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K Number
K113630
Device Name
DIGITAL FLAT PANEL X-RAY DETECTOR/1210SGA
Manufacturer
RAYENCE CO., LTD
Date Cleared
2011-12-29

(21 days)

Product Code
MQBMOB
Regulation Number
892.1680
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
1210SGA Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for human anatomy including head, neck. spinal column, arm. leg and peripheral (foot, hand, wrist, fingers, etc.). It is intended to replace film based radiographic diagnostic systems and provide a case diagnosis and treatment planning for physicians and other health professionals. Not to be used for mammography.
Device Description
1210SGA is a digital solid state X-ray detector that is based on flat-panel technology. This radiographic image detector and processing unit consists of a scintillator coupled to an a-Si TFT sensor. This device needs to be integrated with a radiographic imaging system. It can be utilized to capture and digitalize X-ray images for radiographic diagnosis The RAW files can be further processed as DICOM compatible image files by separate console SW (not part of this SIOK submission) for a radiographic diagnosis and analysis.
More Information

K101590

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 technologies in the device description, intended use, or performance studies. The image processing is described as converting RAW files to DICOM, which is a standard format conversion, not indicative of AI/ML analysis.

No
The device is an X-ray detector used for diagnostic imaging, not for treating diseases or conditions. Its purpose is to capture and digitalize X-ray images for radiographic diagnosis.

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "intended to replace film based radiographic diagnostic systems and provide a case diagnosis and treatment planning for physicians and other health professionals."

No

The device description explicitly states it is a "digital solid state X-ray detector that is based on flat-panel technology" and "consists of a scintillator coupled to an a-Si TFT sensor," indicating it is a hardware device for capturing X-ray images. While it mentions software for processing, the core device is hardware.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health.
  • Device Function: The 1210SGA Digital Flat Panel X-Ray Detector is used to capture images of the human body using X-rays. It does not analyze specimens taken from the body.
  • Intended Use: The intended use clearly states it's for digital imaging of human anatomy for radiographic diagnosis and treatment planning. This is an in vivo (within the living body) imaging process, not an in vitro (in glass/outside the body) diagnostic process.

Therefore, the device falls under the category of medical imaging devices, not IVDs.

N/A

Intended Use / Indications for Use

1210SGA Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for human anatomy including head, neck. spinal column, arm. leg and peripheral (foot, hand, wrist, fingers, etc.). It is intended to replace film based radiographic diagnostic systems and provide a case diagnosis and treatment planning for physicians and other health professionals. Not to be used for mammography.

Product codes

MQB, MOB

Device Description

1210SGA is a digital solid state X-ray detector that is based on flat-panel technology. This radiographic image detector and processing unit consists of a scintillator coupled to an a-Si TFT sensor. This device needs to be integrated with a radiographic imaging system. It can be utilized to capture and digitalize X-ray images for radiographic diagnosis The RAW files can be further processed as DICOM compatible image files by separate console SW (not part of this SIOK submission) for a radiographic diagnosis and analysis.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-Ray

Anatomical Site

head, neck, spinal column, arm, leg and peripheral (foot, hand, wrist, fingers, etc.)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

physicians and other health 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(2001). All test results were satisfactory.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K101590

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.

0

510(k) Submission - 1210SGA

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.

Date: _ December 5th, 2011

    1. Company sponsoring this submission:
      Name -Rayence Co., Ltd. Address - 2F/4F, 23-8, Hwasung-si, Seogu-dong, Gyeonggi-do, 445-170, Korea Telephone - +82-31-8015-6459 Fax - +82-31-8015-6598 Contact - Kee Dock Kim / Manager Internet - http://www.rayence.com
    1. Official correspondent (U.S. Designated agent)
      Mtech Group 12946 Kimberley Ln Houston, TX 77079 Tel: +713-467-2607 Fax: +713-464-8880 Contact person: Mr. Dave Kim Email: davekim@mtech-inc.net
    1. Device :
Trade/proprietary name: 1210SGA
Common Name: Digital Flat Panel X-ray Detector
Classification Name: Solid State X-ray Imaging Device
    1. Predicate Device :
Manufacturer: Rayence Co., Ltd.
Device: Xmaru1210P
510(k) Number: K101590 (Decision Date - Nov. 29th, 2010)

Rayence Co., Ltd.

1

5. Classifications Names & Citations :

21CFR 892.1650, MQB, Solid State X-ray Imaging Device, Class2

6. Description :

  • 6.1 General
    1210SGA is a digital solid state X-ray detector that is based on flat-panel technology. This radiographic image detector and processing unit consists of a scintillator coupled to an a-Si TFT sensor. This device needs to be integrated with a radiographic imaging system. It can be utilized to capture and digitalize X-ray images for radiographic diagnosis The RAW files can be further processed as DICOM compatible image files by separate console SW (not part of this SIOK submission) for a radiographic diagnosis and analysis.

    1. Indication for use :
      1210SGA Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for human anatomy including head, neck, spinal column, arm. leg and peripheral (foot, hand, wrist, fingers, etc.). It is intended to replace film based radiographic diagnostic systems and provide a case diagnosis and treatment planning for physicians and other health professionals. Not to be used for mammography.
    1. Comparison with predicate device :
      Rayence Co., Ltd. believes that 1210SGA is substantially equivalent in comparison with Xmaru 1210P of Rayence Co., Ltd.
    1. 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(2001). All test results were satisfactory.
    1. 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 Rayence Co., Ltd. concludes that 1210SCA is safe and effective and substantially equivalent in comparison with the predicate device as described

Rayence Co., Ltd.

2

510(k) Submission - 1210SGA

herein.

    1. Rayence Co., Ltd. will update and include in this summary any other information deemed seasonably necessary by FDA.

3

Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle or bird symbol, with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol. The text is in all caps and appears to be in a sans-serif font.

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

Rayence Co., Ltd. % Mr. Dave Kim Medical Device Regulatory Affairs Mtech Group 12946 Kimberly Lane HOUSTON TX 77079

AUG 23 2013

Re: K113630

Trade/Device Name: Digital Flat Panel X-Ray Detector/1210SGA Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: December 5, 2011 Received: December 8, 2011

Dear Mr. Kim:

This letter corrects our substantially equivalent letter of December 29, 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 r ou may, decree, 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 my 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

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 requirements as set form in the quality Systems (en section 510(c) premarket will allow you to begin marketing your active of your device to a legally marketed notification. The FDA indulig of substandar equivalier of 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 If you desire specific advice for your device of our insolution and Safety at (301) 796809), please contact the Office of In Vitro Diaguostic Device Lyssence on premarket 5450. Also, please note the regulation entitled, "Misbranding by reference to premarket 5450. Also, please note the regulation variations regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to under the MDR regulation (27 Crc C at 605), picts of the CDRH's Office
http://www.fda.gov/MedicalDevices/Safety/Reports/coolem/default.html

of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the You may obtain other general informational 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

5

Indications for Use

510(K) Number (if known): K ! | 3630

Device Name: Digital Flat Panel X-Ray Delector / 1210SGA

Indications for Use:

1210SGA Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for human anatomy including head, neck. spinal column, arm. leg and peripheral (foot, hand, wrist, fingers, etc.). It is intended to replace film based radiographic diagnostic systems and provide a case diagnosis and treatment planning for physicians and other health professionals. Not to be used for mammography.

AND/OR Over-The-Counter Use Prescription Use (Part 21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation(ODE)

Mary S Pool
(Division Sign-Off)
Division of Radiological Devices
Evaluation and Safet

Office of In Vitro Diagnostic Device Evaluation and Safety

510K. K113630

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