(105 days)
Not Found
No
The provided 510(k) summary does not mention AI, ML, deep learning, or any related terms, nor does it describe features or performance metrics typically associated with AI/ML-powered devices.
No
The device is an X-ray imaging system used for diagnosis, not for treating conditions.
Yes
The device is an imaging system used for general projection radiography, which is a diagnostic modality. While the document focuses on the device itself rather than a specific software or algorithm, imaging systems used for radiography are inherently diagnostic tools.
No
The device is described as a "Digital X-ray Imaging System," which inherently implies hardware components for image acquisition, not just software.
Based on the provided information, the XGEO GR40CW Digital X-ray Imaging System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "general projection radiographic applications." This involves imaging the human body using X-rays, which is an in vivo (within a living organism) process, not an in vitro (outside of a living organism, typically in a lab) process.
- Device Description: While the description is "Not Found," the intended use is the primary indicator of whether a device is an IVD.
- Input Imaging Modality: "Digital X-ray" is an imaging modality used on the body, not on biological samples in a lab.
IVD devices are used to examine specimens (like blood, urine, tissue) obtained from the human body to provide information for diagnosis, monitoring, or screening. The XGEO GR40CW is an imaging system that directly images the body.
N/A
Intended Use / Indications for Use
The XGEO GR40CW Digital X-ray Imaging System is intended for use in general projection radiographic applications wherever conventional screen-film systems may be used. This device is not intended for mammographic applications.
Product codes (comma separated list FDA assigned to the subject device)
MQB
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Not Found
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)
Not Found
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.
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
MAY 15 2014 K140235
SAMSUNG ELECTRONICS Co., Ltd.
510(k) Premarket Notification - Traditional
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted accordance with requirements of 21 CFR 807.92
-
- Date: Jan. 29, 2013
-
- Submitter
- A. · Company Name: SAMSUNG ELECTRONICS Co., Ltd.
- Address: 129, Samsung-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, 443-742, B. Republic of Korea
Primary Contact Person 3.
- Name: Donald D. Fickett A.
- Title: Vice President Regulatory & Quality Assurance B.
- Phone Number: 978-564-8523 ﻥ
- FAX Number: 978-750-6677 D.
- E. E-Mail: dfickett@samsungneurologica.com
Secondary Contact Person 4.
- A. Name: Ha, Aeyoung
- B. Title: Regulatory Affairs Manager
- C. Phone Number: +82-31-200-1537
- FAX Number: +82-31-200-1199 D.
- E. E-Mail: ay.ha@samsung.com
5. Device
- A. Trade Name: XGEO GR40CW
- Common Name: Stationary x-ray System B.
- ். Classification Name: Solid state x-ray imager (flat panel/digital imager)
- D. Product Code: MQB
Predicate Device 6.
- Manufacturer: SAMSUNG ELECTRONICS Co., Ltd. A.
- B. Trade Name: XGEO GC80
- C. 510(k) Number: K123098
VI - 2
1
Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol of medicine. The caduceus has three lines representing the snakes and a staff in the center.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 15, 2014
SAMSUNG ELECTRONICS Co., Ltd. % Jeongpyo Hong Assistant Manager. Regulatory Affairs 129, Samsung-ro, Yeongtong-gu Suwon-si, Gyeonggi-do, 443-742 REPUBLIC OF KOREA
Re: K140235
Trade/Device Name: XGEO GR40CW Regulation Number: 21 CFR 872.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: April 15, 2014 Received: April 16, 2014
Dear Jeongpyo Hong:
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. Please note: CDRFI does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not mislcading.
If your device is classified (sec above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2-Jeongpyo Hong
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Smh.7)
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K140235
Device Name XGEO GR40CW
Indications for Use (Describe)
The XGEO GR40CW Digital X-ray Imaging System is intended for use in general projection radiographic applications wherever conventional screen-film systems may be used. This device is not intended for mammographic applications.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
$m_{h,7}$
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