(178 days)
Not Found
No
The provided text describes a standard digital X-ray detector and its integration with a PC and X-ray generator for image acquisition and conversion to DICOM files. There is no mention of AI, ML, or any advanced image processing that would typically involve these technologies. The performance studies focus on electrical, mechanical, environmental, and EMC testing, not algorithmic performance metrics associated with AI/ML.
No.
The device is for diagnostic imaging (X-ray acquisition and digitalization) to aid in diagnosis and treatment planning, not for therapy itself.
No
The device is an x-ray detector that captures images for diagnosis and analysis by other software, it does not perform the diagnosis itself.
No
The device description explicitly states it is a "portable digital X-ray flat panel detector" and describes its hardware components (scintillator, a-SI TFT sensor). It is an image acquisition device, not solely software.
Based on the provided information, 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 SDX-4336CP is an X-ray detector. It acquires images of the internal structure of the human body using X-rays. This is an in vivo (within the living body) imaging technique, not an in vitro (in glass, or outside the body) diagnostic test.
- Intended Use: The intended use clearly states it's for "digital imaging solution designed for providing general radiographic diagnosis of human anatomy." This involves taking images of the body, not analyzing samples taken from the body.
Therefore, the SDX-4336CP falls under the category of medical imaging devices, not in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
SDX-4336CP Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy for adults and pediatric care. 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 who are licensed by the law of the State in which he or she practices to use the device. Not to be used for mammography.
Product codes
MQB, MOB
Device Description
The SDX-4336CP 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. SDX-4336CP 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
any part of the body, human anatomy
Indicated Patient Age Range
adults and pediatric
Intended User / Care Setting
physicians and other health care professionals who are licensed by the law of the State in which he or she practices to use the device.
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 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 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
Revised 510(k) Summary
FEB 11 201
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: November 29th, 2010
-
- Company and Correspondent making the submission:
Name -Samsung Mobile Display Co., Ltd. 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
- Company and Correspondent making the submission:
-
- Device :
| Trade/proprietary name | : SDX-4336CP |
|---|---|
| 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
The SDX-4336CP is a portable digital X-ray flat panel detector that can generate The SDX-4336CP 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
1
510(k) Submission - SDX-4336CP
- TFT sensor. It makes high-resolution, high-sensitive digital images. SDX-4336CP 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.
{
5.2 Product features
SDX-4336CP is an 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 do to utilize as digitalizing x-ray images and transfer for radiography diagnostic
6. Indication for use :
SDX-4336CP Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy for adults and pediatric care. 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 who are licensed by the law of the State in which he or she practices to use the device. Not to be used for mammography.
7. Comparison with predicate device :
Samsung Mobile Display Co., Ltd., believes that the SDX-4336CP is substantially equivalent to the 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.
- Safety, EMC and Performance Data :
9. 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-4336CP is safe and effective and substantially equivalent to predicate devices as described herein.
-
- Samsung Mobile Display Co., Ltd. will update and include in this summary any other information deemed seasonably necessary by the FDA.
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo consists of two parts: a symbol on the left and the text on the right. The symbol is a stylized representation of a human figure, and the text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES" in blue 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
SEP 1 4 2012
Re: K102321
Trade/Device Name: Digital Flat Panel X-Ray Detector/SDX-4336CP Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: January 21, 2011 Received: January 26. 2011
Dear Mr. Kim:
This letter corrects our substantially equivalent letter of February 11. 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 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 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 comply with 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 of
3
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements 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 notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device 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 809), please contact 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 Division 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
Janine M. Morri Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(K) Number (if known):
Device Name: Digital Flat Panel X-Ray Detector /SDX-4336CP
Indications for Use:
SDX-4336CP Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy for adults and pediatric care. 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 who are licensed by the law of the State in which he or she practices to use the device. 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)
Mary Post
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
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510K K162321