(69 days)
SDX-4343GV 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.
SDX-4343GV digital X-ray flat panel detectors can generate radiographic images of any part of the body. Each of them consists of a scintillator directly coupled to an a-SI TFT sensor. It makes high-resolution, high-sensitive digital images. SDX-4343GV 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 the user's designated console software which is not included in SDX-4343GV, digital flat panel X-ray detector.
The provided document is a 510(k) summary for the SDX-4343GV Digital Flat Panel X-Ray Detector. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about specific acceptance criteria related to device performance (e.g., sensitivity, specificity, or accuracy metrics) or a study that specifically proves the device meets such criteria.
The document primarily focuses on regulatory compliance, outlining:
- Company and device information.
- Comparison with a predicate device (LLX240AB01).
- Statement of compliance with electrical, mechanical, environmental, and EMC safety standards (EN/IEC 60601-1, EN/IEC 60601-1-2, EN/IEC 61000-3-2, EN/IEC 61000-3-3).
- Conclusions regarding safety, effectiveness, and substantial equivalence.
Therefore, I cannot populate the requested table and answer the study-specific questions as the necessary information is not present in the provided text. The document confirms that "All test results were satisfactory" for safety and performance testing according to the listed standards, but it does not detail specific performance metrics, acceptance criteria, or the methodology of a clinical or performance study that would demonstrate such.
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510(k) Submission - SDX-4343GV
Special 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.
NOV 1 0 2011
Date: ________________________________________________________________________________________________________________________________________________________________________
- 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(s) | : SDX-4343GV |
|---|---|
| Common Name | : Digital Flat Panel X-Ray Detector |
| Classification Name | : Solid State X-ray Imaging Device |
-
- Predicate Device :
| Manufacturer | : Samsung Mobile Display Co., Ltd |
|---|---|
| Device(s) and 510K No. | : LLX240AB01(K012587, Decision Date - Dec 1, 2010) |
-
- Classifications Names & Citations :
21CFR 892.1650, MQB, Solid State X-ray Imaging Device, Class2
- Classifications Names & Citations :
-
- Description :
- 5.1 General
SDX-4343GV digital X-ray flat panel detectors can generate radiographic images of any part of the body. Each of them consists of a scintillator directly coupled to an a-SI TFT sensor. It makes high-resolution, high-sensitive digital images. SDX-4343GV is designed specifically to be integrated with an operating PC and a X-Ray generator to digitalize x-ray
Samsung Mobile Display Co., Ltd.
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510(k) Submission - SDX-4343GV
images into RAW files. The RAW files can be made to DICOM compatible image files for a radiographic diagnosis and analysis by the user's designated console software which is not included in SDX-4343GV, digital flat panel X-ray detector.
6. Indication for use :
SDX-4343GV 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.
-
- Comparison with predicate device :
Samsung Mobile Display Co., Ltd., believes that SDX-4343GV is substantially equivalent to the predicate devices: LLX240AB01.
- Comparison with predicate device :
-
- Safety, EMC and Performance Data :
Electrical, mechanical, environmental safety and performance testing according to standard ENVIEC 60601-1 was performed, and EMC testing was conducted in accordance with standard EN/IEC 60601-1-2(2007), EN/IEC 61000-3-2:2006+A2:2009 and EN/IEC 61000-3-3:2008. All test results were satisfactory.
- Safety, EMC and Performance Data :
- 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 SDX-4343GV is safe and effective and substantially equivalent to its predicate device as described herein.
- Samsung Mobile Display Co., Ltd. will update and include in this summary any other information deemed necessary by the FDA.
Samsung Mobile Display Co., Ltd.
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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 a stylized eagle emblem on the left, followed by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in a clear, sans-serif font. The text is aligned horizontally and is in a blue color.
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 Affairs Mtech Group 12946 Kimberly Lane HOUSTON TX 77079
AUG 2 3 2013
Re: K112558
Trade/Device Name: Digital Flat Panel X-Ray Detector/SDX-4343GV Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: October 18, 2011 Received: October 21, 2011
Dear Mr. Kim:
This letter corrects our substantially equivalent letter of November 10. 2011.
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 for ass stated in the encrosal 0776, 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 I va may, mereloro, mains 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 or any Federal statutes and regulations administered by other Federal agencies. You must or any 1 vith all the Act's requirements, 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 mouirements 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 witi anow you to oogin finding of substantial equivalence of your device to a legally marketed predication. The I Drin intellig or section 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 Pars 801 and If you desire specific antive of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-007), prease vonaot 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 under the MDA regulation (2) "CFFF at 000), promo gooders/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 Tou may 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): K112558
Device Name: Digital Flat Panel X-Ray Detector /SDX-4343GV
Indications for Use:
SDX-4343GV 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)
(Division Sign. Off) Division of Asdiological Devices Office of In Vitro Diagnestic Device Evaluation and Sefety Page 1 of 1
510K K112558
§ 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.