(126 days)
No
The summary describes a standard digital X-ray system with image processing, but there is no mention of AI, ML, or related concepts.
No
The device is described as a "Digital Diagnostic X-ray System" used for "generating radiographic images of human anatomy" and "diagnosis of diseases". It does not mention any therapeutic function.
Yes
The "Intended Use / Indications for Use" explicitly states that the device is a "Digital Diagnostic X-ray System," and the "Device Description" mentions it is "primarily used in a hospital for diagnosis of diseases."
No
The device description explicitly lists multiple hardware components (HV generator, tube support unit, X-ray beam limiting device, wall stand unit, bucky table unit, detector, tube) in addition to the operating software. The performance studies also include electrical, mechanical, and environmental safety testing, which are relevant to hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The DIAMOND-5A,6A,8A Digital Diagnostic X-ray System generates radiographic images of human anatomy using X-rays. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states "generating radiographic images of human anatomy," which is an in-vivo (within the living body) diagnostic method, not in-vitro.
- Device Description: The description details components related to generating and capturing X-ray images, not analyzing biological samples.
Therefore, based on the provided information, this device falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The DIAMOND-5A,6A,8A Digital Diagnostic X-ray 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.
Mentions image processing
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.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
human anatomy (specifically, skeletal, respiratory and urinary systems)
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
510(k) Summary
DEC 2 7 2010
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: _Mar. 18, 2010
- Company and Correspondent making the submission:
Name - DRGEM Corporation
Address - 7th FL, Dongil Techno-town 1st, 826, Guro-dong, Guro-gu,
Seoul, Republic of Korea, 152-050
Telephone - +82-2-869-8566
Fax -- +82-2-869-8567
Contact - Mr. Ki-Nam Yang
- Internet http://www.drgem.co.kr/
-
- Device :
| Trade/proprietary name | : DIAMOND-5A,6A,8A |
|---|---|
| Common Name | : Digital Diagnostic X-ray System |
| Classification Name | : System, x-ray, stationary |
-
- Predicate Device :
| Manufacturer | : Sedecal, Inc. |
|---|---|
| Device | : Sedecal X-Plus LP Plus Digital |
| 510(k) Number | : K090238 (Decision Date - Feb. 27. 2009) |
-
- Classifications Names & Citations :
21CFR 872.1680, KPR, System, x-ray, stationary, Class2
- Classifications Names & Citations :
- Description :
- 5.1 General
The digital X-ray imaging system consists of a high voltage (HV) generator, a tube
DRGEM Corporation
1
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.
5 Indication for use :
The DIAMOND-5A,6A,8A Digital X-ray Imaging System is indicated for use in generating radiographic images of human anatomy. This device is not intended for mammographic applications.
6 Comparison with predicate device :
DRGEM Corporation, believes that the DIAMOND-5A,6A,8A is substantially equivalent to the Sedecal X-Plus LP Plus Digital of Sedecal, Inc..
7 Safety, EMC and Performance Data :
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-
DRGEM Corporation
2
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 DRGEM Corporation concludes that The DIAMOND-5A,6A,8A is safe and effective and substantially equivalent to predicate devices as described herein.
- Conclusions :
-
- DRGEM Corporation will update and include in this summary any other information deemed seasonably necessary by the FDA.
END
- DRGEM Corporation will update and include in this summary any other information deemed seasonably necessary by the FDA.
DRGEM Corporation
3
Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
DRGEM Corporation % Mr. Charlie Mack International Regulatory Consultants 77325 Jovce Way ECHO OR 97826
DEC 2 7 2010
Re: K102408
R 102406
Trade/Device Name: Digital Diagnostic X-ray System / DIAMOND-5A, 6A, 8A Regulation Number: 21 CFR 892.1630 Regulation Name: Electrostatic x-ray imaging system Regulatory Class: II Product Code: KPR Dated: November 13, 2010 Received: November 22, 2010
Dear Mr. Rodenberger:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your boother be 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 conninered phay 20, 1978, in occordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmelle Act (Act) that do not requence to the general controls provisions of the Act. The 1 ou may, dictore, market 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 If your device is classified (see acover) interesting your device can be found in Title 21, additional controls. Existing major regards on 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 Prease oe advised had I DA 3 issuated or a on ot one one other requirements of the Act that I DA has made a decermination an administered by other Federal agencies. You must of any I ederal statutes and regulations and instituting, but not limited to: registration and listing (21 Comply with an the Act 31equirements, Moraning, Solanding, Solor Starting (reporting of
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Page 2
medical device-related adverse events) (21 CFR 803); and good manufacturing practice modious device reated as not the quality systems (QS) regulation (21 CFR Part 820). This letter requirences as set form in the your device as described in your Section 510(k) premarket while would to begin mading of substantial equivalence of your device to a legally marketed nontication. The I Drice 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 done optice of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket 5 1501 11100, p. 1000 100 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 overni oner gearers, 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,
signature
David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use
DEC 2 7 2010
510(k) Number(if known): という408
Device Name: Digital Diagnostic X-ray System / DIAMOND-5A,6A,8A
Indications for Use:
The DIAMOND-5A,6A,8A Digital Diagnostic X-ray System is indicated for use in generating radiographic images of human anatomy. This device is not intended for mammographic applications.
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)
Page 1 of _ 1
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnosuc Device Evaluation and Safety
510K K162408