(83 days)
LLX240AB0! digital flat panel X-Ray detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy targeting both adult and children. It is intended to replace film based radiographic diagnostic systems and provide a case diagnosis and treatment planning for physicians and other health care professionals. Not to be used for mammography.
LLX240AB01 is a portable digital X-ray flat panel detector that can generate images of any part of the body. This X-ray imaging system consists of a scintillator directly coupled to an a-SI TFT sensor. It makes high-resolution, high-sensitive digital images. LLX240AB01 is designed specifically to be integrated with an operating PC and a X-Ray generator to digitalize x-ray images into RAW files. The RAW files can be made to DICOM compatible image files for a radiographic diagnosis and analysis by console SW. LLX240AB01 is a X-Ray image acquisition device that is based on flat-panel. This device should be integrated with an operating PC and a X-Ray generator. It can be utilized for digitalizing x-ray images by converting X-ray photons into visible light and then to electronic image data that a computer can read and display for diagnostic purposes.
I am sorry, but I am unable to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text. The document is a 510(k) submission summary for a Digital Flat Panel X-Ray Detector, and it focuses on general information about the device, its classification, and its substantial equivalence to a predicate device.
The provided text does not contain any information regarding:
- Specific acceptance criteria for device performance (e.g., sensitivity, specificity, image quality metrics).
- Details of a study proving the device meets acceptance criteria.
- Sample sizes for test sets, data provenance, or ground truth establishment.
- Information on expert readers, adjudication methods, or MRMC studies.
- Details on standalone algorithm performance.
- Training set information.
The document primarily states that "Electrical, mechanical, environmental safety and performance testing according to standard EN/IEC 60601-1 was performed, and EMC testing was conducted in accordance with standard EN/IEC 60601-1-2(2001). All test results were satisfactory." This is a general statement about regulatory compliance and safety testing, not specific clinical performance criteria or a comparative study against such criteria.
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510(k) Submission - LLX240AB01
DEC 1 2010
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: __August 30th, 2010
510(k) Summary
I . Company and Correspondent making the submission:
Samsung Mobile Display Co., Ltd. Name -
Address - San #24, Nongseo-Dong, Giheung-Gu, Yongin-Si,
Gyeonggi-Do, Korea, 446-711
Telephone - +82-18-323-4075
Fax - +82-31-209-4881
Contact - Mr. Kyung Hun Yoon / Senior Manager
Internet - http://www.SAMSUNG.com
-
- Device :
| Trade/proprietary name | : LLX240AB01 |
|---|---|
| Common Name | : Digital Flat Panel X-Ray Detector |
| Classification Name | : Solid State X-ray Imaging Device |
- Predicate Device :
| Manufacturer | : Canon Inc. |
|---|---|
| Device | : CXDI-50G |
| 510(k) Number | : K031447 (Decision Date - Mar. 26. 2003) |
-
- Classifications Names & Citations :
21CFR 892.1650, MQB, Solid State X-ray Imaging Device, Class2
- Classifications Names & Citations :
-
- Description :
5.1 General
- Description :
LLX240AB01 is a portable digital X-ray flat panel detector that can generate images of any part of the body. This X-ray imaging system consists of a scintillator directly coupled to an a-SI TFT sensor. It makes high-resolution, high-sensitive digital images. LLX240AB01 is
Samsung Mobile Display Co., Ltd.
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510(k) Submission - LLX240AB01
· designed specifically to be integrated with an operating PC and a X-Ray generator to digitalize x-ray images into RAW files. The RAW files can be made to DICOM compatible image files for a radiographic diagnosis and analysis by console SW.
5.2 Product features
LLX240AB01 is a X-Ray image acquisition device that is based on flat-panel. This device should be integrated with an operating PC and a X-Ray generator. It can be utilized for digitalizing x-ray images by converting X-ray photons into visible light and then to electronic image data that a computer can read and display for diagnostic purposes.
6. Indication for use :
LLX240AB01 Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy targeting both adult and children. It is intended to replace film based radiographic diagnostic systems and provide a case diagnosis and treatment planning for physicians and other health care professionals. Not to be used for mammography.
7. Comparison with predicate device :
Samsung Mobile Display Co., Ltd., believes that LLX240AB01 is substantially equivalent to CXDI-50G of Canon Inc..
- Safety, EMC and Performance Data :
Electrical, mechanical, environmental safety and performance testing according to standard EN/IEC 60601-1 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 Samsung Mobile Display Co., Ltd. concludes that LLX240AB01 is safe and effective and substantially equivalent to the predicate device as described herein.
-
- Samsung Mobile Display Co., Ltd. will update and include in this summary any other information deemed seasonably necessary by FDA.
Samsung Mobile Display Co., Ltd.
- Samsung Mobile Display Co., Ltd. will update and include in this summary any other information deemed seasonably necessary by FDA.
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Image /page/2/Picture/0 description: The image shows the logo of the Department of Health & Human Services. The logo consists of two parts: a symbol on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The symbol is a stylized image of an eagle, and the text is written in a sans-serif font.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Samsung Mobile Display Co., Ltd. % Mr. Dave Kim Medical Device Regulatory Consultant VATECH America 333 Meadowlands Parkway, #303 SECAUCUS NJ 07094
AUG 2 3 2013
Re: K102587
Trade/Device Name: Digital Flat Panel X-Ray Detector/LLX240AB01 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: August 30, 2010 Received: September 9, 2010
Dear Mr. Kim:
This letter corrects our substantially equivalent letter of December 1, 2010.
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosare) to the enactment date of the Medical Device Amendments, or to commerce pror to May 20, 2011 devices mat have been 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 11 your device to last is is is is in 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 Dri has Intacted and regulations administered by other Federal agencies. You must or any I catal statutes that reguirements, including, 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 modion do roo related at rette ovality 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 nothoution. THE FDF Imania of thestion 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 desire spoonio annot 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 I ou may obtain 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
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
510(K) Number (if known):
DEC1 2010
Device Name: Digital Flat Panel X-Ray Detector /LLX240AB01
Indications for Use:
LLX240AB0! digital flat panel X-Ray detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy targeting both adult and children. It is intended to replace film based radiographic diagnostic systems and provide a case diagnosis and treatment planning for physicians and other health care professionals. Not to be used for mammography.
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)
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(Division Sign-Off)
Radiological Devices
Division of Radiological Devices Division of Radiological Device Evaluation and Safety
510K K102582
§ 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.