(69 days)
LLX240AB01(K012587, Decision Date - Dec 1, 2010)
Not Found
No
The summary describes a digital X-ray detector that captures images and outputs RAW files. It explicitly states that the console software for diagnosis and analysis is not included and is the user's designated software. There is no mention of AI/ML in the device description, intended use, or performance studies.
No
The device is an X-ray detector used for diagnostic imaging, not for treating diseases or conditions. Its purpose is to provide images for diagnosis and treatment planning.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy." This directly indicates its role in a diagnostic process.
No
The device description explicitly states it consists of a scintillator directly coupled to an a-SI TFT sensor, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- 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. These tests are performed outside of the living body (in vitro).
- Device Function: The SDX-4343GV is a digital flat panel X-ray detector. Its function is to capture X-ray images of the human anatomy within the living body (in vivo). It does not perform tests on samples taken from the body.
- Intended Use: The intended use is for general radiographic diagnosis of human anatomy, replacing film-based systems for case diagnosis and treatment planning. This is a form of medical imaging, not in vitro testing.
Therefore, the SDX-4343GV falls under the category of medical imaging devices, not In Vitro Diagnostic devices.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MQB, MOB
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
human anatomy
Indicated Patient Age Range
adult and children
Intended User / Care Setting
physicians and other health care professionals
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 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.
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.
LLX240AB01(K012587, Decision Date - Dec 1, 2010)
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
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.
1
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.
2
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
3
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