(202 days)
No
The document describes standard digital X-ray imaging system components and image processing without mentioning AI or ML.
No.
The device is indicated for generating radiographic images for diagnostic purposes, not for treating any condition.
Yes
The device description states that the system is "primarily used in a hospital for diagnosis of diseases in skeletal, respiratory and urinary systems," which directly indicates its use for diagnostic purposes.
No
The device description explicitly lists multiple hardware components (HV generator, tube support, detector, etc.) in addition to the operating software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "generating radiographic images of human anatomy." This is an in-vivo imaging process, meaning it's used on a living patient, not on samples taken from a patient.
- Device Description: The description details components like an X-ray generator, tube support, detector, etc., which are all part of an in-vivo imaging system.
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. This device does not perform such tests.
The device is a digital X-ray imaging system, which is a type of medical imaging device used for diagnostic purposes, but it operates by generating images of the inside of the body directly, not by analyzing samples.
N/A
Intended Use / Indications for Use
The CXD-DR80D Digital X-ray Imaging System is indicated for use in generating radiographic images of human anatomy. This device is not intended for mammographic applications.
Product codes
KPR
Device Description
The digital X-ray imaging system consists of a high voltage (HV) generator, a tube support unit, an X-ray beam limiting device, a wall stand unit, a bucky table unit, a detector, operating software, and a tube, operates on a high-frequency inverter method, and is primarily used in a hospital for diagnosis of diseases in skeletal, respiratory and urinary systems. Rated voltage from external power supply is introduced into the X-ray control device, and the tube voltage, tube current and time are set up. When an X-ray radiation command is given, the preset voltage is applied to the primary side of the high voltage generator and a high voltage to produce X-ray is generated from the secondary side. When this high voltage is applied to the X-ray tube, it strikes substance named target and X-ray is generated. This X-ray passes part of a human body to be diagnosed. Electric charges are collected by electrodes located at each pixel, and outputted to the image processing unit through the thin film transistor (TFT) array. Amplification and digital data conversion take place in the image processing unit, and the data that has been transmitted to the workstation (image processing computer) through a cable is stored in medical standard DICOM files by operating software. Stored images are used for image analysis after transmitted to the picture archiving and communication system (PACS) by operating software. The detector which is used proposed device is FLAATZ 750 of DRTECH Co., Ltd.. This detector is cleared by FDA 510(k) (K080064). The CXD-DR80D X-ray Imaging System utilizes the FLAATZ 750 detector, manufactured by DRTECH.
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
hospital
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)
Electrical, mechanical, environmental safety and performance testing according to standard EN/IEC 60601-1, EN/IEC 60601-1-1, EN/IEC 60601-1-3, EN/IEC 60601-2-7, EN/IEC 60601-2-28 and EN/IEC 60601-2-32 was performed, and EMC testing was conducted in accordance with standard EN/IEC 60601-1-2(2001). All test results were satisfactory.
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
08364
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: Nov. 18, 2008
-
- Company and Correspondent making the submission: Name -- CHOONGWAE MEDICAL CORPORATION Address - 698, Shingdaebang-Dong, Dongjak-Gu, Seoul, Korea Telephone — +82-2-285-6950 Fax – +82-2-286-3007 Contact - Mr. Dong Un, Shin Internet - http://www.cwm.co.kr/
-
- Device :
| Trade/proprietary name | : CXD-DR80D |
|---|---|
| Common Name | : Digital X-ray Imaging System |
| Classification Name | : System, x-ray, stationary |
3. Predicate Device :
| Manufacturer | : General Electric Company |
|---|---|
| Device | : Revolution XR/d |
| 510(k) Number | : K012389 (Decision Date - Aug. 10. 2001) |
| Manufacturer | : DRTECH Co., Ltd. |
|---|---|
| Device | : FLAATZ 750 |
| 510(k) Number | : K080064 (Decision Date - Jan. 23. 2008) |
4 . Classifications Names & Citations :
21CFR 872.1680, KPR, System, x-ray, stationary, Class2
CHOONGWAE MEDICAL CORPORATION
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5. Description :
5.1 General
The digital X-ray imaging system consists of a high voltage (HV) generator, a tube support unit, an X-ray beam limiting device, a wall stand unit, a bucky table unit, a detector, operating software, and a tube, operates on a high-frequency inverter method, and is primarily used in a hospital for diagnosis of diseases in skeletal, respiratory and urinary systems.
5.2 Product features
Rated voltage from external power supply is introduced into the X-ray control device, and the tube voltage, tube current and time are set up. When an X-ray radiation command is given, the preset voltage is applied to the primary side of the high voltage generator and a high voltage to produce X-ray is generated from the secondary side.
When this high voltage is applied to the X-ray tube, it strikes substance named target and X-ray is generated. This X-ray passes part of a human body to be diagnosed.
Electric charges are collected by electrodes located at each pixel, and outputted to the image processing unit through the thin film transistor (TFT) array. Amplification and digital data conversion take place in the image processing unit, and the data that has been transmitted to the workstation (image processing computer) through a cable is stored in medical standard DICOM files by operating software. Stored images are used for image analysis after transmitted to the picture archiving and communication system (PACS) by operating software.
The detector which is used proposed device is FLAATZ 750 of DRTECH Co., Ltd.. This detector is cleared by FDA 510(k) (K080064).
- Indication for use : 5
The CXD-DR80D Digital X-ray Imaging System is indicated for use in generating radiographic images of human anatomy. This device is not intended for mammographic applications.
The CXD-DR80D X-ray Imaging System utilizes the FLAATZ 750 detector, manufactured by DRTECH.
2
-
Comparison with predicate device : ం
CHOONGWAE MEDICAL CORPORATION, believes that the CXD-DR80D is substantially equivalent to the Revolution XR/d of General Electric Company and FLAATZ 750 of DRTECH Co., Ltd.. -
Safety, EMC and Performance Data : 7
Electrical, mechanical, environmental safety and performance testing according to standard EN/IEC 60601-1, EN/IEC 60601-1-1, EN/IEC 60601-1-3, EN/IEC 60601-2-7, EN/IEC 60601-2-28 and EN/IEC 60601-2-32 was performed, and EMC testing was conducted in accordance with standard EN/IEC 60601-1-2(2001). All test results were satisfactory. -
- Conclusions :
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification CHOONGWAE MEDICAL CORPORATION concludes that The CXD-DR80D is safe and effective and substantially equivalent to predicate devices as described herein.
- Conclusions :
-
- CHOONGWAE MEDICAL CORPORATION will update and include in this summary any other information deemed seasonably necessary by the FDA.
END
- CHOONGWAE MEDICAL CORPORATION will update and include in this summary any other information deemed seasonably necessary by the FDA.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the eagle. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
JUN 29 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
CHOONGWAE Medical Corporation % Mr. Charles Mack Principle Engineer International Regulatory Consultants 77325 Joyce Way ECHO OR 97826
Re: K083640
Trade/Device Name: Digital X-ray Imaging Systems/CXD-DR80D Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: May 3, 2009 Received: May 15, 2009
Dear Mr. Mack:
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 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
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number(if known): ¿ O 836 40
Device Name: Digital X-ray Imaging System /CXD-DR80D
Indications for Use:
The CXD-DR80D Digital X-ray Imaging System is indicated for use in generating radiographic images of human anatomy. This device is not intended for mammographic applications.
The CXD-DR80D Digital X-ray Imaging System utilizes the FLAATZ 750 Detector, manufactured by DRTECH Co. (K080064)
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)
Walter Reum
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(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices
510(k) Number