(42 days)
Not Found
No
The summary describes a standard digital X-ray detector and image processing unit. There is no mention of AI, ML, or any related concepts in the intended use, device description, or performance studies. The focus is on image acquisition and basic digital processing for diagnosis and information management.
No
The device is described as an X-ray detector and medical image processing unit for digital imaging, intended for diagnostic procedures, not treatment.
Yes
The "Intended Use / Indications for Use" section states: "It is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures." The "Device Description" also mentions: "It can do to utilize as digitalizing X-ray images and transfer for radiography diagnostic." These statements confirm its use in diagnostic procedures.
No
The device description explicitly states that the DFP4343C7 consists of an Electro X-ray Unit, Software package(S/P), Power Supply Unit, and cables set, indicating it includes hardware components in addition to 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 Digital X-ray Detector DFP4343C7 is an imaging device that captures X-ray images of the human anatomy. It works by detecting X-rays that pass through the body, not by analyzing biological samples.
- Intended Use: The intended use clearly states it's for "digital imaging solution designed for general radiographic system for human anatomy" and "intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures." This describes an in-vivo imaging process, not an in-vitro diagnostic test.
Therefore, the function and intended use of this device fall under the category of medical imaging equipment, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Digital X-ray Detector DFP4343C7 is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. Not to be used for mammography.
Product codes
KPR, MQB
Device Description
Digital X-ray Detector DFP4343C7 is a medical image processing unit. Especially, advanced digital imaging process allows considerably efficient diagnosis, all kind of information management, real-time sharing of image information on network.
DFP4343C7 is a high-resolution digital imaging detector designed for general radiography. It is intended to replace conventional film radiography technique .
DFP4343C7 consists of Electro X-ray Unit, Software package(S/P), Power Supply Unit and cables set.
DFP 4343C7 is an X-Ray image acquisition device that is based on flatpanel. This device should be integrated with an operating PC and an X-Ray generator. It can do to utilize as digitalizing X-ray images and transfer for radiography diagnostic.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
human anatomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 IEC 60601-1 was performed and EMC testing was conducted in accordance with standard IEC-60601-1-2.
Biocompatibility testing was conducted in accordance with Standard ISO 10993-1.
Safety of Programmable medical systems in accordance with IEC 60601-1-4 was performed.
A product risk management is executed according to ISO 14971 and all risks are reduced to an acceptable level by implementation and verification of appropriate measures.
Non-clinical considerations according to FDA "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices" was performed. All test results were satisfactory.
Clinical considerations according to FDA "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices" was performed. 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.
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Image /page/0/Picture/0 description: The image shows the word "ELECTRON" in large, outlined block letters. Below the word "ELECTRON" is the phrase "R&D and Manufacturing Company" in a smaller, sans-serif font. The text appears to be a logo or heading for a company specializing in research and development and manufacturing, likely in the electronics field.
Box 12 Saint-Petershuro Russi (812) 325-02-02. Fax +7 (812) 325ectronxray.com e-mail secretary@electronxray.com
Section 3: 510(k) Summary
ОСТ 5 2012
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
Date Summary Prepared: August 20, 2012
-
- Submitter's Identification: Applicant: NIPK Electron Co Leningradskaya ul. bldg.52a, lit.A, Pos. Pesochny, Saint-Petersburg, 197758, Russia Telephone - +7 (812) 325 02 02 Fax - +7 (812) 325 02 09 Contact - Julia Nikitina
Submitter:
mdi Consultants, Inc. 55 Northern Blvd Great Neck, NY 11021 Telephone: 516-482-9001 Fax: 516-482-0186 Contact: Jigar Shah, MS, RAC
Name of Device: 2.
Device trade name: DFP4343C7 Common name: Digital X-ray Detector Classification: Solid State X-ray Imager (Flat Panel/Digital Imager) Class II MQB 21 CFR 892.1650
Predicate Device Information: 3.
Manufacturer: Samsung Mobile Display Co., Ltd.
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Image /page/1/Picture/0 description: The image shows the word "ELECTRON" in large, outlined block letters. Below the word "ELECTRON" is the text "R&D and Manufacturing Company" in a smaller font. The text appears to be the name of a company.
Trade/proprietary name: LTX240AA01-A Common Name: Digital Flat Panel X-Ray Detector 510(k) Number: K090742
4. Device Description:
4.1 General
Digital X-ray Detector DFP4343C7 is a medical image processing unit. Especially, advanced digital imaging process allows considerably efficient diagnosis, all kind of information management, real-time sharing of image information on network.
DFP4343C7 is a high-resolution digital imaging detector designed for general radiography. It is intended to replace conventional film radiography technique .
DFP4343C7 consists of Electro X-ray Unit, Software package(S/P), Power Supply Unit and cables set.
4.2 Features
DFP 4343C7 is an X-Ray image acquisition device that is based on flatpanel. This device should be integrated with an operating PC and an X-Ray generator. It can do to utilize as digitalizing X-ray images and transfer for radiography diagnostic.
Indication for Use: 5.
The Digital X-ray Detector DFP4343C7 is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. Not to be used for mammography.
6. Substantial Equivalence:
NIPK Electron Co believes that Digital X-ray Detector DFP4343C7 is substantially equivalent to LTX240AA01-A Digital Flat Panel X-Ray Detector of Samsung Mobile Display Co., Ltd.
7. Discussion of Non-Clinical Tests Performed for Determination of
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Image /page/2/Picture/0 description: The image shows the word "ELECTRON" in large, outlined letters. Below the word, in a smaller font, is the text "R&D and Manufacturing Company". The text is black and appears to be a company logo.
Substantial Equivalence are as follows:
Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1 was performed and EMC testing was conducted in accordance with standard IEC-60601-1-2.
Biocompatibility testing was conducted in accordance with Standard ISO 10993-1.
Safety of Programmable medical systems in accordance with IEC 60601-1-4 was performed.
A product risk management is executed according to ISO 14971 and all risks are reduced to an acceptable level by implementation and verification of appropriate measures.
Non-clinical considerations according to FDA "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices" was performed. All test results were satisfactory.
7. Discussion of Clinical Tests Performed:
Clinical considerations according to FDA "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices" was performed. All test results were satisfactory.
8. 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 NIPK Electron Co concludes that the Digital X-ray Detector DFP4343C7 is substantially equivalent to the predicate in intended use, operation, safety, function, and is safe and effective for its' intended use.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three arms reaching upwards, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the figure. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
OCT 5 2012
NIPK Electron Co. % Mr. Jigar Shah, M.S., RAC Official Correspondent mdi Consultants, Inc. 55 Northern Boulevard, Suite 200 GREAT NECK NY 11021
Re: K122589
Trade/Device Name: Digital X-ray Detector DFP4343C7 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR, MQB Dated: August 20, 2012 Received: August 24, 2012
Dear Mr. Shah:
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 (reporting of
4
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,
uch D. O'hern for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Image /page/5/Picture/0 description: The image shows the word "ELECTRON" in large, bold, sans-serif font. Below the word "ELECTRON" is the phrase "R&D and Manufacturing Company" in a smaller, serif font. The text is black and the background is white.
NIPK Electron Co P.O. Box 12, Saint-Petersburg, Russia 198188 Tel. +7 (812) 325-02-02, Fax +7 (812) 325-04-44 www.electronxray.com e-mail secretary@electronxray.com
Section 2: Indications for Use
of 1 Page 1
510(k) Number (if known): K122589
Device Name: Digital X-ray Detector DFP4343C7
Indications For Use:
The Digital X-ray Detector DFP4343C7 is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. Not to be used for mammography.
Prescription Use X (Per 21 CFR 801 Subpart D)
OR
Over-The Counter Use (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 Sion.Off
(Division Sign-OH)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K 122589
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