31-784-8856 |
| | 3. Date Prepared | August 16, 2013 |
| | 4. Device Classification Name | Stationary x-ray system |
| | 5. Device Name | Digital X-Ray Detector
FLAATZ 600 Series (FLAATZ 600/601) |
| | 6. Reason for Submission | New Device |
| | 7. Classification | 21 CFR 892.1680 |
| | 8. Product Code | MQB |
| | 9. Predicate Device | FLAATZ 560
DRTECH Corporation
510(k) No. K111583 |
10. Device Description
The FLAATZ 600 Series (FLAATZ 600/601) 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 600 Series (FLAATZ 600/601) system includes a Detector Panel, Case, Grid, Power 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 Power Box functions as a buffer between the Detector
DRTECH
CONFIDENTIAL Premarket Notification: FLAATZ 600 Series
1
Panel and Operating PC while also supplying power to the Detector Panel. The Switch Box transfers signals between the Power 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.
-
- Intended Use
The FLAATZ 600 Series (FLAATZ 600/601) 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).
- Intended Use
-
- Summary of the Technological Characteristics to the Predicate Device
The modification to the predicate device is the change of data communication methods as Ethernet & Wireless type. There are no changes to the product performance specifications, device indications for use/intended use.
- Summary of the Technological Characteristics to the Predicate Device
-
- Summary of Non-Clinical Testing
The performance of Detector can be evaluated by DQE and MTF according to IEC 62220-1:2003 Standard.DQE & MTF have been tested by acquiring the X-ray image with designated devices. Moreover, FLAATZ 600 Series is in accordance with Safety, EMC and DICOM standards (IEC 606001-1:2005, IEC 60601-1- 2:2007 and NEMA PS 3.1-3.20:2011) The test results conclude that FLAATZ 600 Series (FLAATZ 600/601) is substantially equivalent compared to the predicate device (FLAATZ 560)
- Summary of Non-Clinical Testing
-
- Summary of Clinical Testing
Clinical study is to investigate the diagnostic equivalency of detector panels with. the same a-Se technology and same pixel sizes. We've tested for eight body parts (Chest, Shoulder, L-Spine L, L-Spine_AP, Hand, Forearm, Foot and Knee) compared to the predicate device. The result of tests, FLAATZ 600 Series (FLAATZ 600/601) produces diagnostic images of equivalent quality as the predicate device (FLAATZ 560)
- Summary of Clinical Testing
-
- Substantial Equivalence
The proposed FLAATZ 600 Series (FLAATZ 600/601) has identical indication for use / intended use, the principal of operation and user environment. The proposed FLAATZ 600 Series (FLAATZ 600/601) has similar performance in terms of DQE, MTF and is the same physical characteristics as using Amorphous Selenium (a-Se) material. Moreover, FLAATZ Series (FLAATZ 600/601) is the upgraded model of its
- Substantial Equivalence
DRTECH
CONFIDENTIAL Premarket Notification: FLAATZ 600 Series
2
K1327842
Page 3 of 3
previous model FLAATZ 560. TFT panel and main components are almost same.
-
- Functional and Safety Testing
The FLAATZ 600 Series (FLAATZ 600/601) 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.
- Functional and Safety Testing
The FLAATZ 600 Series (FLAATZ 600/601) has also met applicable Electro Magnetic Compatibility (EMC) requirements.
-
- Conclusion
The FLAATZ 600 Series (FLAATZ 600/601) is substantially equivalent to the Predicate Device in design and performance.
- Conclusion
-
- Manufacturing Facility
- DRTECH Corporation Suite No. 2, 3 Floor, 29, Dunchon-daero541beon-gil, Jungwon-gu, Seongnam-si, Gyeonggi-do, Republic of Korea Post code: 462-807
Establishment Registration Number: 3005172103
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with text around the perimeter. Inside the circle is a stylized design featuring three overlapping shapes that resemble human figures or abstract forms. The text around the circle reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 21, 2014
DRTECH Corporation % Choul-Woo Shin 333-1, Sangdaewon 1-Dong Jungwon-Gu Seongnam-Shi, Gyeonggi-Do, 462-807 SOUTH KOREA
Re: K132842
Trade/Device Name: FLAATZ 600 Series (FLAATZ 600/601) Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: January 13, 2014 Received: January 24, 2014
Dear Choul-Woo Shin:
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. Drue, 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical
4
Page 2- Choul-Woo Shin
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
for
Janine M. Morris Director. Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
5
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K132842
Device Name
FLAATZ 600 Series (FLAATZ 600/601)
Indications for Use (Describe)
The FLAATZ 600 Series (FLAATZ 60060) 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, and mammographic applications).
Type of Use (Select one or both, as applicable)
[x] Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Smh.f)
FORM FDA 3881 (1/14)